AcuLight HR Users Manual PB3581110

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aculight HR

OPERATOR’S MANUAL
PB 3581110 Rev. B
July 2001
Copyright © 2001 by ESC Medical Systems Ltd.
All rights reserved. No part of this manual may be reproduced or copied in any form by any means
- graphic, electronic or mechanical, including photocopying, typing, or information retrieval
systems - without written permission of aculight or ESC Medical Systems Ltd.

Use of Manual:
The aculight HR system is designed to meet international safety and performance standards.
Personnel operating the unit must have a thorough understanding of the proper operation of the
system.
This manual has been prepared to aid clinicians and other personnel to understand and operate
the system. Do not operate the system before reading this manual and gaining a clear
understanding of the operation of the system. If any part of this manual is not clear, please contact
your aculight representative for clarification.
The information provided in this manual is not intended to replace the professional training on the
clinical use of the aculight HR System. (Such training should include a review of published
literature, seminars, workshops and appropriate preceptorships.) Please contact your aculight
representative for current information on available training. For professional information and
clinical applications, refer to Appendix A of this manual.
This manual should always accompany the unit, and its location must be known to all personnel
operating the unit. Additional copies of this manual are available from aculight or your local
distributor.

ii PB 3581110 Rev. B
PHYSICIAN RESPONSIBILITY
Federal (USA) law restricts prescription medical devices to sale by or on the order
of a physician, or properly licensed practitioner. That physician will be responsible
for the use and operation of the device and for all user qualifications. aculight
makes no representations regarding federal, state or local laws or regulations that
might apply to the use and operation of any medical device. The physician is
responsible for contacting his or her local licensing agencies to determine any
credentials required by law for clinical use and operation of the device.

MAINTENANCE
The aculight HR is a precision, technical medical device that requires routine
service as well as consumable parts. All service must be performed by an aculight
technician and all parts must be purchased from aculight. Failure to obtain service
and parts through aculight voids all warranties, express and implied. Please call
aculight or your local representative for details.

MODIFICATION OF DEVICE
Unauthorized modification of the hardware, software or specifications of the
aculight HR voids all warranties, express and implied. aculight takes no responsi-
bility for the use or operation of such a device.

PB 3581110 Rev. B iii


iv PB 3581110 Rev. B
INTRODUCTION
The aculight HR is an innovative pulsed light system
for hair removal.
This manual is intended to provide the clinician and
other personnel who operate or maintain the aculight
HR with information on the operating principles,
controls, safety precautions, installation, and
maintenance of the system. While this manual is
intended to aid the clinician in the use and care of the
equipment, it cannot serve as a substitute for proper
training in the clinical applications of intense light pulse
emitting devices. Training in the therapeutic use of the
system is provided by aculight.
This operator manual includes:

Chapter 1 System Overview Contains a general


introduction to aculight HR.
Chapter 2 Safety Contains explanations and
directions concerning safety
measures for operating
aculight HR.
Chapter 3 System Contains a detailed overview
Description of the various subsystems of
aculight HR.
Chapter 4 Installation Explains electrical, space and
environmental requirements
for installation of aculight
HR.
Chapter 5 Operation Explains how to use the
aculight HR.
Chapter 6 Maintenance and Provides a detailed review of
Troubleshooting how to maintain the machine
and its accessories, as well as
troubleshooting.
Chapter 7 Accessories Describes the various
accessories used with
aculight HR and the
procedure for ordering
additional supplies.

PB 3581110 Rev. B v
Appendix A Clinical Guide Provides details on
indications, contrain-
dications, pre-treatment care,
treatment procedures and
post-treatment care.
Appendix B Taking Care of Provides details on the
aculight HR correct maintenance of the
Treatment Heads aculight HR treatment heads.

vi PB 3581110 Rev. B
TABLE OF CONTENTS
Introduction

Chapter 1. System Overview


1.1 Introduction to the System............................................................... 1-2
1.2 Indications for Use........................................................................... 1-2
1.3 Treatment Parameters ...................................................................... 1-3

Chapter 2. Safety
2.1 General............................................................................................. 2-1
2.2 Introduction ..................................................................................... 2-1
2.3 Major Cautions and Warnings ......................................................... 2-4
2.4 Optical Safety .................................................................................. 2-7
2.5 Electrical and Mechanical Safety .................................................... 2-8
2.6 Fire Hazards..................................................................................... 2-8
2.7 System Safety Features.................................................................... 2-9
2.8 Equipment Classification............................................................... 2-12
2.9 Compliance with International Standards...................................... 2-12

Chapter 3. System Description


3.1 System Components and Controls................................................... 3-1
3.2 System Software .............................................................................. 3-6
3.3 System Specifications...................................................................... 3-7

Chapter 4. Installation
4.1 Equipment List ................................................................................ 4-1
4.2 Facility Requirements...................................................................... 4-2
4.3 Moving the System .......................................................................... 4-5

Chapter 5. Operation
5.1 Screens and Functions ..................................................................... 5-2
5.2 Starting the System .......................................................................... 5-3
5.3 The Treatment Screen...................................................................... 5-6
5.4 Treatment......................................................................................... 5-8
5.5 The Menu Screen........................................................................... 5-13
5.6 Calibration ..................................................................................... 5-13
5.7 Changing the Treatment Head....................................................... 5-19
5.8 Idle Mode....................................................................................... 5-22
5.9 Statistics......................................................................................... 5-23
5.10 Advanced Mode............................................................................. 5-24
5.11 Turning Off the System ................................................................. 5-28

PB 3581110 Rev. B vii


Chapter 6. Maintenance and Troubleshooting
6.1 Cleaning the Unit............................................................................. 6-1
6.2 Cleaning the Light Guide ................................................................ 6-1
6.3 Replacing the Treatment Head ........................................................ 6-2
6.4 Filling the Water Tank..................................................................... 6-3
6.5 Power Meter Calibration ................................................................. 6-4
6.6 Preventive Service ........................................................................... 6-5
6.7 Troubleshooting............................................................................... 6-5
6.8 Error Messages ................................................................................ 6-6

Chapter 7. Accessories
7.1 Safety Eyewear ................................................................................ 7-1
7.2 Coupling Gel.................................................................................... 7-1
7.3 Light Guide Covers ......................................................................... 7-1
7.4 Optional Heads with Other Filters................................................... 7-2
7.5 Ordering Accessories....................................................................... 7-2

Appendix A. Clinical Guide


A.1 Training Requirements ................................................................... A-1
A.2 Indications and Contra-indications ................................................. A-1
A.3 Pre-treatment Preparation ............................................................... A-2
A.4 Side Effects of Treatment ............................................................... A-3
A.5 Treatment Parameters ..................................................................... A-4
A.6 Guidelines for Selecting Treatment Parameters ............................. A-8
A.7 Treatment ........................................................................................ A-9
A.8 Post-treatment Care ...................................................................... A-10
A.9 Clinical Studies Summary ............................................................ A-12

Appendix B. Taking Care of aculight HR Treatment Heads


B.1 Introduction ..................................................................................... B-1
B.2 Cleaning the Integral Filter .............................................................. B-1
B.3 Calibrating the System ..................................................................... B-2
B.4 Handling the Treatment Heads ........................................................ B-2

viii PB 3581110 Rev. B


LIST OF FIGURES
Chapter 1. System Overview
Figure 1.1 aculight HR ............................................................................1-1

Chapter 2. Safety
Figure 2.1 Caution Sign for the Treatment Room ...................................2-3
Figure 2.2 Machine Labels ......................................................................2-6
Figure 2.3 System Safety Features on Control Panel ..............................2-9
Figure 2.4 Circuit Breaker .....................................................................2-11

Chapter 3. System Description


Figure 3.1 aculight HR Major Components ............................................3-1
Figure 3.2 aculight HR Block Diagram ..................................................3-2
Figure 3.3 Control Panel ..........................................................................3-5
Figure 3.4 Treatment Head ......................................................................3-6

Chapter 4. Installation
Figure 4.1 aculight HR Physical Dimensions .........................................4-2
Figure 4.2 Location of Line Voltage Label .............................................4-4

Chapter 5. Operation
Figure 5.1 Flowchart of Main Screens ....................................................5-2
Figure 5.2 Current Treatment Head .........................................................5-3
Figure 5.3 Unidentified Head Message ...................................................5-3
Figure 5.4 Initialization Screen ...............................................................5-4
Figure 5.5 Treatment Screen ...................................................................5-4
Figure 5.6 Calibration Warning Message ................................................5-5
Figure 5.7 Fields in Treatment Screen ....................................................5-6
Figure 5.8 Ready Screen ........................................................................5-10
Figure 5.9 Pulse Parameters Window ...................................................5-11
Figure 5.10 Menu screen .........................................................................5-13
Figure 5.11 aculight HR Power Meter ....................................................5-13
Figure 5.12 Location of Socket for Connecting Power Meter ................5-15
Figure 5.13 Calibration Screen ................................................................5-16
Figure 5.14 Calibrating the Treatment Head ...........................................5-16
Figure 5.15 Progress of Calibration .........................................................5-17
Figure 5.16 Recharging between Pulses ..................................................5-17
Figure 5.17 No Power Meter Signal ........................................................5-18
Figure 5.18 Calibration Results Screen ...................................................5-18
Figure 5.19 Calibration Failure ...............................................................5-19
Figure 5.20 Change Head Confirmation .................................................5-20
Figure 5.21 Replacing the Treatment Head .............................................5-20

PB 3581110 Rev. B ix
Figure 5.22 Treatment Head Disconnected .............................................5-21
Figure 5.23 New Treatment Head Identification .....................................5-21
Figure 5.24 Idle Mode Screen .................................................................5-22
Figure 5.25 Statistics Screen ...................................................................5-23
Figure 5.26 Advanced Screen ..................................................................5-25
Figure 5.27 Advanced Screen in User Mode ...........................................5-26
Figure 5.28 Save Parameters Message ....................................................5-27
Figure 5.29 Treatment Screen with User Parameters ..............................5-27

Chapter 6. Maintenance and Troubleshooting


Figure 6.1 Replacing the Treatment Head ...............................................6-2
Figure 6.2 Filling the Water Tank ...........................................................6-3
Figure 6.3 Error Message ........................................................................6-6

x PB 3581110 Rev. B
1
C H A P T E R

SYSTEM OVERVIEW
Chapter 1 is a general introduction to the aculight HR
system.

Caution
Personnel operating or maintaining this
equipment should read this manual thoroughly
before attempting to operate the aculight HR
system.

Figure 1.1 aculight HR

PB 3581110 Rev. B 1-1


1.1 Introduction to the System
The aculight HR is an intense pulsed light device for
hair removal. aculight HR hair removal is based on the
principle of selective photothermolysis. According to
this principle, pulses of light selectively damage the
target hair follicles without damaging the surrounding
tissue.

The aculight HR is an advanced, computer-controlled


system consisting of three major components: system
console, control panel and treatment head.

The system console contains all the components


required for operation and control of the system.
A single-board computer inside the console controls the
operation and continuously monitors the functioning of
the system.

The control panel includes a 10.4" flat-panel touch


screen, which serves as the user interface. It displays
the machine modes and parameters and accepts the
user’s commands.

Also on the control panel are the keyswitch, indicators


and emergency shut-off knob.

The hand-held treatment head contains the light pulse


generator and the light guide delivery system.

Refer to Chapter 3, System Description for a detailed


description of the system.

1.2 Indications for Use


The aculight HR is used for the removal of unwanted
hair from all skin types. It is intended to effect stable
long-term, or permanent hair reduction in skin types I to
V through selective targeting of melanin in hair
follicles.

Permanent hair reduction is defined as long-term stable


reduction in the number of hairs regrowing after a
treatment regimen.

1-2 PB 3581110 Rev. B


System Overview

1.3 Treatment Parameters


The aculight HR system allows the user to adjust the
treatment parameters. The treatment parameters are:
Fluence Determines the amount of light
energy to which the treated area
will be exposed.
Pulse Type Short, Medium and Long.
Determines the number of pulses,
pulse duration and delay between
the pulses.

PB 3581110 Rev. B 1-3


1-4 PB 3581110 Rev. B
2
C H A P T E R

SAFETY
2.1 General
This chapter describes general safety issues regarding
the use of the aculight HR, with special emphasis on
optical and electrical safety.

Warning
Use of controls or adjustments, or performance of
procedures other than those specified herein may
result in hazardous radiation exposure.

Therefore, clinicians and other personnel


operating or maintaining the aculight HR should
read this manual and become thoroughly familiar
with all its safety requirements and operating
procedures before attempting to operate the
system.

2.2 Introduction
The aculight HR is an instrument designed for safe and
reliable hair removal. With proper operation and
maintenance, the system can be used safely by trained,
qualified practitioners. The operator and all other
personnel operating or maintaining this equipment
should be familiar with the safety information provided
in this chapter.
The primary considerations should be for the safety of
the client, the operator and other personnel.

PB 3581110 Rev. B 2-1


Considerable thought was given during the design of the
aculight HR, to maximize safety for both client and
operator. Following are some of the system’s
preventative measures:
• A self-test of the electrical circuits takes place after
the machine is turned on or a treatment head has been
changed. The test circuits continuously monitor the
operation of the system during treatment.
• A closed filter/light guide geometry is used to
transmit light to the client's skin. Light is emitted only
through the front plane of the light guide.
• Independent safety circuits shut down the system to
prevent exposure to a light overdose.
• An emergency shut-off knob expedites shutdown
when necessary.
• A key switch prevents unauthorized activation of the
device.
• A warning buzzer sounds when the machine is ready
to trigger a pulse.

Warning
Any intense pulsed light emitting device can
cause injury if used improperly. High voltages are
present inside the aculight HR unit.

Personnel who work with intense pulsed light


sources should always be aware of the possible
dangers and should take the proper safeguards
as described in this manual.

Caution
Restricted device. Federal law (USA) restricts this
device to sale by or on the order of a physician or
any practitioner licensed by the law of the state in
which he or she practices to use or order the use
of the device.

2-2 PB 3581110 Rev. B


Safety

The Client
Client safety is primarily assured by a well-trained staff
and a well laid out treatment room. Client education is
also important, including information about the nature
of the treatment.

Clients should wear aculight protective eyewear


(optical density 5) during treatment.

The Operator and Other Personnel


Exposure to intense pulsed light requires eye protection
suited to the wavelength. The operator and attending
personnel should wear aculight protective eyewear
(optical density 3) during treatment.

The Treatment Room


The treatment room should be clearly labeled, with
signs indicating that high intensity light is being used.
Figure 2.1 shows the treatment room caution sign that is
supplied with the system.

Figure 2.1 Caution Sign for the Treatment Room

PB 3581110 Rev. B 2-3


2.3 Major Cautions and Warnings
The following cautions and warnings are to be heeded
for safe use of the aculight HR.

Cautions
• Only aculight authorized personnel may service the
aculight HR system, especially inside its protective
covers. This includes making internal adjustments to
the power supply, cooling system, optics, treatment
head, etc. Dangerous voltages are present inside the
unit.
• Verify that the aculight HR is wired for the appropri-
ate electrical voltage of your country (200 V, 208 V
or 230 V).
• Maintenance should be performed by the user only
when the unit is shut down and disconnected from
power. Performing maintenance procedures with the
system powered up may be hazardous to the user and/
or destructive to the system.
• The light guide must be kept clean at all times and gel
should not be allowed to seep inside the treatment
head. The light guide should be covered with the
provided plastic covers, which should be cleaned
thoroughly or replaced after every client.
• If water is detected leaking from the treatment head,
the aculight HR should not be turned on. If it is
already on, it should be turned off immediately.
Replace the leaking head before starting the system.

2-4 PB 3581110 Rev. B


Safety

Warnings Related to Intense Pulsed


Light and Potential for Damage
• Intense pulsed light emission presents an eye hazard
and a potential fire or burn hazard. Take all necessary
precautions in areas where the aculight HR is being
used.
• Delivering excessive energy to the treatment site can
result in thermal damage to the skin, resulting
sometimes in hypertrophy and/or atrophy and/or
abnormal pigmentation.
• The aculight HR emits intense pulsed visible and
near infrared light. Make sure that the client and all
those present in the treatment room guard against
accidental exposure to this emission either directly
from the treatment head or indirectly from a
reflecting surface. To protect against eye damage and
discomfort make sure that the client and all personnel
wear aculight safety eyewear.
• Never look directly at the light beam coming from the
treatment head, even when wearing aculight safety
eyewear.
• Never point the treatment head so that it discharges
into free space. Make sure it is hanging on its hook,
or, during actual treatment, pointed at the target area.
• Keep hands away from the treatment head during
system start-up.

PB 3581110 Rev. B 2-5


Labels
The following labels are affixed to the back of the
aculight HR console.

CAUTION
HIGH VOLTAGE / HIGH
CAPACITANCE

UNIT CONTAINS POTENTIALLY


LETHAL ELECTRICAL CHARGE

BEFORE WORKING ON UNIT:

- Disconnect All Cables including


- Wear insulated gloves
- Short Capacitors to Ground
(See Operating Manual)
AX6018200

CAUTION - HIGH VOLTAGE


BEFORE WORKING ON THIS UNIT
- SWITCH OFF POWER SUPPLY
- DISCONNECT ALL PLUGS
AX6018300

Figure 2.2 Machine Labels

2-6 PB 3581110 Rev. B


Safety

2.4 Optical Safety


The following guidelines are to be followed to ensure
optical safety:
• Guard against accidental exposure to the intense
pulsed light by ensuring that all personnel, including
the client, wear aculight protective eyewear
whenever the aculight HR is in use. If the client
cannot wear the eyewear, fit the client with opaque
eye protection that completely blocks light from the
eyes.
• Clearly identify the room in which the aculight HR is
located, and post the caution sign in a prominent
location (see Figure 2.1).
• Allow access to the aculight HR treatment room only
to personnel essential to the procedure and well
trained in the required safety procedures.
• Make sure that all treatment room personnel are
familiar with the aculight HR’s controls and know
how to shut down the system instantly.
• One qualified person should be responsible for the
aculight HR’s controls during the procedure.
• Never look directly at the intense pulsed light emitted
from the treatment head of the aculight HR or
reflecting surfaces, even when wearing protective
eyewear.
• Do not use the treatment head in any way other than
that specified in this manual.
• Do not use the aculight HR in the presence of
explosive anesthetics or other flammable materials.
• Never direct the pulsed light at anything other than
the targeted area.
• Never permit reflective objects such as jewelry,
watches, surgical instruments or mirrors to reflect the
pulsed light.
• Do not expose any skin to the pulse except the test
patch and the treatment area.

Warning
Delivering excessive energy to the treatment site
can result in thermal damage to the skin possibly
leading to hypertrophy and/or atrophy and/or
abnormal pigmentation.

PB 3581110 Rev. B 2-7


2.5 Electrical and Mechanical Safety
• Keep all covers and panels of the aculight HR closed.
Removing the covers creates a safety hazard.
• The aculight HR produces very high voltages which
may be dangerous. Some components may retain a
charge after the power supply has been turned off, so
no part of the exterior housing should be removed,
except by authorized aculight personnel.
• Never leave the aculight HR turned on, open or
unattended during system maintenance.
• The aculight HR weighs 80 kg (176 pounds) and may
cause injury if proper care is not used when moving
it. The system is well balanced and is designed to be
moved, but should always be moved carefully and
slowly.
• The unit is grounded through the grounding
conductor in the power cable. This protective
grounding is essential for safe operation.

2.6 Fire Hazards


The absorption of optical energy raises the temperature
of the absorbing material. Take precautions to reduce
the risk of igniting combustible materials in and around
the treatment area.
Do not use any flammable substance such as alcohol or
acetone in the preparation of the skin for treatment. If
necessary, use soap and water.
If alcohol is used to clean and disinfect any part of the
aculight HR, it must be allowed to dry thoroughly
before the system is used.

2-8 PB 3581110 Rev. B


Safety

2.7 System Safety Features


The aculight HR is equipped with a number of safety
features (see Figure 2.3 and Figure 2.4). All treatment
room personnel should be familiar with the location and
operation of these safety features.

Emission Indicator

Key Switch
Power-On Indicator
Emergency Shut-off Knob

Figure 2.3 System Safety Features on Control Panel

Key Switch
The key switch connects and disconnects electrical
power to the system, and is used to switch the system
ON and OFF. Operation of the system is possible only
with the key provided by aculight. This prevents
unauthorized use of the unit.
Do not leave the aculight HR unattended with a key in
it.
Verify that the system is inoperable when the key is
removed.

PB 3581110 Rev. B 2-9


Power-On Indicator
After switching on the system, this green indicator lights
up to show that the system is turned ON.

Emergency Shut-off Knob


This red knob is designed for emergency shutdown of
the unit. When pressed, it immediately shuts off power
to the system, regardless of the state of the machine.
To release the emergency shut-off knob, turn it
clockwise in the direction of the arrows. Otherwise, the
system will remain OFF.

Emission Indicator
The aculight HR is equipped with a yellow emission
indicator, which is mounted on the control panel.
The emission indicator has two modes of operation:

Off When the system is turned on


and in Standby mode.
Blinking When the system is charging
the capacitors and in Ready
mode, prior to pulse
emission.

In addition, a buzzer in the machine console sounds


when the system completes charging of the capacitors
and converts to the Ready mode, providing an audible
alert prior to pulse emission.

Remote Interlock Connector


The aculight HR incorporates a safety remote interlock
connector for connecting an external interlock on the
entrance door to the treatment room. The external

2-10 PB 3581110 Rev. B


Safety

remote interlock, when installed, disables the system


and prevents operation when the entrance door is open.

Idle Mode
The inactivity timer feature switches the unit to Idle
mode whenever it has not been used for ten minutes.
The system can also be switched to this mode by
manually pressing the Idle button. When the system is in
the Idle mode, the capacitors are discharged, the light
guide chiller is turned off and the system remains
inoperable until manually activated.

Circuit Breaker
A circuit breaker located inside the aculight HR, at the
bottom of the rear panel of the console, protects the
system against excessive current consumption. The
circuit breaker disconnects power to the system if the
current consumption exceeds 16 A (for 200/208 V AC)
or 13 A (for 230 V AC). To resume system operation,
lift the circuit breaker handle.

Circuit Breaker
Handle

Figure 2.4 Circuit Breaker

PB 3581110 Rev. B 2-11


Self-Test
A self-test of the electrical circuits occurs after the
machine is switched ON or the treatment head is
changed. The test circuits continuously monitor the
operational system during the treatment period.

2.8 Equipment Classification


• Electric shock protection: Class I, Type BF
• Protection against ingress of liquids: Ordinary
equipment
• Not suitable for use in presence of flammable
anesthetic mixture with air or nitrous oxide
• Mode of operation: Continuous

2.9 Compliance with International


Standards
The aculight HR is designed to comply with the US
Federal Performance Standards 21 CFR 1010 and 1040.
The aculight HR is designed to comply with IEC 601-1
standard for Safety of Medical Devices and IEC 601-1-2
for Electromagnetic Compatibility.
The aculight HR complies with the Medical Device
Directive (MDD) 93/42/EEC.
In compliance with these standards, the aculight HR is
equipped with:
• emission indicators
• energy display
• master key switch
• emergency shout-off knob
• remote interlock connector
• proper labeling

2-12 PB 3581110 Rev. B


3
C H A P T E R

SYSTEM DESCRIPTION
This chapter provides a general description of the
aculight HR system, including its main components,
controls, and technical specifications.

3.1 System Components and Controls


The aculight HR consists of the following major
components (Figure 3.1):
• System console
• Control panel
• Treatment head
The system is continuously monitored and controlled by
its internal computer.

Treatment
Head

Control
Panel

System
Console

Figure 3.1 aculight HR Major Components

PB 3581110 Rev. B 3-1


The block diagram of the aculight HR is shown in
Figure 3.2.

Control Panel

Emergency LCD with


Shut-off Touch Screen Key Switch

System Console Treatment Head

PC

Trigger
button

I2C Card

Over
Energy

Light pulse Light


Power & Control generator
Mains Power Interface Module Switching Module
Module

Overvoltage
Capacitor Bank
HV Power Supply TE Cooler

Simmer PS

DC PS

Flow Switch

Cooling System

Level Switch
Power Meter

Figure 3.2 aculight HR Block Diagram

3-2 PB 3581110 Rev. B


System Description

System Console
The system console is the operational heart of the
system. It contains the components required for
operation and control of the system. The console
comprises the following modules:

Name Function
Computer & Interface Controls the operation of the entire system. It
Card (I2C) receives input from all the modules and performs
the appropriate functions.
Power and control module Supplies power to the system modules. It also
shuts down the system in case of any malfunction.
Interface module Serves as an interface between the computer and
system modules.
Switching module Switches the electrical energy into the flashlamp.
High voltage power Charges the capacitor bank.
supply (HVPS)
Capacitor Bank Stores the energy used for the light pulses.
DC Power Supply (DCPS) Provides power for the Simmer power supply, the
Cooling system and the thermo-electric (TE)
cooler.
Simmer Power Supply Ignites the flashlamp and keeps it conducting in
simmer mode.
Cooling System Removes the heat generated in the treatment head.

Access to all internal modules is enabled only by


removal of the side panels and should not be attempted
by the user.

PB 3581110 Rev. B 3-3


Control Panel
The user interacts with aculight HR through the control
panel located on the system console. The control panel
includes:
Key Switch Turns the system ON and OFF. The
system can be operated only with the
key provided by the manufacturer (see
Figure 3.3).
Power ON Green indicator that lights up when the
Indicator system is turned on (see Figure 3.3).
Emergency A red, mushroom-shaped knob for
Shut-off Knob emergency shut-down of the unit (see
Figure 3.3). Pressing it immediately
shuts off power to the entire system.
The emergency shut-off state takes
precedence over the key switch.
To release the emergency shut-off
knob, turn it clockwise in the direction
of the arrows. Otherwise, the system
remains off.
Emission A yellow light that blinks when the
Indicator system is charging and when the
system is in Ready mode.
Display and Serves as the user’s interface to the
Control system. It is a 10.4" color graphic
Liquid Crystal Display (LCD) with a
touch screen. It displays the screens
and command buttons as well as
messages and instructions for the user.
The screen may be tilted to avoid
overhead lighting glare.
Never move the system by holding the
control panel. Always use the handles.

3-4 PB 3581110 Rev. B


System Description

Emission Indicator

Touch Screen Display

Key Switch
Power On Indicator

Emergency Knob

Figure 3.3 Control Panel

Treatment Head
The treatment head houses the mechanisms that
generate the light pulse. It is connected to the system
console by an umbilical cord. A glass light guide coated
with a filter is mounted at the bottom of the treatment
head.
The light pulse is activated by pressing the trigger on the
treatment head handle. The light passes through an
aperture and a 34 x 8 mm filter-coated light guide onto
the treatment area. The light guide transmits the light
from the treatment head to the client’s skin. It is
important to keep the light guide clean at all times.

PB 3581110 Rev. B 3-5


Available There are several head types available for treatment
Treatment with the aculight HR, to provide greater utility in the
Heads treatment of a broad range of skin and hair types. Each
type of treatment head has a filter with a different
wavelength. The standard treatment head has a 695 nm
long-pass filter. The other head types are optional.

Trigger
Handle

Thermo-Electric Cooler
Glass Light Guide (inside)

Figure 3.4 Treatment Head

Thermo-Electric Cooler
The light guide is cooled by a thermo-electric (TE)
cooler, which is incorporated in the treatment head. The
cooled light guide reduces skin temperature, thus
reducing client discomfort. The TE cooler has two
cooling levels and can also be turned off.

3.2 System Software


The software installed in the aculight HR serves three
major purposes:
1. To enable the system to select optimal treatment
parameters for every client, according to the specific
parameters input by the user.
2. To control the machine operation and to prevent the
occurrence of safety hazards.
3. To check and perform energy calibration.

3-6 PB 3581110 Rev. B


System Description

3.3 System Specifications


Light source Intense pulsed light source
Pulse type Short, medium or long
25 to 45 J/cm2 for the 695 nm and 645 nm heads
Fluence range
20 to 35 J/cm2 for the 755 nm head
Spot size 8 x 34 mm
Optical filter 695 nm (645 nm and 755 nm optional)
Cooled with an embedded cooling system. Two
Light guide
temperature settings of approx. 1°C and -14°C.
Operating screen 640 x 480 pixel flat-panel touch screen
200 V AC ± 10%, 16A, single phase
208 V AC ± 10%, 16A, single phase
Electrical requirements 230 V AC ± 10%, 13A, single phase
50/60 Hz dedicated line (standard outlet according
to country)
40 x 55 x 106 cm (16" x 22" x 42") without
umbilical support
Physical dimensions
40 x 55 x 186 cm (16" x 22" x 73") with umbilical
support
Weight 80 kg (176 lb)

Environmental Conditions
Operating Temperatures: l0°C– 30°C (50°F – 86°F)
Storage Temperatures: 0°C – 55°C (32°F – 131°F)
Relative Humidity - Operating: Up to 80%
Relative Humidity - Storage: Up to 90%

PB 3581110 Rev. B 3-7


3-8 PB 3581110 Rev. B
4
C H A P T E R

INSTALLATION
The aculight HR is designed for installation in a clinic
and requires minimal site preparation. When the
aculight HR system is purchased, complete on-site
installation including initial system test and calibration
is included.
Installation is carried out by authorized aculight
personnel, who do the following:
• Unpack the aculight HR system and position it in the
pre-selected location.
• Verify the integrity of the unit and its components.
• Plug the system into a designated electrical outlet.
• Test the system for proper calibration and functional
operation of all components.

4.1 Equipment List


The aculight HR system includes the following:
• aculight HR system console and Control panel
• Two standard 695 nm treatment heads
• Four pairs of protective eyewear (2 pairs optical
density 3 for the operator and staff, and 2 pairs optical
density 5 for the client)
• One power meter
• Coupling gel
• Light guide covers (plastic)
• Funnel for adding distilled water
• Operator’s Manual

PB 3581110 Rev. B 4-1


4.2 Facility Requirements
Before unpacking the aculight HR system, ensure that
the site meets the requirements described in this section.

Space Requirements
The physical dimensions of the system are:

Width: 40 cm (16"), height: 186 cm (73") (with


umbilical support) and depth: 55 cm (22").

Place the system away from heating ducts or other


outlets. Keep at least 60 cm (2 ft.) of free space around
all sides of the system.

186 cm
(73")

55 cm
40 cm

40 cm

Figure 4.1 aculight HR Physical Dimensions

4-2 PB 3581110 Rev. B


Installation

Electrical Requirements
The aculight HR system is factory pre-wired for the
local line voltage, as ordered by the customer.
Accordingly, the unit will require a separate line supply
of at least:
• Single phase 230 V AC ±10%, 16 A, 50/60 Hz, or
• Single phase 208 V AC ±10%, 20 A, 50/60 Hz, or
• Single phase 200 V AC ±10%, 20 A, 50/60 Hz.
The unit is grounded through the grounding conductor
(yellow/green) in the power cable that is plugged into
the wall power outlet. Proper grounding is essential for
safe operation.
Input power lines should be free of transients, voltage
and current spikes, sags and surges. Consequently the
system power line should not be shared with other
heavy variable loads such as elevators, air conditioning
systems, large motors etc.
It is strongly recommended that the system be
connected to a separate power line with separate circuit
breakers. aculight cannot guarantee adequate
performance unless the system is connected to a
dedicated circuit.
The main fuse located within the unit is a 13 A circuit
breaker (for 230 VAC) or 16 A (for 200 V or 208 VAC).
When the circuit breaker trips, it disconnects power
from the system.
To restore the power after the circuit breaker has
tripped, raise the circuit breaker handle.

Caution
Verify that the aculight HR is wired for the
appropriate line voltage of your country (200 V,
208 V or 230 V) by checking the label located on
the back of the system (see Figure 4.2).

PB 3581110 Rev. B 4-3


Rear Panel

Local
Line
Voltage

Figure 4.2 Location of Line Voltage Label

Environmental Requirements
Air Quality The aculight HR should operate in a non-corrosive
atmosphere. Corrosive materials such as acids can
damage electrical wiring, electronic components and the
surfaces of optical components.
Air-borne dust particles should be kept to a minimum.
Dust particles absorb light and heat up. Hot particles
located on the optical filters can cause damage.

Temperature To ensure that the aculight HR can perform optimally, it


is recommended to maintain a room temperature
between 20°C and 25°C and relative humidity of less
than 80%. When the system is used intensively, it emits
up to 2 kW of heat. Therefore, it is recommended to
install air conditioning.

4-4 PB 3581110 Rev. B


Installation

4.3 Moving the System


To move the system within the facility:
1. Disconnect the power cable.
2. Hang the treatment head on its hook.
3. Release the wheel brakes.
4. Slowly push or pull the unit using the handle.
Never pull on the touch screen panel.
If the aculight HR has to be moved to another facility,
consult your service representative.

PB 3581110 Rev. B 4-5


4-6 PB 3581110 Rev. B
5
C H A P T E R

OPERATION
This chapter contains detailed operating instructions for
the aculight HR.

Information about the therapeutic applications of the


system is provided in Appendix A: Clinical Guide.

Warning
Dangerous voltages are present inside the unit!
Keep all panels and covers closed.

The treatment head should be hanging on its hook


during machine start-up.

The aculight HR emits intense light pulses. Make


sure that everyone present in the room during
treatment wears the appropriate safety eyewear.

Never look directly at the light pulse coming from


the treatment head, even when wearing the
appropriate safety eyewear.

Never direct the treatment head at anything other


than the targeted treatment area.

Warning
Delivering excessive energy to the treatment site
can result in thermal damage to the skin possibly
leading to hypertrophy and/or atrophy and/or
abnormal pigmentation.

PB 3581110 Rev. B 5-1


5.1 Screens and Functions
The aculight HR is operated by touching the screen to
adjust treatment parameters and to navigate from screen
to screen. Figure 5.1 shows the relationship between the
main screens.
The Treatment screen is used for setting pulse type and
fluence level. When these settings are confirmed by
pressing the Ready button, treatment can start.
From the Menu screen, you can navigate to four other
screens:

To calibrate the treatment head


Calibration
using the power meter
To enter Idle mode, when the
Idle system will not be used for a short
period of time
To view information about the
Statistics treatment head and number of
pulses since the last calibration
Intended for experienced users.
Advanced This mode allows manipulation of
Pulse-Type settings.

HR Treatment Calibration
Standby
Reset counter Idle
Set pulse type Menu
Menu
Set fluence
Statistics
Ready
Ready to treat Advanced

Treat

Figure 5.1 Flowchart of Main Screens

5-2 PB 3581110 Rev. B


Operation

5.2 Starting the System


Plug the aculight HR into the wall outlet. Insert the key
in the key switch, turn it fully clockwise and then
release it. The key springs back and the computer start-
up screen appears followed by the aculight logo. The
system identifies the head type and the following
window appears, indicating which head is connected to
the machine.

Figure 5.2 Current Treatment Head

If the appropriate treatment head is connected, press OK.


If you wish to use a different head, press Change Head
(see Section 5.7 Changing the Treatment Head).
If the unit cannot identify the treatment head, the system
displays the following window (Figure 5.3).

Figure 5.3 Unidentified Head Message

If this happens:
1. Press Change Head.
2. Replace the treatment head (see Section 5.7 Changing
the Treatment Head).

PB 3581110 Rev. B 5-3


After confirming the treatment head, the Initialization
screen appears (Figure 5.4) and the system begins a
self-test routine.

Figure 5.4 Initialization Screen

When the self-test is completed, the Treatment screen


appears (Figure 5.5) in Standby mode (Standby button
is green).

Figure 5.5 Treatment Screen

If there is a malfunction during the self-test routine or


during normal operation, an error message appears on
the screen and the machine stops. If this happens,
record the error message, turn off the system and contact
the company’s Service Department.

5-4 PB 3581110 Rev. B


Operation

Calibration
Calibrating your system on a regular basis ensures the
greatest accuracy of its output, as well as consistent
clinical results.
Calibration is mandatory in the following cases:
• When a new head is connected to the system.
• When the connected head was last calibrated on a
different machine.
• When 3000 pulses were emitted from the current
head without performing calibration. Calibration is
required since the actual fluence output of the
treatment head may otherwise decrease over time,
due to age and wear.
In these cases, the following warning message
appears on the screen when you switch on the system,
or after you changed the treatment head.

Figure 5.6 Calibration Warning Message

Pressing the OK button brings the system to the


calibration screen (see Section 5.6 Calibration). After
calibration, it is recommended to perform test patches
before proceeding with the treatment.

PB 3581110 Rev. B 5-5


5.3 The Treatment Screen
The Treatment screen is the main working screen of the
aculight HR. It is divided into four fields, as described
below (Figure 5.7).

Instructions/
Messages

Pulse Counter Function


Buttons

Treatment Parameters

Figure 5.7 Fields in Treatment Screen

Instructions/Messages
This field displays instructions for the operator and
messages on the parameter status.

Note
If the previous use was with user defined pulse
parameters, an additional (third) line appears
indicating that such settings are active (Figure
5.29).

5-6 PB 3581110 Rev. B


Operation

Treatment parameters
From this field the operator selects the treatment
parameters:
• Pulse Type—determines the number of pulses in the
sequence, the pulse duration and the delay between
the pulses. Short, Medium and Long are the available
options. The user may choose either the default
settings or one of his own.
• Fluence—The Treatment screen always appears with
the minimum fluence setting. The operator changes
this setting by pressing the + and - arrows. The
progress bar indicates the position within the
available fluence range.

Pulse Counter
The pulse counter on the Treatment screen indicates the
total number of pulses triggered since the last time the
counter was reset. Each time a pulse is triggered, the
number is incremented by one. The Reset button can be
pressed at any time to reset the counter to zero.

Function Buttons
Ready Pressing the Ready button confirms the selected
treatment parameters and transfers the system to the
Ready mode (Ready button is green). This is the only
mode that enables triggering of the light pulse.

Standby Pressing the Standby button puts the system into the
Standby mode. In Standby mode, the Standby button is
green and light pulses cannot be triggered. All the other
buttons are available and the user can modify treatment
parameters. To return to Ready mode the user presses
the Ready button on the screen.

Change Head Pressing the Change Head button enables changing the
treatment head (see Section 5.7 Changing the Treatment
Head).

PB 3581110 Rev. B 5-7


Chiller The Chiller button controls the thermo-electric (TE)
cooler that cools the light guide in the treatment head.
The chiller has three settings: Chiller Off,
Chiller Medium, and Chiller Max. The button toggles
through the three settings when pressed successively.

Pulse Type The Pulse Type button enables the display of the current
pulse parameters (see Section 5.4 Treatment).

Menu The Menu button displays the Menu screen (see Section
5.5 The Menu Screen).

5.4 Treatment
A typical treatment procedure begins with the system in
Standby mode. The Treatment screen is displayed with
the Standby button green (Figure 5.5).
To begin treatment, proceed as follows:
1. Shave the treatment area to eliminate any surface hair
that could interfere with the treatment.
2. Press the Reset button to reset the Pulse Counter.
3. Select Chiller level by toggling the Chiller button.
4. Set the Pulse Type by pressing Short, Medium or
Long.
The preset pulse type parameters (defaults) for the
available treatment head types are:
Table 5.1 Preset Pulse Type Parameters for 695 nm (standard)
and 645 nm (optional) Treatment Heads

Pulse Type # of Pulse Pulse


Pulses Width Delay
(ms) (ms)

Short 2 5.5 20
Medium 3 3.6 40
Long 3 3.6 100

5-8 PB 3581110 Rev. B


Operation

Table 5.2 : Preset Pulse Type Parameters for 755 nm


Treatment Head (optional)

Pulse Type # of Pulse Pulse


Pulses Width Delay
(ms) (ms)

Short 2 5.5 20
Medium 3 3.6 40
Long 3 3.6 150

The minimum fluence value appears on the screen.


For the 695 nm and 645 nm treatment heads, this
value is 25 J/cm2. For the 755 nm treatment head, this
value is 20 J/cm2. To change the fluence value, press
the plus or minus arrows. Each time the minus arrow
is pressed, the fluence decreases by 1 J/cm2. Each
time the plus arrow is pressed, the fluence increases
by 1 J/cm2.
It is recommended to start with a low fluence
value and trigger a test pulse to evaluate the
client’s response.
5. Press the Ready button to confirm the selected
settings. The system begins charging and the
Emission Indicator starts blinking. When charging
has finished, a buzzer sounds and the system switches
to Ready mode. The Ready button is now green
(Figure 5.8).

PB 3581110 Rev. B 5-9


Pulses can be triggered only when the system is in the
Ready mode.

Figure 5.8 Ready Screen

6. Ensure that the light guide is clean and free of frost


and debris.
7. Mount a clean light guide cover over the light guide.

Note
The light guide cover should be cleaned
thoroughly or replaced for every new client.

8. Apply a thin layer of cold aculight coupling gel to the


treatment site. (Light pulses should be triggered on
cold gel, so spread gel only on the immediate
treatment area and treat immediately, then spread gel
on next area.)
9. Place the treatment head perpendicular to the skin.
The light guide should gently touch the skin.
10.Trigger a pulse by pressing the trigger button on the
treatment head handle (Figure 3.4). The system
recharges automatically. The recharging process
takes about two seconds.
11.Evaluate skin and hair response.
Wipe off the gel and examine the treated site. The
smell of burnt hair and/or a brownish color in the gel
should be detected. Swelling around the hair follicles
should appear within about five minutes after
treatment.

5-10 PB 3581110 Rev. B


Operation

If the skin shows no adverse effects and there are no


visible changes in the hair follicles, increase the
fluence.
12.Treat an adjacent site, slightly (~1 mm) overlapping
the previous site.
Examine the treated site and, if necessary, increase
the energy after each pulse until satisfactory results
are achieved.
13.Record the treatment parameters (Pulse Type and
Fluence) in the client’s file, for future treatments.

Note
It is recommended that the client return several
weeks after treatment for examination of the
treated site, and continuation of treatment if
necessary.

PB 3581110 Rev. B 5-11


Viewing the Current Pulse
Parameters
The currently used values of the pulse parameters can be
viewed any time from the Treatment screen.
1. To view the parameter values press Pulse Type (Fig-
ure 5.5). A message window appears, displaying the
pulse parameters (Figure 5.9).

Figure 5.9 Pulse Parameters Window

2. Press OK to return to the Treatment screen.


3. Press Change Parameters if you wish to change the
parameter values.
Pressing this button displays the Advanced mode
screen (Figure 5.26), which enables you to modify
the parameter values (see Section 5.10 Advanced
Mode).

Note
Changing pulse type parameters is
recommended for advanced users only.

5-12 PB 3581110 Rev. B


Operation

5.5 The Menu Screen


To display the Menu screen (Figure 5.10), press the
Menu button on the Treatment screen with the system in
the Standby mode (Figure 5.5). Select an item from the
menu by pressing the appropriate button. Press the
Treatment button to return to the Treatment screen.

Figure 5.10 Menu screen

5.6 Calibration
aculight recommends daily calibration of the treatment
head output. Calibration is performed with the supplied
power meter.

Slide cover aside to


insert Treatment Head

Figure 5.11 aculight HR Power Meter

PB 3581110 Rev. B 5-13


Note
To provide accurate readings, the power meter
must be kept clean and free of dust and debris.
Clean it with a lint-free cloth and alcohol. Also,
make sure to slide back the power meter cover
after performing calibration.

Caution
The fluence output of a treatment head decreases
over time. Thus, if calibration is performed after
too long a period of time, the actual fluence
emitted may be higher than before the calibration,
for the same setting. Be sure to perform a test
patch before starting treatment.

5-14 PB 3581110 Rev. B


Operation

Calibration Procedure
To calibrate the treatment head output:
1. Plug the power meter connector into the round socket
(marked) on the rear panel of the aculight HR and
screw the connector closed (Figure 5.12).

Socket

Figure 5.12 Location of Socket for Connecting Power


Meter

2. Turn on the machine.


3. On the Treatment screen, press Menu to access the
Menu screen.
4. On the Menu screen, press Calibration.

PB 3581110 Rev. B 5-15


5. After defrosting of the cooled light guide, the
Calibration screen appears (Figure 5.13).

Figure 5.13 Calibration Screen

6. Wipe the light guide with a lint-free cloth to remove


any frost or water droplets and to ensure that it is
clean.
7. Slide the power meter cover open and make sure that
the power meter is clean. Remove the light guide
cover. Carefully mount the treatment head on the
power meter to prevent damage to the light guide
(Figure 5.14).
.

Treatment Head

Power Meter Cover

Power Meter

Figure 5.14 Calibrating the Treatment Head

8. Press the Ready button. The system charges and


enters Ready mode (Figure 5.15).

5-16 PB 3581110 Rev. B


Operation

9. Press the trigger five times to trigger five pulses. The


machine recharges between pulses (Figure 5.16) and
after the last pulse the treatment head is calibrated
automatically.

Number of Pulses
is decremented by
one after each
triggered pulse

Figure 5.15 Progress of Calibration

Figure 5.16 Recharging between Pulses

PB 3581110 Rev. B 5-17


If the system detects no signal from the power meter,
the following message appears.

Figure 5.17 No Power Meter Signal

Verify that the power meter is properly connected to


the console (Figure 5.12) and press OK. The
calibration process restarts.

10.To stop the calibration process, press the Abort


button. This button is disabled if calibration is
mandatory.

11.When calibration is completed successfully, the


Calibration succeeded message appears on the
Calibration screen (Figure 5.18).

Figure 5.18 Calibration Results Screen

12.Press the Treatment button to return to the Treatment


screen, or press the Menu button to return to the Menu
screen.

5-18 PB 3581110 Rev. B


Operation

13.Unscrew the power meter connector and return the


power meter to its box, or you may leave it connected
to the system. Make sure to slide back the power
meter cover before storing it. This prevents dust from
accumulating inside.
14.If the calibration fails, the following screen and
message appear:

Figure 5.19 Calibration Failure

• Verify that the light guide and power meter are clean
and free of dust and debris.
• Press the Calibrate button and repeat the calibration
process.
• If the calibration fails a second time, press the
Change Head button and replace the treatment head
(see Section 5.7 Changing the Treatment Head).

5.7 Changing the Treatment Head


You can change the treatment head anytime during
operation, without shutting down the entire system.
To change the current treatment head, proceed as
follows:

PB 3581110 Rev. B 5-19


1. Press the Change Head button on the Treatment
screen (Figure 5.5). The following message appears.

Figure 5.20 Change Head Confirmation

2. Press Yes to confirm. The application closes


automatically, the logo screen appears, followed by a
message allowing the head replacement (Figure
5.21). The head type and serial number appear in the
message.

Figure 5.21 Replacing the Treatment Head

If you decide to resume operation without replacing


the head, press the Treatment button. This will restart
the application and the Treatment screen will
reappear.

If you want to shutdown the system completely, press


the Shut down button.

3. Remove the treatment head (see Section 6.3


Replacing the Treatment Head).

5-20 PB 3581110 Rev. B


Operation

Once the head is disconnected, the message on the


screen changes accordingly (Figure 5.22).

Figure 5.22 Treatment Head Disconnected

4. Install the selected head. (see Section 6.3 Replacing


the Treatment Head). Once the head is connected, the
system identifies it and displays a message showing
the new head type and serial number (Figure 5.23).

Figure 5.23 New Treatment Head Identification

5. Press Treatment to restart the application. The system


performs the required tests and checks if calibration is
required.

6. If calibration is not required, the Treatment screen


reappears and the treatment can resume.

7. If calibration is required, the calibration screen


appears (Figure 5.13). Follow the calibration
procedure (see Section 5.6 Calibration).

PB 3581110 Rev. B 5-21


5.8 Idle Mode
When the Idle button is pressed, the system switches to
Idle mode and the Idle screen appears (Figure 5.24).
The capacitors discharge and the light guide chiller is
turned off. The system should remain in Idle mode
whenever it is ON and not in use, for example between
clients or during a break. When the system is in Idle
mode, settings cannot be changed, and pulses cannot be
triggered.
Touch the Idle screen to exit and return to the Treatment
screen in Standby mode.

Note
The aculight HR automatically enters Idle mode
if it has not been used for ten minutes. The
system shuts down automatically after one hour
in Idle mode.

Figure 5.24 Idle Mode Screen

5-22 PB 3581110 Rev. B


Operation

5.9 Statistics
When the Statistics button is pressed, the Statistics
screen appears (Figure 5.25).

Figure 5.25 Statistics Screen

The screen provides the user with the following


information:
Serial No. The treatment head’s serial number
Software The system computer’s software
Version version
On System Total number of pulses that the
machine has emitted
Delivered Total number of pulses that the
current treatment head has emitted
Since Number of Pulses that the machine
Calibration has emitted since the last calibration

PB 3581110 Rev. B 5-23


5.10 Advanced Mode
The Advanced mode is intended for the experienced
user. In this mode, the user can determine his own set of
pulse parameters (Number of Pulses, Pulse Width and
Pulse Delay) and then save them for future use.
See table 5.3 for the range of Pulse Type parameters in
the Advanced user mode.

Head Type Pulse # of Pulse Width Pulse Delay


Type Pulses (ms) (ms)

Short 2 or 3 3 - 6 @ 0.1 10 - 30 @ 5
695
Medium 2 or 3 3 - 6 @ 0.1 35 - 80 @ 5
(Standard)
Long 2 or 3 3 - 6 @ 0.1 85 - 150 @ 5

Short 2 or 3 3 - 6 @ 0.1 10 - 30 @ 5
755
Medium 2 or 3 3 - 6 @ 0.1 35 - 80 @ 5
(Optional)
Long 2 or 3 3 - 6 @ 0.1 85 - 150 @ 5

Short 2 or 3 3 - 6 @ 0.1 10 - 30 @ 5
645
Medium 2 or 3 3 - 6 @ 0.1 35 - 80 @ 5
(Optional)
Long 2 or 3 3 - 6 @ 0.1 85 - 150 @ 5

Table 5.3 Pulse Type Parameters


See table 5.4 for the fluence range for each of the
treatment heads.
Table 5.4 Fluence Range for the Treatment Heads

Pulse Fluence Range (J/cm2)


Type
695-nm Head 645-nm Head 755-nm Head

Short
Medium 25–45@1 25–45@1 20–35@1
Long

5-24 PB 3581110 Rev. B


Operation

To access the Advanced mode from the Treatment


screen, press Menu and press the Advanced button.
The following screen appears:

Current
Parameter Values

Parameter
Values
Window

Figure 5.26 Advanced Screen

The screen shows the current parameter values. These


can be either the default values (Default button is green)
or the user defined parameters (User button is green).

Note
For each Head Type, each Pulse Type (Short,
Medium or Long) has one set of default
parameters. The user can modify these settings
and save them as user-defined parameters.

To change a value of a parameter:


1. Press the parameter button that you want to change,
(# of pulses, Pulse width or Pulse delay). The
selected parameter name appears next to Pulse Type
with the current value in the window (Figure 5.26) .
Use the + and - arrows to change the value. The
progress bar indicates the position of the current
value within the parameter’s range.
As you change the parameter value, the current value
changes accordingly in the top section of the screen.

PB 3581110 Rev. B 5-25


When you modify a parameter value, the User button
is green (User mode, Figure 5.27). This indicates that
the current parameters are User-defined.

Figure 5.27 Advanced Screen in User Mode

2. Repeat the procedure for each parameter that you


want to modify. When you have finished updating,
press Save. The updated set of parameters is now
saved and will be used for treatment when you return
to the Treatment screen.
Pressing Save overwrites any previously saved set of
user parameters. Pressing the Default button always
resets the system to the default parameters.

Note
Only one set of user defined parameters can be
saved. Pressing the Save button saves the
current values that appear on the screen as the
user defined parameters.

3. Press the Treatment button to return to the Treatment


screen. If you have not saved the modified
parameters, the following message appears,
prompting you to save.

5-26 PB 3581110 Rev. B


Operation

Figure 5.28 Save Parameters Message

• If you do not save, the last saved user defined


parameters will be used during treatment.
• If you decide to use the default values, press the
Default button before exiting the Advanced
screen.
• When user parameters are selected, the Treatment
screen indicates that User Defined Parameters
are being used (Figure 5.29). You may view the
User Defined Parameters at any time by pressing
the Pulse Type button.

Figure 5.29 Treatment Screen with User Parameters

PB 3581110 Rev. B 5-27


5.11 Turning Off the System
Turn the aculight HR off by turning the key switch
counter-clockwise. The shut-down process takes
approximately one minute.
In an emergency, press the red emergency shut-off
knob, to shut the system down immediately.
This emergency state takes precedence over the key
switch and bypasses the controlled shut-down sequence.
This knob should be used only in an emergency.
To release the emergency shut-off knob, turn the red
knob clockwise (in the direction of the arrows). If it is
not released, the system will not react when turned on
again.
The aculight HR should be turned off at the end of each
workday and whenever it is not in use for an extended
period of time.

5-28 PB 3581110 Rev. B


6
C H A P T E R

MAINTENANCE AND TROUBLESHOOTING


This chapter describes routine maintenance procedures
performed by the user: cleaning the unit, cleaning the
light guide, replacing the treatment head and output
calibration. It also provides a troubleshooting guide
which contains the most common system problems and
their solutions.
The procedures in this chapter and those listed in the
troubleshooting guide at the end of the chapter should
be the only maintenance activities you perform. All
other service procedures are to be performed only by the
company’s authorized service personnel.

Warning
Maintenance by the user should be performed
only when the unit is shut down and disconnected
from power. Performing maintenance procedures
with the system ON can be hazardous to you and/
or destructive to the system.

6.1 Cleaning the Unit


Clean the aculight HR at least once a week. Wipe
surfaces with a soft, damp, non-abrasive cloth. A mild
cleansing solution may be used. Be careful not to spill
any liquids on the unit.

6.2 Cleaning the Light Guide


The light guide should be kept clean at all times and
should be cleaned after each client.

PB 3581110 Rev. B 6-1


To clean the light guide, first dry it with a lint-free cloth.
Then clean it with a cloth moistened with ethyl alcohol
or isopropyl alcohol and let it dry thoroughly.

Caution
Never immerse the light guide or any other part of
the treatment head in water, nor hold it under
running water.

6.3 Replacing the Treatment Head


Each aculight HR treatment head contains an ID chip
with a unique serial number, as well as important
parameters such as calibration data.
If a treatment head becomes unusable, replace it and
return the unusable head to aculight.
Head replacement should be performed when the
system is turned off, or in the Change Head mode
(see Section 5.7 Changing the Treatment Head).

Open
Top Cover

Catch on each side

Figure 6.1 Replacing the Treatment Head

6-2 PB 3581110 Rev. B


Maintenance and Troubleshooting

To replace the treatment head:


1. Lift the top cover of the system.
2. Press on both sides of the catch to disengage the
treatment head connector.
3. Pull the treatment head connector out.
4. Verify that you are inserting the appropriate head.
Hold the new treatment head connector in front of the
connector base and slide the treatment head connector
along the groove until it clicks into place.
5. If the sytem was turned off , restart the system.
If the system was in Change Head mode, press
Treatment to restart the application.
6. Calibrate the new treatment head (refer to Section 5.6
Calibration).
The new treatment head is now ready for use.
If you have any questions, contact your aculight service
representative.

6.4 Filling the Water Tank


When the Add Water error message appears on the
screen, you should fill the water tank. Press the OK
button and the system turns off automatically.
Insert the funnel (supplied with the system) into the two
connectors located on the rear panel of the system.
Using the funnel, fill the tank with 0.8 liters of distilled
water (only).

Connectors for
filling water tank

Figure 6.2 Filling the Water Tank

PB 3581110 Rev. B 6-3


Note
If you introduce too much water to the system, it
will begin to drip harmlessly out of the second
connector. If this happens, stop pouring water
into the funnel and disconnect it from the
system.

6.5 Power Meter Calibration


The aculight HR power meter calibration should be
checked once a year. Calibration check and, if
necessary, meter calibration, are performed only by
authorized aculight service personnel.

Calibration Check
The calibration check compares the fluence reading on
the aculight HR screen to that of a calibrated power
meter.
The calibration check is performed by aculight service
personnel, using a calibrated power meter made by
Ophir Optronics Ltd. (An equivalent calibrated power
meter may be used.)
To check the power meter calibration:
1. Using the aculight HR power meter, the Field Service
Engineer performs standard output calibration (see
Section 5.6 Calibration).
2. The Field Service Engineer then selects a fluence
value on the Treatment screen and measures the
output of the calibrated machine with the calibrated
Ophir power meter. He then compares the measured
fluence with the value on the Treatment screen.

Calibration Procedure
If the fluence reading on the screen and that of the Ophir
power meter differ by more than 10%, the Field Service
Engineer should calibrate the aculight HR power meter.

6-4 PB 3581110 Rev. B


Maintenance and Troubleshooting

6.6 Preventive Service


Preventive service of the aculight HR is available from
aculight Field Service Engineers. Contact your local
representative for more information.

6.7 Troubleshooting
If one of the following symptoms appears, follow the
recommended action as listed below:
Troubleshooting Guide

Symptom Probable Cause Action


No display Power disconnected Check power cable.

Plug cable into wall


socket.
Red emergency shut- Release emergency
off knob is depressed shut-off knob by turning
it clockwise.
Circuit breaker tripped Raise circuit breaker on
rear panel. If problem
persists call aculight’s
Service Department.
When pressing a button on Call aculight’s Service
the screen, no response Department.
Treatment screen does not Call aculight’s Service
come up after the usual few Department
mintues startup
System does not start Key switch not Turn key switch fully
engaged clockwise.
If screen is tilted or Call aculight’s Service
becomes distorted Department

If any other problem occurs, contact your aculight HR


service representative.

PB 3581110 Rev. B 6-5


6.8 Error Messages
If the aculight HR malfunctions during start-up or
normal operation, the system is immediately disabled
and an error message appears on the screen indicating a
machine problem.
A machine problem can only be solved by authorized
service personnel, except filling the water tank which is
handled by the user (see Section 6.4 Filling the Water
Tank).

Caution
If an error message appears, write down its
contents and contact aculight service.
The text on the error message window describes
the machine’s status and may be helpful to the
Field Service Engineer in diagnosing the problem
and knowing how to solve it

The following is an example of an error message.

Type of
error

OK

Figure 6.3 Error Message

After recording the error message, press OK and the


system will automatically turn off. Call Service.

6-6 PB 3581110 Rev. B


Maintenance and Troubleshooting

See Table 6.1 for the list of Error Messages.

Table 6.1 List of Error Messages

Error No. Error Message on Screen

78 Measured HV is too low


80 Measured HV is too high
88 Charge Time
19, 104, 105, 143 Simmer
142 Leakage Error
150 Test 100 V Error
151 HV Power Supply
152 Over Energy
153 Water Flow
154 Add water
155 Temperature Switch Error
156 Door Error
157 Self Test: Holding Voltage
Error
158 Discharge Time

PB 3581110 Rev. B 6-7


6-8 PB 3581110 Rev. B
7
C H A P T E R

ACCESSORIES
The aculight HR accessories are:
• Safety eyewear
• Coupling gel
• Light guide covers (plastic)
• Optional heads with other filters

7.1 Safety Eyewear


aculight safety eyewear protects eyes from the intense
light emitted by the system. The eyewear must be worn
by all those present during an aculight HR treatment
session. The clinician and other staff members should
wear safety eyewear with optical density 3. Clients
should wear safety eyewear with optical density 5.
Two pairs of each type of safety eyewear are provided
with purchase of the aculight HR system.

7.2 Coupling Gel


aculight coupling gel is used for skin cooling and
optical coupling. The gel comes in 0.25 and 1 liter
bottles.

7.3 Light Guide Covers


Light guide covers are made of plastic and are used to
keep the light guide clean and to prevent gel from
getting into the treatment head.

PB 3581110 Rev. B 7-1


7.4 Optional Heads with Other Filters
In additon to the 695 nm filter treatment head, there are
treatment heads available with a 755 nm and 645 nm
filters. These heads provide greater utility in the
treatment of a broad range of skin and hair types.

7.5 Ordering Accessories


An initial starter kit is provided with the installation of
the aculight HR. It includes safety eyewear, coupling
gel and light guide covers.
The following additional accessories can be ordered
from the company or your local distributor. Please refer
to the part numbers when ordering.

Part
Product
Number
Optical
AX 0000010
density 5
Safety eyewear
Optical
AX 0000011
density 3
Coupling gel 0.25 liter GL 0000006
Coupling gel 1 liter GL 0000007
Treatment head, 695 nm Standard SA 3507000
Treatment head, 645 nm Optional SA 3509000
Treatment head, 755 nm Optional SA 3508000
Light guide cover Set of 3 MI 3557030

7-2 PB 3581110 Rev. B


A

A
P P E N D I X

CLINICAL GUIDE
CHAPTER0

A.1 Training Requirements


The aculight HR is designed to be operated only by
personnel properly trained in its handling and use. This
may include physicians, clinicians, nurses,
cosmeticians, technical staff or other professional staff
members.

Training for the aculight HR is provided by aculight.

A.2 Indications and Contra-indications

Indications The aculight HR is used for the removal of


unwanted hair from all skin types. It is intended
to effect stable long-term, or permanent hair
reduction in skin types I to V through selective
targeting of melanin in hair follicles.
Permanent hair reduction is defined as long-term
stable reduction in the number of hairs regrowing
after a treatment regimen.
Contra- Pregnancy
indications Use of medication for which 645 nm to 1200 nm
light exposure is contra-indicated
Recently tanned skin
History of keloid scarring
Diabetes

PB 3581110 Rev. B A-1


A.3 Pre-treatment Preparation

General
During the client’s first visit, the clinician (or an
authorized staff member) should:
1. Exclude from treatment anyone who was exposed to
sun or artificial tanning during the last month.
2. Take a detailed client history, including previous
treatment modalities, and determine the suitability
for treatment with the aculight HR.
3. Determine why the client is seeking treatment and
understand his/her expectations.
4. Discuss the aculight HR treatment plan with the
client.

Counseling
During the first visit, the clinician (or an authorized
member of the staff) should inform the client of the
following:
• There may be some discomfort or pain associated
with treatment.
• Transient erythema/edema may appear immediately
following treatment.
• Hair removal may take a number of treatments.
• There is a small risk of adverse reactions such as
changes in the texture and pigmentation of the skin.
These are usually transient.

A-2 PB 3581110 Rev. B


Clinical Guide

Eye Protection
It is imperative that all people present in the treatment
room (client and personnel) during treatment protect
themselves from retinal damage by wearing aculight
recommended safety eyewear whenever the aculight
HR is in use.

A.4 Side Effects of Treatment


The most common side effects of treatment are:
Discomfort When a pulse is triggered, it may cause various degrees
of discomfort. Some describe the sensation as stinging,
while others liken it to a rubber band snap. A burning
sensation may last for up to an hour after treatment.
Most adults and older children are able to tolerate this
discomfort, but some people may require a topical
anesthetic.
Damage to A crust or blister may form, which may take from five
Natural Skin to ten days to heal.
Texture
Change of There may be a change of pigmentation in the treated
Pigmentation area. Most cases of hypopigmentation (lightening) or
hyperpigmentation (darkening) occur in people with
darker skin, or when the treated area has been exposed
to sunlight before treatment. In some people hyperpig-
mentation occurs despite protection from the sun. This
discoloration usually fades in three to six months, but in
rare cases, the change of pigment may be permanent.
Scarring There is a very small chance of scarring, such as
enlarged hypertrophic scars, or in very rare cases,
abnormal, large, raised keloid scars. To reduce the
chance of scarring, it is important to carefully follow all
post-treatment instructions.
Excessive Immediately after treatment, especially of the nose and
Swelling cheeks, the skin may swell temporarily. Swelling
usually subsides within three 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.

PB 3581110 Rev. B A-3


Bruising A blue-purple bruise may appear on the treated area. It
may last from five to fifteen days. As the bruise fades,
there may be rust-brown discoloration of this skin,
which fades in one to three months.

A.5 Treatment Parameters

Introduction
The aculight HR is an intense pulsed light device for
hair removal. aculight HR eliminates hair, employing a
method known as selective photothermolysis. This
involves disabling hair regrowth mechanisms by raising
the temperature of the hair follicle high enough to
damage the follicle’s germinative cells without
damaging the epidermis and the surrounding tissue. The
germinative cells are those cells which divide and
differentiate into the cells comprising the hair.
Following photoepilation, the debris of these cells and
the shattered melanin are eliminated from the tissue by
phagocytosis.
Hair on different parts of the body is of different depths.
For example, upper lip or mustache hair follicles are 1 to
2.5 mm deep, while axillae or pubic hair follicles are 3.5
to 4.5 mm deep.
The aculight HR is furnished with a set of default Pulse
Type settings. These defaults are based on successful
results obtained by experienced users. In addition, the
user can select and set his own parameter values.
The aculight HR treatment parameters consist of light
pulse parameters (Pulse Type) and light energy
(Fluence).
For each treatment with the aculight HR, these
parameters are to be set, either by selecting one of the
three default settings, or by entering a User setting of
your own, and then selecting the treatment fluence.

A-4 PB 3581110 Rev. B


Clinical Guide

Definitions

Pulse Type Pulse Type consists of three pulse parameters: Number


of Pulses, Pulse Width and Pulse Delay.
• Number of Pulses
The energy of each IPL pulse can be delivered in a
sequence of two pulses or three pulses.

This unique system allows the target tissue to absorb


all of the pulse energy, while providing periods for
the epidermis to thermally relax and thus to remain
protected.
• Pulse Width
This is the duration of each of the pulses, measured in
milliseconds (ms, 0.001 seconds).
• Pulse Delay
This is the duration of the interval(s) between the
pulses, measured in milliseconds (ms, 0.001
seconds).

Fluence The energy density output, measured in Joules/cm2, is


set by the operator for every case. The fluence
comprises the total delivered energy in the sequence of

PB 3581110 Rev. B A-5


two or three pulses you have selected (measured in
Joules), divided by the area (measured in cm2).

Pulse Type
Choosing the correct pulse type is essential for
optimizing the treatment.
Cooling time of an object is a function of its size.
Cooling time is shorter for small objects and longer for
larger objects.
The aculight HR is designed to take advantage of this
thermal selectivity, i.e. longer cooling time of the
relatively large hair follicles and shorter cooling time of
the thinner epidermis. This is accomplished by dividing
the total energy delivered during treatment into several
sequential pulses:
The delay should be long enough for the epidermis to
cool down between pulses, by losing its heat to the cold
gel and cooled light guide. But the delay should also be
shorter than the cooling time of the follicle, so that the
follicle retains its heat and its temperature increases
with each successive pulse. For most clients short delays
are suitable. Dark skin absorbs more light and heats to a
higher temperature. Consequently, longer delay times
are necessary.
The aculight HR provides three preset pulse sequences,
labeled Short, Medium and Long (the Advanced mode
enables customized settings as well).
The operation of selecting presets, setting parameters
and ranges of parameter values is detailed in Chapter 5,
Operation.

Fluence
Fluence measures the light energy delivered to the skin,
in units of energy per unit area (Joules/cm2). The
aculight HR’s intense light pulses pass through the light
guide and the coupling gel onto the client’s skin. With a
large spot size (8 x 34 mm) the scattering effect is
minimized, resulting in a constant fluence and deeper
penetration (unlike the smaller spot sizes used with
lasers). The greater the fluence, the higher the

A-6 PB 3581110 Rev. B


Clinical Guide

temperature of the target hair, the surrounding tissue and


the epidermis.
The cold gel and cooled light guide reduce the initial
epidermis temperature and thereby the maximum
temperature reached during the pulse. This reduces
client’s discomfort. Alternatively, it enables raising the
fluence when necessary without increasing adverse
effects.
Dense hair (approx. 30-40 hairs per cm2) produces
higher temperatures due to the greater density. Cooling
of the follicles by heat conductivity produces excess
heat in the surrounding tissues, which can result in
tissue damage. Therefore as hair density increases,
fluence should be reduced.

Coupling Gel
Before the light pulse is triggered, apply a thin layer of
cold coupling gel to the treatment site.

PB 3581110 Rev. B A-7


A.6 Guidelines for Selecting Treatment
Parameters

Skin Type Parameter

Light skin Shorter Pulse Type


Higher Fluence
Dark skin Longer Pulse Type
Lower Fluence
Skin type VI Use Optional 755 nm head
Long Pulse Type
Lower Fluence
Thin hair Shorter Pulse Type
Light hair Higher Fluence
Stubborn hair Use optional 645 nm head

Note
Treatment of Skin Type VI

• Effective treatment of skin type VI has been


demonstrated using a 755 nm treatment
head.
• aculight strongly recommends that the
optional 755 nm treatment head be used
whenever skin type VI clients are treated.
• Always use the Long Pulse Type and do test
patches.

Note
aculight does not recommend treating hair that
is lighter than the skin!

A-8 PB 3581110 Rev. B


Clinical Guide

A.7 Treatment
1. Press the Reset button to reset the Pulse Counter.
2. Set the Pulse Type by pressing Short, Medium or
Long.
A minimum fluence value appears on the screen.
To change the fluence value, press the plus or minus
arrows. It is recommended to start with a low
fluence value
3. Shave the treatment area to eliminate any surface hair
that could interfere with the treatment.
4. Ensure that the light guide is clean and free of frost.
5. Cover the light guide with the provided cover.
6. Apply a thin layer of cold coupling gel to the
treatment site. This aids skin cooling during the light
pulse and improves coupling of the light into the
skin.
Light pulses should be triggered on cold gel, so
spread gel only on immediate treatment area and treat
right away, then spread gel on next area.
7. Place the treatment head perpendicular to the skin.
The light guide should gently touch the skin.
8. Trigger a test pulse. (The system recharges
automatically.)
9. Wipe off the gel and examine the treatment site.
The smell of burnt hair and/or a brownish color in the
gel may be detected. Swelling around the hair
follicles should appear within about five minutes
after treatment.
Darker skin may take longer to react than lighter skin
(from a few minutes to 24 hours).
10.If the skin shows no adverse effects and there are no
visible changes in the follicles, increase the Fluence
and treat an adjacent site.
If the skin shows adverse effects (such as excessive
redness), reduce the Fluence and/or choose a longer
Pulse Type. Treat an adjacent site.
11.Wipe off the gel and examine the treatment site. If
there are still no adverse effects or changes in the
follicles, increase the Fluence and treat an adjacent
site.
Do not overlap treatment sites by more than ~1 mm.

PB 3581110 Rev. B A-9


A.8 Post-treatment Care

General
It is recommended that cold (not frozen) packs be
applied immediately after treatment, to cool the
treatment site, reduce swelling and ease discomfort.
Chemical cold packs are not recommended, if their
temperature is below 4 degrees C. Frozen 4 X 4 gauze,
previously moistened with water and inserted into small
plastic bags (sandwich wrap) can be used.
Blisters or ulcerated skin can be treated with antibiotic
ointment or burn treatment creams. Low concentration
steroid cream can be used to reduce swelling.
Care should be taken to prevent trauma to the treated
area for the first four or five days following treatment:
avoid hot bath, aerobic exercise, massage, etc.
If scabs appear after blistering, they should be kept soft
with a lubricating cream such as petroleum jelly.

Exposure to Sunlight
Clients should use highest factor sunscreen and protect
the treated area from exposure to sunlight for at least
one month following treatment. Tanning after treatment
sessions may enhance melanin regeneration, which may
result in hyperpigmentation.

Makeup
Some users allow their clients to apply makeup
immediately after treatment. However, they advise
clients to notify them, and to stop wearing makeup, if
the treatment site scales or cakes.
Others take a more conservative approach, advising
against the use of makeup for four or five days
following treatment. The skin is sensitive during this
period, and removing makeup, especially if it is difficult
to remove, may damage the skin and predispose the site
to infection.

A-10 PB 3581110 Rev. B


Clinical Guide

Other Post-treatment
Recommendations
If the treatment site could be exposed to dirt routinely,
cover it with a dressing.
Clients should be advised not to participate in rough
sports or similar activities for several days following
treatment, until the skin returns to its normal condition.

Follow-up
Refer to the following recommendations for follow-up,
and then determine your own suitable regime.
The client should return several weeks after treatment (4
to 8 depending on anatomical site treated), for
examination of the treatment site. If hair is visible on
that site, an additional treatment should be performed.
If no additional treatment is necessary, the client should
return for an additional re-examination three to four
weeks later, preferably when new hair has grown in the
treated area.
If there has been partial hair clearance, treatment should
be continued using the same parameters, and the client
should return after 4 to 8 weeks for examination and for
additional treatment, if necessary.
If no change is noted, the fluence for the next treatment
should be increased. With multiple treatments, increase
the time intervals between treatment sessions (after the
second one), to allow new hair to grow in the treatment
area. This depends on the body area and on the
individual client (male or female, hormonal problems,
etc.).

PB 3581110 Rev. B A-11


Adverse Effects
If there are any adverse effects, treatment should be
discontinued until the treatment site has healed.
After the treatment site has healed, if there are
indications of hair clearance, fluence should be lowered
for the next treatment. The client should return for an
examination after three weeks.
If adverse effects were observed and no hair clearance
was noticed during the examination visit four weeks
after treatment, the client should wait another two to
four weeks, and then return for an additional
examination. If partial clearance is noticed then,
treatment can be carried out, with lower fluence.
If no hair clearance was noticed during the second
examination, it should be determined whether the
adverse effects were due to the fact that the client’s skin
was recently tanned. If so, treatment should only be
resumed after the tan has faded. If the adverse effects
were not due to tanning, treatment should cease.

Concluding Treatment
Determining when treatments should be concluded is
left to the user’s discretion. In general, treatment ceases
when the client is satisfied with the amount of hair
removed.

A-12 PB 3581110 Rev. B


Clinical Guide

A.9 Clinical Studies Summary

Note
This section is presented for informational
purposes only and should not be interpreted as
an indication or guarantee of specific results that
could be expected from use of the aculight HR.

Long-term Reduction in Hair Density


Resulting from IPL  (Intense
Pulsed Light) Photoepilation
Treatment
Hair growth in different areas of the human body is a
stochastic process that is controlled by a complicated set
of growth cycles. Each follicle goes through a growth
phase (anagen), followed by a ‘death’ phase (catagen),
followed by a long dormant phase (telogen). Photoepi-
lation using IPL systems is based on the selective
absorption of light energy by the follicle. As the light is
absorbed by the follicle, the temperature of the follicle
rises, leading to a thermal destruction of the follicular
cells. It is well accepted that cells that are in the active,
growing phase of their development (‘anagen’) will be
most sensitive to thermal destruction. Since the hair
follicles in the target area consist of cells in all three
development phases, it is reasonable to expect that
multiple treatments would be needed in order to
thermally destroy all the follicles.
In order to study the long-term effects of photoepilation
treatment using IPL systems, two separate studies
were conducted: A study of the long-term effects of a
single treatment, and a study of the effects of multiple
treatments.

Single The first study was designed to provide a long-term


Treatment follow-up of a group of patients that have undergone a
Study single photoepilation treatment. Twenty four patients
were treated and followed for a period of two years.
Each patient was treated in a single anatomical site, and
the average hair density in the treated site was used as
the main measure of clinical effectiveness. The

PB 3581110 Rev. B A-13


clearance rate for the monitored sites is summarized in
graphical form in Figure A.1.
The clearance observed immediately following the
treatment was 44%±33%, followed by a value of
59%± 35% at one month follow-up. The next two
follow-up visits showed clearance of 56%±26% at the
two months follow-up visit and 62%±30% three months
following the treatment. The clearance rate had
increased to 76%±24% at one year follow-up and to
84%±15% at the conclusion of this study, i.e., two years
post treatment. This study showed that at two years
follow-up, all patients achieved significant permanent
hair reduction.

N=24
76% 84%
59%
62% (24) (24)
(18)
100% 56% (21)
44% (21)
Average clearanc

(23)
80%

60%

40%

20%

0%
0 2 4 6 8 10 12 14 16 18 20 22 24
Follow -up (m onths)

Figure A.1 Average Clearance as a Function of Time in


Single Treatment Study

Note
The number in parentheses for each time period
represents the number of anatomical sites
recorded at that time.
The average clearance value is indicated
above the vertical lines, representing the
standard deviation (SD) for each follow-up.
0 weeks represents the immediate clearance
rate.

A-14 PB 3581110 Rev. B


Clinical Guide

Multiple A second study was conducted to examine the results of


Treatments multiple IPL™ photoepilation treatments. Fourteen
Study patients were enrolled into the study at different times
between April 1997 and August 1998. Each patient had
a single anatomical site treated and followed for over a
year (range, 13-29 months; mean ±SD, 20±5 months).
All patients were asked to undergo a minimum period of
12 months with no treatments, and be examined at the
end of that period for the clearance obtained in the
treated sites.
Clearance observations were conducted at different
times following the last treatment. A detailed account of
the clearance rates observed in this group of patients is
given in Table 2. The table describes the anatomical
sites treated and the total number of treatments for each
site, the duration of the observations conducted since the
initial treatment and since the last treatment, and the
final clearance observed. Average clearance of
75%±15% was observed up to five months following
the last treatment. Observations conducted between five
and ten months after the last treatment showed a
clearance of 66%±16%. The average clearance
continued to rise, culminating in values of 78%±11%
observed between 10 and 15 months after the last
treatment and a final value of 92%±(12%) at 25 to 30
months following the last treatment.
In summary, all the anatomical sites enrolled in this
study showed over 50% clearance more than 12 months
following the last treatment. The average clearance in
the group increased from 78% to 92% more than 12
months following the last treatment. This group clearly
demonstrated the long – term effect that photoepilation
has, more than a year after the last treatment.

PB 3581110 Rev. B A-15


Table A-1: Clearance Rate observed in the Group of patients in the Multiple Treatment
Study

Months Since Months


Anatomical Hair Skin Total No. of Final
Sex Initial Since Last
Location Color Type Treatments Clearance
Treatment Treatment

M chest black V 5 19 15 88.89%


M abdomen dk II 3 15 13 78.58%
brown
M chest dk II 4 24 15 90.91%
brown
F lip brown II 3 20 18 55.56%
M mandible dk II 3 15 13 69.23%
brown
M back dk II 3 20 18 77.78%
brown
F bikini dk III 3 14 12 75.00%
brown
F bikini dk III 3 24 22 70.00%
brown
F bikini dk IV 6 20 14 97.50%
brown
F abdomen brown II 5 21 15 96.00%
F chin brown III 6 26 16 100.00%
F upper lip lt brown II 3 29 26 83.33%
F face black II 2 13 12 93.75%
F face dk III 5 21 15 86.11%
brown

Skin Type VI
No data on the effects of multiple treatments on skin
type VI is available at this time.

A-16 PB 3581110 Rev. B


B
A P P E N D I X

TAKING CARE OF ACULIGHT HR TREATMENT


CHAPTER0

HEADS
B.1 Introduction
aculight HR treatment heads have a built-in integral
filter that controls the spectral output of your
aculight HR system. The filter is coated on the inner
side of the light guide. The integral filter is not
interchangeable, therefore proper care is important.

Defects such as spots or chipping of the light guide can


adversely affect the treatment outcome. Keeping the
integral filter clean and damage-free will aid in
achieving the desired results and help extend the life of
the filter dramatically.

B.2 Cleaning the Integral Filter


1. Remove excess gel from the end of the light guide
with a tissue or lint-free cloth. Make sure all gel is
removed after each treatment.

2. Remove the white protective cover after each client


and wash it with hot water.

3. Using gauze and ethyl alcohol or isopropyl alcohol,


gently remove the gel that accumulated on the light
guide underneath the protective cover and let it dry
thoroughly between clients. Do not use acetone to
clean the integral filter.

PB 3581110 Rev. B B-1


Caution
Never immerse the light guide or any other part of
the treatment head in water, nor hold it under
running water.

B.3 Calibrating the System


• When calibrating the system, place the head gently
into the calibration port of the power meter to avoid
chipping the glass light guide.
• When removing the head, slowly lift it straight up,
making sure the light guide is clear of the calibration
port before moving it away from the system (this
avoids chipping the light guide).

B.4 Handling the Treatment Heads


• Make sure the head is always placed on the umbilical
cord support when you are not treating a client.

Note
Remember to clean the integral filter
immediately after each client.

• After disconnecting a treatment head from the


system, immediately place it in the padded suitcase
provided by aculight.

B-2 PB 3581110 Rev. B


Note: This equipment has been tested in accordance
with EN 60601-1-2 and found to comply with the limits
of EN55011 class A and with part 18 of the FCC rules.
These limits provide reasonable protection against
harmful interference when the equipment is operated in
an industrial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not
installed and used in accordance with the operation
manual, may cause interference to radio
communications.
Operation of this equipment in a residential area may
require conformance with national regulations (e.g. in
Germany, special permission may be obtained from the
BAPT).
If this equipment does cause interference, the user is
encouraged to try and eliminate the interference by the
following measures:
Reorient or relocate the aculight HR or the other
equipment.
Ensure that the aculight HR is connected to a dedicated
electrical outlet.

PB 3581110 Rev. B 1
2 PB 3581110 Rev. B

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