STANDING

Device Instruction Manual

issue 1.4 data: 12.06 .2015

Dear Customer, SUMMARY
Ch. 1: Introduction ................................................................................ page 4
you our full availability for any help or advice you may need. Ch. 2: Unpacking ................................................................................... page 4
Ch. 3: System Set-up ............................................................................. page 6
Ch. 4: Ordinary maintenance ............................................................... page 10
device produced by
Ch. 5: Safety ......................................................................................... page 13
Biotec Italia S.r.l. Ch. 6: General information .................................................................. page 18
Viale della Repubblica 20 - Dueville (VI) ................................................................................. page 21
tel. +39 (0) 444 591683 Ch. 8: XlasePlus treatment procedures............................................... page 22
fax. +39 (0) 444 361032 Ch. 9: Pigmented lesions removal and skin peeling procedure....... page 35
Ch. 10: Tattoo Removal ....................................................................... page 39
www.biotecitalia.com
Ch. 11: Rejuvenation, Acne and Onychomicosis procedure............ page 45
info@biotecitalia.com Ch. 12: Vascular procedure, facial and leg telangectasias .............. page 53
Ch. 13: Skin Resurfacing .................................................................... page 62
Ch.14: Maintenance ............................................................................. page 70
Ch. 15: Troubleshooting ..................................................................... page 72

In order to keep the maximum level of security, users must use the
device in respect of the indications and limits for use contained in
this manual. The manufacturer declines every responsibility in case of
different uses from what is prescribed in the manual. The reproduction
or other use of all or part of any information or picture found in
this manual is strictly prohibited without written permission of the
manufacturer.
 Introduction
The Medical Device Directive (MDD 93/42/EEC) and subsequent
amendments and integrations considers as a field incident any lacking
in the labels or instructions for using a device which has, or could have,
caused the death or serious worsening in the health of a patient or a
user.

Reference legislation
- Medical Device Directive 93/42/EEC, published in the OJEU (Official
Journal of the European Union) n, L.169 in 1993.
- Legislative Decree n. 46 of 24 February 1997 “Implementation of di-
rective 93/42/EEC of 14 June 1993 and subsequent amendments and
integrations”.
- Medical Device Directive 2007/47/EC, published in the OJEU L.
247/21 in 2007.
- Legislative Decree n. 37 of 25 January 2010 “Implementation of direc-
tive 2007/44/EC, amending directive 90/385/EEC, for the approximation
of legislation in member states regarding active implantable medical de-
vices, 93/42/EC regarding medical devices and 98/8/EC regarding the
introduction of biocides to the market (10G0053) (O.G. General Series
n. 60 of 13 March 2010)”.

Manufacturer details
- Company name: Biotec Italia S.r.l.
- VAT/tax n.: 03488271218
- EAR: VI - 302069
- Head office: Viale della Repubblica, 20 – 36031 Dueville (VI)
- Legal Representatives: Piovan Francesco (tax n.: PVNFNC62T07L840Y)
Ferrari Fulvio (tax n.: FRRFLV67C12F839T)

The serial number is located on the nameplate located on the rear of

the device; please record below for
future reference:
Model Number:
Serial Number:
Purchase Date:
Purchased From:
3
Chapter 1: Introduction
1.1 The System
Xlase Plus is a platform containing touch screen and electronics that
provide energy and control of the power. The lasers and the IPL appli-
cators are connected to the system by means of a flexible cable, which
provides power and circulating (demineralised) water supply to the
applicators.
1.2 Use of the manual
This manual offers a brief hands-on guide to use and further
background information on the theory behind Xlase Plus.
The Operative Manual will use the international symbols Caution or
Warning to denote a possible safety risk if instructions are not carried
out correctly.
Caution is used to identify conditions or actions for which a potential
hazard may exist which will or can cause minor personal injury or pro-
perty damage if the instructions are ignored.
Warning is used to identify conditions or actions for where a known
hazard may cause severe personal injury, death or substantial property
damage if the instructions are ignored.
In order to reduce the likelihood of injury or equipment damage, it is
important to read the manual, specifically the chapter referring to the
safety. Always keep the manual nearby, and review the procedures and
safety precautions periodically. Contact your Biotec Italia representative
if you have any questions or feel that additional training is required.
Caution Xlase Plus is a class IV medical device. Do not try to install or
run any software not provided by Biotec Italia on the built-in computer
system.
Warning This equipment is intended to be used by qualified and autho-
rized personnel (medical doctors) only after they have been trained to
use the equipment.
Before starting any procedure with the Xlase Plus system, the authori-
zed personnel should be aware of all the standard rules about laser
4
safety (CEI EN 60825-1) and read the safety instructions contained in
this manual.
The Xlase Plus device must be locked. Only authorized personnel can
have the key to operate the system. Only authorized technical person-
nel can have access to the electrical internal components.
Chapter 2: Unpacking
Warning 1.3 Introduction
Safe and efficient patient treatments require suitable training and basic
understanding of dermatologic sciences and interaction between high
energy light and human tissues.
Software installation is carried out prior to delivery. The equipment
should only be set by your Biotec Italia representative.
As part of this he will:
• Unpack the system from its shipping case and check
that all components are present;
• Connect the power cable (supplied) to the mains input;
• Connect the applicators cable to the corresponding
machine’s outputs;
• Connect the interlock switch;
• Connect the foot pedal switch;
• Connect the key switch and power up (switch on) the system;
• Fill the system with water (if necessary);
• Train you how to perform the above actions safely.
Warning 1.4 Reparation and modifications of the device
• Only authorized technical staff can carry out repairing
and maintenance.
• It is recommended to follow the standard maintenance program.
• It is recommended to replace all the damaged components.
• Use only original spare parts.
• Modification of the device can result dangerous.
1.5 CONTENTS OF THE PACKAGING
Depending from the applicators purchased, the complete Xlase Plus device is constituted by Type
Code (consumable/perishable/disposable)

MAN.116 1 complete Nd:YAG long pulse 1064 nm applicator; Perishable

CAR.1641 1 Laser hand-piece tip 2,5mm; Perishable
CAR.1520 1 vascular focal lens case for hand-piece tips; Perishable
CAR.1852 1 Erbium Fractional Lens Perishable
CAR.1746 1 Laser hand-piece tip 4mm; Perishable
CAR.1637 1 Laser hand-piece tip 5mm; Perishable
CAR.1748 1 Laser hand-piece tip 10mm; Perishable
CAR.1747 1 Laser hand-piece tip 7mm; Perishable
CAR.1720 1 1064 nm focal lens case for hand-piece tips; Perishable
CAR.1638 1 KTP 532 nm focal lens case for hand-piece tips; Perishable
MAN.115 1 complete Q-switched Nd:YAG LASER applicator; Perishable
MAN.114 1 complete diode LASER applicator; Perishable
MAN.117 1 complete CPL applicator; Perishable
OTT.041 1 cut-off 550-1200nm; Perishable
OTT.023 1 cut-off 550-950nm; Perishable
OTT.024 1 cut-off 650-950nm; Perishable
OTT.040 1 cut-off 420-1200nm; Perishable
OTT.035 1 cut-off 695-1200nm; Perishable
OTT.036 1 cut-off 755-1200nm; Perishable
ELE.577 1 footswitch; (connector ELE.555) Perishable
ELE.244 1 remote interlock connector Perishable
3-147 1 CPL Xlase Plus safety goggles; Perishable
3-181 1 KTP 532nm safety goggles; Perishable
3-151 1 Nd:YAG 1064nm safety goggles; Perishable
3-146 1 patient safety goggles; Perishable
CAR.568 1 water refilling set Perishable
3-145 1 pack of disposable eye shields Disposable
5
Chapter 3: System Set-up b Transport and storage:
- Minimum temperature: 5°C
- Maximum temperature: 50°C
3.1 Inspection and unpacking
- Minimum Relative Humidity: 30% without condensation
It is extremely important to check the packed materials immediately
- Maximum Relative Humidity: 95% without condensation
upon their arrival, when possible in the presence of the shipper’s delivery
- Minimum Atmospheric Pressure: 700hPa
employee, as follows:
- Maximun Atmospheric Pressure: 1060hPa
- Administrative check:
Number of cases c Operation:
Weights and dimensions - Minimum Temperature: 10°C
- Technical check: - Maximum Temperature: 24°C
Condition of the packing - Minimum Relative Humidity: 30% without condensation
3.2 Customer Responsibility - Maximum Relative Humidity: 75% without condensation
Before first installation the site has to be prepared. The working area - Minimum Atmospheric Pressure: 700hPa
has to be comfortable enough to incorporate the laser system, with - Maximun Atmospheric Pressure: 1060hPa
power socket in line as required.
3.3 Requirements for the electrical connection
Caution To avoid risk of electric shock, the equipment must be only 3.5 Space requirements
connected to supply mains with protective earth. Sufficient floor space is also required for the Xlase Plus system.
The length of the connection wire of Xlase Plus is 3 meters. Following The suggested minimum room size is 3 X 3 meters. Allow 50 cm of
the European safety standard the device requires an electrical clearance on both sides of the machine so that the air vents will not be
connection of 230V 16A with a socket type CEE 7/7. The room electrical obstructed. The Xlase Plus system is easily movable from room to room.
system must have 2 different line protections: Make sure that adequate space and appropriate electrical sockets are
-Electromagnetic switch; available in each room.
-Differential electrical switch. 3.6 Remote Door Interlock Connection
The device must be connected to a line with the following impedance: The Xlase Plus System comes equipped with a remote door interlock
Ra=0.053Ohm jXa=0.032Ohm connection (following the CEI EN 60825-1 European Standard), which
Ra=0.034Ohm jXa=0.021Ohm prevents emission of laser radiation when entrance to the treatment
Do not position the equipment so that is difficult to operate the device area is made and the laser is operating. An appropriate micro-switch
disconnection. may be wired to the remote door interlock cable and mounted on the
doorframe so that a contact closure is activated when the doors to the
3.4 Temperature and Humidity treatment room are closed.
a Place the machine in a dry, dust-free and with adequate Check that the remote door interlock cable leading to the door-mounting
ventilation area. It is preferable but not essential, that the selected microswitch is connected to the remote doors interlock receptacle on
environments are also equipped with air conditioning systems. the back of the laser unit.

6
3.7 Footswitch Connection
Xlase Plus in CPL and diode laser mode can be operated with the 3.8 Installing the Xlase Plus Standing
manual switch or the footswitch. When using the Nd:YAG applicator
and Q-switched mode only the footswitch can be used. When
operating with the footswitch, check that its cable is firmly connected
to the relevant connector on the back of the Xlase Plus unit.

Output Diode Output Nd:YAG

Q-Switched

water level indicator Interlock pedal

CPL

Erbium

7
To plug the handpiece To remove the handpiece

plug

water
pipes

press the switch to release the handpiece

Caution Do not start the Xlase Plus system before the official
personnel have performed the installation procedure. The
warranty does not include any damage to the Xlase Plus device
before the installation.

8
 3.9 General System Functions
Fractional lens
and spacer 3.10 System Application and Capabilities
Xlase Plus is designed to support four handpieces for the treatment
of skin ageing, benign pigmented lesions, onychomycosis, benign
vascular lesions, acne, hair removal and tattoo removal. The specific
types of handpieces supported by Xlase Plus system are factory
Laser Handpiece tips

configured.
3.11 Controls and Indicators
It is assumed that the system is to be used exclusively by trained
physicians (medical doctors). This section of the manual explains the
controls of the system itself; it does not attempt to instruct on clinical
applications. Before attempting to operate the system, all personnel
should read and understand this section, and the safety considerations
discussed in the manual.
KTP 532nm focal lens 1064nm focal lens Indicators:
- acoustic indicator when selecting operative mode and when flashing;
- yellow light (on top of the machine) indicating when flashing;
- green light (on top of the machine) indicating that the device is
ready to operate;
- blinking screen indicator, indicating that the device is ready
to operate.
CPL Cut off

3.12 Key Switch

This key switch controls electrical power to the system. Xlase Plus can
be operated only with the key provided by Biotec Italia. The key switch
has two positions, which are labeled “0” and “1”. To start the system,
turn the key to the “1” position.

Key Switch

0 1

9
3.13 Emergency Stop Switch
When the red Emergency Stop switch is pressed, the system shuts
down immediately. The system cannot be restarted as long as this
switch is depressed. To restart the system, release the Emergency Stop
switch by rotating it clockwise.
3.14 Standby/Ready Switch and Indicator
After turning the system power and the start-up sequence is
completed, the console is automatically placed into STANDBY mode,
and the language selection information is displayed.
10
Chapter 4: Ordinary maintenance
4.1 Cleaning and Disinfecting
The glass light guide in the CPL hand-piece, the cut-off filters and the
laser focal lens need to be kept always clean to avoid energy dispersion
and burning.
MAKE SURE TO CLEAN THE CPL LIGHT GUIDE FREQUENTLY
WHILE WORKING
Note: if debris cannot be removed after repeated cleaning, contact your
local Biotec Italia service representative and replace the handpiece guide
with a new one.
4.2 Cleaning the external covering panels
The exterior of the system may be cleaned with a soft cloth moistened
with a solution of mild soap and water. Do not use harsh detergents.
This should be done weekly or more frequently under heavy use. Avoid
the penetrations of the cleaning detergent liquid inside the device.
4.3 Clean the System Screen
Apply special cleaner for screen use to a soft cloth to clean the system
screen.
Warning Do not spray or pour cleaning agents directly on the system
console or control screen. You may damage the console, screen, and
the system electronics.
Note: not sterilizable device.
4.4 Water cooling system
The Xlase Plus is equipped with two different cooling circuits. Both
circuits can be filled with distilled water by accessing the handpiece
output. (see pict.1).
DIODE APPLICATOR water cooling circuit.
The Diode applicator cooling circuit utilizes a water chiller and it is
commonly called “cold circuit”.
To proceed with the refilling of the Diode applicator water cooling
circuit, the second applicator CPL, NDYAG, QSWITCHED, ERBIUM or
cone Bypass(see pict.2) needs to be connected to the device.
If not connected “ CHECK WATER FLOW!” alarm will be displayed on
the screen.
Please proceed follows:
1. Disconnect the DIODE handpiece by pressing the release button.
pict. 1
2. Take the water refilling kit (see pict.3) and proceed with the following
connections (see pict. 4):
a) The device joint O (OUT) together with the refilling plastic bottle IN
joint.
b) The refilling plastic bottle OUT joint with one of the two DIODE
handpiece joints, no difference between the 2 joints.
c) The second DIODE handpiece joint with the device joint I (IN).
Prefill the plastic bottle with distilled water keeping the water bottle fully
open.
3. Switch-on the device and once the “BIOTEC ITALIA” logo is
displayed, push on the right corner (see “display” pict.) and the service
menu will appear (see “service menu” pict.).
4. Please wait for few seconds till the water pump begins to work. Keep
the water level below the IN joint in the refilling plastic bottle. Once the
“COLD” circuit is full of water, switch off the device.
display

water in
I I
service
menu

Diode o o
Output
water out IPL
Laser
Output

pict. 2 Cone Bypass pict. 3 Water Refilling kit

OUT
IN pict. 4

11
LAMP APPLICATOR (CPL,NDYAG,Q-SWITCHED,ERBIUM) water cooling 4.5 Check of the cable
circuit. The Xlase Plus system has a line cable mechanically connected to it.
The “lamp” applicator cooling circuit utilizes a radiator and it is commonly The cable has a length of 3 m. The cable can deteriorate with time. It is
called “hot circuit”. necessary to check periodically the status of the cable.
To proceed with the refilling of the lamp applicator water cooling circuit, 4.6 Fuse replacement
the diode applicator needs to be connected to the device. If not connected Turn off the device and pull the fuse drawer placed on the back of the
“ CHECK WATER FLOW!” alarm will be displayed on the screen. machine near the key switch (see picture). Extract the fuses and replace
them with same size fuses (8x31 10 A, 400 V).
Please proceed follows:
1. Take the water refilling kit (see pict.3) and proceed with the following
connections:
a) Attach the provided air flow tube on the back of the machine (see Fuses
pict.6)
b) The device joint O (OUT) together with the refilling plastic bottle IN
joint. (see pict.5).
c) The refilling bottle O (OUT) joint to the device joint I (IN). (see pict.5).
2. Refill the water bottle with distilled water and close the tank’s plug and
cup.
Please note that during this operation the machine has to be switched
off. You should notice a water drop coming out from the transparent air
flow tube on the back of the device. Keep refilling until a drop of water is
released from the air flow tube. Add water if needed.

Pict.5
IN

OUT

OUT
IN
Pict.6
12
Chapter 5: Safety
5.1 Introduction
This chapter contains important information concerning potential
hazards and general safety precautions.
The purpose of the safety instructions is to draw attention to potential
hazards if instructions are ignored. These hazards may lead to accidents
or serious injury to the patient, operator or service personnel.
Xlase Plus incorporates many safety features to protect the patient and
the operator. However, as with all medical devices, safe use of Xlase
Plus relies on a “safe attitude” from a suitable trained operator. Do not
use the system if a malfunction of the equipment or a safety problem is
believed to exist.
5.2 Restrictions on Use
Warning Never attempt to perform a treatment outside the specified
intended use, or on a patient outside the approved patient parameters.
Warning This equipment is only intended for use by suitable trained
personnel (medical doctors), who understand the clinical application as
well as the dynamics of light-tissue interaction.
Caution Do not attempt to run or install any software - other than that
provided by Xlase Plus – on the built in computer system.
Warning Injury to patient can be caused by unintended flash release.
Do not leave the equipment in a condition ready to flash at any time.
Caution Use of controls or adjustments or performance of procedures
other than those specified herein may result in hazardous radiation
exposure. LASER EQUIPMENT not in use should be protected against
unqualified use, for example by removal of the key from the key switch.
Caution Laser plume may contain viable tissue particulates.
As the AIMING BEAM passes down the same delivery system as the
WORKING BEAM it provides a good method of checking the integrity
of the delivery system. If the AIMING BEAM SPOT is not present at
the distal end of the delivery system, its intensity is reduced or it looks
diffused, this is a possible indication of a damage or not properly
working delivery system.
The use of flammable anaesthetics or oxidizing gases such as nitrous
oxide (N2O) and oxygen should be avoided. Some materials, for
13
example cotton wool when saturated with oxygen-may be ignited
by the high temperatures produced in NORMAL USE of the LASER
EQUIPMENT. The solvents of adhesive and flammable solutions used
for cleaning and disinfecting should be allowed to evaporate before the
LASER EQUIPMENT is used. Attention should also be drawn to the
danger of ignition of endogenous gases.
Warning In some conditions high external magnetic fields cab affect
the device with an “over temperature” alarm showed on display: this
does not affect patient safety and operating with device, message
disappear when EM disturb is not more active.
5.3 Hazards
Warning Certain hazards are associated with the application of light
energy to the skin. For this reason it is important that Xlase Plus is used
only by suitable trained personnel (medical doctors), who understand
both the clinical applications and the dynamics of light-tissue interaction.
Caution Proper evaluation of both patient Skin Type and Degree of
Suntan is of paramount importance for efficient operation; it is therefore
vital that a dermatological examination is carried out prior to any tre-
atment.
Note: dark skin, whether natural or due to sun-tan, will increase the risk
of side effects such as burns, and will also reduce the efficiency of the
treatment area.
5.4 Eye protection
Warning Xlase Plus emits high energy that could cause severe eye
damage.
Direct absorption of light energy by the retina can result in temporary
clouded vision, retina lesion, long-term scotoma and long-term photo-
phobia.
A danger exists in any case of:
• Direct light and laser emission;
• Reflected light and laser emission;
• Diffused light and laser emission.
Everyone in the area where the system is operating or being serviced
must wear appropriate protective glasses.
Before wearing the protective glasses be sure that they are in good
condition.
Caution Never trigger the flash lamp or the laser system without war- 5.5 Other patient-related Hazards
ning all personnel present. Injury to the patient’s eyes and skin may result from incorrect use of the
Caution Never leave a patient unattended if the system is in the ready equipment. Always take the following precautions:
mode. Warning Always follow the patient parameters set-up instruction
Warning Never direct the Light toward the eye. Aim away from the eye detailed in this manual.
and regard the cheek bone as the highest point that can be treated. If Warning No part of the area to be treated should be covered with any
necessary, move skin to be treated down over the cheek bone or up type of metal foil. When exposed to light radiation, foil may heat up and
over the frontal cranial bone to use the bone as an additional shield. cause epidermal damage.
Warning Do not use the applicator in the presence of flammable
Warning Nominal Ocular Hazard Distance (N.O.H.D.) area within anesthetic mixture with oxygen or nitrous oxide.
which the beam irradiance or radiant exposure exceeds the appropriate Warning Do not flash in proximity of flammable materials.
corneal maximum permissible exposure (MPE), including the possibility Note: such materials may be liquid (e.g. alcohol swabs) or solid (e.g.
of accidental misdirection of the laser beam dark clothing).
Warning Do not use an applicator with a chipped or damaged light
LASER N.O.H.D.
guide.
Diode 5,16987102 m Caution Only use approved and tested optical coupling gel.
Note: Abnormalities of the skin, such as pigmented lesions, birth marks
YAG 22,5057018 m and tattoos must be evaluated by a medical doctor or dermatologist with
experience in photo-therapeutics prior to treatment.
Q-Switched 24,8982049 m Dark skinned patients should only be treated with extreme caution. Take a
sample shot and evaluate reactions to this before continuing.
Erbium 0,4883932 m When performing hair removal over tattooed regions (including permanent
make up) the tattoo may be partly removed or discolored, or epidermal
adverse effects may be noted. Therefore avoid treating these areas.
NON LASER LIGHT SOURCE N.O.H.D.
5.6 Operator Training Requirements
IPL 0,24745 m The Xlase Plus system is designed to be operated only by personnel
properly trained in its handling and use. All personnel who operate the
system must read the operator’s manual. This includes physicians,
nurses, technical staff or other professional staff members.
The device does not include human blood derived substances or Biotec Italia provides in-service training for the Xlase Plus system. At
animal origin tissues the end of this in-service training, personnel are considered trained for
the operation of the Xlase Plus system.
The device does not include latex and phthalates
The physician is responsible for contacting the local licensing agencies
to determine any credentials required by law for clinical use and
operation of the device.
14
5.7 Operator related hazards
Severe injury to the operator could be caused by incorrect use of the
equipment. Please ensure that the following precautions are observed:
Warning Do not use a power cable other than that supplied with the
system.
Warning Only power the Xlase Plus system as specified on the rear of
the cabinet. If the voltage specified does not correspond with that of
the local supply, please contact your Biotec Italia representative.
Warning Never use the Xlase Plus System if the system is wet or
appears to be leaking water.
Warning Due to electrical safety requirements, the applicators
must only be refurbished by Biotec Italia or Biotec Italia authorized
distributors.
Warning Xlase Plus has covers to protect operators from electrical
shock and mechanical hazards. Always contact qualified service
personnel for your servicing needs. Do not attempt to service the
equipment yourself and do not remove any covers.
Note: Do not place coffee cups or other liquid containers on Xlase Plus
equipment. Spillage may damage the system and lead to malfunction.
Note: Do not lean anything against the equipment. Doing so could cause
equipment damage.
Warning Equipment without protection against ingress of liquids (IPX0).
5.8 General Precautions
Do not attempt to operate the Xlase Plus System without the applicator
connected.
Always reposition the applicators in the holder when not used.
Warning Do not attempt to use the Xlase Plus System if a safety problem
is known to exist.
Warning Do not attempt to use the Xlase Plus System if any applicator
is leaking water.
Warning All areas that come into direct contact with the patients should
be regularly cleaned and disinfected.
Improper cleaning may result in equipment damage. This applies
particularly to the applicator’s lenses.
15
5.9 Electromagnetic Interference
Caution Xlase Plus generates, and can radiate, radiofrequency energy.
The equipment may cause radiofrequency interference to other medical
and non-medical devices and to radio communications.
Portable and mobile RF communications equipment can affect the
operation of the device.
Mobile phones and similar electrical devices must be switched off when
the Xlase Plus system is working.
Warning Use of accessories, and cables other than those specified,
with the exception of accessories, and cables including the provided
mains power cable sold by the manufacturer of Xlase Plus, as
replacement parts for internal and external components, may result in
increased emissions or decreased immunity of the equipment. Use of
cables not properly shielded and grounded may result in the equipment
causing radiofrequency interference in violation of the European Union
Medical Device Directive and FCC regulations.
Warning Xlase Plus should not be used adjacent to other equipment.
If the system is used while positioned adjacent to other equipment, it
should be observed to verify normal operation in the configuration in
which it will be used.
Warning The ME APPLIANCE requires precautions regarding EMC,
and it must be installed and commissioned in accordance with the
information regarding EMC given in the attached documentation.
5.10 High Voltage Hazards
The Xlase Plus Device works with internal high-tension generator, any
type of internal control on the electrical circuit has to be performed by
trained technical personnel.
The internal power electric circuit contains high energy capacitors and
when the device is switched off it is necessary to wait a few minutes
until the capacitor discharges completely.
Only the official Technical Personnel can have access to the internal
electrical circuit of the Xlase Plus device.
Only Biotec Italia Srl technical staff or authorized service personnel can
operate directly on the internal of the Xlase Plus cavities device, with
the safety block disconnected.
5.11 Fire Hazards 5.13 Safety Labels
Xlase Plus emits high energy light flashes that, when absorbed in any On the device there are some safety labels (Fig 3.2), including
material can cause a dramatic increase of temperature or even cause
danger notes for the operator and information about the laser device
the material to catch fire. To prevent this, take the following precautions: characteristics.
Warning Never expose flammable material to the radiation emitted
from Xlase Plus equipment. Used symbols:
Note: Cleaning: never use flammable liquid like alcohol to clean or Warning labels placed nearby the
disinfect any part of Xlase Plus. Biotec Italia recommends cleaning the source of laser emission
applicator with mild soap solvent, followed by disinfection using a mild
non-flammable disinfectant. When cleaning the applicator’s lens, use pure
acetone and wait to fully dry prior to start the treatment.
Warning
Do not use Xlase Plus in presence of flammable anesthetic mixture, or
other flammable gases.

5.12 Working area

After the device has been delivered and its content checked, it is
necessary to prepare the place where the laser will be used. Doors
Informative label placed
must limit the working area, and each of these doors must visibly carry on the Laser Diode handpiece
a warning Label (Fig. 3.1) like the one shown in figure:

Informative label placed on the

YAG handpiece

Informative label placed on the

Qswitched handpiece

Figure 3.1 Warning label

16
Informative label placed on the
Erbium handpiece
Informative label placed on the
IPL handpiece
Danger label placed
on machine nearby
Diode Laser connector
Danger label placed on machine
nearby Lamp connector
(YAG – QSWITCH – ERBIUM – CPL)
Information label
near water tank
(on top side of equipment)
Earth connection point
(metal chassis inside equipment)
17
Warning near connections
with 230V inside equipment
Emergency stop
(near the Emergency stop red button)
5.14 Conformity
Xlase Plus equipment conforms with the main requirements concerning
medical devices (CEI EN 60601)
Xlase Plus and its accessories disposal
Pursuant to Art. 26 of Italian Legislative Decree 49 dated
14 March 2014 on “Implementation of Directive 2012/19/EC
on Waste Electrical and Electronic Equipment (WEEE)” and
Italian Legislative Decree 188 dated 20 November 2008.
The crossed bin symbol on the appliance or its packaging means that at
the end of its lifecycle, the product must be disposed of separately from
other waste, and consequently the user must consign the old appliance to
the authorised waste collection centres for electronic and electrotechnical
waste, or it must be reconsigned to the retailer when a new appliance of
the same type is purchased, on a one to one basis. If a person uses the
appliance in their business, they may request the supplier or Biotec Italia
S.r.l. to collect the old appliance, in the manner that is agreed when the
new one is delivered. Correct sorted waste disposal and compliance with
these instructions help to prevent any adverse effects to the environment
and public health, and also helps the recycling of the materials of which
the appliance is made. Incorrect disposal of the appliance will entail the
user being subjected to the administrative sanctions applied by current
legislation.
Chapter 6: General information
6.1 System specification XlasePlus Standing
General specifications
Laser Type High-power diode indications/intended use
Laser Class IV - Irsutism (Aesthetic Medicine) System cooling
- Skin Rejuvenation (purely Aesthetic) Water, Air, Thermoelectric
Wavelength 810nm Skin Cooling
- Microvascular Lesions (Aesthetic Medicine) Tip integrated
Pulse width < 60ms using continous pulses Interface Touchscreen Color LCD display
Repetition rate From 1 to 10 Hz
DIODE Fluence to tissue Up to 60J/cm² Dimensions
Spot size 9x9mm standard 340 x 670 x 1000 mm
Weight 71 Kg
Skin cooling Water cold sapphire
Expected lifetime 20.000.000 pulses
Laser emission Control Footswitch and handpiece switch NOTE:
Tolerance should be intended ±20% if not indicated
Laser Type Nd:YAG indications/intended use
Laser class IV - Vascular lesions (Aesthetic Medicine)
Wavelenght 1064nm - Skin rejuvenation (purely Aesthetic)
Energy Density Up to 24J - Irsutism (Aesthetic Medicine)
Pulse Duration From 5μs to 40ms - Onychomycosis (Aesthetic Medicine)
- Non Ablative (purely Aesthetic)
Nd:YAG Repetition Rate From 1 to 3 Hz
Spot Size 2.5 - 4 - 5 - 7 - 10mm
Laser Emission Control Footswitch
Aiming Beam Diode laser, 1mW @ 635nm - class II
Laser Type Cr:YAG indications/intended use
Laser Class IV - Tattoos removal (purely Aesthetic)
Wavelenght 1064 (532nm with KTP lens) - Skin peeling (purely Aesthetic)
Pulse Duration 9-10nsec - Pigmented Lesions (Aesthetic Medicine)
Spot Size 2,5-4-5-7mm - Vascular Lesions (Aesthetic Medicine)
Q-SWITCHED Pulse Repetition Rate From 1 to 6Hz
Energy Density passive Q-switched Up to 2.4J
Aiming Beam Diode laser, 1mW @ 635nm - class II
Laser emission Control Footswitch

Source Xenon Lamp indications/intended use

Spectrum of Emission 550-1200nm; 550-950nm; - Irsutism (Aesthetic Medicine)
650-950nm; 420-1200nm; - Acne (Aesthetic Medicine)
695-1200nm; 755-1200nm; - Skin Rejuvenation (purely Aesthetic)
Energy per pulse Up to 25J/cm2 - Vascular Lesions (Aesthetic Medicine)
CPL Pulse Duration from 1 to 60ms
Delay Between Pulses from 5 to 60ms
Number of pulses from 1 to 5
Repetition Rate From 1 to 3 Hz
Treatment Area 50mm X 10mm (5cm²)
Emission Control Footswitch and handpiece switch

Laser source Er:YAG indications/intended use

Wave lenght 2940nm - Wrinkles (purely Aesthetic)
Class 4 - Acne scarring (Aesthetic Medicine)
Energy Up to 2J - Age spots (purely Aesthetic)
Pulse duration 0,5ms-1ms-1,5ms-2ms - Deep pigment (purely Aesthetic)
Er:YAG (Erbium) - Redness (purely Aesthetic)
Spot size 6 mm (ablative/fractional) - Large pores (purely Aesthetic)
Repetition rate From 1 to 6Hz
Number of stack from 1 up to 6
Lamp Expected lifetime 500.000 pulses
Laser emission Control Footswitch
18
6.2 General Contraindications
• Cancer; in particularly, skin cancer
• Pregnancy (including IVF)
• Use of photosensitive medication and herbs for which 810nm light
exposure is contra-indicated
• Diseases which may be stimulated by laser light
• Prolonged exposure to sun or artificial tanning during the 3 to 4 weeks
prior to treatment and post treatment
• Active infection of herpes simplex in the treatment area
• History of keloid scarring
• Diabetes (insulin dependent)
• Fragile and dry skin
• Hormonal disorders (that are stimulated under intense light)
• Use of anticoagulants
• Epilepsy
• History of coagulopathies
6.3 Adverse Effects of Treatment
The use of the Xlase Plus system is similar to the use of other light-
based technologies. Historically, traditional systems have demonstrated
the ability to cause a certain degree of controlled and uncontrolled
tissue damage. In addition, there are the following risks:
• Severe or prolonged erythema (redness) and edema (swelling) within
2-24 hours of treatment that could last for several weeks.
• Irritation, itching, a mild burning sensation or pain (similar to sunburn)
may occur within 48 hours of treatment at the application site.
• Blisters, epidermal erosions, or peri-lesional hyperpigmentation may
develop and remain evident for several days to several weeks following
treatment.
• Eye damage from reflected or prolonged unprotected exposure to
intense light. Protective goggles (appropriate to the wavelength) must
be worn during all treatments to prevent eye injury.
• It is important to observe tissue reaction during treatment. Poor
patient screening and excessive optical energy may cause thermal
damage and cause unwanted adverse effects.
19
6.4 Potential Side Effects of Treatment
• Discomfort – when a pulse is triggered, some patients experience
various degrees of discomfort. Some patients describe the sensation
as stinging, while others liken it to a rubber band snap or a burning
sensation that may last for up to one hour after treatment. Most patients
tolerate the sensation during treatment, but some patients may require
a topical anesthetic.
• Damage to Natural Skin Texture – in some cases, a crust or blister
may form. Normal wound care should be followed.
• Change of Pigmentation – there may be a change of pigmentation in
the treated area. Most cases of hypopigmentation or hyperpigmentation
occur in people with skin types IV to VI, or when the treated area has
been exposed to sunlight within 3 weeks before or after treatment.
In some patients, hyper-pigmentation occurs despite protection from
the sun. This discoloration usually fades in three to six months, but in
rare cases, (mainly hypo-pigmentation) the change of pigment may be
permanent.
• Scarring – there is a chance of scarring; such as, enlarged
hypertrophic or keloid scars. To reduce the chance of scarring, it is
important to carefully follow all pre- and post-treatment instructions.
• Excessive Swelling – immediately after treatment, especially on
the nose and cheeks, the skin may swell temporarily. Swelling usually
subsides within hours, but may continue for up to seven days.
• Fragile Skin – the skin at or near the treatment site may become
fragile. If this happens makeup should be avoided, and the area should
not be rubbed (as this might tear the skin).
• Bruising – purpura, or bruising, may appear on the treated area which
may last from a few hours to several days.
6.5 Eye Protection
• It is essential that all people present in the treatment room during the
treatment (patient and medical personnel) protect their eyes by wearing
recommended eyewear supplied with the system.
• It is good practice to instruct the patient to close their eyes during
treatment even when wearing protective eye glasses.
• If the patient cannot wear the protective eyewear, fit the patient with
opaque eye protection that completely blocks light from the eyes.
• If the treatment area is very close to the eyes (e.g. eyelids), protect the
eyes with corneal shields.

6.6 Optical Safety

• Guard against accidental exposure to laser emission.
• Never look directly at the light emission from the Xlase Plus applicator
or at any reflecting surface, even when wearing protective eyewear.
• Always set the system to Standby (Stop switch) mode when there is a
pause in treatment; this prevents inadvertent laser emission.
• Press the applicator’s trigger and/or footswitch only when the beam is
aimed at the target tissue under direct visualization.

6.7 Fire Safety

• Remove any hair from the treatment site. Use only drapes soaked in
sterile water near the treatment site if required.
• Make sure a fire extinguisher (rated for electrical fires) is available at all
times.
• Avoid the use of flammable tissue-prepping agents or allow the
material to completely evaporate before using the laser.
• Do not use the system in the presence of flammable, explosive
anesthetic gases or oxygen.
• Any oxygen tubes present in the room should be of a laser-safe type.

20
Chapter 7: Definitions
7.1 Fluence
The energy density output, measured in Joules per squared centimeter
(J/cm2), is set by the user for every treatment. The fluence is the total
energy delivered in the selected pulse type (measured in Joules),
divided by the spot size (measured in cm2).
With a large spot size the scattering effect is minimized, resulting in a
constant fluence and deeper penetration. The greater the fluence is,
the higher the temperature of the target hair or tissue, the surrounding
tissue and the epidermis.
7.2 Pre-Treatment
The treatment parameters depend on the skin type. Before the
treatment parameters are selected make sure that the area is marked
and has well defined boundaries (15 x15 cm or 30 x 7.5 cm) . In cases
where the treatment area is hairy, shave and clean the treatment site
to eliminate any surface hair and debris that could interfere with the
treatment.
• Pulse Width/Duration/Length – the total duration of each of the
pulses segments (the pre-heating segment and the therapeutic
segment), measured in milliseconds.
7.3 Counseling
During the first visit, the physician (or an authorized member of the
staff) should:
• Determine why the patient is seeking the treatment and clearly
understand his/her expectations.
• Discuss the treatment with the patient:
The Xlase Plus therapy may consist of multiple treatments given over
several months.
- There may be some discomfort or pain associated with the
treatment. Transient erythema/edema may appear immediately
following the treatment. Gradual recovery of the dermatological
condition may take a few months.
- There is a small risk of adverse reactions, such as changes in the
texture and pigmentation of the skin, which are usually transient.
21
7.4 Photography
When working with the laser module, it is recommended to take
“before and after” photographs to document the treatment progress.
These photographs provide objective evidence because many patients
are not able to assess the progress of treatment through the gradual
improvement.
Standard conditions and similar camera speed, flash and focal distance
should be used to photograph all patients. This consistency enables an
objective comparison of photos taken at different times.
7.5 Post-Treatment Care
Cold (not frozen) packs should be applied immediately post-treatment
to cool the treatment site, reduce swelling and ease discomfort. Pre-
chilled 10x10 cm gauze pads, previously soaked with water may be
used.
Care should be taken to prevent trauma to the treated area for the
first four or five days following the treatment: avoid hot baths, aerobic
exercise, massage, etc.
• Exposure to Sunlight – patients should apply high-factor sun
protection (SPF>30), and protect the treated area from exposure to
direct sunlight for at least one month post-treatment. Tanning after
treatment sessions may enhance melanin regeneration, which may
result in hyper-pigmentation.
• Makeup – makeup may be applied on the day following treatment
unless blistering or crusts develop. Since the skin is sensitive during
this period, take special care while removing makeup to avoid damage
to the skin, which can predispose the site to infection.
• Other Post-Treatment Recommendations – if the treatment site
is exposed to dirt, it should be covered with a dressing for ten days.
Patients should be advised not to participate in rough sports or similar
activities for several days following the treatment, until the skin returns
to its normal condition.
Chapter 8: XlasePlus treatment procedures
8.1 Language selection

choose your language (fig. 4.2) (fig. 4.3) (fig. 4.4)

Following the language selection, the console is still placed into STANDBY mode, and the applicator selection information is displayed. The
displayed selection depends on the connected applicator, being the diode laser applicator always present. In STANDBY mode, the footswitch
and the applicator buttons are disabled. To enter a program, select on the touch screen display (fig. 4.4) the handpiece according to the treatment
application.

8.2 Applicator selection

Select Skin Type Select Hair Colour Select Hair Thickness

Proceed to continue

22
 8.3 Hair Removal Procedure
DIODE
(Applicators: Diode 810nm, Nd:YAG long pulse, CPL)
Xlase Plus provides different treatment options for laser-assisted hair
removal, it provides safe, convenient hair removal from large body
surface areas. In most cases, guarantees longer lasting hair loss than
waxing, shaving, depilatories, or tweezing and can provide prolonged
hair removal after only few treatments.
This chapter provides guidelines for laser or light assisted hair removal
with the Xlase Plus system in a typical patient, discusses the scientific
background of laser hair removal, and examines the specifics of
different wavelength applicators systems which can be used with the
Xlase Plus.
Unwanted hair falls into four main categories. Each one of them can be
a reason for seeking a method for hair removal.
1. Hypertrichosis is defined as an increase in hair growth that is not
androgen dependent. It may result from intake of certain medications
such as phenytoin, ciclosporin, cortisone, or penicillamine.
Select Skin Type It has also been seen in a variety of diseases such as porphyria cutanea
Select Proceed to continue tarda, thyroid disorders, metastatic carcinoma, and malnutrition/
anorexia nervosa.
2. Hirsutism is characterized by the growth of terminaI hair in women
on androgen dependent areas of the body such as the upper lip,
chin, or chest. Often the result of androgen excess, hirsutism may
be accompanied by acne, androgenetic alopecia, and acanthosis
nigricans. The most common hormonal cause of hirsutism is polycystic
ovary disease, estimated to occur in 1-4% of the female population of
reproductive age. Rapid onset of hirsutism or other signs of androgen
excess should prompt a hormonal evaluation, including levels of free
testosterone and dehy droepiandrosterone-sulfate (DHEA-S), to rule out
the presence of an androgen secreting neoplasm.

23
3. Most individuals seek consultation for unwanted hair, primarily
because of cosmetic concerns.
Facial or body hair in excess of the cultural norm can be very distressing
to some patients. The most common areas treated include the axilla,
bikini line, legs, and face in women, and the chest, back, shoulder, neck,
and ears.
8.4 Photothermal hair destruction
Photothermal hair destruction is based on the principIe of selective
photothermolysis. This principle predicts that selective thermal damage
of a pigmented target structure will result when sufficient fIuence at a
wavelength, preferentially absorbed by the target, is delivered during a
time equal to or less than the thermal relaxation time of the target.
The 810 nm pulsed diode applicator, long pulsed 1064 nm Nd:YAG
applicator, and CPL filtered fIashlamp technology, alI employ this
mechanism.
In the visible to near infrared region, melanin is the natural chromophore
for targeting hair folIicles.
Lasers or light sources that operate in the red or near-infrared wavelength
region lie in an optical window of the spectrum, where selective absorption
by melanin is combined with deep penetration into the dermis. Deep,
selective heating of the hair shaft, hair folIicle epithelium, and the heavily
pigmented matrix is therefore possible in the 600-1100 nm region.
Pulse lenght also appears to play an important role, as suggested by
thermal transfer theory.
Thermal conduction during the laser pulse heats a region around
each microscopic site of optical energy absorption. To obtain spatial
confinement of thermal damage, the pulse duration should be shorter or
equal to the thermal relaxation time of the hair follicle. Thermal relaxation
of human terminaI hair follicles has never been measured, but is estimated
to be about 10-50ms, depending on size.
24
Sometimes the actual target is not pigmented and is at some distance
from a pigmented structure. For example, the follicular stem cells, which
line the outer root sheath. These cells are not pigmented and reside
at some distance from the pigmented hair shaft and appear to be an
important target for permanent hair destruction. The concept of thermal
damage time (TDT) has therefore been proposed in the case of the hair
follicle. Pulses Ionger than the thermal relaxation time of the hair shaft
allow propagation of the thermal damage through the entire volume and
better damage of the follicular stem cells.
8.5 Patient selection
Any individuaI wishing to have hair removed permanently may be
considered a candidate for laser and CPL hair removal. Hair can be
removed from most areas of the body. The individual’s skin type, hair
color, and coarseness will determine which Xlase Plus applicator is the
most appropriate as well as predict response to treatment. The ideaI
candidate for hair removal is a patient who presents with dark, coarse
hair. Current techniques are not generally successful in permanently
removing white hairs or fine vellus hairs. Additionally, due to increased
risk for eye injury, patients should not be treated within the orbital and
perianal and perivaginal areas as this may be at increased risk for infection
and should be treated with caution. As stated above, certain medications
and hormonal imbalances may inhibit permanent hair removal due to hair
stimulation. The ideaI patient has realistic expectations, normal endocrine
status, with thick dark hair and light skin tones. Laser and IPL treatment
is much more effective when the pigmented hair shaft is present within
the follicle. Therefore patients are advised to refrain from plucking or
waxing for a period of time prior to treatment. Shaving, bleaching, or use
of chemical depilatories are acceptable alternatives for patients awaiting
laser treatment. While treatment can be safely performed with a shorter
wavelength applicator (e.g. CPL) in fair skinned patients, it is preferable
to use longer wavelength devices in darker skinned patients.
Further epidermal protection is also afforded by utilizing longer pulse
durations and active cooling. Suntanned patients are advised to avoid
treatment until skin tan has faded. Recent clinical reports indicate the
rare induction of hair growth after laser hair removal. This usually occurs
in young female patients with skin types III-VI, who present with fine dark
hairs on the lateral face. Laser induced hypertrichosis is observed in the
treated areas as well as in the adjacent non treated zones.
Although the exact mechanism for this observation is not known, patients
should be advised of this possibility prior to treatment.
8.6 Expected benefits
Generally, the average number of hair removal treatments to achieve a
significant reduction of excess hair is between five and seven treatments
performed at 1 to 3 month intervals. Clinical improvement includes
absolute hair number reduction, finer, lighter regrowing hair, and slower
regrowth. The concept of hair removal has recently been defined in the
following way. ‘Temporary hair loss’ is defined as a delay in hair growth,
which usually lasts for 1-3 months, consistent with the induction of
telogen. Permanent hair reduction’ refers to a significant reduction in the
number of terminal hairs after a given treatment, which is stable for a
period of time longer than the complete growth cycle of hair follicles at
the given body site. Recently, it has been suggested to add another 6
months to this post-treatment observation time, i.e. the time it takes for
damaged follicles to recover from the laser injury and reenter a normal
growth cycle. A distinction needs also to be made between permanent
and complete hair loss. Complete hair loss refers to a lack of regrowing
hairs (i.e. a significant reduction in the number of regrowing hairs to
Complete hair loss may be either temporary or permanent). Xlase Plus
treatment usually produces complete but temporary hair loss for 1-3
months followed by partial but permanent hair loss.
25
The range of outcome can be summarized as:
• Fewer hairs
• Thinner hairs
• Slower regrowing hairs
• Lighter hairs.
Patients have different expectations of treatment (e.g. temporary versus
permanent, partial versus complete hair removal). All responses are
clinically significant and may be separately desirable for different patients.
Growth delay that provides a few months of hairless skin is far more
reliably achieved than permanent hair loss. Xlase Plus has been shown to
temporarily reduce hair growth for all hair colors (except white).
Blonde, red, or gray haired patients are unlikely to experience a permanent
reduction, but hair loss in these patients can be maintained by treatment
at approximately 1-3 month intervals. Complications are rare if treatments
are done carefully and with the patients’ skin type in mind. The most
common side effects are temporary pigmentation changes. Effectiveness
for permanent hair reduction is strongly correlated with hair color and
fluence. Long term, controlled hair counts indicate an average of 20-30%
hair loss with each treatment, indicating the need for multiple treatments
to obtain near complete hair removal. Research also shows that in the
ideaI patient with fair skin and dark hair, the probability for long term hair
removal is about 80-89%, depending on the Xlase Plus applicator used.
Long term comparison of different wavelengths used (diode, neodymium:
yttrium-alurninurngarnet (Nd: YAG) and light sources (intense pulsed
light) indicates that effective long term hair removal can be achieved with
all three systems. The maximum fluence tolerated is determined by the
epidermal pigmentation. Fair skinned dark haired patients are most easily
treated. Dark skinned patients pose a greater challenge. All the Xlase Plus
applicators for hair removal are safe and effective in light skinned patients,
while longer wavelengths (near-infrared) and longer pulse durations have
been shown to treat darker skin type more safely (810nm, 1064nm).
8.7 Pretreatment considerations
Prior to treating patients for hair removal, the physician should obtain a
comprehensive patient history and physical examination. The procedure
is discussed and patient expectations and reasonable outcomes are
addressed.
8.8 History
Important questions regarding the patient’s history should include the
patient’s generaI medicaI condition and a history of local skin infections,
scarring, allergies, medications, and cutaneous and endocrine diseases.
Methods of hair removal used previously should also be reviewed.
8.9 Infection and Immune Status
Although not a contraindication to treatment, patients who are either
immune-compromised or have a history of recurrent infection should
be treated with appropriate care because laser therapy occasionally
produces open wounds. When treating immunosuppressed patients,
limited areas should be treated to minimize side effects. Diligent wound
care should be performed, and, as always, patients should be followed
closely during the post-treatment period. Patients who have a history
of local infections, particularly herpes simplex, should receive antiviral
prophylaxis immediately before and for 1 week after irradiation in order
to avoid activation of herpetic infection (if treatment is delivered to that
area).
8.10 Scarring and Wound Healing History
A history of hypertrophic scars or keloids should be noted. Although
the presence of scars is not an absolute contradiction to treatment,
physicians must use their own judgment when treating these patients.
Patients who are undergoing treatment with isotretinoin (Accutane) are at
increased risk of scarring. Thus, treatment with laser surgery should be
avoided during therapy. Tretinoin (Retin-A, Renova) renders the skin more
prone to injury, and therefore its use should be discontinued for at least 2
weeks prior to treatment with hair removal lasers to avoid increased risk
of epidermal damage.
26
8.11 Skin Diseases
Patients who have skin diseases prone to koebnerization (e.g., psoriasis)
should be treated with caution. Laser test sites as well as patient
education are important. Laser hair removal treatment may lead to
hypopigmentation in patients with vitiligo due to the pigment specificity
of the lasers used. This risk should therefore be discussed with patients.
8.12 Hair Growth
Patients may have excess hair growth that is influenced by drug intake or
hormone imbalance. Some medications promote hair growth and lead to
hirsutism or hypertrichosis. Other medications may control hair growth
(e.g., spironolactone, oral contraceptives). Physicians treating patients
using these medicines should be aware of the influence of these drugs
on hair growth and should explain these effects to patients. Patients
with endocrine disturbances and hirsutism must also understand that
without treating the underlying endocrinologic defect (regardless of the
success of the hair removal method), they will still be at increased risk for
additional hair growth.
8.13 Pertinent history for laser/pulsed light hair removal
• Presence of conditions that may cause hypertrichosis due to hormonal
familiar and drug (ie. corticosteroids, hormones, immunosuppressives)
• History of local or recurrent skin infection
• History of herpes simplex, especially perioral
• History of herpes genitalis, important when treating the pubic
or bikini area
• History of keloids/hypertrophic scarring
• History of skin disorders such as vitiligo and psoriasis
• Previous treatment modalities-method, frequency, and date of last
treatment, as well as response
• Recent suntan or exposure to tanning or solarium
• Onset of hair regrowth (recent)
• Tattoos or nevi present
• Tattoos or nevi present
• Patient’s expectations
• Patient’s hobbies or habits which might interfere with treatment
• Present medications:
• Photosensitizing medications
• Accutane intake within the past year
8.14 Other drugs which may produce hair growth
Acetazolarnide, Cyclosporine, Danazol, Diazoxide, Fenoterol,
Hexachlorobenzene, Interferon, Minoxidil, Oxadiazolopyrirnidine,
Penicillarnine, Phenytoin sodiurn, PUVA, Sodiurn tetradecyl sulfate,
Streptornycin. Topical steroids
8.15 Physical Examination
When assessing a patient for hair removal, the physicians must be
mindful of several factors that influence response to treatment.
8.16 Skin and Hair Color
In generaI, when treated dark-haired, light-skinned patients have the best
results, tolerate higher fluences, and have fewer side effects.
Dark-skinned or tanned individuals should be treated with extreme
caution because they are more prone to side effects and pigmentation
changes.
8.17 Tattoos or Nevi
The presence of tattoos and nevi in the treatment areas should be noted
by the treating physician. There is a risk that hair removal will partially or
totally remove any nevi or pigmented lesions as well as tattoo pigment
in the treatment area. On the other hand, flesh-colored tattoo inks may
darken after laser irradiation due to the presence of iron or titanium oxide
pigment. Patients should be warned of these risks prior to treatment to
ensure proper understanding and reasonable expectations.
27
8.18 Pretreatment Patient Preparation
Prior to treating patients, the procedure is discussed and appropriate
expectations are addressed. Patients are advised to avoid tanning skin
and to avoid sunless tanning products. Hair should be shaved, not waxed,
by the patient or the physician prior to laser treatment.
The upper lip, axilla, and bikini regions may be particularly sensitive to
pain. Topical EMLA or another lidocaine-containing cream may be applied
to hair-bearing areas for 60-90 minutes prior to treatment for large areas.
Many patients may prefer to undergo laser-assisted hair removal without
any anesthesia.
8.19 Sample patient information for Xlase plus hair removal
Xlase Plus has been recommended for removal of your unwanted body
hair. This laser/light source enables hair removal by applying a bright light
to the skin surface.
The light is absorbed by the hair shaft and follicle within your skin because
the light is attracted to the dark pigment in your hair. Long-lasting hair
loss may result from each treatment or, alternately, a growth delay may
occur after each treatment.
Most patients experience at least a growth delay if not some long-term
hair loss. Generally, multiple treatments are required since growing hairs
respond best (see hair cycle below).The following will provide you with
additional information regarding your laser treatment.
Skin pigment: Patients with darker skin are more prone to side effects.
If your skin is sun-tanned, treatment may be deferred until your tan has
faded.
Hair color and test treatment: Since the laser seems to work best in
growing dark hairs, you will be asked not to wax, bleach or tweeze hairs
for at least four weeks before treatment to obtain maximum benefit. Hair
will be shaved or trimmed prior to the laser treatment. A test site may be
suggested to determine your own response to the laser treatment.
Precautions/Contraindications:
Infection: Patients who have active infections will be treated prior to
laser therapy to avoid spreading the infection. Patients who have a history
of herpes simplex may be asked to take an antiviral (acyclovir, famciclovir
or valacyclovir) medication to avoid activating infections.
Tattoos: Patients who have decorative, medicaI or cosmetic tattoos in
the areas to be treated are advised that the laser treatment may darken,
lighten, or remove the tattoo.
Drugs: Tretinoin (Retin-A, Renova): Although tretinoin (Retin-A, Renova)
use in the area to be treated is not an absolute contraindication to the
use of these light sources, tretinoin (Retin-A) is known to make skin more
sensitive and prone to exfoliation. You may be advised to discontinue
your use of tretinoin during the course of your hair removal treatment.
Isotretinoin (Accutane): The use of isotretinoin (Accutane) makes skin
extremely sensitive. Slow healing and severe scarring may result in
patients who are taking isotretinoin (Accutane). Therefore, no patients
on isotretinoin (Accutane) will be treated for at least one year after
discontinuing isotretinoin (Accutane).
Brown Skin Lesions, Moles, Freckles: Some patients may have
brown skin lesions in areas undergoing treatment. These may include
moles, freckles or birthmarks. Care will be taken to avoid treating these
areas, however, inadvertent treatment of brown spots may occasionally
be unavoidable due to their size,
number, or location. These lesions may lighten, darken or be completely
removed from the laser treatment.
Hair Cycle: Human hair grows in a cyclical pattern which includes a
growth phase (anagen), a resting phase (telogen), and a transition phase
(catagen). At any point in time, most hairs are in the growth phase of the
cycle. Hairs in the growing phase are believed to be most sensitive to
laser treatment.
28
Scarring: Patients who have a history of keloid or hypertrophic scarring
should inform the treating physician. In many cases, previous scarring is
considered a contraindication to laser treatment.
Test Treatment: Test treatments are often performed to determine a
patient’s skin tolerance as well as treatment efficacy. These tests do not
always predict future response, but may help the physician guide the
treatment.
Pain/Discomfort: Discomfort associated with the procedure is usually
mild, however, some individuals prefer to have treatment discomfort
ameliorated. Topical anesthesia with EMLA cream may be given. This
medication is applied by you (at home prior to your appointment). A nurse
or physician will explain how to use the cream.
Regrowing Hairs: Hairs which regrow are often lighter in color and
thinner than originaI hairs.
8.20 Sample post treatment care form for laser hair removal
Appearance: The area may redden, become swollen, and occasionally
form crusts or blisters.
Care: Polysporin ointment should be applied until side effects resolve
(usually 24 hours for redness, one to two weeks for crusting or blistering).
Ice packs may be applied to decrease swelling during the first 24 hours,
but should only touch the affected area for 10-minute intervals.
Make-Up: Make-up may be applied after the first 24 hours in the
absence of blister formation or crusting. In the case of crusting or blister
formation, avoid make-up until skin has healed completely.
CalI Us: The areas treated by the laser should not be extremely painful
or develop oozing, pus or increased redness. In the case of any of the
above occurring or a delay in healing noted, call your clinic.
History of Herpes: If you have a history of herpes simplex infection
(cold sores), you may be asked to take acyclovir, famvir or valtrex to avoid
reactivating an infection.
Avoid Sun: Avoid sun while area is healing.
Pigmentation and Scarring: If you develop any scarring or
pigmentation changes in your skin, return to our clinic for evaluation.
Follow-Up: You should schedule a return appointment in one month for
physician evaluation even if your hair is gone.
8.21 Treatment option considerations
Treatment considerations vary depending on which applicator is
used.
CPL Applicator (IPL Filtered Flashlamp)
The CPL applicator uses a noncoherent intense pulsed light source
that emits a spectrum of light ranging from 420 to 1200 nm. The system
utilizes up to five crystal filters that allow different wavelengths of light
to be emitted at the skin surface. Cut-off filters are used to eliminate
short wavelengths so that only the longer, more deeply penetrating
wavelengths are emitted. Pulse durations vary in the millisecond.
A single or multiple pulse mode (1-5), with fix pulse delay intervals,
can be chosen. The wide choice of wavelengths and pulse durations
makes the CPL applicator effective for a wide range of skin types. The
device comes with software which guides the operator in determining
treatment parameters depending on the patient’s skin type, hair color,
and coarseness.
Long pulsed 1064 nm Nd: YAG laser applicator
The Nd:YAG (1064 nm wavelength) applicator delivers pulses in the
millisecond and is available for hair removal laser treatment on all skin
types.The long pulsed Nd:YAG applicator emits deeply penetrating 1064
nm wavelengths. The reduced melanin absorption at this wavelength
necessitates the need for high fluences in order to adequately damage
hair. However, the poor melanin absorption at this wavelength makes
the long pulsed Nd:YAG laser a safer laser treatment for darker skin
types up to phototype Vl. The Nd:YAG laser is also often used for
treatment of pseudofolliculitis barbae, a skin condition commonly seen
in darker skin types.
29
810 nm diode laser applicator
An extremely high powered (2000 W) diode laser module is a very
effective hair removal option. Long term results suggest that the
pulsed, 810 nm diode applicator is very effective for removal of dark,
terminaI hair: permanent hair reduction can be obtained in a significant
percentage of patients. This laser operates at 810 nm, has pulse widths
between 5 and 60 ms, a 10 x 10 mm spot, a up to 10 Hz repetition rate,
fluences between 6 and 70 J/cm2, and a contact cooling skin benefit.
Because of the longer wavelength, the active cooling, and the longer
pulse widths, darker skin types can be treated safely and effectively.
8.22 Treatment Technique
6 weeks before laser treatment
Research has shown greater hair loss results at shaven rather than
epilated sites, suggesting that light absorption by the pigmented hair
shaft itself plays an important role. Patients who seek optimal results
should therefore avoid plucking, waxing, or electrolysis. Shaving and
the use of depilatory creams will not interfere with laser hair removal
results. Use of a broad spectrum sunscreen is recommended. Sun
avoidance must be practiced if hair removal is planned on sun exposed
sites.
Day before laser treatment
The patient is instructed to shave the area to be treated. lf the patient
is uncomfortable with the idea of shaving the area, a depilatory cream
can be used instead. Alternately shaving or trimmering may be done
on the day of treatment after physician assessment is performed.
Day of treatment
The area to be treated should be clean and free of make-up. lf required,
1-2 hours before the scheduled laser treatment, a thick layer of a topical
anesthetic cream (e.g. EmIa) may be applied on the area with a cover
of plastic wrap. lf shaving is done on the day of treatment, it should
precede the application of topical anesthetic.
8.23 Treatment operation

Warning Warning
wear wavelenght related wait for energy calibration
safety goggles before firing the laser

Fluence: select fluence level

Pulse lenght: select pulse duration
Freq.: select pulse repetition rate
Pulse train: divide the pulse into micropulses
Pulse delay: select micropulses pause duration
Filter: indicate cut off selection
Start: the applicator is ready to be triggered
Spot size: indicate beam spot dimension
Motion speed: select 10Hz beam repetition rate
Long pulse: select long pulse duration
Chiller: indicates operating diode temperature >15° <25 °
30
Fluence: indicates fluence on the skin
Pulse count: indicates emitted pulses
Lamp life: indicates remaining pulses
Diode life: indicates remaing pulses
Chiller: indicates operating diode temperature >15° <25 °
8.23 Hair removal treatment parameters
CPL Fitzpatrik I - II
Hair Colour Hair thickness Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
fine 695/1200 nm 5 J/cm2 15 ms 1 0 1 Hz immediate
vaporization
LIGHT medium 695/1200 nm 3 J/cm2 15 ms 1 0 1 Hz of the
hair shaft

coarse 695/1200 nm 3 J/cm2 15 ms 1 0 1 Hz

fine 695/1200 nm 5 J/cm2 10 ms 1 0 1 Hz

BROWN medium 695/1200 nm 3 J/cm2 10 ms 1 0 1 Hz

coarse 695/1200 nm 3 J/cm2 10 ms 1 0 1 Hz

fine 695/1200 nm 5 J/cm2 10 ms 1 0 1 Hz

DARK medium 695/1200 nm 3 J/cm2 10 ms 1 0 1 Hz

coarse 695/1200 nm 3 J/cm2 10 ms 1 0 1 Hz

CPL Fitzpatrik III

Hair Colour Hair thickness Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
fine 650/950 nm 5 J/cm2 10 ms 1 0 1 Hz immediate
vaporization
LIGHT medium 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz of the
hair shaft
coarse 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz

fine 650/950 nm 5 J/cm2 10 ms 1 0 1 Hz

BROWN medium 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz

coarse 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz

fine 650/950 nm 5 J/cm2 10 ms 1 0 1 Hz

DARK medium 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz

coarse 650/950 nm 3 J/cm2 10 ms 1 0 1 Hz

31
CPL Fitzpatrik IV - V
Hair Colour Hair thickness Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency
fine 755/1200 nm 3 J/cm2 10 ms 1 0 ms 1 Hz immediate
vaporization
medium of the
BROWN 755/1200 nm 3 J/cm2 10 ms 2 40 ms 1 Hz
hair shaft

coarse 755/1200 nm 3 J/cm2 10 ms 2 40 ms 1 Hz

fine 755/1200 nm 3 J/cm2 10 ms 1 0 ms 1 Hz

DARK medium 755/1200 nm 3 J/cm2 10 ms 2 40 ms 1 Hz

coarse 755/1200 nm 3 J/cm2 10 ms 2 40 ms 1 Hz

comments
May increase fluence if not response.
Decrease fluence if epidermal injury.
After few minutes perifollicular edema and erythema may appear.
To be preferred for the treatment of larger areas.
Pre-set software with corresponding skin type and hair type selection will guide to best cut-off filter choice.

32
Diode 810nm
Fitzpatrik Fluence Pulse lenght Frequency Mode Endpoint
I 19-22 J/cm2 20-30 ms 1 - 2 Hz long pulse Perifollicular
erythema
II 14 J/cm2 30 ms 4 Hz long pulse

III-IV 9 J/cm2 10 ms 6 - 8 Hz motion speed

V 7 J/cm2 10 ms 10 Hz motion speed

VI 5 J/cm2 10 ms 10 Hz motion speed

comments
May increase fluence if not response.
Decrease fluence if epidermal injury.
May increase pulse lenght if not response.
To be preferred for the treatment of larger areas.
Motion Speed
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– SLIDE the handpiece on the skin, keeping the button pressed, for 10 cm up and down, following the hair growth direction and make a second pass
perpendicular to the first one.
Long Pulse Mode: 4 Things to ALWAYS remember while treating:
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– OVERLAP: Pulses should not be overlapped;
– MULTIPLE PASSES are not allowed.

33
NdYAG
Fitzpatrik Hair Type Spot Size Fluence Pulse lenght Frequency Endpoint
light 7 mm 46 J/cm2 20 ms 1 Hz Perifollicular
erythema
I - II brown 7 mm 41 J/cm2 15 ms 1 Hz

dark 7 mm 36 J/cm2 15 ms 1 Hz

light 7 mm 36 J/cm2 18 ms 1 Hz

III - IV brown 7 mm 31 J/cm2 13 ms 1 Hz

dark 7 mm 31 J/cm2 13 ms 1 Hz

light 7 mm 20 J/cm2 13 ms 1 Hz

V - VI brown 7 mm 20 J/cm2 9 ms 2 Hz

dark 7 mm 20 J/cm2 9 ms 2 Hz

comments
May increase fluence if not response
Decrease fluence if epidermal injury
To be preferred for the treatment of smaller areas.
4 to 7mm spot size choice. For deeper beam penetration is best to use larger spot size

34
Chapter 9: Pigmented lesions removal and skin peeling procedure
(Applicator: Nd:YAG q-switched 1064/532nm)
9.1 Introduction
Xlase Plus with the Nd:YAG Q-switched applicator can target pigmented
lesions, as a result of the broad absorption spectrum of melanin.
The Q-switched applicator produces pulses of light shorter than the
thermal relaxation time of melanosomes (1 ms) and is used to selectively
destroy targeted melanin. The process of removing pigmented lesions
using sufficiently shorter laser pulses is called selective photothermolysis.
The targeted melanosome selectively absorbs the laser light, and the
resultant increase in temperature induces thermal damage of the
melanosome. Because this damage occurs over a period shorter than the
melanosome’s thermal relaxation time, the absorbed energy is confined
to the targeted melanin-containing melanosomes within melanocytes
and keratinocytes. Selective destruction of melanosomes results without
damage to surrounding tissue structures. The risk of scarring and
pigmentary changes is, thus, markedly reduced.
Wavelengths that target pigment include the frequency-doubled
Q-switched Nd:YAG (1064 nm), KTP (532 nm). Both wavelengths
can effectively treat pigmented lesions without disrupting the normal
surrounding tissue. The Nd:YAG Q-switched applicator is short pulsed
(Q-switched) and it penetrates deeply in the skin. The KTP 532 nm green
light lasers do not penetrate as deeply into the skin as do the red and
near-infrared lasers owing to their shorter wavelengths.
Green light lasers are therefore effective only in the treatment of epidermal
pigmented lesions. When used in combination with a carbon-containing
topical stick, the Q-switched Nd:YAG 1064 nm laser may also effectively
provide skin peeling. Because carbon-coated skin, is the absorbing
chromophore, it provides a target for the laser beam to effectively heat
and exfoliate the skin.
35
9.2 Q-switched Nd:YAG 1064 nm laser applicator
The Q-switched Nd:YAG laser applicator produces a 1064-nm wavelength
beam with a pulse duration of 9 to10 nsec. Despite decreased absorption
of this wavelength by melanin compared with the green and red light
lasers, there is yet some melanin absorption. Its advantage lies in its
ability to penetrate more deeply in the skin. In addition, this laser is more
useful in the treatment of lesions in individuals with darker skin tones
because of decreased interaction of the infrared light with epidermal
melanin. The Q-switched Nd:YAG laser is highly effective in the treatment
of nevus of Ota.
9.3 KTP 532nm Green Light Applicator
This applicator produces energy with pulses shorter than the thermal
relaxation time of melanosomes. The 532 nm frequency-doubled
Q-switched Nd:YAG laser produces a 9-10 nsec pulse of energy. It
provides excellent results when used to treat epidermal pigmented lesions
such as solar lentigines and ephilides. Because the green wavelength of
these lasers is also well absorbed by oxyhemoglobin, purpura formation
may occur following laser irradiation. The purpura resolves in 1-2 weeks
after treatment, with resolution or lightening of the clinical lesion in 4-8
weeks after treatment. Occasionally, purpura leads to postinflammatory
hyperpigmentation. This applicator produces a variable clinical response
when used to treat epidermal pigmented lesions such as café-au-
Iait macules, Becker’s nevi, and epidermal melasma. Because of the
variability in response, performing a test treatment within a small area of
the respective lesion may be prudent prior to engaging in a full treatment.
Even when café-au-lait macules and Becker’s nevi show resolution after
treatment, recurrences have been reported. Recurrences may occur
because of the impact of these lasers on melanosomes, with little effect
on the pigment-producing melanocytes. Careful sun protection may
retard, but will not prevent, recurrence.
Because melasma appears secondary to a combination of genetic,
sun-induced, and hormonal factors, successful laser treatment is the
exception rather than the rule in this condition. The green pulsed lasers,
because of their short wavelengths, do not penetrate very deeply into the
dermis and are, thus, ineffective for treating dermal pigmented lesions.
9.4 Treatment Protocol
Q-Switched Nd:YAG Applicator (1064 nm)
Energy densities averaging 8.0 J/cm2 with a 4 mm spot size are required
to treat nevus of Ota. Similar parameters are used to treat benign
melanocytic nevi; however, lower fluences are used for infraorbital
hyperpigmentation.
Frequency-Doubled Nd:YAG KTP (532-nm) Applicator
Solar lentigines and café-au-lait macules are typicalIy treated at
fluences of 2.0 - 2.5 J/cm2 with 2.5 mm spot at 2 - 3 Hz. Only one to
two laser sessions are needed to treat lentigines. The response of café-
au-lait marks is variable, and purpura is to be expected.
9.5 Sample patient information and consent form for the treatment
of pigmented lesions
You have a condition that is caused by a deposit of pigment (melanin)
at various depths under the skin surface. There have been no truly
effective methods of treatment for pigmented skin conditions without
significant side effects, such as scarring, prior to the development of
laser technology.
36
The following factors should be considered in your decision to
undergo laser treatment.
1. Multiple treatments may be necessary (especially for pigmented
birthmarks such as café-au-Iait spots and nevus of Ota).
2. Treatments are separated by intervals as short as 4 to 8 weeks.
3. It may not be possible to completely remove alI the pigmentation.
4. Immediately after treatment, there may be swelling and bruising, as
well as crusting and scabbing, which may persist for 1 to 2 weeks.
5. Significant fading may occur for up to 6 months following treatment in
some instances.
6. Possible side effects or complications of laser treatment include:
(a) skin texture changes or scarring, (b) pigmentary (color) changes,
including whitening or darkening of the skin (these changes are almost
always temporary), (c) infection, and (d) allergy.
I give permission for (name of the Physician) to perform laser surgery on my
(area treated) . I have been given a detailed description of the treatment
and have had ampIe opportunity to ask questions, which have been
answered to my full satisfaction.
I agree to have photographs taken that will identify only the area to be
treated. The photographs may be used for medical records and if, in
the judgment of my physician, medicaI research, education, or science
will benefit by their use, such photographs and information relating to
my case may be published in medicaI journals or books or be used
for any other purpose that is deemed proper in the interest of medical
education, knowledge, or research. It is understood that in the event that
any photographs are used for these purposes, I shall not be identified by
name.
9.6 Treatment operation

Select pigmentation program replace the focal tip (532nm) replace the focal tip (1064nm)
superficial pigmentation deep pigmentation

Warning Warning
wear wavelenght related wait for energy calibration
safety goggles before firing the laser

Fluence: select fluence level Fluence: indicates fluence on the skin

Pulse lenght: indicate pulse duration (fix) Pulse count: indicates emitted pulses
Freq.: select pulse repetition rate Lamp life: indicates remaining pulses
Spot size: indicate beam spot dimension
Start: the applicator is ready to be triggered

37
9.7 Pigmented Lesion Removal treatment parameters
pigmentation
Pigment Lens Fluence Pulsed lenght Frequency Spot size Endpoint
Superficial light KTP 532 nm 11.2 J/cm2 9 ns 3 Hz 4 mm Whitening

Superficial dark KTP 532 nm 8.0 J/cm2 9 ns 3 Hz 4 mm

Deep light 1064 nm 7.8 J/cm2 9 ns 3 Hz 6 - 7 mm

Deep dark 1064 nm 5.6 J/cm2 9 ns 3 Hz 6 - 7 mm

comments
May increase fluence if not response.
May decrease spot size to increase fluence.
May treat deeper pigmented lesions with Qswitched 1064nm and superficial pigmentation lesions with KTP 532nm applicator (Wood light examination criteria).
May be combined with lightening skin formulations.
Procedure: 4 Things to ALWAYS remember while treating:
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– OVERLAP: Pulses can be overlapped;
– MULTIPLE PASSES are allowed if endpoint is not achieved in a single pass.

skin peeling
Lesions Lens Fluence Pulsed lenght Frequency Spot size Endpoint
Scars / Wrinkles 1064 nm 3.1 J/cm2 9 ns 2 Hz 7 mm Erythema

Apply Carbon Ice solution on the area to be treated. Pay attention to even Carbon distribution on the area. comments
Increase fluence if the Carbon is not removed.
Procedure: 4 Things to ALWAYS remember while treating:
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– OVERLAP: Pulses can be overlapped;
– MULTIPLE PASSES are allowed if endpoint is not achieved in a single pass.
To be used to enhance skin chromophore.

38
Chapter 10: Tattoo Removal
(Applicator: Nd:YAD q-switched 1064/532nm)
10.1 Introduction
Tattoos are the visible result of exogenous material implanted in the
dermis, usually by tattoo artists, cosmetologists, or a traumatic event. The
fascination with decorative tattoos continues, with over millions people in
the world having at least one tattoo. Considered permanent, tattoos are
also placed for identification purposes (prisoners of war, gangmembers)
or to mark a location such as radiation ports for medicinal purposes.
Cosmetic tattoos in which black, red, or brown pigments are used
to mimic eye, lip, or eyebrow liner have also become increasingly
popular. In addition, flesh-toned pigments have been tattooed over
vascular and pigmented birthmarks, as well as over undesired tattoos,
for camouflaging purposes. Finally, traumatic tattoos arise from the
inadvertent implantation of graphite, asphalt, or gunpowder into the skin
with visible con sequences.
A long existence prior to regulatory agencies enabled tattooing to remain
an unlicensed, yet invasive, procedure for many years. A needle or
tattoo gun introduces ink into the dermis (with potential transmission of
hepatitis or HIV by contaminated needles), where it remains free until
engulfed by macrophages, the predominant responding phagocyte. Ink
particles have been found in draining lymph nodes prior to any attempt
at tattoo removal, suggesting lymphatic drainage as one mode of ink
dispersement. The majority of ink particles are too large to be carried
away, however, accounting for the permanence of tattoos. In most cases,
tattoos maintain their varied colors and designs are originally placed,
rarely inciting any tissue reaction, although many tattoos fade and
become less distinct with time. In a few individuals, however, some inks
may incite an allergic response with an erythematous, indurated region in
part or all of the tattoo.
39
This is most frequently seen with red ink, in response to the mercuric
sulfide base of the red pigment, but can also be elicited by blue (cobalt),
green (chromium), or yellow (cadmium) inks. Rarely, a systemic response
may even be triggered.
10.2 Laser Treatment
For a variety of reasons, many patients seek removal of that once
beloved tattoo. Historically, traditional modalities employed to remove
tattoos centered around tissue removal or destruction in the area of ink
deposition.
Dermabrasion or salabrasion with or without the addition of chemicals,
cryosurgery, surgical excision, and electrosurgery have all been effective
in removing tattoo ink; however, the resultant scar or dyspigmentation
was often as undesirable as the original tattoo.
Laser procedure for tattoo removal utilizes selective photothermolysis,
the concept of producing preferential injury to pigment-containing
structures using brief, selectively absorbed laser pulses revolutionized
laser treatment for a variety of cutaneous lesions.
By using a wavelength that is selectively absorbed by the target and a
pulse duration shorter than or equal to the thermal relaxation time of the
desired microscopic structure, damage could effectively be contained
within the targeted tissue. Using these principles, endogenous
chromophores (hemoglobin, melanin), as well as exogenous chromophores
(tattoo ink, graphite), can be targeted while leaving the adjacent collagen
intact, thereby minimizing the potential for scarring.
Ultrashort pulse durations (nanoseconds) in Q-switched (QS) Xlase Plus
systems are criticaI for the treatment of tattoos. The high energy delivered
leads to extremely high temperatures over a very short time period,
resulting in rapid thermal expansion of ink particles with subsequent
shattering. The ultimate fate of laser-irradiated tattoo ink is not well
understood. Ink removal is inhibited by the large particle size, as well as
by the engulfment by immobile macrophages.
The lymph system presumably plays a significant role in clearing the
pigment after shattering the particles, which frees them from macrophage
entrapment. Changes in optical properties also play a role in the apparent
improvement seen. Six weeks following QS laser irradiation, residual
dermal tattoo ink appears markedly smaller, less dense, and paler in color.
The epidermis is preserved with negligible dermal fibrosis.
The QS Nd:YAG laser applicator at 1064 nm has shown to have less
melanin absorption and deeper tissue penetration. In addition, the
frequency-doubling crystal with the 1064 nm Nd:YAG laser produced
532-nm green light, which is well absorbed by red ink.
10.3 General Treatment Principle
Different wavelengths account for variations in absorption and efficacy
for different tattoo colors and pigmented lesions. The QS laser applicator
for tattoo removal may be somewhat painful, require multiple treatment
sessions, and may pose at risks for hyperpigmentation and textural
changes.
Many patients are able to tolerate the YAG QS lasers without anesthesia.
The sensation most often described is that of a snap of a rubber band
hitting the skin. A few laser pulses may be given to assess the patient’s
tolerance to treatment. If anesthesia is desired, it can be administered
locally using EMLA under occlusion for 30-120 minutes.
Given the multitude of colored inks available and the varying response to
treatment, it is difficult to predict how many laser treatments are needed
to clear a tattoo; however, use of a wavelength well absorbed by the
tattoo ink enhances the ability to treat that particular color. In generaI,
opposite-colored light is best absorbed by a particular pigment (e.g.,
green light best treats red ink and vice versa). In addition, amateur tattoos
are easier to clear than professional tattoos, presumably due to the type
and amount of ink contained in the tattoo.
40
Professional tattoos have large amounts of metallo-organic dyes, whereas
amateur tattoos have smaller amounts of carbon-based ink. Finally, older
tattoos often fare better than recently placed tattoos, as the body slowly
disperses ink over time. Unfortunately, this is unpredictable, and some of
the oldest tattoos can be quite stubborn. The inability to predict how well
an individuaI tattoo will respond to treatment cannot be overemphasized
and suggests that other unknown factors are also important. Multiple
treatment sessions are usually required. Although the optimal treatment
interval is unknown, treatment sessions at 6-8-week intervals are most
common. This allows for adequate healing time and removal of the smaller
particles by the macrophage system.
Traumatic tattoos usually respond quickly, again supporting the idea that
the lower pigment load and more superficially located tattoos clear easily.
Medicinal tattoos respond similarly. Of concern is that red, brown, flesh-
toned, and white inks, which are commonly seen in cosmetic tattoos
of the lips, eyebrows, and eyelids, have been noted to turn slate-gray
or black after QS laser treatment. The iron oxide - or titanium oxide-
based pigments in these tattoo colors presumably undergo an oxidation-
reduction reaction that leads to the ink darkening. It is not currently
possible to predict which inks will darken or, in those cases that have
darkened following QS laser irradiation, which ones will lighten with further
laser treatments. Small test sites are recommended for these pigments.
Wound care following treatment with the QS laser systems consists of
application of antibiotic ointment and a clean nonstick bandage following
gentle cleansing with mild soap and water once or twice daily until all
crusting resolves (usually 5-10 days). Use of a larger spot size minimizes
tissue trauma, enhances healing, and decreases side effects. Also
of concern, both localized and systemic allergic reactions have been
reported with QS laser treatments. In contrast to physical removal of the
ink with older methods, QS lasers mobilize the ink and may further incite
an allergic response. Indeed, urticarial and anaphylactic reactions have
occurred.
Caution must be exercised even with localized granulomatous reactions,
but in particular, with urticarial eruptions. While specific treatment
parameters are provided, it is important to use them only as guidelines
and to evaluate each patient’s skin type and tattoo response individually.
10.4 Frequency-Doubled Q-Switched Nd:YAG
Laser Applicator 1064 nm / 532 nm
The longer wavelength (1064 nm) of the Q-Switched Nd:YAG laser allows
for deeper dermal penetration and less melanin absorption, making this
laser applicator very suitable for deep dermal pigment including tattoos
and for treating tattoos in darker skinned individuals. The spot size is
2.5 - 4 - 6 - 7 mm, with a repetition rate of up to 3 Hz. A clinical study
of fluences up to 12 J/cm2 demonstrated enhanced removal of black ink
with higher fluences without increasing side effects.
The side effects encountered with the QS Nd:YAG laser include
hypopigmentation and transient textural changes (particularly at higher
fluences). Postinflammatory hyperpigmentation may also be seen,
requiring the use of bleaching creams or longer intervals between
treatments.
In summary, while it is apparent that multiple wavelengths are necessary
to treat multicolored tattoos, the Q-Switched Nd:YAG laser shows to
be the most versatile and safe. It can effectively remove blue-black-red
tattoos with minimal risk of scarring or texturaI change.
The Q-Switched Nd:YAG laser can target blue-black-red tattoos even
in darker skin types and red tattoos at 532 nm; however, it is not very
effective in removing green ink.

Q-Switched Nd:YAG (1064 nm) laser treatment is initiated at 2.0 - 7.0 J/

cm2 when the recommended 2.5 / 4mm spot size is used. The larger
spot size allows lower fluence and equal ink removal with fewer side
effects. The Xlase Plus applicator allows use of 4 to 7 mm spot sizes
with sufficient fluences (10 and 2.5 J/cm2, respectively) to more rapidly
treat tattoos often with less epidermal damage. Amateur tattoos usually
require two to four treatments, and professional tattoos usually respond
within four to eight treatments.
As with all the Q-Switched lasers, less tissue reaction is seen with
subsequent treatment sessions as the amount of ink decreases. Thus,
fluences may need to be increased with subsequent treatments to
achieve the desired degree of lightening.

Frequency-doubling of the 1064 nm wavelength produces 532 nm visible

green light that is well absorbed by red ink. Available spot sizes and pulse
durations are the same as for the 1064 nm wavelength.
Only two to four treatment sessions are needed to remove red tattoos.

41
10.5 Sample patient information and consent form for tattoo treatment I have been given the opportunity to ask questions and have had them
A tattoo is made by depositing various colored pigments under the skin answered to my complete satisfaction. I also agree to have photographs
surface. Many methods have been tried to remove tattoos including taken that will identify only the areas to be treated. The photographs may
surgical excision, use of various acids and bleaching agents, destruction be used for medicaI records and if, in the judgment of my practitioner,
by heat or cold, overtattooing with flesh-colored pigment, sanding or medical research, education, or science will benefit by their use, such
dermabrading, and various lasers. The Q-switched Nd:YAG laser is the photographs and information relating to my case may be published in
latest in a new class of state-of-the-art laser technology specifìcally professional journals or medicaI books or be used for any other purpose
designed for tattoo treatment. that is deemed proper in the interest of medicaI education, knowledge,
or research, provided that I shall not be identified by name.
The following factors should be considered in your decision to
undergo treatment.
1. lt may not be possible to remove 100% of your tattoo.
Certain pigments are especially “stubborn” and may require multIple
treatments for particle lightening or use of an alternative laser.
2. A series of treatments may be required averaging four to six sessions
for amateur tattoos and eight or more sessions for professional tattoos.
3. There may be a crust or scab on the skin requiring special care with
topical antibiotic ointment, bandages, and limitation of activity in some
cases for a period of 1 to 2 weeks following treatment.
4. Paradoxical darkening can occur in some facial cosmetic tattoos
(eyeliner, lipliner) and, occasionally, in some colored tattoos.
5. Skin hyperpigmentation (brownish or dark discoloration) or
hypopigmentation (lightening of the sldn) may occur.
6. lndentation or depression of the skin may occur.
7. Skin texture changes or scarring may occur.
Knowing the alternative procedures available to me and with an
understanding of the laser treatment protocol, I agree to participate and
cooperate with (name of the physician).

42
10.6 Treatment operation

Select Tattoo program replace the focal tip (1064nm) replace the focal tip (532nm)
dark tattoo coloured tattoo

Warning Warning
wear wavelenght related wait for energy calibration
safety goggles before firing the laser

Fluence: select fluence level Fluence: indicates fluence on the skin

Pulse lenght: indicate pulse duration (fix) Pulse count: indicates emitted pulses
Freq.: select pulse repetition rate Lamp life: indicates remaining pulses
Spot size: indicate beam spot dimension
Start: the applicator is ready to be triggered

43
10.7 Responses of Different Tattoo Ink Colors form QS Nd:YAG Laser 10.8 Treatment for different types of tattoos
Color 1064nm 532nm Type Usual number of treatment

Blue/black Very good -------- Amateur 6-10 or more

Green Poor Average Professional Average

Red -------- Very good Traumatic 1-4

Orange -------- Good Cosmetic Variable

Flesh/white May darken May darken Medicinal 1-4

10.9 Tattoos Removal treatment parameters

Tattoo Colour Lens Fluence Pulse lenght Frequency Spot size Endpoint

BLUE / BLACK /
1064 nm 5.6 J/cm2 9 ns 3 Hz 6 - 7 mm Whitening
BROWN

LIGHT BLUE /
KTP 532 nm 8.0 J/cm2 9 ns 3 Hz 4 - 5 mm
RED / ORANGE

GREEN / YELLOW KTP 532 nm 11.2 J/cm2 9 ns 3 Hz 4 - 5 mm

comments
May increase fluence if not response.
May decrease spot size to increase fluence.
Procedure: 4 Things to ALWAYS remember while treating:
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– OVERLAP: Pulses can be overlapped;
– MULTIPLE PASSES: are allowed if endpoint is not achieved in a single pass.

44
Chapter 11: Rejuvenation, Acne and Onychomycosis procedure
(Applicator CPL, Nd:YAG long pulse 1064nm)
Onychomycosis with Nd:YAG long pulse 1064nm
11.1 Introduction
CPL applicator
Polychromatic light devices were fìrst developed to thermocoagulate
vascular malformations in the 1970s. In the mid 1990s, the fìrst high-
intensity intense pulsed light sources (IPL) were marketed to physicians.
Since then, multiple IPL have become available for different skin
conditions. CPL (Calibrated Pulsed Light) is a type of IPL system where
the broad spectrum of light is adjusted by dual filtered mode cut off filters.
It is a high intensity polychromatic light sources that emit pulsed light in
a broad band of wavelengths between 420 and 1200 nm.
Cut-off fìlters are available to narrow the bandwidth of emitted
wavelengths in order to selectively target variable structures at different
depths in the skin.
For example, fìlters may be changed to correspond to vessels of different
depths and caliber, the hair follicle, or pigmented celIs. High cut-off fìlters
can be used to reduce melanin absorption and protect the epidermis in
patients with darker skin types. In addition, higher cut-off fìlters emit
longer wavelengths for nonspecifìc absorption of dermal water.
This results in widespread dermal heating that causes colIagen damage
and subsequent remodeling.
Similar to lasers, CPL systems produce their effect based on the principIe
of selective photothermolysis. Hemoglobin’s absorption peaks are
approximately 418 nm, 542 nm, and 580 nm, whereas melanin absorbs
energy throughout the entire visible spectrum (400 - 700 nm) with a lower
absorption coefficient occurring in the infrared spectrum (1200 nm).
Unlike lasers, which treat one chromophore with monochromatic light,
IPL systems can be used to simultaneously treat both pigmented and
vascular lesions.
45
In addition, polychromatic light irradiates these chromophores with both
major and minor absorption peaks theoretically allowing for greater
selective energy absorption. The CPL applicator is effective to treat skin
photo ageing. The mechanism of action is thought to be light-induced
thermal denaturation of dermal collagen leading to a reactive cascade
of inflammatory mediators and subsequent collagen synthesis. Several
studies have shown successful clinical improvement in rhytides after
CPL treatment. Some have also shown good results in treating large
pore size and telangiectasias. CPL contact cooling applicator allows the
epidermis and superficial, small caliber vessels to cool while thermal
energy accumulates in the deeper, larger vessels or hair follicles. The
CPL system have pre-programmed settings based on both clinical
indications and treated skin types, making the equipment user friendly.
CPL applicator can be used for virtually all of the same indications as
laser systems. The system is successful for the treatment of essential
telangiectasias of the face, mild dyschromia, and poikiloderma of Civatte.
Other applications have shown success in therapy-resistant port-wine
stains, venous malformations, and hemangiomas. CPL system provides
multiple treatment options for the patient with photodamaged skin. It
is an excellent chance for those patients with confluent networks of
telangiectasias on the forehead, glabella, nose, cheeks, chin, neck, and
upper chest or with multiple types of photodamage including lentigines,
mild to moderate pikiloderma.
Nd:YAG long pulse applicator
A substantial number of studies have examined the clinical and histologic
effects following treatment with long pulse YAG lasers. The goal of
this system, similar to that of all nonablative resurfacing devices, is
improvement of rhytides without the creation of an epidermal wound.
The long pulse YAG laser is advantageous because of its high scattering
coefficient.
Thus, the emitted laser irradiation scatters throughout the treated dermis
after nonspecific absorption of dermal water. The ensuing thermal injury
theoretically triggers vascular damage and a cascade of events leading
to remodeling of dermal collagen and clinical improvement of rhytides.
11.2 Photodamage classification
Type I
Lentigenes, telangiectasias, increased coarseness, symptoms of rosacea
Type Il
Rhytides, laxity, dermatochalasis
Type III
Actinic keratoses, nonmelanoma skin cancers
11.3 Acne
IPL acne treatments induce improvement in the appearance of the skin
by limiting the degree of Proprionibacterium acnes infection, by reducing
the secretion of sebum and promoting the synthesis of collagen to
prevent acne scars.
Since acne IPL treatments use different mechanisms, it is necessary
to hit multiple targets at different depths in the tissue, which is
why, X-Lase CPL filter for acne treatments is 420 nm - 1200 nm.
Short wavelengths are absorbed by porphyrin and induce the
destruction of P. acnes. Longer wavelengths instead heat water in
the dermis and induce a reduction of sebaceous glands volume with
a consequent reduction of the secretion of sebum. The contemporary
activation of fibroblasts promotes the synthesis of collagen and other
extracellular matrix biomolecules, improving firmness and regularity
of the tissue and preventing the possible appearance of acne scars.
11.4 Onychomycosis
Onychomycosis, a persistent fungal infection of the nail bed, matrix or
plate, is the most common nail disorder in adults, accounting for one
third of all fungal skin infections and up to 50 percent of all nail diseases.
46
Toenails are affected more often than fingernails. The causative agents
of onychomycosis include dermatophytes (fungi that invade only dead
tissues of the skin, nails, or hair), nondermatophyte moulds, and rarely,
yeasts of the Candida species. The risk of infection increases with age:
15-20% of persons between the ages of 40 and 60 have the condition,
32% of those who are between 60 and 70, and 48% of those older than
70. Recent evidence suggests that the incidence of onychomycosis
is increasing. Therapeutic options for the treatment of onychomycosis
include palliative care, mechanical or chemical debridement, topical and
systemic antifungal agents, and various combinations of these modalities.
Long pulse Nd:YAG Laser radiation significantly reduces the
onychomycosis phenomenon, thus improving the nail appearance.
Desired average tissue temperature for laser irradiation of onychomycotic
nails is about 43-51°C, at a treatment time of at least 2-3 minutes; these
parameters provide an adequate therapeutic dose. Toleration of higher
temperatures is possible with desensitization of the treated area or with
increased blood flow. The amount of laser energy that can deactivate 80-
99% of the organisms present in an affected nail is the deactivating dose.
That dose does not instantly kill the fungal colonies but results in their
disability to replicate or survive according to apoptotic mechanism. The
beam diameter recommended for onychomycosis treatments with Xlase
Plus is normally associated with the use of the 4 mm spot size spacer.
11.5 Treatment Strategy
Patient Selection
Patient selection for skin rejuvenation is based on an evaluation of the
individual’s degree of photodamage and aging. The ideaI patient is 35-
55 years old with moderate signs of photodamage and aging. Younger
patients with mild photodamage may also show improved skin texture
after non-ablative skin resurfacing; however the results will be subtle.
Conversely, patients with deep rhytides and severe laxity may show
minimal to no response. Such patients may be better candidates for
ablative resurfacing or other more invasive cosmetic techniques.
In darker skin types Iight sources and lasers that target pigment must
be used with caution and at settings to minimize thermal damage. Side
effects such as blisters, scars, focal atrophy, textural change, and hyper-
or hypopigmentation are all more likely to be seen in darker complexion
individuals. Mid-infrared laser with emitted wavelengths varying between
1064 nm target water in the dermis and theoretically can be used safely in
darker skin types. However, when irradiated at high fluences nonspecific
laser energy absorption by melanin can lead to thermal damage and side
effects even in darker skin types. The most common but rare side effect
experienced by patients with darker skin color after non-ablative skin
resurfacing is transient hyperpigmentation. There are some individuals
who are not appropriate candidates for non ablative resurfacing. These
include those patients who have taken oral retinoids (for 6 months) prior
to non-ablative treatment, who have had recent ablative resurfacing with
either lasers or deeper chemical peels, and/or have active skin disease
within the treatment area. Finally, in the rare patient reactivation of herpetic
eruptions may occur. Pre-medication in these patients is indicated.
47
11.6 Mid-infrared lasers YAG Long Pulse (1064nm)
Treatment with the long pulse YAG applicator begins with a consultation.
It is used for improvement of overalI skin texture, laxity, and mild
rhytides. Consent is signed outlining the risks of dyschromia, scarring,
pain, erythema, or crusting. Initial parameters are set according to skin
type and treatment area. The skin is cleansed to remove oil, make-up,
or substances that will impede the laser light delivery to the dermis
and to minimize the possibility of infection. There is some controversy
as to whether topical anesthesia can be used. It has been postulated
that since topical anesthetics increase the epidermal water content,
the target of mid-infrared lasers, they might decrease the ensuing laser
delivered thermal damage. This is unproven and many patients will require
topical anesthesia when treated with higher fluences. Appropriate eye
protection is worn by alI present in the room. The patient’s eyes may be
protected with clean, dry gauze or opaque goggles. The patient is placed
comfortably in a supine position.
The fluence is increased incrementally until, with the use of a thermal
sensor, 42°C to 48°C can be read and reached on the skin. One pass is
given over the forehead where the dermis is thinnest and the intensity of
pain the greatest. The cheeks, chin, and upper lip are generalIy treated
with between two and fìve passes. No wound care is required after
treatment. A common side effect is transient erythema and mild edema.
Patients may wish to apply cool packs for a short period of time until the
pain subsides.
Patients may wish to apply cool packs for a short period of time until
the pain subsides. Treatment pearls and pitfalls are relatively few
compared with the other nonablative laser modalities. When treated
with conservative fluences for the initial treatment, it is rare to incur side
effects with the mid-infrared applicator. Moderate erythema is expected.
Post-Iaser-induced hyperpigmentation when occurs, generally requires
no treatment and will fade over the course of time. Hypopigmentation is
a very rare side effect.
11.7 CPL Calibrated Pulsed Light Applicator
CPL treatment begins with a consultation to define the patient’s goals.
The CPL applicator is used for a combination of essential telangiectasias,
solar lentigines and, less commonly, early rhytides. Parameters are
selected based on skin type and target tissue. For example, for facial
telangiectasias in a patient with types I-III skin the initial setting might
be 550 nm cut-off filter, 15-20 J/cm2, with single or double varying pulse
duration delivered pulses. The skin is cleansed to remove make-up or
any material that may interfere with or absorb the CPL energy. UsualIy no
topical anesthesia is needed. Appropriate eye protection in the form of
dark lenses is obtained for alI persons present. An assistant places gauze
over the patient’s eyes or opaque goggles may be worn. After placing
the handpiece in the desired location the operator can close the eyes for
further eye protection when the CPL applicator is fired. The CPL applicator
emits a bright flash of light that may be seen by the patient even with eye
protection. If the eye is covered this incidental light is not harmful. The
skin is covered with a layer of cool coupling gel. The handpiece is placed
on the skin with uniform contact. When the pulse is fired the patient
will experience a brief sensation of pain and heat. Treatment endpoints
for vessels are edema, erythema, evanescent purpura, intravascular
coagulation and temporary blanching of vessels. Treatment endpoints for
pigmented lesions include immediate hyperpigmentation. Side effects
are uncommon. Transient erythema occurs in nearly alI patients. This is
due to the cooling gel, the mechanical pressure of the handpiece, plus the
CPL effect on the target chromophores. Purpura, dyschromia, blistering
and scarring are extremely rare with appropriate treatment parameters.
Pitfalls to avoid during CPL procedure treatment are multiple. When
treating the skin of the forehead care must be taken to avoid vaporizing
the eyebrow hair. PIace the handpiece at least 1 mm away from hair
bearing areas (unless photoepilation is a desired endpoint).
Lipstick and other cosmetics must be completely removed, otherwise
the patient may suffer an unintentional burn due to energy absorption by
48
the cosmetic pigment.
It is also reasonable to start with conservatively low fluences when treating
patients with moderate to severe signs of rosacea in order to prevent
unexpected side effects such as intensified pain, prolonged erythema or
seconddegree burns.
11. 8 Treatment Tips for Experienced Practitioners
Future applications of non-ablative resurfacing promise to significantly
advance the field of anti-ageing procedures. Indeed the non-ablative
resurfacing field is quite new. It is also true that histologic proof of
neocollagenesis does not always correlate with clinical improvement.
Most do believe that non-ablative dermal remodeling does play a
substantial role in the noninvasive cosmetic treatment of patients.
A more advanced approach to non-ablative laser resurfacing combines
the use of more than one non-ablative procedure in the same setting. The
Xlase Plus non-ablative innovation can also combine the CPL procedure
with the 810 nm diode laser Dermacare procedure for the treatment of
wrinkles. This should be done judiciously and at a minimum risk to the
patient. It is wise to explain to the patient that although no epidermal
wound is created with non-ablative technologies, these systems do
intentionally create a wound in the dermis. Mid-infrared lasers may be
used on the same day as other non-ablative CPL procedure.
11.9 Applicator selection

DIODE

Select Skin Type

Select Proceed to continue

49
Warning Warning
wear wavelenght related wait for energy calibration
safety goggles before firing the laser

Fluence: select fluence level

Pulse lenght: select pulse duration
Freq.: select pulse repetition rate
Pulse train: divide the pulse into micropulses
Pulse delay: select micropulses pause duration
Filter: indicate cut off selection
Start: the applicator is ready to be triggered
Spot size: indicate beam spot dimension
Motion speed: select 10Hz beam repetition rate
Long pulse: select long pulse duration
Chiller: indicates operating diode temperature >15° <25 °
Fluence: indicates fluence on the skin
Pulse count: indicates emitted pulses
Lamp life: indicates remaining pulses
Diode life: indicates remaing pulses
Chiller: indicates operating diode temperature >15° <25 °

50
Rejuvenation and Acne Procedure
CPL Rejuvenation
Fitzpatrik Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
I - II 550-1200 nm 3 J/cm2 20 ms 5 60 ms 1 Hz erythema

III - IV 550-1200 nm 3 J/cm2 15 ms 5 60 ms 1 Hz

V 550-1200 nm 3 J/cm2 10 ms 5 60 ms 1 Hz

CPL Acne
Fitzpatrik Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
I - II 410-1200 nm 4 J/cm2 10 ms 5 60 ms 1 Hz erythema

III - IV 410-1200 nm 4 J/cm2 10 ms 5 60 ms 1 Hz

V 410-1200 nm 2 J/cm2 5 ms 5 60 ms 1 Hz

CPL Volumetric toning

Fitzpatrik Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
V - VI 550 - 1200 nm 5 J/cm2 2 ms 5 50 ms 1 Hz erythema

May increase fluence if not response. Decrease fluence if epidermal injury. comments
After few minutes edema and erythema may appear.
Use abundant coupling transparent gel.
Keep a slight distance (3-5mm) between applicator’s tip and the skin.

51
DIODE Dermacare
Fitzpatrik Fluence Pulse Lenght Frequency Mode Endpoint
I 9 J/cm2 10 ms 10 Hz Motionspeed Erythema

II 9 J/cm2 10 ms 10 Hz Motionspeed

III - IV 8 J/cm2 10 ms 10 Hz Motionspeed

V 8 J/cm2 10 ms 10 Hz Motionspeed

VI 7 J/cm2 10 ms 10 Hz Motionspeed

May increase fluence if not response. Decrease fluence if epidermal injury. May increase pulse lenght if not response. comments
Motion Speed
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– SLIDE: the handpiece on the skin, keeping the button pressed, for 10 cm up and down, following the hair growth direction and make a second pass perpendicular to the first
one.

Nd:YAG Non Ablative

Wrinkle Spot Size Fluence Pulse Lenght Frequency Endpoint
Superficial 7 mm 46 J/cm2 30 ms 1 Hz Erythema

Medium deep 7 mm 46 J/cm2 30 ms 1 Hz

Deep 7 mm 52 J/cm2 20 ms 1 Hz

Nd:YAG Onychomycosis
Spot size Pulse Lenght Fluence Pause delay Frequency Endpoint
4 mm 30 ms 80 J/cm2 0 ms 1 Hz Erythema

May increase fluence if not response comments

Decrease fluence if epidermal injury
Procedure: 4 Things to ALWAYS remember while treating:
– FLUSH: The applicator’s tip should be flat and in contact with the skin’s surface;
– PERPENDICULAR: The hand piece should be 90° to the skin’s surface;
– OVERLAP: Pulses can be overlapped;
– MULTIPLE PASSES are allowed if endpoint is not achieved in a single pass.
To be preferred for the treatment of smaller areas. Use cold coupling transparent gel. 7mm spot size.

52
Chapter 12: Vascular procedure, facial and leg telangectasias
Applicators: Nd:YAG long pulse 1064nm KTP/532nm,
12.1 Introduction
CPL Calibrated Pulsed Light
The term telangiectasia refers to a dilated venule, capillary, or arteriole
visible to the human eye and measuring 0.1 - 1.0 mm in diameter.
Telangiectasias develop on the face secondary to genetic predisposition,
chronic actinic damage, collagen vascular disorders, topical steroid
application, and disorders of vascular regulation such as acne rosacea.
Linear and “spider” telangiectasias develop on the legs, especially in
women, beginning in the second to third decade due to multiple factors
including genetic predisposition, gravity, pregnancy, and trauma.
Spider telangiectasias typically occur in school-aged children, with
most persisting into adulthood. They are a cosmetic concern and have
the propensity to bleed with minor trauma. The predominant presenting
symptom of patients with facial telangiectasia is cosmetic disfigurement.
Therefore, effective treatment should be as free of adverse sequelae as
possible. Traditional treatment modalities for superficial telangiectasias
have included sclerotherapy, electrodesiccation, and, more recently,
laser therapy. Vascular lesions are one of the most common indications
for laser therapy. The most frequently used light devices for vascular
lesions are the 532 nm potassium titanyl phosphate (KTP), the 1064 nm
Nd:YAG lasers and the intense pulsed light (IPL) devices.
These systems work through selective photothermolysis with
oxyhemoglobin (oxy-hb) as the target chromophore in vascular lesions.
The absorption peaks for oxy-hb are 418 nm, 542 nm and 577 nm.
By targeting oxy-hb, pulses of energy are transferred to the surrounding
vessel walI to selectively heat and destroy the abnormal blood vessels.
• The wavelength used needs to have sufficient penetration depth and
selectivity for the target vasculature.
53
• The pulse duration should be less than thermal relaxation time (TRT) to
affect the intended target, while sparing surrounding structures. The TRT
is the cooling time of the target and is proportional to the square of the
vessel diameter. For example, a vessel 0.03 mm in size has a TRT of 0.86
ms, as compared to a 0.1 mm vessel, which has a 9.6 ms TRT. Longer
pulse durations alIow for slower heating of the target, which prevents
rapid temperature spikes, which cause vessel walI rupture and purpura.
When pulse durations exceed the TRT of the target structure, more heat
diffuses outside the vessels, leading to unwanted thermal damage to
surrounding tissue.
• The spot size should match as possible the diameter of the target structure.
Nd:YAG 1064nm KTP/532 Applicator
The YAG applicator utilizes a neodymium:yttrium-aluminum-garnet
(Nd:YAG) crystal (1064 nm) to produce light that is then passed through
a KTP crystal to yield a frequency-doubled wavelength of 532 nm. The
laser light is shuttered to produce a quasi-continuous beam and may be
used with a variety of spot sizes and power settings.
Several clinical trials have achieved good results with the KTP laser for
the treatment of facial telangiectasias ranging from fine matted vessels
to those of large caliber. The laser applicator is traced along the course
of the vessel in a noncontact mode with a clinical endpoint of vessel
disappearance. Variable parameters with the use of the KTP laser include
fluence (10-18 J/cm2), pulse duration (5-50 msec), pulse rate (up to 3
pulses per second) and spot diameter (2.5 and 4 mm). Elimination of a
vessel may require one laser pass for small-caliber telangiectasias or two
or more passes for larger caliber vessels. In one study, 38.2% of treated
facial vessels achieved at least a 70% improvement following one laser
treatment, while 31.9% required a second treatment to achieve similar
results.
Cases in which involvement was more severe or extensive were more likely
to require multiple treatments. The most common side effect was linear
crusting along the course of the lased area, which generally resolved
within 1 week following treatment. There were no instances of purpura,
scarring, or pigmentary change.
The KTP long-pulse in the treatment of lower extremity vessels resultes in
greater clinical improvement after one or two laser treatments.
KTP parameters laser were calibrated to 10 - 15 J/cm2 (facial
telangiectasias) or 26 J/cm2 (leg telangiectasias) with a 1O-msec pulse
duration using a 2.5, 4 mm spot tip size at a rate of two to three pulses
per second.
Nd:YAG long pulse 1064nm Applicator
The Nd:YAG laser, with its wavelength of 1064 nm, can penetrate to a
depth of 4 - 6 mm and is useful in the treatment of deeper blood vessels
often resistant to treatment with the shorter-wavelength lasers such
as the KTP. In addition, it has a lower absorption for melanin, making
its use safer in patients with darker skin pigment. However, the longer
wavelength has a diminished affinity for oxygenated hemoglobin, and
much higher fluencies are required for efficacy. In our experience, the
1064 nm Nd:YAG is the treatment of choice for facial reticular veins,
particularly periorbital.
54
CPL Calibrated Pulsed Light
CPL applicator emits noncoherent light in the 555 - 1200nm range, with
pulse durations in the millisecond range. Filters are used to block out shorter
wavelengths, allowing the CPL to emit blue-green to yellow wavelengths
that selectively target cutaneous vessels. A primary advantage of the CPL
is its wide range of wavelengths and pulse durations. This facilitates the
treatment of vessels of various depths and diameters as well as treating
darker skin types. By treating with longer pulse durations or double and
triple pulsing, additive heating of larger vessels is achieved, while the
chilled crystal provides epidermal protection. The large surface area of
the crystal allows for efficient use of energy, greater depth of penetration,
and quicker treatment sessions.
The CPL is primarily used for the treatment of facial telangiectasias
and is the treatment of choice for poikiloderma of the neck and chest.
CPL can also be used to treat telangiectasias of the trunk and lower
extremities; however, because of the broad spectral filters and wide
range of wavelengths, energy delivery is not as easily controlled as with
laser devices. Caution should be employed when using high fluences,
pulse stacking, or multiple passes, especially in darkly pigmented or tan
patients and in locations other than the face.
12.2 Vascular lesions telangiectasias
Telangiectasias are superficial cutaneous vessels at a depth of 200 - 300
µm that measure 0.1 - 0.5 mm and represent dilated venules, capillaries,
or arterioles. Factors such as alcohol, estrogen, corticosteroids, and
chronic actinic damage can precipitate their onset. Telangiectasias are
also a common feature of rosacea and an increased number of smaller
vessels can manifest as facial erythema or flushing.
Trauma or tension after surgical procedures, such as excisions, face lifts or
rhinoplasty, can promote neovascularization, resulting in telangiectasia.
Telangiectasia that are arteriolar in origin are small in diameter, bright
red in color, and do not protrude about the skin surface. Those that arise
from venules are wider, blue in color, and often protrude. Telangiectasia
arising at the capillary loop are often initially fine, red lesions but become
larger and bluish-purple with time because of venous backflow from
increasing hydrostatic pressure. Telangiectasia have been subdivided
into four classifications based on clinical appearance:
(1) simple or linear, (2) arborizing, (3) spider, and (4) papular.
Linear and arborizing telangiectasias are very common on the nose,
midcheeks, and chin. These lesions are also seen with frequency on the
legs but may often be blue. Spider telangiectasias, also referred to as
spider angiomas, are always associated with a centraI feeding arteriole.
They typically appear in young children but can also appear in healthy
adults. In the past, these have been treated with electrocautery, which is
painful and can lead to punctuate scarring. Papular telangiectasias are
frequently part of genetic syndromes, such as Osler Weber-Rendu, or
systemic conditions, such as CREST syndrome, and collagen vascular
diseases, such as lupus erythematosus.
Poikiloderma of Civatte is a variant of telangiectasia involving the neck
and upper chest and occurring from accumulated ultraviolet exposure.
Poikiloderma consists of a combination of telangiectasia, irregular
55
pigmentation, and atrophic skin changes. While 532 nm KTP have been
successful, multiple treatments are often needed, and mottled response
may be seen because of the small, circular spot size of the laser and
large surface area to be treated.
In addition, as vascular-specific lasers, they may do little to improve
hyperpigmentation and textural changes. For this reason, in our opinion,
the CPL is the first-line treatment for poikiloderma. The entire neck and
chest can be treated in one session without any anesthesia in five to ten
minutes. Patients must be aware that footprints representing the shape
of the contact crystal may be present, and great care must be taken to
avoid skip areas and to not treat tan patients to minimize the appearance
of these footprints.
Cherry hemangiomas and venous lakes are commonly encountered
vascular lesions that represent dilated venules and are amenable to
treatment with the same laser systems.
Cherry hemangiomas, also known as cherry angiomas, are the most
common vascular proliferation. They most commonly occur in patients
after the third decade and increase in size and number with advancing
age. They occur predominantly on the trunk and proximal extremities.
They may initially appear as red macules 0.5 - 2 mm in size and may
become dome shaped with time. Unlike angiomas, venous lakes are
dark-biue to violaceous, compressible lesions that commonly occur in
sun-exposed areas, especially the ear and lower lip, in older patients.
12.3 Facial veins
Facial reticular veins are often seen on the tempIe and periorbital areas
in patients with genetic predisposition or after facial cosmetic surgery.
Because of their size and depth, reticular facial veins are better treated
with longer wavelengths that provide deeper penetration. The variable
spot-sized long pulse 1064 nm Nd:YAG applicator is the laser of choice
in the treatment of facial reticular veins.
One should always treat the vessel from distal to proximal so that blood
flow is not compromised, thereby minimizing the laser target. Remember
to always stay outside the orbital rim when treating periorbital veins. It is
also important to avoid treating vessels mediaI to the midpupillary line as
veins in this area have a retroorbital flow, unlike veins lateral to the
midpupillary line, which flow into the jugular vein. The 4 mm spot size is
recommended for most vessels with fluencies ranging from 180 to 230
J/cm², with a 20 ms pulse duration for 1 mm vessels and a 50 ms pulse
lenght for 2 to 3 mm facial reticular veins.
12.4 Patient Selection
Because of the competitive absorption of melanin at many of these
wavelengths, the easiest patients to treat are those with fair skin
(Fitzpatrick I-III). Tan patients and Fitzpatrick skin types IV-VI are more
challenging and have a higher risk of complications. They require
modifications of CPL filters, wavelength, and laser settings and the
use of test spots. Patients must have realistic expectations and should
be willing to undergo multiple treatments at four to six week intervals
to achieve optimal results. Patients’ medicaI history, medications, and
previous laser treatments should also be discussed.
12.5 Contraindications
Treatments should be avoided in tan patients or phototypes IV-VI, unless
the practitioner is very experienced with the laser and light systems and
56
with managing potential complications. Other contraindications include
active herpes simplex infection, history of seizures induced by bright
lights, active lupus erythematosus, gold therapy, and recent history of
isotretinoin use.
12.6 Pretreatment Considerations
Multiple treatment sessions (usually three to five) may be required for
improvement of facial telangiectasia, erythema, poikiloderma, and
leg veins. Angiomas and venous lakes usually only require one to two
treatment sessions for complete resolution. It is important that patients
understand that facial erythema and telangiectasia recur over time and
that laser treatment does not prevent the development of new vessels.
Maintenance treatments are often recommended six to nine months
after the initial series. Patients with a significant history of herpes
simplex infections should be given a five to seven day course of antiviral
medication (valacyclovir or famciclovir) starting the day of treatment. The
post treatment course is usually limited to mild erythema and edema,
usually lasting less than twenty four hours. However, always inform
patients of the potential for redness, swelling, burning, pain, bruising,
crust formation, hyper and hypopigmentation, blistering, and scarring,
which are very rare potential adverse effects of treatment.
12.7 Safety Concerns
AlI individuals in the treatment room should wear wavelength-specific
glasses. Patients should have intraocular metal eye shields placed when
treating the eyelids or any skin within the orbital rim. Even with appropriate
eye protection and closed eyes, patients may still report flashes of light
during treatment. Check to make sure the eye shields or goggles are
wavelength-specific and appropriately placed, then reassure the patient
that this is normal and that his or her eyes are protected. Masks are not
necessary.
12.8 Treatment Technique
Remove all makeup, moisturizers, sunscreen, and lipstick before starting
treatment. Dark makeup and lipstick absorb significant amounts of light,
which can Iead to a burn. Also have the patient remove all sunscreen as
it can interfere with absorption of the laser or light source. Pretreatment
photographs should always be taken prior to any treatment.
Cover the eyebrows and other hair-bearing areas to avoid unintended
epilation with the laser and light therapy.
The 532 nm KTP is very effective in treating telangiectasias. In generaI,
large spot sizes of 7mm with fluences of 6-8 J/cm2 are used for erythema,
whereas smaller spot sizes of 5 - 6 mm at 8 - 10 J/cm² are used to treat
discrete telangiectasias. The clinical end point for telangiectasias is
a transient purpura of a few seconds’ duration that corresponds with
intravascular thrombus formation. While most facial telangiectasias are
amenable to treatment, perialar telangiectasias are more difficult to treat.
Recurrences occur more easily, and multiple treatments and purpuric
settings are often needed to achieve clearance. Small cherry angiomas
and venous lakes respond well to long-pulsed KTP 532 nm; however,
larger, more hypertrophic lesions often require purpuric settings. In
addition, port-wine stains and nevus simplex (not discussed in this
chapter) require purpuric settings for more effective treatment.
Vessel rupture and purpura can be minimized with increased epidermal
cooling, longer pulse duration, and the use of longer wavelengths.
Different areas of the face have different purpuric thresholds, with the
jawline having the highest risk for purpura. Patients may also be on
medications or supplements that increase their risk of bruising. Aspirin,
Advil, Motrin, Ibuprofen, Coumadin, Plavix, vitamin E, garlic, ginkgo
biloba, ginseng, and green tea are a few common medications that are
frequent offenders. Pretreatment with herbal supplements bromelanin or
arnica as well as posttreatment ice for ten minutes every hour for the
remainder of the day of treatment can be employed to mitigate this risk.
57
When there is corresponding photodamage or when treating large
surface areas, the CPL is often preferred because of its ability to treat
other manifestations of sun damage (i.e., solar lentigo) as well as its
treatment efficiency with the large crystal size. In addition, when treating
vascular lesions with the CPL applicator, do not press hard on the skin
surface with the crystal as this blanches the vessel by squeezing out
the target chromophore and decreasing treatment efficacy. When using
the CPL applicator to treat skin types III and IV, longer wavelengths 550
- 950 nm, the use of longer and multiple pulse durations (15-20 ms) are
considered safer.
The Nd:YAG 1064 nm long pulse applicator is our preferred laser when
treating deeper blood vessels and larger target vessels as this longer
wavelength penetrates more deeply into the skin. This longer wavelength
also has less absorption by melanin and is commonly used in patients
with darker skin types. As mentioned earlier, it is also the treatment of
choice in facial reticular veins. This longer wavelength has a diminished
affinity for hemoglobin and fluences up to 10 times that of the KTP are
often required for efficacy. Because of this, this laser tends to be more
painful. In addition, there is an increased risk of blistering, scarring, and
skin atrophy at these high energy levels; therefore pulse stacking is never
used with the 1064 nm laser applicator.
Compared to the treatment of facial telangiectasias, fluencies should be
lowered by about 2-3 J/cm² in the treatment of poikiloderma of the chest
and neck to avoid adverse effects. A good rule of thumb is to decrease
fluence by 10 to 20% when treating nonfacial skin. For example, while
the CPL setting of a 10 ms double pulse at a fluence of 17 J/cm² may be
a modest setting for facial telangiectasias, it may lead to footprints and
hypopigmentation if used on a chest with photodamage.
While the treatment is usually well tolerated, many practitioners use
topical anesthesia to increase patient comfort. If anesthesia is needed, we
recommend the use of epidermal cooling devices, as topical anesthetic
creams cause local vasoconstriction and minimize target chromophore.
Some practitioners recommended skin stimulation, activity, rubbing, or
warmth to increase the target and therefore treatment response.
12.9 Post treatment Instructions
The immediate application of ice packs for ten to fifteen minutes is
extremely helpful in reducing post treatment erythema and edema. Prior
to leaving the office, SPF 30+ is applied on the patient, with instructions
to avoid sunlight until healing is complete.
In addition to discussing expected post treatment sequelae, patients are
given written instructions to:
• avoid excessive sunlight and wear sunscreen SPF 30+ every day
• if the treated area is red or swolIen, apply an ice pack or cold compress
for ten to fifteen minutes every hour, as needed
• use only gentle cleansers and moisturizers until healing is complete and
avoid use of acne medications, lightening agents, acids, or fragranced
products until healing is complete
• if blistering or crusting occurs, apply a topical antibiotic healing ointment
to the area twice daily; do not pick the area as this increases the risk of
scarring,and avoid direct sunlight to the area
• calI the physician’s office if any problems, questions, or concerns arise
12.10 Complications
CPL and YAG systems have minimal and transient adverse effects such
as erythema or burning during treatment. Graying or blanching of the skin
after a pulse is indicative of epidermal damage. This will usually result in a
blister and possibly hypopigmentation and textural change.
58
12.11 Leg veins
Leg vein therapy is one of the most commonly requested cosmetic
procedures. Leg veins are more challenging to treat than facial vessels
because of their varied size, hydrostatic pressure, thicker vessel walls,
feeding reticular system, and deeper locations. Leg vein changes include
spider veins, reticular veins, perforators, tributaries, and varicose veins
arising from reversed blood flow in the great and small saphenous vein.
30% of the population by age twenty, and 80% of the population by
age eighty, have some type of abnormal leg vein. Symptoms range from
heaviness to aches and pains, night cramps and/or restless leg, and
ankle edema. An appropriate patient evaluation should be performed
before considering treatment options. When larger varicose veins are
present, the associated telangiectases cannot be successfulIy treated
without addressing the underlying hydrostatic pressure.
12.12 Procedure
While the 532 nm KTP, and IPL are very useful for small vessels, they
have a limited depth of penetration and may result in dyspigmentation
in tan patients or Fitzpatrick skin types V-VI. The longer-wavelength
applicator, such as the YAG long pulse, alIow for treatrnent of larger-
diameter vessels, deeper vessels, and patients with darker skin types. A
higher fluence is needed with the Nd:YAG to compensate for decreased
hb absorption, and this can lead to more pain. To maximize efficacy, it is
important to match laser parameters to vessel size, for example, smaller
vessels require high fluence with a small spot size, whereas larger, blue
vessels require a lower fluence, larger spot size, and longer pulse widths.
Pulse stacking is not recommended with the Nd:YAG as too much
epidermal heat is generated, which can lead to epidermal damage. If
necessary, a second pass can be performed after waiting for the skin to
cool.
The clinical end point of therapy with lasers of leg veins is immediate 8.2 Applicator selection
vessel contraction and erythema. Prolonged vessel contraction and
blanching are signs of overtreatment and can result in epidermal
necrosis, pigmentary changes, and scarring. Epidermal cooling, the use
of conservative settings, and test spots in darker patients help minimize
this risk. There is a higher risk of depigmentation in tan and patients
with Fitzpatrick skin types IV, V, and VI; therefore sun protection is
recommended. Vessels greater than 3 mm are not responsive to lasers.

Select Vascular program replace the focal tip (1064nm)

59
Warning Warning
wear wavelenght related wait for energy calibration
safety goggles before firing the laser

Fluence: indicates fluence on the skin

Fluence: select fluence level Start: the applicator is ready to be triggered Pulse count: indicates emitted pulses
Pulse lenght: select pulse duration Spot size: indicate beam spot dimension Lamp life: indicates remaining pulses
Freq.: select pulse repetition rate
Pulse train: divide the pulse into micropulses
Pulse delay: select micropulses pause duration
Filter: indicate cut off selection

60
Nd:YAG Applicator Treatment Protocol
Nd:YAG Vascular
Vein Size Spot Size Fluence Pulse lenght Frequency Endpoint
superficial 2.5 mm 81 J/cm2 5 ms 2 Hz Vessel
face contraction
deep 2.5 mm 81 J/cm2 8 ms 2 Hz
Erythema
superficial 2.5 mm 122 J/cm2 8 ms 2 Hz
body
deep 2.5 mm 122 J/cm2 10 ms 2 Hz

CPL Applicator Treatment Protocol

CPL Vascular
Fitzpatrik Cut Off filter Fluence Pulse Lenght Pulse train Pause Delay Frequency Endpoint
I - II 550-950 nm 5 J/cm2 10 ms 5 30 ms 1Hz Vessel
contraction
III - IV 550-950 nm 3 J/cm2 9 ms 5 30 ms 1Hz Erythema
V 550-950 nm 2 J/cm2 8 ms 5 30 ms 1Hz

Q-Switched Applicator Treatment Protocol

Nd:YAG Q-SWITCHED Vascular
Lens Fluence Pulsed lenght Frequency Spot size Endpoint

9.6 J/cm2 4 mm Vessel

Face KTP 532 nm 9 ns 2 Hz
contraction
Erythema

61
Chapter 13: Skin resurfacing
13.1 Applicators: Erbium YAG
Ablative laser treatments have long been considered the gold standard
for the treatment of photoaging, scars, and wrinkles. However, the high
efficacy of ablative treatments does not come without a price; the healing
and downtime, up to two weeks, associated with complete cutaneous
ablation and reepithelization are often prohibitive to patients.
Physicians seek a device that combines the increased clinical efficacy of
ablative resurfacing with the safety and minimal recovery associated with
nonablative resurfacing. The development of fractional photothermolysis
technology may ultimately allow for this ideaI treatment.
Rather than treating the entire cutaneous surface uniformly, the overlying
concept of fractional phototheimolysis is treatment of the cutaneous
surface in microbeams diameter 100-250 µ.m; these microbeams create
microscopic thermal zones of high energy fluences, while sparing the
areas surrounding these zones. Thus the fractional therapies may achieve
high efficacy due to the high energy in the microthermal zones, while
limiting the potential for adverse reactions by decreasing the amount
of skin subjected to these high-energy fluences. Initially, fractional
photothermolysis technology was implied to nonablative lasers. The
microthermal zones treated with nonablative fractional devices result
in homogenization and coagulation of the collagen in the dermis;
additionally, the overlying epidermis is damaged with the formation and
extrusion of necrotic epidermal debris.
As these microthermal zones heal, clinical improvement develops in the
texture, tone, and appearance of the skin. Further efficacy is achieved
by heating of the skin between the microthermal zones as a result of
diffusion. In contrast to nonablative fractional devices, ablative fractional
technologies instantly ablate and eliminate the epidermis and superficial
dermis in the microthermal zones.
62
There is reported to be less heating of the skin between the microthermal
zones, potentially decreasing the healing time and pain associated
with the procedure. As the microthermal zones are completely ablated,
the healing process will result in more significant clinical improvement
compared to nonablative treatments.
The Erbium module laser is a plug-in device to Xlase Plus’s modular
platform. Since the laser unit is situated inside the handpiece itself, a
physician can add on the Pixel fractional lens to the handpiece without
the purchase of an additional machine.
The Erbium module that can be added to the Xlase Plus laser platform,
offers physicians the opportunity to utilize ablative laser therapy, while
incorporating fractional technology. The module utilizes a 2,940-nm Er:
YAG laser; this laser can be coupled with a special fractional lens that
generates the pattern of ablative channels. The Er:YAG laser targets water
as its chromophore. The Erbium applicator can be adjusted to achieve
precise, uniform ablative columns to depths of between 25 and 1,500
µ.m; these microchannels heal rapidly for a faster recovery.
These zones of ablative fractional photothermolysis produce tiny thermal
wounds, while sparing the tissue that surrounds the tiny columns of
tissue injury.
The thermal ablative areas of treatment stimulate a wound healing
response that tightens the skin and smoothes wrinkles. Most or much
of the treatment area remains intact and becomes a reservoir for rapid
wound healing.
Topical anesthesia may be utilized to reduce the mild discomfort
associated with the treatment.
The Erbium module has been proven to be efficacious in the treatment
of scars (specifically acne scars), rhytids, skin tone, and pigmentary
irregularities in clinical practice.
As a result of its ablative technology, only a single treatment pass per
treatment session can be necessary. Substantial clinical efficacy has
proven following a single treatment session.
One of the options offered by the device is that it is capable of delivering
pulses in a variety of methods: there is a shallow, short and medium
pulse, purely ablative mode; a longer-pulsed, coagulative mode. Early
white papers have detailed treatments up to 300 µ.m in depth, but the
theoretical maximum depth is over 1 mm. The 2,940-nm Er:YAG handpiece
utilizes pixel designed to deliver 81 (9x9) pixels. The maximum pulse
energy is 7 Jcm2/pulse, which is spread among the laser microbeams
lens, alIowing for a less dense, higher-fluence (per spot) treatment. The
width of each pixel starts from approximately 50 µ.m.
Micromanagement of the thermal ablative effect is achieved by altering
the laser energy, the pulse duration, the number of passes, and the
number of stacks. In addition to varying pulse width and energy, the user
can also deliver stacked pulses for deeper grooves.
Stacking of pulses means that the handpiece is placed on the skin and
the laser is fired in succession at a pre-selected repetition rate without
movement of the handpiece between laser pulses. Repetition rate of the
laser firing can range from about 1 Hz to 8 Hz depending on the
laser parameter settings.
The 9x9 (81) pixel pattern, at maximum energy, provides approximately
450 mJ/pixel at a pulse energy of 7J of thermal damage because the
energy is delivered in 16 zones of injury, according to the 6mm beam size.
The delivered laser energy is also variable, the available pulse energy can
be increased to 2000 mJ pulse of 2,940-nm energy.
The erbium laser (2,940 nm) ablates more tissue with less thermal zone
of destruction than the carbon dioxide laser.
Because of this, it provides excellent control of the delivered energy to
tissue. Unlike the carbon dioxide laser, multiple passes and the stacking
of pulses allow the physician to titrate both the energy delivery and the
thermal damage that he or she wishes to create.
63
Because of the rapidity of pulse delivery, multiple passes can be delivered
quickly, with diminished gain per pass. The thermal effect can also be
varied by altering the pulse width. A short pulse (0,5 ms) produces less
thermal effect than a long pulse (2 ms).
In clinical use, we will usually begin treatment with a short pulse and an
81-pixel grid, using a pulse energy of 1000 mJ for a patient with Fitzpatrick
skin type I . For Fitzpatrick types I and II patients without dermographia,
the treatment can be increased by using greater energies with a long
pulse. For Fitzpatrick types IV and V patients, less energy is used and/or
laser energy is titrated with a series of test spots.
Generally, we use a “one-two-three” treatment method: one pass is used
for the arms and chest; two passes are used for the neck; and three
passes are used for the face. Additional stacks are used for problem
areas such as the circumoral and circumocular regions.
Usually, the patient will have sunburn pain for about a day. This can be
mostly alleviated with topical sunburn preparations that contain aloe.
There is a sunburn that progresses to a bronzed area, which eventually
flakes. The whole process takes about four days but can last six days.
Most patients return to work the next day, excusing their appearance as
a sunburn. Treatment parameters are discussed with the patient. If the
patient requests a minimal treatment to assess the effects, desires little
or no downtime, has extremely sensitive skin, has skin type IV or up, or
can tolerate little or no discomfort, the treatment can be reduced by short
pulse and 600-800 mJ of energy.
If the patient desires the maximum response with the minimal number of
treatments, the treatment parameters can be increased, depending on
skin type. Generally, three to five treatments are performed about four
weeks apart.
With each treatment, the delivered energy is increased, depending on
the result of the previous treatment. If little response is seen from the
first treatment, the parameters are adjusted to increase the treatment
intensity greatly.
Pixel treatment may be used in combination with other modalities, The right therapeutic ablation depth is the minimum depth needed to
including microdermabrasion (to remove the stratum corneum) and achieve the desired clinical result, whether it is the effacement of rhytids,
radiofrequency skin tightening. It can also be alternated with intense removal of photo-damage and/or collagen tightening.
pulsed light treatments for patients with rosacea and telangiectasias. Generally full laser resurfacing is performed by treating the area
Treatments primarily are performed on patients with sun damage, and completely until the to-be-removed lesions have been ablated or until
Fractional Pixel is an excellent modality for the treatment. Fractional punctuate bleeding appears which indicates the papillary dermis has
Pixel procedure can be also utilized for acne scars, hyperpigmentation, been reached. At the level of the papillary dermis a maximum therapeutic
wrinkles, rhytids, and skin tightening. effect is achieved with a minimum of risk of side effects. Continuing to treat
Deeper rhytids respond to higher energies and stacked pulses. any deeper than the papillary dermis, has minimal clinical effects, while
Xlase Plus laser systems allow the user to pre-select the ablation depth the potential of complications and side effects may even exponentially
for specific treatments. increase. With experience it is advisable to select laser treatment settings
However, exact ablation rate and thus ablation depth depends on the that will give the desired result in 2-4 passes. As a general rule, the final
skin type, location of the treated area, the level of skin hydration and treatment outcome is more pronounced when more aggressive treatment
other non-laser related parameters. The practitioner is therefore strongly parameters are used. More aggressive treatments are achieved with
advised not to rely solely on preset parameters but rather to adjust the deeper ablation and thermal parameters while patient downtime and risk
parameters depending on the observed clinical effects. of complications increase.
Visual markers of depth are:
• Whitish colouring of the skin after administering laser pulses generally
indicates the Er:YAG laser treatment has reached the intra-epidermal
level.
• Yellowish colouring of the skin after administering laser pulses generally
indicates the Er:YAG laser treatment has reached the intra-dermal level.
• Punctate bleeding suggests that the papillary dermis has been reached.
Generally this indicates that the clinical end-point has been reached in
Er:YAG laser resurfacing treatments. When the Er:YAG laser treatment is
continued on the papillary dermis level, punctate bleeding will become
more frequent.

64
13.2 Preoperative considerations
13.2.1 Relative Contraindications
The ideal patient for treatment, regardless of condition, has type 1 or 2 skin.
Darker patients are certainly treatable, but the risk of hypopigmentation
increases with the depth of injury; this should be discussed with the
patient. Any patient in whom decreased adnexal structures are suspected
from previous radiation therapy (or even laser hair removal or electrolysis)
should probably receive a test site. The recommended minimum time
interval between isotretinoin treatment and resurfacing (and vice versa)
ranges from 6 months to 2 years.
If wound infection should be suspected the patient could be advised oral
antibiotic and antiviral medications until 2 days after re-epithelialization
is complete. Normally narcotic analgesics are only required for 1-2 days
after treatment.
If needed systemic steroids are helpful in reducing swelling in the first 2
days, particularly around the eyes, where edema can be severe.
After surgery a layered dressing may be placed over the wound for at
least 24 hours, or a variety of healing ointments may be used.

13.2.2 Preoperative Regimen

Day of surgery, preoperatively
1. Premedicate (see anesthesia, below).
2. Apply aseptic cleanser to area.
3. Metal eyeshields or equivalent eye protection should be used:
Tetracainehydrochloride 0.5% ophthalmic drops (Bausch and Lomb) are
instilled prior to shield insertion.
4. Use as wet drape at perimeter of treatment area and over teeth
(remember that the erbium laser is very effective in removing tooth
enamel).
5. Provide laser-safe masks and wavelength-specific goggles for
operating staff.

13.2.3Postoperative Care
For laser resurfacing, patient selection, operative technique, and
postoperative care are equally important in achieving the desired result.
Follow-up in the initial 1 weeks after therapy is very important. This allows
the physician to intervene in a timely fashion for suspected complications
(ie.,wound infection or incipient scarring). Full-face resurfacing patients
often require follow-up a few times within the first week, followed by
weekly and then monthly visits for 6 months.
65
13.2.4 Anesthesia 13.3 Complications
The erbium laser has been touted as not requiring anesthesia, or only
13.3.1 Dyspigmentation
requiring EMLA cream, a eutectic mixture of lidocaine or another topical
This is related to skin type and depth of wounding. Most cases of
anesthetic. While it is true that erbium laser resurfacing requires less
hyperpigmentation occur in skin types > 3 .
anesthesia than with the CO2 laser, where IV sedation (with or without
Normally hyperpigmentation occurs about 3-4 weeks after treatment,
tumescence) or generaI anesthesia is usually required for full-face cases,
predominantly in areas receiving three to five passes from the skin surface.
the anesthesia requirement for erbium laser resurfacing increases with
(In areas receiving only one to two total passes, virtually no postoperative
the depth and breadth of ablation, as well as the speed of the procedure
dyschromias are observed).
(repetition rate). An office regime that works well for some full-face patient
Hyperpigmentation usually responds rapidly to daily treatment with
is 120 minutes before the case, the face is wiped with 70% isopropyl
topical hydroquinone as long as UV light exposure is strictly avoided.
alcohol or acetone after which EMLA cream is applied. For best results,
Hypopigmentation has been observed in areas where aggressive
the skin should be hydrated with a wet towel before application. Plastic
treatment (five to eight passes at 7J/cm2) was used. It should be noted
wrap is placed over the thick layer of cream or gel.
that what is often called hypopigmentation represents only a retum to the
The safety margin with EMLA is well documented, even when applied
constitutive pigment of the skin. AIso, the underlying fibroplasia after laser
to diseased skin, because of the lower toxicity of lidocaine. The time of
therapy can change the hue of skin to a whitish color even with normal
application for EMLA is critical. In a study of laser-induced pain, EMLA
melanization. Full-face treatments tend to neutralize dyspigmentation
caused total sensory blockade in alI patients after 120 minutes,
because lines of demarcation are not as conspicuous as after treating
but still allowed “warmth” sensations after 60-minute applications in
only cosmetic units, where, for example, hyperpigmentation can be quite
the majority of patients. The greatest reason for EMLA failure is lack of
noticeable when it assumes a “raccoon eyes” appearance. In a side-
sufficient application time, and it is far better to wait the full 120 minutes
by-side study of erbium and CO2 laser resurfacing using treatment
than to confront a writhing patient. Just before the procedure, the topical
protocols producing comparable cosmetic results the incidences of,
anesthetic is removed, and a first pass is made over the entire area to be
hyperpigmentation with the CO2 and erbium systems were similar, but
treated.
At this point, most patients will tolerate the laser impacts. If there is resolution was faster after erbium laser irradiation. In contrast, the
continued discomfort, it has been suggested that EMLA can be reapplied risk of hypopigmentation was clearly less with the erbium laser.
for 1-3 minutes (the stratum comeum barrier will have been removed
after the first pass). However, it has been shown that, after application 13.3.2 Infection
to denuded skin, plasma levels are much greater than when applied to The risk of bacterial infection has not been established, but, due to the
normal skin with occlusion. Usually this topical regimen will be adequate. reduced time to healing, it is lower than after CO2 laser resurfacing.
Regardless of how carefully the above regimen is followed, some patients Topical antibiotics are discouraged in larger cases due to the high rate
will complain of extreme discomfort and may require injectable lidocaine. of sensitization. They seem to be well-tolerated for test sites, discrete
They should be informed of this possibility. lesions, and regional resurfacing for photodamage or acne scars.
66
If there is significant pain or delayed reepithelialization, the physician 13.3.6 Ectropion
should consider infection by a gram-negative pathogen, or yeast This has not been reported with erbium resurfacing but could potentially
infection. Cultures should be obtained, and a broad-spectrum antibiotic occur. Limiting the number of passes in the periorbital areas should
(such as ciprofloxacin) may be started while awaiting culture results. Yeast eliminate this side effect.
infections, typically caused by Candida albicans, can be treated with
topical or systemic antifungals (econazole cream or oral fluconazole). 13.3.7 Petechiae
The aforementioned antiviral strategies should reduce the risk of herpes This can be seen beginning 10 days after surgery, often where the skin
simplex reactivation. has been inadvertently traumatized during healing. These pinpoint red
macules usually resolve spontaneously within 8 weeks, and those lesions
13.3.3 Acne and Milia
that persist can be treated with the pulsed dye laser or other vascular-
Like CO2 resurfacing, an exacerbation in acne may be encountered 10-
specific laser.
90 days after treatment. By rapidly switching to a light moisturizer and
adding tretinoin nightly once re-epithelialization is complete, the risk can
be reduced. If acne persists, large discrete lesions can be gently incised
and drained; for multiple lesions, topical clindamycin lotion or even oral
tetracycline may be prescribed. The use of minocycline is discouraged
due to possible development of dyschromias. The incidence of milia is
also reduced by early tretinoin application.

13.3.4 Persistent Erythema

This will occur primarily in the areas with the deepest injury. Early use of Ablation + # of stack clinical
thermal zone pulse indications
steroid cream is usually helpfuI. Rapid erythema resolution accelerates depth (microns)
the skin’s return to social acceptability.
AIso, the risk of hyperpigmentation appears to be associated with the 50+75 single stack Surface smoothing
presence of erythema. If severe erythema persists focally after 2 weeks, 100+75 double stack Fine lines
this may herald an incipient scar, and a more potent steroid should be 150+75 triple stack Perioral / thick skin
applied acutely (i.e., clobetasol cream) for 7-10 days, after which a less 200+75 quadruple stack
Deep acne scars
potent steroid can be resumed for an additional 2 weeks. 250+75 five stack

~1000 Microns
300+75 six stack
13.3.5 Scarring
Epidermis

Focal textural changes have been observed in areas receiving more than
seven passes. These changes have resolved with topical steroids and time.
In the periorbital area, atrophic scarring is more likely than hypertrophic
scarring. Therefore, as a generaI rule, no more than three passes should
be applied to the immediate infraorbital and mediaI canthal areas. The
periorbital dermis is very thin so that multiple passes can inadvertently
lead to transdermal injury and scarring.
67
13.4 Applicator selection

Erbium YAG applicator is selected:

to select Ablate procedure to select Fractional procedure

Shallow; Superficial; Medium; Deep Shallow; Superficial; Medium; Deep

Fluence: select fluence level Fluence: indicates fluence on the skin

Pulse lenght: select pulse duration Pulse count: indicates emitted pulses
Freq.: select pulse repetition rate Lamp life: indicates remaining pulses
Stack:
Start: the applicator is ready to be triggered

68
 Ablative

Spot Size Energy (J) Fluence (J/cm²) Pulse Duration (ms) Stack No. of passes Endpoint

Pigmentation 6mm 0,4 1,4 0,5 (shallow) 1 1 Tissue

Vaporization
Scar (first step) 6mm 0,4 - 0,8 1,4 - 2,8 0,5 (shallow) 1-2 1

Scar (second step) 6mm 0,6 2,1 1,5 (medium) 1 1

Stretchmark (first step) 6mm 0,4 - 0,8 1,4 - 2,8 0,5 (shallow) 1-2 1

Stretchmark (second step) 6mm 0,6 2,1 1,5 (medium) 1 1

Skin Resurfacing 6mm 0,4 1,4 0,5 (shallow) 1 1

Fractional

Lens/Spot Size Energy (J) Fluence (J/cm²) Pulse Duration Stack No. of passes Endpoint

Pigmentation Fractional/6mm 0,4 1,4 0,5 (shallow) 1 1 Tissue

Vaporization
Scar (first step) Fractional/6mm 0,4 - 0,8 1,4 - 2,8 0,5 (shallow) 1-2 1

Scar (second step) Fractional/6mm 0,6 2,1 1,5 (medium) 1 1

Stretchmark (first step) Fractional/6mm 0,4 - 0,8 1,4 - 2,8 0,5 (shallow) 1-2 1

Stretchmark (second step) Fractional/6mm 0,6 2,1 1,5 (medium) 1 1

Skin Resurfacing Fractional/6mm 0,4 1,4 0,5 (shallow) 1 1

69
Chapter 14: Maintenance
14.1 Introduction
This chapter contains maintenance instructions for the Xlase Plus system. Warning
Routine maintenance may be performed by clinic staff unless otherwise • The Xlase Plus system generates hazardous voltages within the main
specified. Any maintenance procedure not mentioned in this chapter console.
must be performed only by Biotec Italia authorized technical personnel. • The interior of the system may be serviced only by Biotec Italia authorized
The outer surfaces of the system should be kept clean for hygienic technical personnel.
reasons and the lightguide and applicator’s lenses should be cleaned Warning Following operations have to be performed by manufacturer
between sessions to enable effective treatment. every 3 years or 5000 hours functioning:
• Calibration of laser output
Warning
Maintenance by the operator should be performed only when the system • Functional test
is shut down and disconnected from the mains power source. Performing • Safety tests (earth conductor, leakage current)
maintenance procedures with the system turned on may be hazardous to
the operator and/or destructive to the system. 14.3 Service Information
In communications with Biotec Italia authorized representatives regarding
14.2 Periodic Service
the system, always include the part description/number and serial number
The system should be periodically inspected and maintained to keep
indicated on the identification label located on the back of the system.
it in peak operating condition. The following routine service operations
Warning
should be performed by Biotec Italia authorized technical personnel
• Unauthorized servicing or modification of this system not described in
every 6 months:
this manual may expose the operator or patient to potential high voltage
• General system check
and laser radiation hazards.
• Interior inspection, including cleaning accumulated layers of dust
• Improper use or adjustment of this system may invalidate the service
• Verification of the light output power rates with a power meter
warranty agreement.
• Cooling system:
• Check the water level in the cooling system; refill if necessary Questions or problems should be referred to your Biotec Italia
• Replace the deionizer filter representative, or to the Biotec Italia Service Centers at:
• Clean the radiators Biotec Italia Srl
• Clean the fins of the heat exchanger’s fan Viale Della Repubblica 20
• Clean the water particle filter 36031 Dueville (VI) – Italy
• Check the water quick-connector O-rings on the applicators connectors Tel. 00390444591683
Email service@biotecitalia.com
70
7.4. Routine Maintenance
The following routine maintenance procedures should be performed by
the clinic staff on a regular basis determined by the clinic protocol.
Warning
• The Xlase Plus system generates high voltages and intense light /
pulsed laser radiation when powered up.
• Always turn the system off and unplug the power cable before performing
maintenance procedures.
• The interior of the system or its components may be serviced only by
Biotec Italia authorized technical personnel.

7.4.1. Cleaning and Disinfecting the System

In order to prevent the system from overheating, it is important to
periodically check the air intake and outlet air grills, both sides of the
system. Clean the dust from these grills once a week.
The outer surface of the system may be wiped clean with a soft cotton
cloth swabbed in 70% alcohol.

7.4.2. Applicators
Caution A preventive inspection of the applicators should be done
on a daily basis. Inspection consists of checking the integrity and the
appearance of the lightguide and lenses.
The outer surface of the applicator’s body and the umbilical cable may
be wiped clean with a soft cotton cloth swabbed in 70% alcohol.
The lightguide window and applicator’s lenses should be cleaned following
each patient treatment. Use a gentle optical lens cleaning solution.

71
Chapter 15: Troubleshooting
15.1 Introduction
The Xlase Plus system is equipped with a self-testing software routine
that continuously monitors the system operation. If a system malfunction
is detected, an error message will appear on the LCD display.
An error will disable the system operation and the operator should turn
the system off using the keyswitch and the main switch.
The following troubleshooting tables do not attempt to list all possible
system failures. Any fault not listed should be referred to Biotec Italia
Service personnel.
Warning
Do not attempt to open or disassemble the system covers.
15.2 Warranty
The system warranty period is one year.
15.3 Troubleshooting Guides
Table provides a list of alarms and error messages that may appear on
the screen, their possible causes and corrective actions to be performed.
If the corrective actions listed in the table do not solve the problem,
contact your Biotec Italia Service representative.
The following troubleshooting guides do not attempt to list all possible
system failures. Any fault not listed should be referred to your Biotec
Italia srl service representative.
Please advise the Biotec Italia Service Department of all error messages
that occur, with the exception Connect interlock.

Note: Improper use or adjustment of this system may invalidate the service warranty
agreement. Please contact your authorized Biotec Italia distributor before attempting to
troubleshoot this system in any manner other than specified in this manual.

72
Error Message/Alarm/Fault Probable Cause Corrective Action

The system does not turn ON
1. Power cable 1. Make sure the power plug is properly inserted
2. Fuses and that the supply voltage corresponds to the
system.
2. Unplug the power cable network, and
check the status of the two fuses in the fuse
box located in the back of the machine, the
defective fuses must be replaced with fuses of
the same value.
3. Contact Biotec Italia Service personnel

The machine does not respond to 1. Display fault 1. Contact Biotec Italia Service personnel
commands from the display set

“FLOW ALARM” is displayed
Applicator’s lamp does not turn
on. “Lamp Alarm”
1. Disconnected applicator
2. Water level
3. Water pump
4. Air bubbles in the water system
1. Applicator may be disconnected
2. You have reached maximum lamp’s life spam
3. (CPL applicator), the cut off filter is inserted
in the slot
1. Ensure that the applicators are properly
connected
2. Check the water level in the reservoir placed
on the top of the system and the transparent
water hose in the back of the system. Add
deionized water if necessary, (refer to the
refilling procedure paragraph)
3. Contact Biotec Italia Service personnel
1. Ensure that the applicator’s electrical
connectors are plugged in firmly (refer to the
system installation paragraph)
2. If you have reached maximum lamp life
spam, contact Biotec Italia Service personnel to
arrange lamp replacement
3. When you trigger CPL applicator’s lamp
remove cutoff filter from applicator’s slot.
4. Switch off and restart the system
5. Contact Biotec Italia Service personnel

73
The applicator is ON (flash lamp bulb ON)
but the laser beam is not emitted.
Alarm “ Overheating”
Alarm “Alarm Interlock”
1. Foot pedal/ applicator’s switch
2. Power supply
1. Working environment too warm, above 24º
2. System air grills dirty or obstructed
1. Interlock connector not connected
74
1. Check the connection of the pedal and / or
applicator
2. When pressing on the foot pedal make sure
to press properly in order to favor the magnetic
contact in the switch
3. Contact Biotec Italia Service personnel
1. Check the room temperature, should be kept
constantly below 24º
2. Switch off the system and let it to cool for a
few minutes
3. Clean the air grills and make sure that the
system air vent are not too close to the wall
4. Contact Biotec Italia Service personnel
1. Verify that the connector interlock is properly
connected on the back of the system
2. Contact Biotec Italia Service personnel
Attached documentation:
Tables 1, 2, 4, 6 required by the 60601-1/2 (2010) Standard.

tab. 1
Manufacturer’s guide and declaration – Electromagnetic emissions
The XLase is intended for use in the electromagnetic environment
specified below. The customer or the user of the XLase should assure
that it is used in such an environment.

Emission test Compliance Electromagnetic

environment
RF emissions The Xlase device must emit
electromagnetic energy in
CISPR 11 Group 2 order to perform its intended
function. Nearby electronic
equipment may be affected.

RF emissions Class A The XLase is suitable for use in

CISPR 11 all establishments, including
domestic establishments and
Harmonic emissions Class A those directly connected to
the public low-voltage power
supply network that supplies
Voltage fluctuations/ Complies buildings used for domestic
purposes.
flicker emissions

75
tab. 2
Immunity Test level Compliance Electromagnetic
test IEC 60601 level environment-guidance
Floors should be wood, concrete
Electrostatic ± 6 kV contact or ceramic tile. If floors are covered
± 6 kV on contact with synthetic material, the relative
discharge ± 8 kv in air ± 8 kv air
humidity should be at least 30 %.

Electrical fast ± 2 kV for power ± 2 kV common Mains power quality should be that
transients/ burst supply lines mode of a typical commercial or hospital
± 1 kv for the input/ ± 1 kv differential environment.
output lines mode

± 2 kV common Mains power quality should be that

± 2 kV phase (s) of a typical commercial or hospital
Overtensions ± 1 kv phase (s)- mode
± 1 kv differential environment.
phase(s)
mode

< 5% Ut (95%dip in < 5% Ut (95%dip in Mains power quality should be that

Voltage dips, short UT) for 0.5 cycles
interruptions and UT) for 0.5 cycles of a typical commercial or hospital
40% Ut (60% dip in 40% Ut (60% dip in environment. If the user of the
voltage variations UT) for 5 cycles
on power supply UT) for 5 cycles XLase requires continued operation
70% Ut (30% %dip 70% Ut (30% %dip during power mains interruptions,
input lines in UT) for 25 cycles
in UT) for 25 cycles it is recommended that the XLase
< 5% Ut (95% < 5% Ut (95% % of
dip) for 5 seconds be powered from an uninterruptible
% of dip) for 5
seconds power supply or a battery.
Magnetic field Power frequency magnetic fields
at the mains should be at levels characteristic
frequency (50/60 3 A/m 3 A/m
of a typical location in a typical
Hz) commercial or hospital environment.

76
tab. 4
Electromagnetic
Immunity Test level Compliance environment
test IEC 60601 level guidance

Portable and mobile RF

Conducted RF 3 Vrms 3 Vrms communications equipment
should be used no closer to
any part of the XLase, 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

Radiated RF 3V/m (1GHz÷2,5GHz) 3 V/m d = 0,35 P

da 80 MHz a 800 MHz
d = 0,7 P
da 800 MHz a 1 GHz
d = 2,33 P
da 1 GHz a 2,5 GHz
where p is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in metres (m).

tab. 6
The XLase is intended for use in an
Rated maximum
output of Separation distance according to frequency of transmitter (m) electromagnetic environment in which
transmitter (W) radiated RF disturbances are controlled. The
customer or the user of the XLase can help
15 KHz to 80MHz 80MHz to 800MHz 800MHz to 1GHz 1GHz to 2.5GHz prevent electromagnetic interference by
0.01 0.12 0.04 0.07 0.23 maintaining a minimum distance between
portable and mobile RF communications
0.1 0.37 0.11 0.22 0.74 equipment (transmitters) and the XLase
1 1.17 0.35 0.70 2.33 as recommended below, according
to the maximum output power of the
10 3.69 1.11 2.21 7.38 communications equipment.
100 11.67 3.50 7.00 23.33

77