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2 m22英语
2 m22英语
2 m22英语
Operation manual
This manual is copyrighted and all rights reserved. Pursuant to the Copyright Act, all or any part of this
manual may not be reproduced or reproduced in any medium without the written consent of Lumenis.
Approved copies must carry the same proprietary and copyright notices as those attached to the original.
According to the law, reproduction includes translation into another language.
Please note that our company has made every effort to ensure that the data provided in this document is correct,
but the information, diagrams, diagrams, tables, specifications and diagrams contained in this document are
subject to change without prior notice.
Lumenis, its logo, M22, IPL, ExpertFilters, SapphireCool, Multi-Spot Nd: YAG, ResurFX and
CoolScan is a trademark or registered trademark of Lumenis.
Attention
US federal law stipulates that this device can only be sold by a doctor or on the
prescription of a doctor.
Directory
Chapter
1 System Overview Page Number
1.1. Introduction and intended use 1
1.2. System Preparation 2
1.3. Scope of application of manual 2
1.4. Manual Practice 4
1.5. Physician's responsibility 4
1.6. Maintenance 4
1.7. Modification of the device 5
1.8. Resale inspection 5
1.9. Resale inspection 5
1.10. Introduction to M22 System 6
1.11. Therapeutic parameter 7
1.11.1. ..........................................................................................................Spectrum and Filter 7
1.11.2. ....................................................................................................Size of irradiation point 8
1.11.3. ..................................................................................................................................Dose 8
1.11.4. .............................................................Number of pulses (IPL and ND: YAG modules) 8
1.11.5. ...................................................................................................................Pulse duration 8
1.11.6. .......................................................................Pulse delay (IPL and ND: YAG modules) 8
1.11.7. ..........................................................................................Scan Shape, Size and Density 8
2.1. Introduction 1
2.2. Treatment Room 2
2.3. Important precautions, precautions and warnings 3
2.3.1. ..........................................................................................................Preventive measure 3
2.3.2. ..................................................................................................................................Note 3
2.3.3. .............................................Warning related to laser and intense pulsed light emission 3
2.3.4. .............................................................................................................................Module 4
2.3.5. .................................................................Related Warnings for IPL and Laser Modules 4
2.3.5.1. Harm of burn and scald 4
2.3.5.2. Hazards of eye exposure 4
2.3.5.3. Goggles 4
2.3.6. .........................................................Related Warning for Universal IPL Module Filters 4
2.4. Optical safety 4
2.5. IPL and Laser Safety Goggles 5
2.6. Electrical and mechanical safety 6
2.6.1. ....................................................................................................Leakage circuit breaker 7
2.7. Fire hazard 7
2.8. Operational precautions 7
2.9. System security function 7
2.9.1. ..........................................................................................................................Password 8
2.9.2. ..............................................................................................Emergency shutdown knob 8
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E.4.6.5. ...................................................................................................................Scar 6
E.4.6.6. ............................................................................................Excessive swelling 7
E.4.6.7. ....................................................................................................Sensitive skin 7
E.4.6.8. ...............................................................................................Burns and scalds 7
E.5. Therapeutic parameter 7
E.5.1. ......................................................................................................................Introduction 7
E.5.2. .........................................................................................................................Definition 8
E.5.2.1. .................................................................................................Pulse parameter 8
E.5.2.2. .......................................................................................................Energy (mJ) 8
E.5.2.3. .........................................................................................................Module tip 8
E.5.3. .....................................................................................................Use ice water machine 9
E.6. Setting Treatment Parameters 9
E.7. Pre-treatment 9
E.7.1. .......................................................................................................................Assessment 9
E.7.2. ...........................................................................................Preparation of treatment sites 9
E.8. Treatment 11
E.9. Lumenis Default-Treatment Parameter 12
E.10. .......................................................................................................Post-treatment maintenance 21
E.10.1. Overview 21
E.10.2. Sunlight exposure 21
E.10.3. Cosmetics 21
E.10.4. Other post-treatment recommendations 21
E.10.5. Follow-up course 22
E.10.6. Adverse reactions 22
E.10.7. End of treatment 22
F.1. Introduction 1
F.2. Training requirements 1
F.3. Indications and contraindications 1
F.3.1. ..........................................................................................................................Indication 1
F.3.2. .............................................................................................................Contraindications 2
F.3.3. ..................................................................................................................................Note 2
F.3.4. ............................................................................................................................Warning 3
F.4. Pre-treatment information 4
F.4.1. ..........................................................................................................................Overview 4
F.4.2. .....................................................................................................................Consultation 4
F.4.3. ....................................................................................................................Eye Protector 5
F.4.4. ...............................................................................................................Local anesthesia 5
F.4.5. ......................................................................................................................Take photos 5
F.4.6. .....................................................................................Possible side effects of treatment 6
F.4.6.1. Discomfort 6
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F.4.6.2. Erythema 6
F.4.6.3. Damage to natural skin texture 6
F.4.6.4. Pigment change 6
F.4.6.5. Scar 6
F.4.6.6. Excessive swelling 7
F.4.6.7. Sensitive skin 7
F.4.6.8. Burns and scalds 7
F.5. Therapeutic parameter 7
F.5.1. ......................................................................................................................Introduction 7
F.5.2. .........................................................................................................................Definition 8
F.5.2.1. Pulse parameter 8
F.5.2.2. Energy (mJ) 8
F.5.2.3. Module tip 8
F.5.3. .....................................................................................................Use ice water machine 9
F.6. Setting Treatment Parameters 9
F.7. Pre-treatment 9
F.7.1. .......................................................................................................................Assessment 9
F.7.2. ...........................................................................................Preparation of treatment sites 9
F.8. Treatment 11
F.9. Lumenis Default-Treatment Parameter 12
F.10. Post-treatment maintenance 13
F.10.1. ........................................................................................................................Overview 13
F.10.2. ...........................................................................................................Sunlight exposure 13
F.10.3. .......................................................................................................................Cosmetics 13
F.10.4. .........................................................................Other post-treatment recommendations 13
F.10.5. ............................................................................................................Follow-up course 14
F.10.6. ...........................................................................................................Adverse reactions 14
F.10.7. .............................................................................................................End of treatment 14
G.1. Introduction 1
G.2. Training requirements 1
G.3. Indications and contraindications 1
G.3.1. .................................................................................................................Use Instruction 1
G.3.2. .............................................................................................................Contraindications 1
G.3.3. ..........................................................................................................Preventive measure 2
G.3.4. ............................................................................................................................Warning 3
G.4. Patient treatment 4
G.5. Pre-treatment information 4
G.5.1. ..........................................................................................................................Overview 4
G.5.2. .....................................................................................................................Consultation 4
G.5.2.1. .................................................................................Treatment of Dark Tattoo 4
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Illustrated catalogue
..................................................................................................................................................................Figu
re 2-1: Warning at the door of the treatment room 2
................................................................................................................................................................Figur
e 2-2: System and Module Labels (for illustration only) 10
Figure 3-1: M22 System Entity Dimensions: With ResurFX Module (right) and Without ResurFX Module
(left) 2
.................................................................................................Figure 3-2: Module Bracket Installation 4
......................................................................................................Figure 3-3: Module Connection Port 5
............................................................................................Fig. 3-4: Light guide and filter storage tray 6
...............................................................................................................Figure 3-5: Maintenance Panel 7
......................................................................................Figure 3-6: Remote Interlock Plug Connection 8
...................................................................................................................Figure 3-7: Foot Switch Port 9
.........................................................................................................Figure 3-8: Coolant Storage Tank 10
......................................................................................................................Figure 3-9: Control Panel 11
..................................................................................................................................................................Figu
re 4-1: M22 Strong Light and Laser Skin Therapy System (with Optional ResurFX Module) 2
..................................................................................................................................................................Figu
re 4-2: Maintenance Panel 4
..................................................................................................................................................................Figu
re 4-3: Universal IPL Hand 6
..................................................................................................Figure 4-4: Multi-Spot Nd: YAG Hand 8
......................................................................................................................Figure 4-5: ResurFX Hand 9
..............................................................................................Figure 4-6: Q-Switched Nd: YAG Hand 10
..................................................................................................................................................................Figu
re 5-1: "Login" panel 3
..................................................................................................................................................................Figu
re 5-2: System Controls 4
..................................................................................................................................................................Figu
re 5-3: M22 Main Screen 5
................................................................................................................Figure 5-4: Utility menu panel 6
........................................................................................Figure 5-5: Features-User Preferences Screen 6
...............................................................................................Figure 5-6: Default Backup Utility Panel 8
............................................................................................................Figure 5-7: USB Flash Disk Port 8
.................................................Figure 5-8: Functions-User Management Panel (Administrators Only) 9
...................................................Figure 5-9: Functions-User Management Panel (Non-Administrator) 9
...................................................................Figure 5-10: User Management-Change Password Screen 10
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.....................................................................................Figure 5-11: New Password Virtual Keyboardtory
10
.............................................................Figure 5-12: User Management-Changing User Details Panel 11
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Table catalog
..................................................................................................................................................................Tabl
e 2-1: Safety specification for laser eyes 5
..................................................................................................................................................................Tabl
e 2-2: Safety Goggles Specification 5
................................................................................................................................................................Table
2-3: Label Description 11
................................................................................................................................................................Table
2-4: Symbolic Terminology 13
................................................................................................................................................................Table
5-1: General IPL and Multi-Spot Nd: YAG Treatment Screen Elements 18
................................................................................................................................................................Table
5-2: ResurFX Treatment Screen Elements 20
................................................................................................................................................................Table
5-3: Q-Switched Nd: YAG Treatment Screen Elements 23
........................................................................................................................................................................Table
5-4: Lesion/disease characteristics applicable to each application treatment: IPL31
........................................................................................................................................................................Table
5-5: Lesion/disease characteristics for each application treatment: Multi-Spot Nd: YAG31
................................................................................................................................................................Table
5-6: Lesion/disease characteristics applicable to each application treatment: ResurFX (outside the United
States) 31
................................................................................................................................................................Table
5-7: Lesion/disease characteristics applicable to each application treatment: ResurFX (in the United
States) 32
........................................................................................................................................................................Table
5-8: Lesion/disease characteristics for each application: Q-Switched Nd: YAG32
................................................................................................................................................................Table
6-1: Error messages and related corrective actions 20
................................................................................................................................................................Table
6-2: Error messages to contact the Lumenis Service Center for processing 21
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6-3: Troubleshooting Guidelines for Unshown System Troubleshooting 26
..................................................................................................................................................................Tabl
e 7-1: M22 Accessories List 5
................................................................................................................................................................Table
A-1: Lumenis Presupposition, IPL Skin Therapy: Rosacea, Using 8 x 15 and 15 x 35 mm Light Guide 23
................................................................................................................................................................Table
A-2: Lumenis Presupposition, IPL Skin Treatment: Erythema rosacea, using 8x15 and 15x35mm light
guides 23
................................................................................................................................................................Table
A-3: Lumenis Presupposition, IPL Skin Therapy: Liver Spot, Using 8 x 15 and 15 x 35 mm Light Guide
24
................................................................................................................................................................Table
A-4: Lumenis Presupposition, IPL Skin Therapy: Heterochromia of the Skin, Using 8 x 15 and 15 x 35
mm Light Guide 24
Table A-5: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/Senile Plaque (Mild), Using
8x15 and 15x35mm
.................................................................................................................................................Light
guide 25
Table A-6: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/Senile Plaque (Severe),
Using 8x15 and 15x35mm
.................................................................................................................................................Light
guide 25
Table A-7: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/Senile Plaque (non-facial),
using 8x15 and
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.................................................................................................................................................15x35
mm Light Guide 26
Table A-8: Lumenis preset, IPL acne (notch filter 400-600 to 800-1200) treatment, using 8 x 15 and 15 x
.................................................................................................................................................35
mm Light Guide 27
Table A-9: Lumenis Presupposition, IPL Acne (Notch Filter 400-600 to 800-1200)
Treatment, 6mm Light Guide 28 for solitary lesions only
................................................................................................................................................................Table
A-10: Lumenis Presupposition, IPL Skin Therapy: Limit, Use 8 x 15 and 15 x 35 mm Light Guide 29
................................................................................................................................................................Table
A-11: Lumenis IPL Preset, Skin Therapy: Minimum and Maximum Dose Limit, Using 6 mm Round Light
Guide 30
................................................................................................................................................................Table
A-12: Recommended Presupposition, Stage II Treatment for Microvasodilatation/Senile Plaque 31
................................................................................................................................................................Table
A-13: Burton Acne Area 32
................................................................................................................................................................Table
A-14: AOPT dose limit (continued next page) 33
................................................................................................................................................................Table
B-1: Lumenis Presupposition: IPL Angiopathy, PWS Children Type 20
................................................................................................................................................................Table
B-2: Lumenis Presupposition: IPL Angiopathy, PWS Adult Type 21
................................................................................................................................................................Table
B-3: Lumenis Presupposition: IPL Angiopathy, Hemangioma 22
................................................................................................................................................................Table
B-4: Lumenis Presupposition: IPL Angiopathy, Facial Microvasodilatation 23
Table B-5: Lumenis Presupposition: IPL Angiopathy, Facial Microvasodilatation, Using IPL Vasculature
(Notch Filter 530-
.................................................................................................................................................650
and 900-1200) 23
Table B-6: Lumenis Presupposition: IPL Angiopathy, Facial Microvasodilatation, Using IPL Vasculature
(Notch Filter 530-
.................................................................................................................................................650
and 900-1200) and 6mm light guide 24
................................................................................................................................................................Table
B-7: Lumenis Presupposition: IPL Angiopathy, Trunk Microvasodilatation 24
Table B-8: Lumenis Presupposition: IPL Angiopathy, Trunk Microvasodilatation, Using IPL Vasculature
(Notch Filter 530-
.................................................................................................................................................650
and 900-1200) 25
Table B-9: Lumenis Presupposition: IPL Angiopathy, Trunk Microvasodilatation, Using IPL Vasculature
(Notch Filter 530-
.................................................................................................................................................650
and 900-1200) and 6 mm light guide 26
................................................................................................................................................................Table
B-10: Lumenis Presupposition: IPL Angiopathy, Leg Veins 26
................................................................................................................................................................Table
B-11: Lumenis Presupposition: Nd: YAG angiopathy, 6 mm diameter irradiation spot size 27
................................................................................................................................................................Table
B-12: Lumenis Presupposition: Nd: YAG Angiopathy, 2 x 4 mm Radiation Size 29
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B-13: Lumenis Presupposition: Nd: YAG angiopathy, 1.5 mm irradiation site size * 29
Table B-14: Lumenis Presupposition, IPL Angiopathy: Minimum and Maximum Dose Limits, Using 8 x
15 and 15 x 35 mm Light Guides
................................................................................................................................. 30
................................................................................................................................................................Table
B-15: Lumenis Presupposition, IPL Angiopathy: Minimum and Maximum Dose Limitation, Using 6 mm
Circular Light Guide 31
................................................................................................................................................................Table
B-16: Lumenis Presupposition, Nd: YAG Angiopathy: Minimum and Maximum Dose Limits 32
................................................................................................................................................................Table
C-1: Lumenis Presupposition, Pigmented Lesion Treatment: Freckles 16
................................................................................................................................................................Table
C-2: Lumenis Presupposition, Treatment of Pigmented Lesions: Freckles, Use 6 mm Light Guide 17
................................................................................................................................................................Table
C-3: Lumenis Presupposition, Treatment of Pigmented Lesions: Keratosis 17
................................................................................................................................................................Table
C-4: Lumenis Presupposition, Pigmented Lesion Treatment: Coffee Milk Spot 18
................................................................................................................................................................Table
C-5: Lumenis Presupposition, Treatment of Pigmented Lesions: Blood Iron 19
................................................................................................................................................................Table
C-6: Lumenis Presupposition, Pigmented Lesion Treatment: Beck's Motherland 20
................................................................................................................................................................Table
C-7: Lumenis Presupposition, Pigmented Lesion Treatment: Daejeon/Ito Motherland 20
................................................................................................................................................................Table
C-8: Lumenis Presupposition, Pigmentation Treatment: Pigmentation 21
................................................................................................................................................................Table
C-9: Lumenis Presupposition, Pigmented Lesions: Minimum and Maximum Dose Limitations, Using 8 x
15 and 15 x 35 mm Light Guides 22
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Table C-10: Lumenis Presupposition, Pigmented Lesions: Minimum and Maximum Dose Limits, Using 6
mm Circular Light Guide 23
................................................................................................................................................................Table
D-1: Lumenis Preset, IPL Hair Removal 15
................................................................................................................................................................Table
D-2: Lumenis Preset, IPL Hair Removal: Minimum and Maximum Dose Limits 17
................................................................................................................................................................Table
E-1: Impact on organizations 10
...........................................Table E-2: Lumenis Presupposition, Heterochromia Treatment: Freckles 12
.......................................Table E-3: Lumenis Presupposition, Heterochromia Treatment: Liver Spot 12
..................................................................Table E-4: Lumenis Presupposition, Acne Scar Treatment 13
.............................................Table E-5: Lumenis Presupposition, Surgical Scar Treatment: Atrophic 15
.....................................................Table E-6: Lumenis Presupposition, Surgical Scar Treatment: Flat 16
................................................Table E-7: Lumenis Preset, Skin Treatment: Laser Skin Replacement 17
.........................................Table E-8: Lumenis Presupposition, Skin Treatment: Periorbital Wrinkles 18
................................................Table E-9: Lumenis Presupposition, Dermatoglyphic Treatment: Rubra19
...............................................Table E-10: Lumenis Presupposition, Dermatoglyphic Treatment: Alba 20
................................................................................................................................................................Table
F-1: Effects on tissues 10
................................................................................................................................................................Table
F-2: Lumenis Preset, Skin Treatment: Laser Skin Replacement 12
................................................................................................................................................................Table
G-1: Lumenis preset, remove dark tattoos 12
.......................................Table G-2: Lumenis Presupposition, Removal of Local Pigmented Lesions 13
.........................Table G-3: Lumenis presupposition, removing a large number of pigmented lesions 14
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Chapter 1
System
Overview
1.1. Brief introduction and intended use Lumenis M22 system has the ability
to connect the following treatment modules to provide multi-application
treatment schemes. All modules are designed for cosmetic and therapeutic
skin procedures, as follows:
"Strong pulsed light" (IPL) has a spectrum of 400-1200 nm (with 9
different filters) and is suitable for treatment:
Benign epidermal lesions, including heterochromia, pigmentation, liver
spots and freckles.
Skin lesions, including warts, scars and dermatoglyphics.
ResurFX modules and hand tools, with a wavelength of 1565 nm, are
specially designed for skin procedures requiring skin replacement
and soft tissue coagulation.
Q-Switched Nd: YAG laser, with a wavelength of 1064 nm, dedicated to
therapy:
Remove dark tattoos.
Notes
Permanent hair removal is defined as a long-term, stable reduction
in the amount of hair regrown after the treatment plan is adopted at
6 months, 9 months and 12 months.
Lumenis ® M 22 System content
™ topic
1.2. When the system is ready for shipment, it will be delivered directly from the factory to your
site. This system is designed for installation in clinical environment.
After that, you or your agency's treatment staff will perform routine daily
maintenance related to the system, all delivery systems, and/or accessories
used in the treatment, including checking, cleaning the M22 and delivery
systems, and connecting/disconnecting all tips and/or filters. These
maintenance procedures will be detailed separately in this manual.
Most treatment staff prefer daily examination system and delivery system,
which usually completes the examination before making an appointment for
patients. This ensures sufficient time to troubleshoot problems or seek
professional services with the least impact on patient care.
1.3. The purpose of this manual is to provide physicians and other personnel who operate or
maintain the system with information on operating strategies, controls,
safety precautions, and installation and maintenance of the system.
Although this manual is intended to assist in the use and maintenance of
equipment, it must not be used as a substitute for any appropriate training
in the use of medical devices for clinical use.
Notes
This M22 operation manual contains two clinical guidelines for
ResurFX optional modules:
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Appendix B: G
Clinical ui
de
Guideline:
lin
Viscous lesions es:
(VL) se
Appendix C: Clinical g
m
Guidines:
en
Pigmented tat
lesions io
(PL) n
Ty
Appendix D: Clinical
pe
Guidelines: IPL
no
Hair Removal
n-
(HR)
pe
Appendix E: eli
Clinical ng
Guidelines: sk
segmentation in
Type non- ch
peeling skin an
changing gi
ng
Appendix F:
Clinical Ap
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Clinical guidelines for the treatment of
Guidelines:
monetary diseases using this system.
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1.4. Manual Practice All notes, notes and warnings in this manual are
used to provide important information that must be known before using
the device.
Example:
Notes
A note is a statement to remind the operator of some partially
important information.
Attention
Attention is a statement used to residual operators of possible
problems when using or misusing equipment. Such problems
include malfunction of the device, failure of the device, and
damage to the device or other items. Note that the statement
contains relative preventive measures to be taken to void hazards.
Warning
A warning is a statement that alerts the operator to the possibility
of injection, death or serial side effects caused by the use or
misuse of equipment.
The licensed physical will be responsive for the use and operation of the
device and the conditions of the user, and Lumenis will not be responsive for
any federal, state or local laws and regulations that may apply to the use and
operation of any medical device. If the law requirements any credentials for
the clinical use and operation of the device, it is the physical's response to
contact His local authority for determination.
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1.8. Resale perspective The M22 is a medical device. If any Lumenis device
is a person other than an authorized sales presentation
For resale, Lumenis can offer it technicians to carry out resale inspection to
ensure that the device is shipped
Make it conform to the manager's specifications. It is import to resell the
device and use it before it has been inspected.
The use of actions may cause personal injection and will make all
warranties, express and implied, null and void
Effective.
Lumenis also provides service contracts and extended warranties for its
devices. For more information about services, check charges, or service calls,
please contact your local Lumenis service presentation.
AOPT Cm cm
HR Hair
Removal Hz
Hertz
ID identification
in. inches
IO input/output
KHz kilohertz
Mm mm
Ms milliseconds
μ s microsecond
impurity Nm nanometer
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Sec seconds
SN serial number
SPF Skin Care Coefficient
For skin types, please refer to Freund's skin type
Classification
TE thermoelectric
TEC Thermoelectric
Cooler
Telan.Microvasodilatation
USB Universal Serial Bus
VLangiopathy
VAC AC Voltage
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Q-switched Nd: YAG treatment does not directly touch the cooling treatment area.
The M22 is designed to allow users to flexibly choose wave, pulse width
and pulse sequence to treat skin conditions and lesions without
damaging surrounding complaints.
The M22 system resolutions of the following main components:
System console
Operation control panel
Display with touch screen technology
Module
The build-in computer of the system will continuous monitor and control
the system. The selected parameters and user information are displayed on
the monitor screen.
1.11. Therapeutic parameters the M22 system provides great flexibility when
performing variable cosmetic treatments and using different modules.
Treatment parameters are set according to clinical indications. For more
detailed information, please refer to the appendix of clinical guidelines in
this manual.
Notes
The term "skin type" mentioned everything in this manual
reference to Freund's skin type classification.
Before treatment begins, the operator selects the appropriate module and
regulations the parameter values required for a partial treatment.
Each parameter has a defined range of values. Build-in security features prior
the selection of values out this specified range. (However, since some
parameter settings dependent on other parameters, the incentive range of
each parameter is not always achived.)
1.11.1. Spectrum and Filter Universal IPL Module-Wavelength Range and Filter
will determination the depth of light penetration and determination its
specific selection agreement to the color base of the target.
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1.11.2. Irradiation point size universal IPL-When the distal end of the light guide is perpendicular to
the top of the patient's skin, the light guide selected regulations the skin
area covered.
Multi-Spot Nd: YAG-The size of the selected irradiation point
determinations the size of the skin covered when the remote vertical point of
the tip points to the patient's skin. It will be selected according to the
characters (diameter and depth) of blood vessels.
ResurFX-ResurFX tip can treat the treatment area with a diameter of up to 18
mm and absorbing laser energy. During treatment, the remote point of the tip
must point vertically to the patient's skin.
Q-Switched Nd: YAG-The selected tip details the size of the skin covered
when the tip is placed remotely on the patient's skin surface.
1.11.3. The energy density exposed to the dose treatment area, in joules/square
centimeter.
1.11.4. Number of Energy is transferred by a single pulse, or by two to three sub-pulses. Using
Pulses (IPL and energy in pulse sequence can control the transferred energy more
ND: YAG accuratively, and let the skin cool between sub-pulses, thus reducing the
Module) possibility of reverse actions.
1.11.5. Pulse duration the duration of skin expose for each pulse.
1.11.6. Pulse delay (IPL Pulse delay will determination the interval between Neutron pulses in
and ND: YAG the sequence, so that the skin can cool between sub-pulses and help
modules) advance reverse actions.
1.11.7. Scan Shape, The shape, size, and density of the segmented scan pattern transferred to the
Size, and treatment site by the ResurFX module are set on the touch screen control
Density panel before treatment.
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Chapter 2
2.1. Introduction This chapter descriptions general safety issues related to the
use of the M22 system, with partial emphasis on optical and electrical
safety.
M22 is a medical system that uses Intense Pulsed Light (IPL) and laser
energy for safe and reliable treatment. Through proper operation and
maintenance, the system can be safe used by trained and qualified medical
practitioners. The instructor and all other person who operator or maintainthis
equipment must be family with the safety information provided in this
chapter.
The safety of patients, doctors and other personnel should be the most
important consideration. The safety of patients mainly dependent on well-
trained staff and well-planned treatment rooms. At the same time, patient
education is always very important, which must provide information on the
basic nature of treatment.
Considable effort was devoted to the design of the M22 to maximize patient
and staff safety. Here are some systematic preventive measures:
Self-test the selected module, including module identification.
After the system is turned on, the electronic circuits and
modules will be tested by themselves. During the treatment, the
test circuit will continuous monitor the operating system. If an
error occurs, a message will appeal on the screen.
The closed filter/light guide geometry is used to transmit light to
the patient's skin, and the light will only be emitted from the
front plane of the light guide/tip.
Independent safety circuit can shut down the system to advance
expose to exceptional strong light.
Emergence interrupt knob, and turn off the laser quickly if necessities.
The login screen requirements a password to advance unauthorized
system startup.
When the system is ready to trigger a pulse, it beans.
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MultiSpot Nd: YAG and Q-Switched Nd: YAG modules have
manual safety switches to advance inadvertent triggering of
laser pulses.
Warning
Any laser or strong light device may cause injection if used
improperly. The M22 system contains high voltage electricity.
Personel using lasers or powerful light sources must always be
aware of possible hazards and must take appropriate safety
measures as show in this manual.
2.2. Treatment room Entrance to the treatment room should be clearly labeled
with a marker indicating that high intensity light and/or laser is being
used. Figure 2-1 shows the treatment room marker attached with M22.
Please allow the use of the M22 treatment room only if necessities duration
the course of treatment and well trained in the required safety procedures.
Ensure that all treatment room personality are family with M22 controls and
know how to shut down the system immediately.
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2.3. Important In order to use the M22 system safely, please pay attention to the following
precautions, precautions and warnings.
preventive
measures,
Attention and
Warning
2.3.1. Preventive measures General physicians and clinicians should read this manual carefully before
attempting to operate M22 system.
Light guide, tip and filter must be kept clean at all times.
Light guides and filters must be kept clean at all times. Please
remember to remove the coupling gel from the light guide during the
course of treatment and after each patient uses it. Please take all
precautions to ensure that the coupling gel does not penetrate into the
module.
2.3.2. Note that only Lumenis authorized personnel can repair the M22 system,
especially the system protection cover
The inner part. Internal adjustment actions including power supply,
cooling system, optical system, module, etc. There is dangerous high
voltage in the system.
2.3.3. Laser and intense Laser and intense pulsed light emission will cause eye hazards and
pulsed light potential fire or burn hazards. Please take all necessary precautions
Warnings related to launch in areas where M22 is used.
M22 will emit intense pulsed light and laser pulses. Please confirm
that patients and personnel in the treatment room are protected from
accidental radiation exposure from pulses emitted directly from the
module or indirectly from the reflection plane.
Even when wearing goggles, do not look directly at the beam of the module.
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2.3.4. Module
on M22
The system performs a self-test to identify the module to connect to. If the
system detects that the connector is not connected to the module, or that
there is a problem with the module, an error message appears on the screen.
2.3.5. IPL
And related
warnings of laser
modules
2.3.5.1. Harm of burns and scalds M22 laser radiation is invisible to naked eyes, which may induce third-
degree burns and scalds.
2.3.5.2. Eye exposure hazards the laser module will emit invisible radiation, which
may be caused by direct or indirect viewing
Into harm.
Never look at the laser beam or let it reflect from any metal surface or other
reflective surface.
2.3.5.3. Goggles must be worn by patients, physicians and all personnel near the laser system to
provide laser radiation
(1064 nm or 1565 nm, see section 2.5
Adequately protected goggles. The goggles must have shields on both sides
to protect the eyes from lateral exposure.
Do not point the light of the module anywhere outside the target area.
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Do not use jewelry, watches, surgical instruments, mirrors and other reflective
objects to reflect light.
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Do not expose skin to light pulses except for test blocks and treatment sites.
Even if wearing safety glasses, do not directly look at the laser hole of the
module.
2.5. IPL and Laser It is necessary to wear laser safety goggles every day when using
Safety Goggles most lasers and IPL light sources. The following specifications are
used to calculate the system:
All personnel within the rated eye hazard distance (including patients,
doctors and staff) should wear goggles in the control area and must wear
goggles according to the following specifications:
Table 2-2: Specification for Safety Goggles
EN 207 & ANSI Z136.1
Lase Wavelength Minimum
Protection level of
r used optical
density
Universal IPL 400-1200 nm 5 N/A
Multi-Spot
1064 nm 4 I LB8
Nd: YAG
Q-Switched
1064 nm 4 D LB3, R LB6
Nd: YAG
ResurFX 1565 nm 3.1 DI LB4
Warning
Specify different goggles for different M22 modules. Make sure to
wear the correct type of goggles that match the wavelength used.
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4. According to the procedure, the doctor should always use laser safety
goggles and any of the following objects stained with non-
combustible solution to protect the patient's eyes: thick cloth, eye
mask or gauze 4x4. When treating the face, the doctor should always
use blunt metal eye mask to protect the patient.
Be sure to provide eye protection for patients. Wet thick cloth or 4x4 wet
gauze can be used in combination with goggles to reduce patient discomfort.
It is forbidden to use these items instead of goggles.
Warning
Do not use Multi-Spot Nd: YAG and Q-Switched Nd:
YAG hand devices to treat eyebrows, eyelashes or other
parts around the eyes within the eye frame. The
wavelength of this laser is enough to cause serious eye
damage or blindness.
When using IPL and/or ResurFX, patients must wear
corneal goggles in order to work safely in the edge of eye
socket (upper eyelid fold, anterior tarsal bone and anterior
orbital diaphragm).
2.6. Electrical and mechanical safety Please keep all M22 covers and panels
closed. Removing the lid will pose a safety hazard.
The use of M22 system may cause dangerous ultra-high voltage.
Some components may have residual charge after the power supply
is turned off, so do not open any part of the system housing unless
someone authorized by Lumenis.
When performing system maintenance, do not open the M22 when the
shell is opened or when no one is looking after it.
When moving the M22 system, please be careful to prevent any
personal injury. This system is portable and designed to be easily
moved, but attention should be paid to moving.
This system is grounded through the grounding wire in the power
cable. For the safety of operation, this protective grounding measure
is necessary and indispensable.
Connect the system to a dedicated line/socket. Do not connect the system
to at most plugs and sockets!
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2.6. 1. Leakage Circuit Breaker Lumenis strongly recommends the installation of a leakage circuit
breaker (RCCB), also known as a ground fault circuit interrupter (GFCI).
This is electrical wiring equipment, which disconnects the circuit when an
imbalance of current between the phase line ("live line" or "live line") and
the neutral line is detected. This imbalance is sometimes caused by leakage
caused by accidental contact of grounded human body with the live part of
the circuit. These conditions can cause fatal electric shocks; RCCB is
designed to disconnect the circuit as quickly as possible to reduce this
electric shock damage. The RCCB must be purchased locally and installed by
a qualified electrician.
2.7. The absorption of light energy by fire hazards will increase the temperature of
substances. Please take precautions to reduce the risk of igniting
flammable substances in or near the treatment area.
Warning
Do not use M22 system in the presence of the following
inflammable and explosive substances: volatile anesthetics,
alcohol, volatile preparation solutions and similar substances,
otherwise it will cause explosion or fire.
2.8. Operational precautions Please do not leave the system unattended when it
is in ready mode.
Be sure to shut down the system when you are not using it.
Do not let untrained personnel operate the system.
2.9. The system security function M22 is equipped with several security
functions. All treatment room personnel must be familiar with the
location and operation of these safety functions.
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2.9. Password Users can access the system only after entering the assigned user name and
1. password through the login screen.
This prevents unauthorized use of the system.
2.9. Emergency This red mushroom knob (see Figure 4-1) is designed for emergency
2. shutdown knob shutdown only. When pressed, it
The output of the beam from the module is immediately stopped.
To continue, turn the knob clockwise in the direction of the arrow, and then
restart
M22 system.
Do not use the emergency shutdown knob as a normal procedure for shutting
down the system.
2.9. Ready and The "Ready" and "Standby" buttons are located on the front side panel
3. standby buttons of the system
(See Figure 4-1). When the "Standby" button is red, the system is in standby
mode
Type. At this time, clinical indications and treatment parameters can be input,
but pulse cannot be triggered.
When the operator presses the "Ready" button, the system can be enabled for
operation. When the progress indicator bar is full, the system switches to the
"Ready" and "Ready" buttons
Will turn green to trigger the pulse.
When the system is in "Ready" mode, any touch to the screen (except the
cooler button) will automatically switch the system to "Standby" mode.
2.9. Emission indicator The M22 system is equipped with emission indicators visible on the control
4. light panel. This indicator light has three modes of operation
Formula:
2.9.5. Safety Switch Multi-Spot Nd: YAG and Q-Switched Nd: YAG modules are equipped with
safety switches and indicator lights. The safety switch must be pressed
before the laser is fired and before (but not at the same time) the laser
trigger is pulled. This will limit the laser emission to a specified time
interval (34 seconds). When the laser trigger is activated, the orange
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indicator light on the safety switch lights up. If the specified time is
exceeded, the safety switch must be pressed again.
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2.9.6. When the idle mode does not use the system for 30 minutes, the rest timer
function will switch the system to "Idle" mode.
2.9.7. Remote control The M22 system includes a remote interlock connector that connects the
interlocking external interlock located on the operating room entrance door. When an
device connector external remote control interlocking device is installed, if the entrance door is
opened, the device will disable the system and prevent pulse emission.
2.9.8. Electromechanic This system contains an electromechanical safety isolation shield, which is
al safety isolation enabled only when the system is in "Ready" mode and only when the
shield plate operator activates the trigger switch of the module.
If the system encounters an error condition, the isolation shield will remain
closed, and the subsequent light output will be blocked until the error is
resolved.
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Risk Group 3
Wavelength: 400-1200 nm
Maximum throughput: 56 J/cm2
Pulse duration: 4-20 ms
Warning
The light emitted may cause eye injury. Do not
look directly at the light source
The IR emitted by the device may
irritate the eyes. Do not stare at the
light source
IEC 60601-2-57 Version 1
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CE Certification Mark
Manufacturer
Date of manufacture
Serial number
Serial number
Model name
Electrical requirements
Type B equipment
Laser aperture
US federal law stipulates that this device can only be sold by or on the
instruction of a doctor.
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Temperature limit
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Immunity test IEC 60601 Test Level Compatibility level Electromagnetic Environment-
Guide
Floors shall be made of wood, concrete
Electrostatic discharge ± 8 kV contact ± 8 kV contact
(ESD) or ceramic tiles. If the floor is covered
± 15 kV air ± 15 kV air with synthetic material, the relative
IEC 61000-4-2
humidity
Should not be less than 30%.
Electrical fast 2 kV (for power cord) 2 kV (for power cord) The quality of main power supply
transient/pulse group should be the quality of ordinary
1 kV (for SIP/SOP lines) 1 kV (for SIP/SOP lines)
IEC 61000-4-4 commercial or hospital environment.
1 KV line to line 1 KV line to line The quality of main power supply
Surge IEC61000-4-5
2 KV line to ground 2 KV line to ground should be the quality of ordinary
commercial or hospital environment.
0% UT for 0.5 cycles 0% UT for 0.5 cycles
Instantaneous The quality of the main power supply
voltage drop, 0% UT for 1 cycle 0% UT for 1 cycle should be the quality of the general
short-term 70% UT for 25/30 cycles 70% UT for 25/30 cycles commercial or hospital environment. If
interruption and the user of the equipment needs to
voltage gradient 0% UT for 25/30 cycles 0% UT for 25/30 cycles continue operation during the power
of power supply outage, it is recommended to supply the
input line equipment with an uninterrupted system
IEC 61000-4-11 or battery.
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3 V/m
IEC 61000-4-3 Radiated [E] = 3 Vrms
RF 80 MHz to 2.7 GHz
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Warning
Do not use non-M22 accompanying cables or accessories
as this may result in increased electromagnetic emissions
or reduced immunity to such emissions.
When in use, if the M22 is adjacent to or stacked with
other devices, pay attention to and confirm whether the
laser system in this configuration is functioning properly
before using it for a surgical operation.
Attention
Portable and mobile RF communication equipment may affect the
normal function of M22 system.
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Chapter 3
System
Installation
Plug the system power plug into the designated power socket.
Attention
This chapter contains information about the ResurFX module.
Only Lumenis trained staff can install the ResurFX
module and its accessories into the M22 system.
3.2. Before the facility requires unpacking the system, ensure that the site meets
the requirements set out in the following sections.
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3.2.2. Space and positioning requirements should be configured to facilitate adequate ventilation
and smooth air flow. The system working area shall be prepared
according to the dimensions shown in Figure 3-1. To ensure proper
ventilation, all sides of the system should be kept at least 0.5 m (20
inches) away from walls or other objects that will obstruct airflow.
Figure 3-1: M22 system physical dimensions: with ResurFX module (right) and without ResurFX
module (left)
Attention
Only Lumenis trained staff can install the ResurFX module and
its accessories into the M22 system.
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3.2. 3. Environmental Requirements Air Quality:
The system shall operate in a non-corrosive air environment. Corrosive
substances (such as acids) may damage the surfaces of circuit wiring,
electronic components and optical components.
Dust particles in the air should be kept to a minimum. Dust absorbs light and
warms up. The hot particles on the optical lens will damage the lens. Metal
dust can damage electrical equipment.
Temperature and humidity:
Operating environment: 10 ℃ to 30 ℃ (50 ℃ to 86 ℃), relative humidity
10% to 75%, and no condensation at 30 ℃.
Storage:-20 ℃ to 70 ℃ (-4 ℃ to 158 ℃), relative humidity 10-93%, no
condensation at 40 ℃
The system will emit heat under intensive use. Therefore, it is suggested
that the treatment room should be equipped with air conditioning.
Atmospheric pressure:
Operation and storage time: 77-106 kPa.
3.4. Install and set up the system has passed all quality assurance tests before
shipment, and should be in normal operation upon arrival.
Notes
Before starting the installation and setup process, it is necessary to
ensure that the M22 system is at room temperature.
M22 should be placed next to the power socket to be connected; This is to
avoid the accident caused by the power cord scattered on the floor casually.
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3.4.1. Refer to Figure 3-2 for module bracket installation:
Insert the connecting handle of the bracket into the corresponding slide rail (1)
under the side handle of the system. Push it in until you feel the lock button
"snap" into positioning; So that that bracket is lock and fixed
(2).
Insert the module into the bracket (3).
To remove the bracket from the system, press the lock button (4) and slide the
bracket away from the slide rail.
Notes
This bracket is designed to accommodate all kinds of M22 system
hand tools.
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3.4.2. Connect/disconnect module M22 system is a system combining multiple applications and
multiple technologies. Each M22 module contains an ID chip. The chip has
a unique set of serial numbers, as well as important parameters such as
calibration data and installation date.
Universal IPL, Multi-spot Nd: YAG, or Q-Switched Nd: YAG are all
connected to the same connection port when used.
Install as follows: Remove the protective cover on the module connector. Insert
the connector and rotate clockwise until it stops to connect the connector to the
exposed connection port (see Figure 3-3) to ensure that the connector is
securely attached to the connection port. Turn the connector counterclockwise
to release it.
Place the module on the bracket (see section 3.4. 1).
Notes
Before inserting the connector, make sure that the module
connector is correctly aligned with the connection port.
Attention
Only Lumenis trained staff can install the ResurFX module and its
accessories into the M22 system.
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3.4.3. The light guide and filter M22 system platform provides a die tray for
accommodating the general IPL and Multi-Spot Nd: YAG module light
guide and filter. The tray is under the hinge cover on the front panel.
See Figure 3-4: Open the tray cover (1) on the front panel of the system and put
SapphireCool
Light guide, ExpertFilters and ND: YAG sapphire light guide 1 are arranged
into tray (2).
Notes
Other optional accessories such as filters, tips or light guides are not
suitable for the above tray. When not in use, store them in their
original packaging boxes.
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3.4.4. The service panel connection service panel is located in the lower half of the
rear side panel of the system and contains the following parts (see Figure 3-5):
1. External grounding
Attention
Do not connect any cables to the LAN connection port of
M22 system.
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3.4.4.1. Remote Remote control interlocking device is a safety function. When the system is
control in "Ready" mode, if the door of the treatment room is opened or the plug of
interlocki the interlocking device is removed, the device will disable the laser.
ng
Placement Remote control interlocking is optional; However, whether you use an
connection external door interlock or not, you must plug the interlock into the
"INTERLOCK" connection port (see Figure 3-6). If the plug is not inserted
into the connection port, the system will continue to fail.
When using the remote interlocking device, if the door of the treatment room
is opened or the interlocking device plug is removed, the system will
automatically deactivate and then return to the "Standby" mode. An error
message will appear on the control panel display.
Inserting the plug of the 3-pin interlocking device into the connecting port to
connect the interlocking device; Turn the fixed locking ring of the plug
clockwise until the finger feels tight. The main body of the plug has a biased
design, which can be used to prevent wrong insertion.
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3.4.4.2. Foot If the M22 system is equipped with an optional ResurFX module, its foot
switch switch must be connected to the system; Position the foot switch on the floor
connection and insert its power cord into the foot switch connection port on the rear side
panel of the system (see red circle in Figure 3-7). Then lock the cable nut to
the connection port. Polarizing plates on the slots prevent incorrect cable
connections.
Always keep the foot switch next to the system.
Attention
This section only applies to ResurFX modules.
Only Lumenis trained staff can install the ResurFX
module and its accessories into the M22 system.
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3.5. Fill the cooling system Fill the coolant storage tank with distilled water. The
water level must be between "MIN. LEVEL" marked by the storage tank
(Lowest water level) "and" MAX. LEVEL ".
Attention
Only distilled water can be used when filling
the storage tank of the cooling system. Fill the coolant
storage tank (see Figure 3-8):
1. Pull up the black handle (1).
2. Press the black release button (2).
3. Pull the storage tank assembly (including bottle and lid assembly) out of
the system (3).
4. Unscrew and remove the bottle from the lid assembly, and fill the bottle with
distilled water to the highest water level.
5. To reinstall, press the bottle and lid assembly into the system until you
feel it clapping in place.
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3.6. Initial system testing Before clinical use, test the M22 system to confirm
that the system (including its built-in security features) works properly.
Before turning on the power supply of the system, read the whole operation
manual carefully. Chapter 2-Safety is especially important.
Before starting the system test, please make sure that the operating area is safe
and proper. When performing any laser program, the combustible material
should be wet or away from contact with the laser beam. All personnel should
wear goggles.
If there is any abnormal operation of the system during the test, please stop
using it and contact Lumenis
Service center.
3.6.1. Before starting the initial system test of system controls, you should be
familiar with the following system controls. The usage of the control is
detailed in the "Operation Instructions" section of this manual.
3.6.2. Main Control Panel the main control panel is located at the top of the
console (see Figure 3-9) and contains system controls and touch screen
detectors.
When conducting preliminary system testing, it is necessary to know the touch
screen display (1) and the start button
(2), position of laser/light emission indicator (3) and emergency shutdown knob
(4).
触摸屏显示器
紧急关机旋钮
光发射指示灯
启动按钮
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3.6.3. System Startup 1. Turn on the main power supply of the system located
in the service panel (see Figure 3-5) to the on position.
2. Make sure that the emergency shutdown knob is not turned on (pressed).
If it has been started, please turn it counter-clockwise until it is released
and bounced.
3. Press the start button-located on the control panel (see Figure 3-9);
The system will be turned on, the software will be initialized, and the
touch screen display will display the startup screen.
Attention
Do not touch the display during system initialization
4. The system will perform a series of internal routine self-tests. When these
tests are successfully completed, the main operation screen will appear on
the touch screen display.
5. If the system does not execute as described, please stop using it and
contact Lumenis Service Center.
3.6.4. Emergency The emergency shutdown knob is designed to disable laser/light emission
shutdown knob when pressed. To check the knob:
check
1. When the system is in the startup state and the main "Treatment"
screen is displayed, press the emergency shutdown knob; The system
should display the following error message: Laser has been pressed
to stop.
2. To continue, turn the knob clockwise until you jump. Restart the system
to continue normal operation.
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3.7. Movement and Handling Warning
The standard M22 system weighs about 40kg (88lb) and will be
heavier if the optional ResurFX module is installed. To avoid
human injury, two people should lift the system. Please protect
your back!
3.7. Move the Some users of M22 system have multiple treatment sites. If the system is
1. assembled system placed on the cart, it will
Unified The system can be easily moved between different places. The only thing that
needs to be removed is to disconnect the power cord.
3.7. Disassembly and Remove M22 system and move out of office:
2. handling system
1. Unplug the system from the wall socket.
3. Separate the general IPL, Multi-Spot Nd: YAG or Q-Switched Nd: YAG
modules,
Then put them in a special handling box.
Attention
The optional ResurFX module cannot be removed! Place
the module in the bracket. Ensure that it is placed in a
safe position so that the module will not fall off when
moving or lifting the system.
When the bracket is not in use, remove the bracket.
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Chapter4
System description
4.1. Brief introduction This chapter provides a general description of the M22 system. This
description contains the main components of the system, control and function
subsystems, modules and related accessories.
The system specification is described in the last section of this chapter.
4.2. System Components The M22 is an advanced computer-controlled pulsed light emission system
and Control consisting of:
Control panel-located above and in front of the system console,
including:
System control
Switch Module-The system will start the module lamp and keep the
module lamp in the ready state. When the system switches to
"Ready" mode, the computer passes instructions to release some of
the electricity from the capacitor bank to the lamp.
Universal Power Supply-Provides the regulating power required to
generate pulsed light and other additional modules, as well as low-
voltage DC power required by other subsystems.
Cooling system-The cooling system includes a water pump, a water
storage tank, a fan cooling radiator, deionizer, flow switch and
thermal sensor. This system circulates distilled water from the fan
cooling radiator to the module.
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Modules-The M22 is designed to be used with the Universal IPL
Module, Multi-Spot Nd: YAG Module, Q-Switched Nd: YAG
Module, ResurFX Module. A more detailed explanation will be
given later in this chapter.
Figure 4-1 illustrates the M22 system. Lumenis has been ISO certified, and this
product and all
Like Lumenis products, they are designed and manufactured according to the
highest quality standards of ISO 13485.
Figure 4-1: M22 Strong Light and Laser Skin Therapy System (with optional
触摸屏显示器
光发射指示灯
紧急关机旋钮
ResurFX 手 具 接 头 ( 可
选)
启动按钮
手 具 接 头: IPL 、 Multi-
Spot 或 Q-Switched
Nd:YAG
ResurFX module)
4.2.1. Touch Screen Display Touch Screen Display will display the status and settings of M22
system and other related information. Chapter 5 of this manual will
explain the contents of each screen in detail.
Communication with the system can be performed through the touch screen
display. All commands can be entered into the system by "pressing" the
appropriate "button" or key on the touchscreen display. The "Operating
Instructions" chapter of this manual will discuss all aspects of the operating
system.
4.2.2. Start button This is a button switch that controls the opening/closing of system functions.
The green LED indicator built into the button is on to indicate that the
system is turned on.
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4.2. Pulsed light This system has two light emission indicators: one is the yellow indicator on
3. emission indication the control panel,
Lamp The other is a speaker.
The yellow indicator light has three operating modes:
4.2. Emergency This is a two-position push button (this button should be released under normal
4. shutdown knob circumstances) for emergency use. The button actuator is a big red mushroom-
shaped knob. Press the knob to start running. If you want to open it,
When the switch is released to return to its normal position, the knob must be
rotated (the direction is marked on the knob surface).
When the emergency shutdown knob is pressed, the pulse light output of the
module will be stopped. Follow the direction indicated by the arrow
The button can be released by turning the emergency shutdown knob.
Otherwise, the system will remain in error
The state of.
Attention
Activate the emergency shutdown knob only in case of
emergency.
4.2.5. Service panel the service panel is located at the bottom of the rear side panel
of the system. The panel contains controls and ports for the following items
(See Figure 4-2):
Attention
Do not connect any cables to the LAN connection port of M22
system.
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4.2.5.1. External For equipotential (equalized) ground connection, use the equipotential ground
equipotential terminal of the system maintenance panel
connection (See Figure 4-2).
Ground
Warning
The system can only be used after proper grounding is completed
through the protective grounding terminal.
Figure 4-2:
Maintenance panel
4.2. Calibration This is the position where the calibration device for the calibration module is
5.2. device connected (see Figure 4-2). Please refer to Section 6
connection port Chapter-Maintenance-for complete information.
4.2. Mainon/offswitch This is the main control switch (see Figure 4-2). When the system is left
5.3. unattended for a long time, it should be
Turn off this switch.
4.2. Power cord Please connect the power cord to this connection port (see Figure 4-2).
5.4. connection
Use only:
Specify power cords and plugs that are specific to your system
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4.3. Module M22 can use four modules:
Universal Intense Pulsed Light (IPL) Module
Multi-Spot Nd: YAG Laser Module
Q-Switched Nd: YAG Laser Module
ResurFX laser module
The M22 console includes a universal IPL, Multi-Spot Nd: YAG or Q-
Switched Nd: YAG module connection port and a ResurFX laser module
connection port.
After the module is connected to the connection port, clinical treatment can be
performed.
The module is connected to the system console by an umbilical cable, which
contains power supply and cooling water pipes. For ResurFX module, there
is also an optical fiber that transmits laser energy.
In addition, the module contains a thermoelectric (TEC) cooler, which can
cool the light guide and provide continuous conductive cooling for the skin,
so as to reduce the skin temperature and reduce the discomfort of the patient.
You can turn the cooler on/off by pressing the cooler button on the control
panel display. You can turn the cooler on/off by pressing the cooler button on
the treatment panel. When the module is not in use, it should be placed in the
brackets on both sides of the M22 console.
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4.3.1. Universal IPL Module Universal IPL Gadget (see Figure 4-3) provides a
mechanism for generating and transmitting powerful pulsed light
(wavelength range 400-1200 nm). The content covers the following:
IPL Component
IPL Cooling Assembly
ExpertFilters
光导
Figure触发按钮
4-3: Universal IPL Hand
Press any trigger button to activate the light pulse (suitable for right-handed,
left-handed and different grip users), and these buttons are located on the grip.
The pulsed light will pass through a hole with a filter and enter the light guide
inserted into the bottom of the gripper. The light guide will transmit light
energy to the treatment site.
ExpertFilter
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4.3.1.1. IPL M22 system provides a series of ExpertFilters with different cut-off
ExpertFilters wavelengths or notch wavelengths for customized treatment.
Cut-off filters: 515, 560, 590, 615, 640, 695 and 755 nm.
Notch filters: 400-600 and 800-1200, and 530-650 and 900-1200
Nm.
The system automatically identifies the filter currently used in this hand.
You can change the filter at any time when the system is in "Standby"
mode (see Chapter 6).
755 nm filters, acne filters (400-600 and 800-1200 notch filters) and vascular
filters (530-650 and 900-1200 notch filters) are optional accessories and can
be ordered separately.
4.3.1.2. SapphireCool SapphireCool Light Guide is made of sapphire and provides 0.28, 1.2 and
Light 5.25 cm2 treatment coverage for 6 mm diameter circular, 8x15 mm
guid rectangular and 15x35 mm rectangular light guides, respectively. The light
e guide is cooled by a thermoelectric cooler (TEC).
Notes
The 6 mm round light guide is optional and can be ordered
separately.
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4.3.2. Mu The optional Multi-Spot Nd: YAG handpiece (see Figure 4-4) includes a
lti-SpotNd: solid-state Nd: YAG laser operating at 1064 nm.
YAG Module
This module provides the mechanism for generating and transmitting laser
pulses. It comprises the following devices:
4.3.2.1. Size of ND: The optional Multi-Spot Nd: YAG handpiece offers two sizes of illumination
YAG points (2x4 rectangular and 6 nm round). Each illumination point size
irradiation requires a different light guide assembly. The light guide assembly can be
point replaced by the user.
The Multi-Spot Nd: YAG handpiece automatically identifies which light
guide assembly is currently installed (actual illumination point size).
The 1.5 mm and 9 mm light guides are optional and can be ordered separately.
4.3.2.2. Safety switch The Multi-Spot Nd: YAG hand gear is equipped with a safety switch, which
and indicator must be pressed before laser emission. The safety switch must be pressed
light before pressing the laser trigger (not at the same time).
This switch allows the laser to be emitted only within a specified time
interval (34 seconds). When the laser trigger is activated, the orange
indicator light on the safety switch lights up. If the specified time is
exceeded, please press the safety switch again.
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4.3.3. ResurFX Module ResurFX Gadget (see Figure 4-5) contains a laser
operating at 1565 nm. This gadget provides the mechanism for generating
and transmitting laser pulses. It comprises the following devices:
Galvanometer scanner for transferring segmented patterns
尖端
Sapphire 尖端
扳机
精密尖端
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4.3.4. Q-Switched The Q-Switched Nd: YAG device (see 4-6) consists of a solid-state Nd: YAG
ND: YAG laser and Cr: YAG operating at 1064 nm.
Module
This hand tool provides a mechanism for generating and transmitting laser
pulses. It comprises the following devices:
Q-Switched Nd: YAG Laser Module
● Safety switch and indicator light
● Laser trigger
● Lens assembly
● Therapeutic tips of various sizes
透镜组件
安全开关
扳机
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4.3.4.1. Q-Switched The standard Q-Switched Nd: YAG hand tool can provide a lens assembly,
Size of ND: four disposable treatment tips (2.0, 2.5, 3.5 and 5.0 mm) with different
YAG illumination point sizes, and a 6.0 mm gold plate treatment tip.
irradiation
The Q-Switched Nd: YAG hand will recognize whether the lens
point
assembly has been inserted. It does not recognize which therapeutic tip is
inserted.
The system will guide the user through the verification process to ensure that
the user has installed the correct treatment tips, and provide seven optional
gold plate treatment tips: 2.0, 2.5, 3.5, 4, 5, 6 and 8 mm irradiation point
sizes.
Notes
Before starting treatment, make sure the lens assembly and
selected treatment tip are installed and locked in place.
Q-Switched Nd: YAG hand gear is equipped with a safety switch, which
4.3.4.2. Safety switch must be pressed before laser emission. The safety switch must be pressed
and indicator before pressing the laser trigger (not at the same time).
light
This switch allows the laser to be emitted only within a specified time
interval (34 seconds). When the laser trigger is activated, the orange
indicator light on the safety switch lights up. If the specified time is
exceeded, please press the safety switch again.
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4.4. Note to Module Specification
The specification shown refers to the widest wavelength range and
the highest dose value, which has been approved in the United
States and is allowed to be sold in the EU market. Relevant norms
depend on the specific permission of each country.
Pulse delay:
5-150 ms
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Pulse repetition rate [Hertz]:
Maximum 1.0
Skin cooling:
Continuous conduction cooling
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Pulse repetition rate [Hertz]:
Maximum 1.0
Skin cooling:
Continuous conduction cooling
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Pulse energy:
SapphireCool tip: 10-70 mJ per microbeam
Precision tip: 10-40 mJ per microbeam
Scanning density:
SapphireCool tip: 50-200 microbeam/cm2
Precision tip: 50-200 microbeam/cm2
Pulse duration:
Up to 10 milliseconds
Pulse repetition rate [Hertz]:
0.5 to 2.0
Pattern shape:
Hexagon, Ring, Circle, Square, Horizontal Rectangle, Vertical
Skin cooling:
With or without continuous conduction cooling
ResurFX aiming beam:
Wavelength: 650 nm
CDRH classification: 3R
International (IEC-60825) laser classification: IIIa
二极管Laser medium:
红Color:
Maximum power: 5 mW
Mode: CW
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4.6. Console specification electrical requirements:
100-120V ~ 12A max/200-240V ~ 10A max, 50/60 Hz, single
phase
Cooling system:
Frequency: 50/60 Hz
Water pumps:
Voltage: 24 VDC
Current 2 A (Max)
Fan:
Voltage: 24 VDC
Current: 1.26
Voltage: 4-30 V
Category of electric shock protection:
Category I
Anti-inflow level (console):
IPX0
Liquid entry prevention level (foot switch):
IP68
Dimensions:
Standard system: 51 x 51 x 49 cm/20 x 20 x 19 in
System with ResurFX Module: 51 x 51 x 62 cm/20 x 20 x 24 in
Environmental requirements:
Operating environment:
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Transportation and
storage:
Temperature: (-20)-70 ℃/(-4)-158 ° F
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Chapter 5
Operating
Instructions
5.1. This chapter, which introduces the M22 system operation manual, will
explain the general system operation. The content covers the following:
Preparation work before system operation
Operating system through graphical user interface
Please refer to Chapter 3-Installation for relevant system installation
instructions. Maintenance and troubleshooting are detailed in Chapter 6-
Maintenance and Troubleshooting.
Notes
Please read this manual before any course of treatment. The
information in the manual should be used in conjunction with
formal training, rather than replacing professional clinical
training with a reference manual.
Warning
Only a service representative authorized by Lumenis can repair
the M22 system, especially the internal parts of the system
protection cover. Including internal adjustment actions of power
supply, cooling system, optical system, module, etc. Please do
not touch the module during system startup.
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5.2.2. Safety considerations Before taking any course of treatment, please read
Chapter 2-Laser Safety. Please pay attention to the danger of using laser
and take appropriate protective measures. Some important reminders are
as follows:
1. Please control the entry and exit of the operation area. Please post a
laser/pulsed light warning sign before starting any procedure.
2. Please confirm that all personnel are protected from accidental
exposure to IPL and laser pulses directly from the module or
indirectly from the reflection plane.
3. All personnel and patients should wear goggles.
4. Even if you have worn proper goggles, do not look directly at the pulses
emitted from your hand.
5. Do not point your hand to the air, so that it can release light beams into
the air. Please make sure that all hands are pointed at the treatment site
during actual treatment.
Warning
You must first confirm that the aiming beam can be seen before
operating the ResurFX module.
5.2.3. General information Please keep in mind the general information contained
in this section when using this system.
5.2.3.1. Please check whether the hand, light guide, tip and filter are damaged
and/or stained before servicing and using the accessories
Dye.
Check the umbilical cord for rupture, wear or other damage.
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5.3. Startup system
3. The main on/off switch on the service panel has been switched to the
"On" position.
4. The laser turn-off knob should be in a loose state. If it is started, please
turn the knob clockwise to release it.
5. The correct light guide/tip is installed and locked in place.
6. Patients and all other indoor personnel should wear appropriate goggles.
5.3.2. Turn on system 1. Press the green "On/Off" switch on the system console; The system is
Start the initialization process, and the touch screen display will display
the Lumenis flag. Do not touch the screen during the initialization
process.
4. If you touch the wrong button by mistake, please touch the button-
you can clear the last entered character.
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5. When the password is entered, press the "OK" button, and the system
will confirm the password and enter the "Main" screen of the
operating system (see Figure 5-3).
Notes
The M22 system is delivered with the initial password:
5.4. Interaction with the system and the interaction of the system are mainly carried out through
the touch screen panel. This interaction can be used to select treatment
modes and modules, clinical indications and treatment parameters.
Press the corresponding position on the screen to control the system
instruction and operation.
触摸屏显示器
紧急关机旋钮
脉冲光发射指示灯
启动按钮
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5.5. The "Main" screen (see Figure 5-3) is the first working screen of the
system. You can do the following on this screen:
1. If you need to change your hand; Touch the button; The pop-up
message will prompt: Please change your hand gear and press OK.
At this time, you can disconnect the gripper and connect another one.
Notes
ResurFX module cannot be
disconnected.
2. Enter the "Utility" panel (see Figure 5-31); Touch the button to
enter the "Utility" screen.
3. A row of icons at the bottom shows all the modules available for your
particular M22 system.
4. Touch the button to shut down the system (see Section 5.10).
Shut down
the system
Gadget
icon
The system is
configured to
run these
modules
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5.6. The Utility Menu accesses these programs and features through
"UtilityMenu". This screen displays all the buttons available for action,
with a brief description of each button.
To enter the "Utility" menu, press the left side of the "Main" screen
The "Utility" () button (see Figure 5-3); UtilityMenu opens
(Utility menu) ". To select an option, press the appropriate button. To return
For the "Main" screen, press the button (user mode) or the button (administrator
mode).
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Use features to customize preferences for the following features:
Notes
The "Default" button seen in Figure 5-5 is in English
regardless of the interface language selected.
Press the "Default" button to restore the "ClinicalIndication"
(Clinical Indications) "," Language "and" Sound "
) "and return to the UtilityMenu panel (see Figure 5-31).
5.6.2. Idle mode Press this button to set the system to "Idle" mode, during which the screen
protector appears on the screen. To end the "Idle" mode, press anywhere
on the touch screen.
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5.6.3. D efau lt Pressing this button will turn on the PresetsBackup function. Use this feature
backup to perform routine backups of Lumenis and dedicated defaults that can be
utility exported to removable storage devices.
Prog
ram Be sure to back up the presets regularly. If the default database is corrupted for any
reason, the backup
USB flash disk to restore is quite easy and fast.
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5.6.4. User Management Press this button to display the "UserManagement"
panel (see Figure 5-8).
Use this option to change the password, name, and other details of the current
user. You must have administrator rights (authorization) to add and remove
users.
Notes
If the user does not have administrator privileges, the user
administration screen will not provide AddUser
(Add User) "and" RemoveUser "buttons (see Figure
5-9).
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5.6.4.1. To change the password of a user or administrator, press ChangePassword in the
appropriate system mode (user or administrator), and ChangePassword
will appear
(Change password) "Screen:
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5.6.4.2. Change To modify the user name and user login name, press ChangeUserDetails; A
user pop-up window opens to change user details:
details
Detailed
information
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5.6.4.3. To add a new user, you must log in as an administrator (administrator password). In the
"UserManagement" screen, press "AddUser"; The AddUser screen
appears:
5.6.4.4. To remove a user from the system, you must log in as an administrator (administrator
password). Press "RemoveUser" in the "UserManagement" panel; The
SelectUser pop-up window appears. Scroll the screen to select the user to
remove, and then press OK.
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5.6.5. The update system presses this button to display the "Updates" screen.
From this screen, you can perform the following functions:
Install a new Nd: YAG module and/or Q-Switched Nd: YAG module
and/or a new ResurFX module; Connect the new module to the
system, press the "ModulesUpdate" button and follow the instructions
on the screen.
Update the system software suite; Connect the USB flash disk
containing the new version of the software to the USB port on the
back panel of the system, press the "SoftwareUpdates" button and
follow the instructions on the screen.
Notes
ResurFX modules can only be installed by Lumenis authorized
maintenance personnel.
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5.6.6. System Tools If you need to transport the system, or store the system in the
freezer, access this panel to empty the cooling system (see Chapter 6), or
adjust the system time and date settings.
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5.7. The treatment panel M22 system has a maximum of four operating modes,
one for each module, accessed through four treatment panels (see Figures 5-18,
5-19, 5-20 and 5-21).
The connected module (1), treatment mode (2) and pulse counter (3) are
displayed on the left side of all treatment screens.
In the middle of the screen are the clinical indications (which appear after the
"UserPreset-(4)" option), the pulse parameters (5), and the ice water machine
mode radio button (6).
Filter wavelength or light guide/tip size (7), dose window (8),
"Standby" and "Ready" buttons (9 and 10) and progress indicator bars
(11).
The toolbar button at the top can access the Clinical Indication Options window (12)
and the user preset storage area
(13) and Tools Menu (14).
The top toolbar of the IPL treatment panel provides access to the "AOPT" (15)
function. The bottom toolbar displays the light guide selection buttons (16 and
17, see Figure 5-18).
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精密尖端 SapphireCool 尖端
Notes
When working in ResurFX mode, select the power
transfer mode you want to use: hand trigger button
or foot switch. Please refer to Table 5-2.
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Notes
The dosage is set by the system according to the selected
irradiation point size, and the user cannot adjust it. The matching
dose is displayed in the right window of the Q-Switched Nd: YAG
treatment screen.
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Table 5-1 details the functions and display elements of the universal IPL, Multi-Spot Nd: YAG and Q-Switched
Nd: YAG treatment panels
:
Table 5-1: General IPL and Multi-Spot Nd: YAG Treatment Screen Elements
Screen Desc Func
element riptio tion
n
1. Displays the number of pulses emitted since the counter was last reset (top
Pulse counter column).
(See section 5.7. 3) 2. Displays the number of pulses emitted by the module since
installation (middle column).
3. "Reset" button-Touch this button to return the upper column to
zero.
Main screen Touch this button to access the "Main" screen (see Figure 5-3).
Tools menu
Touch this button to access the Tools menu panel.
(See Section 5.9.)
Save Set the current treatment parameters to user preset. This action
(See Section 5.10) overrides pre-existing user presets, but does not delete Lumenis
presets.
Clinical indications Open the "ClinicalIndications" window and select the skin type
(See section 5.8. 1) and lesion characteristics.
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Table 5-1: General IPL and Multi-Spot Nd: YAG Treatment Screen Elements (continued)
Screen Desc Func
element riptio tion
n
IPL Filter Recognition Prompt the filter model currently installed in the general IPL hand gear
1
Size of irradiation point Displays the size of the illumination point connected to the tip of the ND:
2 YAG hand
Displays the pulse characteristics of IPL or Multi-Spot Nd: YAG pulses. Use this
Pulse window
window to set the number of sub-pulses and adjust the pulse duration and delay.
(See section 5.7. 4)
Use the Increase/Decrease arrow or the Equal Sign button to make
adjustments.
Fluence Window Used to set the dose value, press the ▲ or arrow or drag it directly on
(See section 5.7. 5) the strip to set it. The minimum/maximum value displayed in the
default combination.
"Standby/Ready"
Determine whether to set the system or suspend the system. When
(See section 5.7. 6)
the central progress indicator bar is full, the system switches to
"Ready" mode.
AOPT
Press this button to access the AdvancedOPT panel.
(See section 5.7. 9)
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Table 5-2 details the functions and display elements of ResurFX treatment screen:
Table 5-2: ResurFX treatment screen elements
Screen Desc Func
element riptio tion
n
Main screen Touch this button to access the "Main" screen (see Figure 5-3).
Tools menu
Touch this button to access the Tools menu panel.
(See Section 5.9.)
Save Set the current treatment parameters to user preset. This will override
(See Section 5.10) pre-existing user presets, except Lumenis presets.
Clinical indications Open the "ClinicalIndications" window and select the skin type
(See section 5.8. 1) and lesion characteristics.
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Table 5-2: ResurFX treatment screen elements (continued)
Screen Desc Func
element riptio tion
n
Press or hold the arrow to select the shape of the
Pattern shape selector scan pattern: horizontal line, vertical line
Line, horizontal rectangle, vertical rectangle, square,
circle, ring or hexagon.
Press and hold the ▲ or arrow to select the size of the
Pattern size selector scan pattern, ranging from 5 to 5
18mm pattern.
Press and hold the ▲ or arrow to select the density of the scan
Pattern density pattern, ranging from 50 to 50
selector 3
500mm microbeam per square centimeter.
In continuous mode, just pressing the foot switch or
pulling the trigger of the module all the time will
generate continuous pulses:
Continuous mode
selector Press the mode on/off button to start the mode ().
Press ▲ or arrow direction to select the delayed pulse
repetition rate:
0.5, 1, 1.5, or 2 seconds.
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The number of microbeams is limited by scanning time, energy, shape and size.
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Table 5-2: ResurFX treatment screen elements (continued)
Screen Desc Func
element riptio tion
n
Click this icon to select the pulse generation method, which
will open a pop-up window with two optional buttons:
Aiming beam Press the large or small laser icon to adjust the intensity of the
aiming beam.
"Standby/Ready"
Determine whether to set the system or suspend the system.
(See section 5.7. 6)
When the central progress indicator bar is full, the system
switches to "Ready" mode.
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Table 5-3 details the functions and display elements of the Q-Switched Nd: YAG treatment panel:
Table 5-3: Q-Switched Nd: YAG Treatment Screen Elements
Screen element Desc Func
riptio tion
n
Displays which module is connected to the system; QS stands for Q-
Connected modules Switched Nd: YAG
.
Main screen Touch this button to access the "Main" screen (see Figure 5-3).
Tools menu
Touch this button to access the Tools menu panel.
(See Section 5.9.)
Save Set the current treatment parameters to user preset. This will override
(See Section 5.10) pre-existing user presets, except Lumenis presets.
Clinical indications Open the window of "Clinical Indications" and select skin types
(See section 5.8. 1) and lesion characteristics.
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Table 5-3: Q-Switched Nd: YAG Therapeutic Screen Elements (Continued)
Screen Desc Func
element riptio tion
n
4, or 5 Hz.
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5.7.1. Change Application Mode You can change the application mode at any time by pressing the
"Application" icon on the left side of the "Treatment" screen, which will
open the "SelectApplication" screen. See Figure 5-22, which is an
example screen of an IPL module. This screen also works on Multi-Spot
Nd: YAG, Q-Switched Nd: YAG, and ResurFX screens.
To change the treatment mode, press any "Application" button; The
"Treatment" screen will be changed, or when the module needs to be
replaced, it will go to the "Main" screen.
Returnapplication
Figure 5-22: Selecting to treatmentmode
screen
5.7.2. Wavelength/illu Depending on the module used, the following information appears on the
mination point treatment screen:
size/tip size Universal IPL Module-Displays the wavelength of the filter currently
indicator area installed.
.
ResurFX Module-Displays the size of the illumination point.
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5.7.3. Pulse counter the number above the pulse counter represents the number
of pulses that have been triggered in the current treatment. Click to return
the value of this counter to zero.
The numbers below represent the total number of pulses that have been
transmitted since the active module was installed. This value cannot be reset.
总治疗计数器
重置按钮
5.7.4. Pulse Properties the "Pulse Properties" area of this window (when using a
generic IPL or Multi-Spot Nd: YAG module) displays the following
information (see Figure 5-24):
The number of pulses transmitted each time the trigger of the handset is
started
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Pulse delay
duration
Room, the unit
isMs
Increase/Decrea
Lumenis ® M 22 se button Operating
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e"Button s
5.7.5. The Dose "Fluence" window displays the following information (see Figure
5-25):
Dose range bar and limit, showing the current dose value.
A text bar that displays the current dose value.
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5.7.6. The standby/ready button system defaults to "Standby" mode and cannot
trigger any pulses.
To trigger the pulse, select the treatment parameter, and then press "Ready"
to confirm. When the progress indicator bar (between the "Standby" and
"Ready" buttons) is full, the system switches to Ready mode, and the
"Ready" button lights up (green) and the "Standby" button goes out (brown).
At this time, the pulse can be triggered. Pulses can only be triggered when
the system is in "Ready" mode.
Notes
When the system is in "Ready" mode, changing any
parameters will automatically switch the system to
"Standby".
IPL, Multipoint ND: YAG and Q Switch ND: YAG
Module: Press and hold the trigger of the handpiece until
all necessary pulses are completed. Releasing the trigger
too early may lead to an incomplete pulse sequence.
ResurFX Module: Please press and hold the trigger or foot
switch of the hand until all required pulses are completed.
Releasing the trigger (or foot switch) too early may lead to
incomplete pulses.
When the system is not in use (such as the gap between patients), pressing
"Standby" can suspend the system, so that no pulse can be triggered.
5.7.7. Ice water machine button in IPL and laser module, press the ice water
machine button to switch the light guide/tip cooling system on or off.
The ice water machine is set to turn on by default.
Attention
If the temperature of the light guide reaches or exceeds 50
℃, a pop-up warning message will be displayed on the
screen of the touch screen display.
Lumenis strongly recommends suspending treatment until
the light guide cools.
Figure 5-26: Ice Water Machine Button
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5.7. Light guide InIPLmode,alightguidebuttonmustbepressedtoselectalightguidetostarttreatment.
8. button
Press the rectangular button and select one of the hold
light guides, 8 x 15 or 15x 35 mm.
Press the "Round" button to use the optional 6mm round light
guide.
By default, the Rectangle button is selected.
Press the "Ready" button, and then the light guide confirmation dialog box
appears.
5.7. AOPT function In addition to pulse number, pulse duration and pulse delay time, advanced
9. OPT screens (see
Figure 5-27) Let the user select the dose level for each pulse.
Figure
AOPT 5-27:
激活按钮Advanced OPT Screen
每次发射的
总剂量
脉 冲 (
每个)的剂
量水平
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5.8. There are two ways to
select the preset screen:
According to clinical indications
By name
5.8.1. Choice
Press on the "Treatment" screen toolbar to open the
according to "ClinicalIndications" screen corresponding to the selected treatment mode
clinical and current module.
indications
Press the "ByClinical" index label to select clinical indications for patients
who are about to undergo treatment (see Figure 5-28). Clinical indications
include skin type, lesion type, intensity and depth. For more details, please
refer to the Clinical Guidelines for each application (Appendix A-E).
Figure 5-28: Selecting a preset screen according to clinical indications (for an example of a
general IPL module)
Notes
Two Lumenis defaults are provided in the following cases. To use
one of these values, insert the recommended filter and light guide,
and press the OK button.
UseHousehol
dPreset
Closed
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5.8.1.1. Skin type Press the corresponding button according to Freund's skin type to enter the skin
type of the patient (see Figure 5-28). The box of the selected button will
be displayed prominently, and the text color will also change.
Type of lesion
Vascular disease (VL)
Depth of lesion
Hair color
IPL Hair Removal (HR)
Hair texture
Scar type
Acne scar (AcneSc)
Severity
Scar type
SurgScar (SurgSc)
Severity
Type of treatment
Skin therapy (ST)
Severity
Dermatoglyphic type
Dermatoglyphics (Striae)
Severity
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Table 5-7: Lesion/disease characteristics applicable to each application
treatment: ResurFX (in the United States)
Appl Lesion/disease characteristics
icati
on
Type of treatment
Skin therapy (ST)
Severity
Tattoo properties
Dark tattoo (DT)
Ink concentration
If you have entered your own user preset for this set of clinical indications, you
can use the
Switch between Lumenis and user presets.
After pressing "OK", the selected clinical indications and treatment
parameters will be displayed on the "Treatment" screen.
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5.8.2. Select by Name Press the "ByName" index volume label, and select
according to the default name of the operation. For more details, please
refer to the Clinical Guidelines for each application (Appendix A-E).
选择已命名的预设
值
预设名称
治疗参数 冷水机打开/关闭
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5.9. Tools Menu This section describes the software tools that come with the
software operating system for each treatment module and the M22 system.
To enter the Tools menu, press the Tools button located at the top right of the
treatment screen.
Figure 5-31: Tool menu panel of laser hand appliance (multi-point Nd:
YAG, Q switch Nd: YAG and
ResurFX)
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5.9.1. Healing Head Information Press the "HeadInformation" button to open the
following screen:
5.9.2. Calibration Pressing this button will allow you to calibrate the specific
hand you are using. The system is equipped with user calibration tools for
Q-switch ND: YAG and multi-point ND: YAG hand tools. For IPL, the
calibration can be done by the user (e.g. the calibration tool is purchased
separately) or by the maintenance engineer. For ResurFX, calibration
means that the scanner aims at the beam, also known as scanner
adjustment.
Refer to Chapter 6 for a detailed description of calibration options.
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5.9.3. Trigger rate will only be displayed when using universal IPL hand gear. With this feature,
you can limit the trigger rate to a slow mode of 0.5 Hz, which can increase
the interval time between pulses to cool the light guide.
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5.10. There are two ways to save the selected operation parameter protocol as a
user default:
According to clinical indications
By name
After entering the parameters into the "Treatment" panel, press the "Save
() button; The system will enter the" SaveasUserPreset "panel.
5.10.1. A c c o r d i n g t o Press the "ByClinical" index volume label and save the selected operational
clinical protocol parameters as parameter self-defined (see Figure 5-34).
indications
Save
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5.10.2. Saved by name in this window, you can make two different default
configurations (see Figure 5-35):
1. Saves the selected operation protocol parameters as defined by the
proprietary name.
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5.11. To shut down the M22 system, do the following:
Press the "ShutDown" button in the upper right corner of the "Main" screen to close
it
M22; A pop-up window with three options appears (see 5-36):
Press the "ShutDown" button, and then press the main start/close
switch. M22 should be closed at the end of work every day. There is
no need to unplug the connector.
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Chapter 6
6.1. Introduction This chapter explains how the user performs routine
maintenance procedures: cleaning the system, cleaning the optical
components, calibrating the gripper, and replacing the light guide and
gripper. This chapter also provides troubleshooting guidelines, including the
most common system problems and their solutions.
The programs in this chapter are designed only to allow users to perform
maintenance activities. All other maintenance procedures can only be
performed by Lumenis authorized personnel.
Warning
6.2. Cleaning system The system console should be cleaned with clean cloth and sexual detergent.
Touch screen monitors should be cleaned regularly with special screen
cleaning fluid, which can be purchased from any office supplies store.
Please pay special attention to make sure that no liquid spills on the system.
6.3. Module maintenance The M22 module contains components that may be damaged by falling.
Modules should always be placed in their brackets or storage boxes except
during treatment.
Do not let sunscreen or sunscreen products come into contact with hand gear.
The ingredients contained in these products may be damaged or
Damage the hand cover. If sunscreen or sunscreen comes into contact with
hand gear, please clean it immediately to prevent any
Could be damaged.
Do not immerse your hand in water or keep it under running water for a long
time to prevent water droplets from penetrating into your hands
With.
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6.3.1. IPL Optical Assembly
6.3.1.1. IPL Intense Pulsed Light (IPL) ExpertFilters, which control the spectral output of
ExpertFilters the system, are fixed by Lumenis to ensure that the function works well
when received by the user. This product does not provide other warranty
services.
Under normal operation, the performance of these filters may deteriorate
with long-term use and need to be replaced. If there are stains on the
surface of the film, or spots are caused by peeling or removal of the film
from the base, such damage may adversely affect the treatment results.
Peel peeling may also affect the stability of treatment and, in some cases,
may be dangerous to operators or patients.
Although filters are consumables, their service life can be greatly
prolonged with proper maintenance and maintenance. Filters directly
affect the results of the program, so in order to achieve the desired
results, it is important to maintain the filters to ensure that they are clean
and undamaged.
The M22 system provides a series of ExpertFilters with different cutoff
wavelengths or notch wavelengths
(Long wave filter) for customized treatment.
Cut-off filters: 515, 560, 590, 615, 640, 695 and 755nm.
Notch filters: acne filters (400-600 and 800-1200) and vascular
filters (530-650 and 900-1200).
The system will automatically identify the filter currently installed on the hand.
The 755nm filter, acne filter and vascular filter are optional and can be ordered
separately.
Attention
Be sure to keep the filter clean at all times, otherwise it may
harm the patient and cause damage to the module. If the filter is
faulty or there is any damage to the film (i.e. more than 15% of
the film surface is covered with spots), replace the filter.
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Dry the surface of the filter with a dust-free cloth (both sides).
拔出滤
波器
If there are spots, clean the filter with a cloth stained with
ethanol or isopropanol.
Gently wipe the filter with a dust-free cloth until the filter is completely
dry.
After cleaning, make sure that the filter looks clean. If it is not clean,
it should be cleaned repeatedly, otherwise, before reinserting the filter,
hold the grip and put the module in sliding mode.
When not in use, store the filter in a plastic sleeve.
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IPL6.3. 1.2. The light guide should keep the surface free of debris and other foreign
SapphireCool bodies at any time, and clean it up after each patient's course of treatment.
Light guide
Attention
Clean the light guide only after it cools down. Please do not
clean it immediately after treatment.
The light guide should be kept clean, dust-free and free of foreign matter,
because if there are any particles and dust on the light guide, it will absorb
light and become hot, which will cause skin damage and increase the
discomfort of patients.
Hold both sides (3) of the light guide and pull it out from the bottom
to remove the light guide plate assembly from the hand (if the light
guide is slippery, dust-free paper towels can be used).
Hold the light guide (4) and remove the plastic cover.
Clean the lid and light guide with warm running water to remove any residual
gel.
Dry the lid with the light guide with a dust-free cloth.
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Assemble the light guide and its cover, reinsert it into the gripper, and lock the
latch.
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6.3.2. Multi-Spot During treatment, the ND: YAG laser light guide assembly can be routinely
ND: YAG laser replaced to change the size of the irradiation point. Press the spring button at
light guide plate the bottom of the module, and the light guide will pop up.
assembly
Attention
When pressing the spring button, put your hand under the light
guide plate to avoid the light guide plate falling to the ground.
Please keep the light guide clean at all times. The light guide should be
cleaned at the end of each patient's course of treatment. Cleaning light
guides must comply with the following requirements:
For each contaminated surface, it should be contaminated with
0.55% orthophthaldehyde
(e.g. Cidex OPA) The flanneless cloth of the disinfectant wipes the
light guide thoroughly five times in a circular motion.
光导
光导弹出按
钮
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6.3.3. ResurFX laser The optical surface of the tip should be kept free of dust and debris at all
tip assembly times and cleaned after the treatment of each patient.
The optical surface of the tip should be kept clean, dust-free and free of
foreign objects, because any such objects on the tip will absorb light and
become hot, which may cause skin damage and increase patient discomfort.
Cleaning tips must comply with the following requirements:
尖端
触发
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6.3.4. Q-Switched When using the Q-Switched Nd: YAG module for treatment, there are two options
ND: YAG to choose from:
Lens Assembly Four single-use therapeutic tips of different sizes attached to the lens
and assembly after being placed on the hand (see Figure 6-5).
Therapeutic
Tip Gold plate metal therapy tip containing lens assembly and directly
connected to hand device (see Figure 6-6).
To begin using either tip, first remove the protective cover and insert the tip
into the Q-Switched Nd: YAG gripper.
透镜组件盖
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Attention
When the spring button is pressed, the hand should be placed
under the lens assembly to prevent the lens assembly from
falling to the ground.
Therapeutic tip
Discard the used tip and insert a new treatment tip for the next
patient.
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6.4. Multi-Spot Calibrate the Multi-Spot Nd: YAG hand tool as a necessary step to ensure its
ND: YAG optimal performance. The user can perform the calibration according to the
Module operating instructions given in Section 5.9 and Figures 5-31 and when
Calibration required by the system. When the treatment begins, the system checks
whether the module needs calibration and will instruct the user to perform the
calibration if necessary.
The calibration process is the same regardless of how the calibration process
is started (as required by the system or first requested by the user).
Attention
The output energy of the module will decrease with time.
Therefore, if the calibration is performed after a long interval, the
energy emitted after the calibration may be higher than the energy
before the calibration even if the same setting is used. Before
starting treatment, be sure to perform the test in the block.
Calibration is an enforcement item and the system automatically starts
calibration in the form of a pop-up warning message when:
When the hand is first connected to the system.
This module has emitted 3000 pulses without performing any calibration.
1. Connect the calibration unit for the Nd: YAG module (see Figure 6-
18) to the service panel of the system. See Arrow 4 (in Figure 6-20).
2. Remove the light guide of the gripper, and then install the gripper on the
calibration device, as shown in Figure 6-8.
3. Press the Calibrate button on the pop-up window and carefully
follow the instructions on the screen to complete the calibration
process.
Notes
Press and hold the trigger of the gripper until all
calibration pulses are completed. Releasing the
trigger too early may lead to incorrect calibration
results.
If the module has not been used for a long time, any
intermediate calibration procedure (until 3000 pulses are
reached) will not damage the module and may not be
considered in practice.
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Figure 6-8:
Installing
Multi-Spot
Nd: YAG
Hand to
Calibration
Device
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6.5. Q- Calibrating the Q-Switched Nd: YAG hand is a necessary step to ensure the
Switched Nd: best performance of the hand. The user can perform the calibration according
YAG Module to the operating instructions given in Section 5.9 and Figure 5-31 and as
Calibration required by the system. When treatment begins, the system checks whether
the module needs calibration and instructs the user to perform the calibration
if necessary.
The calibration process is the same regardless of how the calibration process
is started (as required by the system or first requested by the user).
Attention
The output energy of the module will decrease with time.
Therefore, if the calibration is performed after a long interval, the
energy emitted after the calibration may be higher than the energy
before the calibration even if the same setting is used. Before
starting treatment, be sure to perform the test in the block.
Calibration is an enforcement item and the system automatically starts
calibration in the form of a pop-up warning message when:
When the hand is first connected to the system.
This module has emitted 50,000 pulses without performing any calibration.
1. Start the system and enter the Q-Switched Nd: YAG treatment panel,
and a pop-up message will appear requesting calibration (see Figure
6-9).
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5. Press the calibration button, which is located on the tool screen, see Figure 6-12
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7. Remove the lens assembly (if inserted) from the gripper, and then
install the gripper on the calibration device.
Notes
If the gripper has been installed to calibrate before the message shown in
Figure 6-14 appears
On the device, you need to remove it first and then install it again
(see Figure 6-15).
Notes
Press and hold the trigger of the gripper until all calibration
pulses are completed. Releasing the trigger too early may lead
to incorrect calibration results.
If the module has not been used for a long time, any
intermediate calibration procedure (until 50,000 pulses are
reached) will not damage the module and may not be
considered in practice.
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6.6. ResurFX beam The shape of ResurFX aiming beam should be complete.
alignment
If the shape is smaller than the full shape or there is a notch, it is necessary to
align it and restore it to the full shape (see Figure 6-18).
Calibrating ResurFX hand gear is a necessary step to ensure the best
performance of hand gear. The user can perform the calibration according to
the operating instructions given in Section 5.9 and Figure 5-31 and as required
by the system.
To enter the Scanner Alignment utility, press the Tools button and
then the Alignment button on the pop-up menu that appears on the
不完整形状 完整形状
ResurFX Therapy screen.
Use the arrow keys to adjust the shape, and then press the OK button to
save the alignment.
Note that once the OK button is pressed, the beam is turned off for one
second and then turned on again.
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6.7. Power meter calibration should check the power meter of M22 system at
least once a year. Calibration checks can only be performed by Lumenis
authorized service personnel, and if necessary, calibration procedures can
only be performed by these personnel.
The calibration check compares the dose readings on the M22 screen with
those on the calibrated power meter. If the difference between these two
readings is greater than 10%, the power meter of the system must perform a
calibration procedure.
Lumenis maintenance personnel perform calibration checks
using the calibrated power meter. Check calibration:
1. Technicians will use M22 calibration device to perform standard
calibration.
2. Then, the technician will use the calibrated power meter to measure
the output value of the calibrated system, and compare the measured
dose with the value on the M22 screen.
3. If the difference between the M22 dose reading and the power meter
dose reading is greater than 10%, the technician will calibrate the
M22 power meter.
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6.8. Fill/drain Maintaining the water level of the coolant storage tank is very important to maintain
cooling the normal operation and safety of the system function. The water level should
system always be between MIN. Level marking on level and maximum reservoir.
When the system is in a refrigerated environment (cold storage, air transportation,
etc.), the cooling system must be drained. The storage tank should be removed from
the system during transportation regardless of the mode of transportation.
Attention
When refilling the storage tank of the cooling system, only distilled water can
be used.
5. To reinstall, press the bottle and lid assembly into the system until you feel
it clapping in place.
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6.9. Troubleshooting M22 system is equipped with self-test software, which can continuously
monitor the operation of the system. If system dysfunction is detected, an
error message will appear on the display screen. If dysfunction occurs,
please refer to the troubleshooting guidelines on the following pages.
Do not attempt to open or remove the system cover.
Attention
Improper use or adjustment of this system may cause the
maintenance warranty agreement to be invalid. Contact an
authorized Lumenis reseller before attempting to troubleshoot the
system in a way other than that described in this manual
Warning
In the main control cabinet and module, the system will generate high
voltage and laser radiation. Only
Lumenis authorized technicians are qualified to repair the internal
components of the system.
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6.9. 1. Error messages The following table lists the various error messages that may occur indicating
and corrective that the M22 system is dysfunctional.
actions
Table 6-1 illustrates several error messages that may appear on a touchscreen
display, all of which can be corrected by the user. If the corrective action
does not resolve the problem, contact your Lumenis dealer or service center
with the error code and message body.
Table 6-2 lists possible error messages that may require repair by someone
authorized by Lumenis. Please try restarting the system. If the error message
continues to appear more than two times, shut down the system and contact
your Lumenis service representative.
Table 6-3 lists some power-related problems that may occur without an error
message. If the corrective actions listed in the form do not resolve the
problem, please contact the Lumenis Service Center.
Table 6-1: Error messages and related corrective actions
Error # Error Correctiv
message e action
The gripper is not connected or is not properly
230 The treatment head is not connected.
connected to the port. Check whether there is any
problem with the connection, and continue in normal
operation mode.
The laser interrupt knob is turned on. Interrupt and connect,
237 Press the laser stop button by mistake.
and continue in normal operation mode.
The remote control interlocking device is faulty. The remote control interlocking device of the M22 system is
240
Please make sure that the door of the treatment connected to the door of the treatment room, which is now
room is closed. open. Please close the door and continue operation.
Cooling system overheating fault, please wait
250 Shut down the system for at least 20 minutes before
20 seconds to let the system cool. continuing normal operation.
Water flow and water level failure, please make Please check the water storage tank on the back plate of the
251
sure that the water storage tank device is system. If necessary, refill the storage tank with distilled
correctly placed. water.
The internal system is dysfunctional, please restart the
353 Please restart the system and try again.
system and continue in normal operation mode.
Please make sure that the pedal plate is Try to switch to Ready mode while stepping on the
2089
pressed before selecting Ready. pedal; Release the pedals and try again.
Press the OK button, wait a few minutes for the
The tip temperature is higher than 50 ℃/122 ℃. light guide to cool down, and then press the
Please wait for a few minutes for the tip to cool Ready button on the Standby screen to continue
1800
down. normal operation.
(System switches to Standby mode) If messages continue to appear after cooling, please
contact Lumenis Service
Service center.
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Table 6-2: Error messages to contact the Lumenis Service Center for processing
Error # Error
message
1 System failure: A communication error occurred in the initial state, and the online connection could not be
started.
2 Subsystem identification error.
10 Communication error.
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Table 6-2: Error messages to contact the Lumenis Service Center for processing (continued)
Error # Error message
255 Door interlocking device IO does not match.
304 Wrong security key! Master system key has been detached. Please insert the system and update the key, and
click OK when you are ready!
305 Wrong security key! Unable to support key.
308 Wrong security key! Secure key separation. Please insert the security key and click OK.
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Table 6-2: Error messages to contact the Lumenis Service Center for processing (continued)
Error # Error message
313 Wrong security key! Unable to update the security key.
316 Wrong security key! Master system key has been detached. Please insert the system and update the key, and
click OK when you are ready!
317 Wrong security key! Timeout-Unable to update key. Please try again. If it fails, please contact Lumenis
support.
351 Bad update file. Please contact Lumenis support.
352/354 Unable to open file. Please check whether the updated key has been inserted.
357 Unable to perform software update. Please try again, or contact Lumenis support.
1050 System failure: The connected treatment head is not a Lumenis device.
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Table 6-2: Error messages to contact the Lumenis Service Center for processing (continued)
Error # Error message
1230 Communication failed, press OK to continue self-test.
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Table 6-2: Error messages to contact the Lumenis Service Center for processing (continued)
Error # Error message
2079 Fiber laser error.
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When the trigger of the 1. The system is not in Ready mode. 1. Set the system to Ready mode.
handpiece is pressed, no 2. System dysfunction. 2. Contact Lumenis service center.
laser/light is emitted.
The system did not 1. The touch screen of the control panel is 1. Contact Lumenis service center.
respond to the not calibrated.
2. Contact Lumenis service center.
instruction of the 2. System dysfunction.
touch screen.
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6.10.1. Warranty Lumenis hereby warrants that the materials and workmanship
of the M22 system and its accessories are free from defects and that the
warranty will be carried out in accordance with the manner and
conditions listed in the Operation Manual. Nonconforming devices must
be returned to Lumenis or its authorized agent. Please refer to the next
section for information on returning Lumenis devices. For specific and
detailed warranty information about this instrument, please refer to the
first page of your Purchase Agreement and the last page of the Terms and
Conditions of Sale.
6.10.2. Return of Equipment Call your local Lumenis representative or your nearest customer
service center (www.Lumenis.com/contact1) to obtain authorization to
return the equipment before sending it to Lumenis
(RMA) Tracking number.
6.10.3. Customer feedback If you have any feedback or any adverse event reports,
contact the nearest customer service center (
Http://www.Lumenis.com/contact1).
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Chapter 7
Accessori
es
7.2. Module M22 can use four modules: IPL module, multipoint ND: YAG module
and Q switch ND: YAG
Module and ResurFX module.
Operating with the universal IPL module are seven filters with
different cut-off wavelengths (515, 560, 590, 615, 640, 695 and
7551nm), two notch filters (Acne 1 and Vessel 1) and three
IPLSapphireCool light guides (8x15, 15x35mm rectangular and
61mm circular).
Multi-Spot Nd: YAG hand tools are available in two irradiation point
sizes: 2x4 mm, 6 mm, 9 mm1 and 1.51 mm. Each illumination point
size requires a different light guide assembly.
The Q-Switched Nd: YAG hand can be operated with four different
disposable therapeutic tips (2.0, 2.5, 3.5 and 5.0 mm) connected by a
lens assembly and five different gold plate metal tips (2.0, 2.5, 3.5,
4.0, 5.0, 6 and 8mm) with built-in lens assembly (2.0, 2.5, 3.5, 4.0, 5
and 8mm gold plate metal tips are optional devices).
The ResurFX module uses two tips to provide different illumination point
sizes, densities and shapes
SapphireCool and Precision 1.
1 Optional accessories.
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7.3. Goggles IPL and all laser modules are equipped with goggles (see
Chapter 2 of this Operator's Manual for safety glasses specifications).
Warning
In order for it to work safely in the edge of the eye socket
(upper eyelid folds, eye platform on the left side of the
patient direction and anterior orbit), the patient must wear
corneal goggles.
7.4. IPL Coupling Gel Used on the skin refrigerated (6-10 ℃) coupling gel can alleviate
discomfort, and can be used as a light guide and the skin surface of the
light coupling medium. The coupling gel can also be used with universal
IPL modules and Multi-Spot Nd: YAG.
Do not use coupling gel with ResurFX or Q-Switched Nd: YAG module, £ 0. 25
available
L and 1 L bottles of gel.
7.5. Light guide and Universal IPL Light Guide is a polished sapphire, which can connect light
filter for general energy from the module to the treatment site. The size of the light guide
IPL module determines the beam footprint ("footprint" is a common term used when
using IPL to cause burns-IPL leaves a "footprint").
Filters using various cutoff wavelengths, notch wavelengths or narrowband
wavelengths.
7.6. Multi-Spot Multi-Spot Nd: YAG lens assembly consists of sapphire light guide and gold
Therapeutic Tip plate metal shell. The size of the therapeutic irradiation point depends on the
Component of ND: light guide. The illumination point sizes provided are a rectangle of 2x4mm
YAG Module and a circle of 6mm, 9mm and 1.5 mm in diameter.
6mm gold plate metal therapy tip with its own lens assembly
(other metal tips of different sizes 2.0, 2.5, 3.5, 4.0, 5 and 8mm
are optional).
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7.8. The Tip of ResurFX has two gold plate metal tips that may be used during treatment.
ResurFX Module Both tips can transmit irradiation points up to 18mm:
Notes
During treatment, it is necessary to combine a precise tip
perpendicular to the skin with external cooling.
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7.9. Light guide, tip The M22 system platform provides a die tray for the module's light guide and
and filter tray filter (see Figure 7-1). The tray is under the hinge cover on the front panel.
Notes
All other M22 accessories are not suitable to be placed on the
above tray and should be stored in their original packing box when
not in use.
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7.10. An initial entry kit is provided when ordering accessories to purchase M22
system.
Table 7-1 lists additional accessories that can be ordered from Lumenis or
your local distributor. Please check the part number when ordering.
Table 7-1: M22 Accessories List
Describe the number of part numbers
General IPL Module Accessories:
Notes
Lumenis reserves the right to change the catalog number and supply an
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Table 7-1: M22 Parts List (Continued)
Describe the number of part numbers
Multi-Spot Nd: YAG Module Accessories:
M22 Nd: YAG Light Guide Kit (6mm and 2mm x 4mm) KT-1048770 1
Notes
Lumenis reserves the right to change the catalog number and supply an
equivalent product.
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Table 7-1: M22 Parts List (Continued)
Desc Part number Qua
riptio ntity
n
M22Q-Switched Metal Therapy Tip Kit Dimension 5mm KT-10024850 1
Notes
Lumenis reserves the right to change the catalog number and supply an
equivalent product.
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Appendix A
Clinical Guidelines: IPL Skin Therapy (ST)
A.1. Brief introduction IPL skin therapy application uses the universal IPL module,
also known as SR/ST mode.
A.2. Training requires that the M22 system should be operated only by
properly trained personnel who are familiar with control and use
methods. Including doctors, nurses, technicians or other professional
staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
A.3.1. Indications IPL skin therapy application of M22 system (and transmission accessories used
with it to transmit light energy) is suitable for cosmetic and cosmetic
applications requiring selective photolysis effect of soft tissue and
hemostasis in general surgery, plastic surgery and medical specialties of
dermatology.
Strong pulsed light with wavelength of 400-1200nm is suitable for the following
treatments:
Benign pigmented epidermis and skin lesions, including
heterochromia, pigmentation, liver spots, scars, and
dermatoglyphics.
A.3.2. Contraindication Continuous ice water machine is suitable for general surgery, plastic surgery
s (non- and dermatology. Before/during/after phototherapy, use it to cool the
exhaustive list) epidermis of the treatment site to achieve the following effects:
Attack of infection
Dysplastic maternal plaque
Tattoo
Severe complicated skin condition or any inflammatory skin condition.
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Cold sores, open tears or abrasions.
Chronic or skin viral, fungal or bacterial diseases.
A.3.3. Preventive measures should be taken with care and in accordance with the
doctor's decision when treating patients with the following medical history or conditions:
Hemorrhagic coagulation disease
Swollen scar of crab foot
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Systemic lupus erythematosus or purpura.
General light allergy or any rash or allergic reaction caused by allergy to sunlight.
Hormonal disorders, such as polycystic ovary syndrome, unless the
condition is under control.
Gold therapy.
Radiotherapy.
Collagen, fat injection or other skin filling methods have
been used before. Patients who have used any of the following drugs
should be treated with care and in accordance with the doctor's
decision:
Anticoagulant; Avoid taking anticoagulants before treatment, which is at
the discretion of doctors.
Immunosuppressive drugs.
Herbal supplements, perfumes or cosmetics that may affect sensitivity to
light.
Oral isotretinoin (eg acne specific medicine).
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Patients with the following conditions should be treated with caution and
according to the doctor's decision:
A.3.4. Warning As with any IPL, appropriate measures must be taken to ensure
safe and proper use. You must thoroughly read and understand all the
contents of this operation manual before operating the instrument.
Moreover, as discussed below, operators should attend laser training
courses before using the system.
IPL may cause skin damage. The higher the dose and the more severe the
skin pigmentation, the higher the risk:
Patients with darker skin types and residual tanning on the skin
have a higher risk of pigment changes in the treatment area.
These patients should strictly follow the treatment plan of the
test location and be treated carefully.
Exposing the treatment area to sunlight immediately after
treatment or within one month after treatment may also increase
the risk of pigment changes in the treatment area. Patients
should be instructed to use broad-spectrum sunscreen (minimum
SPF30) every day and reuse it every 2 hours. Avoid direct
sunlight.
Comply with all safety precautions described in the chapter
"Safety and Regulations" and other parts of this manual.
The light emitted by this module is enough to cause serious eye
damage or blindness. When the main power is turned on, all
personnel in the treatment room, including patients, operators
and any observers, must wear appropriate safety goggles.
Before starting comprehensive treatment, treatment should be
carried out at the patient's test site and skin reaction should be
evaluated. Side effects may not appear until several days after
exposure. For skin type V, wait 48-72 hours after treatment at
the test site to observe tissue reaction. Always allow sufficient
time between test treatment and actual treatment.
Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
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A.4.2. When consulting a patient for an initial visit, the physician (or authorized
staff member) should inform the patient of the following information:
Treatment may cause some discomfort or pain (see section a.4. 4).
Transient erythema/edema may occur immediately after treatment.
After treatment, the pigmented lesions may deepen for up to fourteen
days.
It may take several courses of treatment to achieve acceptable results,
usually four to six times. The whole course of treatment should be
planned at the beginning to promote coordination and reasonable
expectation.
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A.4.3. Eye protection equipment must be worn by all people (patients and staff) in
the treatment room during treatment
Lumenis recommended goggles to protect the eyes. The optical density (OD) of
goggles is as follows:
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
A.4.4. Local anesthesia can be performed without local anesthesia when using M22 module for
general skin therapy. However, because skin therapy generally treats a
large area, such as the whole face, many patients tend to use local
anesthesia for treatment, so that they will not feel uncomfortable during
the course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
Warning
Large-scale use of local anesthesia may lead to unexpected side
effects.
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A.4.5. It is recommended to take photos before and after treatment to record the
progress of treatment. Because many patients can't objectively evaluate
the progress of treatment, these photos can provide concrete evidence.
For all patients, use standard conditions and similar shutter speed, flash and
focal length. In this way, we can objectively compare the photos taken in
different periods.
A.4.6. Possible side Skin therapy for IPL usually requires four to six consecutive sessions with at
effects of least three weeks intervals, and it has been proved that the most appropriate
treatment interval between treatments is three weeks. However, a longer interval has no
adverse effect on the treatment outcome. Dispersing the treatment during this
period can gradually improve the skin, minimize the risk of adverse
reactions, and at the same time maintain the important characteristic of "no
shutdown" of this treatment. A few cases do have side effects, and further
treatment should be postponed until complete recovery. The most common
side effects are:
A.4.6.1. When discomfort triggers pulse, it may cause discomfort to varying degrees. Some people
describe it as tingling, while others say it feels like a rubber band
bouncing. The burning sensation may last up to an hour after treatment.
Most patients can tolerate this discomfort, but some people need local
anesthesia (be sure to use only local anesthetics that do not cause
vasoconstriction).
A.4.6.2. For natural It may form scabs or blisters, and it takes five to ten days to recover.
skin
To cause
damage
A.4.6.3. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months, but in some rare cases (mainly cases of
pigment reduction), the pigment change will last longer or become
permanent.
A.4.6.4. There is little chance that scars (such as enlarged hypertrophic scars) will occur. In rare
cases, large bulges of abnormal crab foot swelling scars may appear. To
reduce the risk of scarring, be sure to carefully follow all preoperative
and postoperative instructions and exclude patients with hereditary scars.
Care should be taken to treat wine stains (PWS) in young children. If too
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A.4.6.5. Excessive swelling After treatment, temporary swelling of the skin may occur
immediately, especially around the nose or eyes. Swelling usually
subsides within hours and no more than seven days at most.
A.4.6.6. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
A.4.6.7. Bruising in very rare cases, blue-purple bruises (purple spots) may appear in the treatment
area. It may last for five to fifteen days. After the bruise subsides, the skin
in this area may turn dark brown and subside within one to three months.
A.4.6.8. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
Do one more stage in the same treatment area during the first course of treatment
and whenever the treatment settings are changed
Before (if allowed), and when replacing the module, be sure to perform small
block tests in an inconspicuous part of the area to be treated.
A.4.6.9. Itching has a small chance of causing burns and scalds on the skin,
especially in the case of xerosis.
A.4.6.10. Xerosis If proper skin care is not carried out during the course of treatment,
the skin may become dry.
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A.5.3. Facial Tiny red concentrated lesions on the face are caused by curved vasodilation.
microvasodilation It usually appears around the nose, cheeks and chin of the face.
A.5.4. Trunk Small dilated blood vessels near the skin surface, usually only a few
microvasodilation millimeters in size. May grow in any part of the body. They may contain
abnormal hyperplasia of arterioles, capillaries or veins.
A.5.5. Pigmentation Pigmentation is a common and usually harmless condition, in which the skin
color is darker than that of the surrounding normal skin, usually due to
excessive melanin forming deposits in the skin, and pigmentation often
presents patches of freckles or small spots induced by sunlight.
A.5.9. Microvasodilata The same as the above but the degree is more serious.
tion/senile
plaque (severe)
A.5.10. Microvasodilata The above conditions occur in the neck, chest, and hands, arms or other non-
tion/senile facial areas.
plaque (non-
facial)
A.5.11. Common acne Propionibacterium acnes (type P acne) multiply in sebum, which causes
(mild, moderate lesions in the follicular intima of sebaceous glands and forms acne. Acne
and non-facial) inflammation can produce pustules papules cysts or nodules and if untreated
can lead to subsequent scarring and persistent erythema. Acne often occurs
in thicker skin and/or parts with dense sebaceous glands and hair follicles;
These areas include the face, upper chest and back.
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A.6.1. Brief introduction M22IPL skin treatment uses universal IPL module. IPL
skin treatment improves the appearance of photoaged skin by removing
age spots (freckles caused by sun exposure), most benign brown
pigments, damaged capillaries and redness (see section A.14).
Many physicians who are very experienced with IPL have different
approaches to the parameters and settings of this course of treatment,
considering the type of skin, the progress of the course of treatment, and the
main condition of the patient's skin.
The M22 has a set of Lumenis preset treatment parameters (see section A.12)
that are based on successful treatment outcomes achieved by skilled users. In
addition, the user can select and set his or her own parameter values.
This section explains what parameters mean, how to choose the right
parameters, and how to achieve effective clinical outcomes.
Parameters for IPL skin treatment using M22 include:
Cut-off, notch and narrowband wavelength
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A.6.2. Definition
A.6.2.1. Pulse Parameters IPL Therapeutic Applications operate using three pulse
parameters: Pulse Number, Pulse Time Length, and Pulse Delay (see
Figure A-1):
Number of pulses:
In SR mode, the energy of each IPL pulse can be transferred into two
pulses (divided into two sub-pulses) or three pulses (divided into three
sub-pulses).
This unique system allows the target tissue to absorb all pulse energy, and
at the same time provides the cooling time required by the epidermis
between sub-pulses to protect the epidermis from damage.
Pulse duration (T):
This is the duration of each sub-pulse, measured in milliseconds (1
millisecond = 0.001 second). The duration of each sub-pulse can be set
individually.
Pulse delay (D):
This is the interval between each sub-pulse, measured in milliseconds.
When using three pulses, the two delay times can be set separately.
时间
三脉冲
时间
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A.6. Advanced Selecting this mode allows the physician to adjust the required pulse
2.2. OPT module parameters for dose and pulse duration
Equation Different in pulse sequence. This function helps doctors to make special
(AOPT) customized treatment according to the needs of patients.
See A.15 for the complete AOPT dose limit table.
A.6. Dose Energy density output measured in joules/square centimeter by the operator
2.3. for each case
Make settings. The dose contains the total energy transmitted by the selected
two to three sub-pulse sequences (with
Measured in joules) and divided by the area (measured in square centimeters)
If the duration of pulses in the column is equal, the dose is evenly distributed
among sub-pulses.
A.6. Spectrum/filter The universal IPL module of M22 will emit optical pulses with broad spectrum
2.4. (400-1200nm). Use truncation
The filter can adjust the spectrum, and the filter will block the transmission
wavelength shorter than the filter indicates
All light waves only transmit the spectrum from above this wavelength to
1200nm.
For acne filters, use a special notch filter that transmits only the following
wavelengths of light: 400-600
And 800-1200nm.
For vascular filters, specific notch filters transmit only the following
wavelengths of light: 530-650 and
900-1200nm.
A.6. Continuous Ice water machines are used in general surgery, plastic surgery and
2.5. cooling dermatology before/during phototherapy
Between/after, it is used to cool the epidermis of the treatment site. The
purpose is to:
Minimize burns (including heat damage) during or related to
phototherapy
Death), thus reducing possible complications such as scars, scars,
pigmentation or pigmentation
Reduce, etc.
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A.7. Setting treatment parameters M22 system comes with Lumenis presupposition for various
clinical indications of skin treatment for IPL. You can use these presets,
or enter your own user presets. This chapter explains the meaning of each
parameter and provides guidelines on how to set parameters to achieve a
successful treatment outcome.
The operation mode of setting parameters is explained in detail in Chapter 5.
A.7.1. Spectral With Lumenis presupposition, cutoff filters for IPL skin treatment are
parameter 560nm, 590nm, 640nm, acne filters (400-600 and 800-1200nm) or vascular
(filter) filters
(530-650 and 900-1200 nm). Each filter cuts off light waves whose
wavelengths are shorter than the number indicated on the filter, and the acne
filter is cut off when the wavelength is in the range of 600-800nm. For the
vascular filter, the wavelength will be cut off when it is at 650-900 nm.
Melanin is the main absorption pigment in skin, and its absorption and
scattering coefficients decrease with the increase of wavelength. Therefore,
longer wavelengths can penetrate deeper into the skin, but produce less heat
energy in the skin than shorter wavelengths.
Another factor in choosing the correct filter is related to the skin color of the
patient. The darker the skin color, the more melanin is contained in the skin.
Melanin will compete with the target lesion to absorb SR mode light energy.
Because the light wave absorbed by melanin decreases with the increase of
wavelength, it is suggested that the filter with longer wavelength should be
used for patients with darker skin color. When treating inflammatory acne on
dark skin types, it is recommended to use three pulses and/or prolonged pulse
delay.
The main component of light absorption in blood is heme. Heme has specific
absorption peaks in the visible and near infrared spectral range. The
absorption coefficient of heme is very high, reaching the wavelength of
600nm, which means that most of the light energy will be absorbed by the
thin blood layer on the surface of blood vessels. Therefore, short wavelengths
can effectively cooperate with smaller blood vessels and surface blood
vessels, while longer wavelengths can effectively cooperate with larger and
deeper blood vessels.
When using the 640nm filter, the longer wavelength can penetrate deeper,
and it produces less heat energy in epidermis, papillary dermis and reticular
dermis compared with the shorter wavelength filter using the same energy.
Propionibacterium sores acne (type P acne) is a bacterium that reproduces in
the sebaceous glands and produces porphyrins as part of its normal aging
metabolism. These mixtures are exposed to specific notches, and high-
intensity light triggers photochemical reaction, releasing hydrogen peroxide
(singlet oxygen), which leads to the disappearance of P-type acne bacteria.
This reaction only has effect on bacteria, but has no effect on surrounding
tissues.
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For surface lesions in lighter skin color (skin type III according
to basic condition), 560nm filter is selected.
For middle and surface lesions in darker skin color (reaching
skin type IV), 590nm filter is selected.
When the desired effect needs to reach deeper dermis or dark
skin color (reaching skin type V), use 640nm filter.
When treating neck, hands, arms and chest, reduce the dose by 1 to 2
joules per square centimeter. When treating the chest, reduce the
dose even lower.
When treating body parts with appendages with dysplasia, use more
conservative dose levels.
Warning
Using strong AOPT settings (short pulse duration and high
dose) may lead to unexpected adverse events. It is
recommended to choose parameters carefully and follow strict
test point protocols.
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A.7.2. Pulse parameter Choosing correct pulse parameters is a necessities condition to achieve the
(Time control) best treatment effect.
The main problem in treating patients with light energy is to heat the target
lesion to a temperature enough to destroy it, while avoiding damaging the
surrounding issues and epidermis. The epidermis contains melanin, which
absorbs pulsed light, which increments the temperature of the epidermis and
causes negative side effects.
Higher doses are needed to treat deeper and larger lesions, because light
energy weakens as it penetrates deeper into the skin. Using this high dose to
warm the epidermis may cause injection or reverse actions. The problem of
treating deep lesions without damaging the epidermis can be controlled by
considering thermal selection (more pulses, longer pulse duration and delay).
The cooling time of an object is proportional to its area, and smaller objects
will cool cast than large objects. Before, when the object area is similar to the
parameter of epidermal thickness (60-100 microns), the cooling time of small
lesions will be shorter than that of large lesions. The cooling time of large
area lesions is longer than that of small area A lesions. Simultaneously,
pigmented lesions with low density pigment cool fast than then with high
density pigment.
The design of M22 can take advantage of this thermal selection, for
example, the cooling time of relative large lesions is longer, while the
cooling time of thinking epidermis is shorter. This can be divided by
dividing the total energy delivered during treatment into severe sub-
pulses (double pulses or triple pulses).
Pulse duration is the duration of each sub-pulse light exposed to the
lesion. This means that the pulse duration should be shorter than the
cooling time of the target.
The delay between sequence Neutron pulses (i.e., pulse interval delay),
the time to allow the skin to dissipate heat through gel between pulses, so
achiving the cooling effect. However, the delay time should also be
shorter than the cooling time of the target lesion, so that heat energy can
be retained and the temperature will increase with each continuous That
pulse.Darker skin color will absorb more light and heat energy, which
will make the temperature higher. Before, when treating darker skin
types, it takes a long delay time to cool the skin.
A.7.2.1. Criteria when treating dark skin, or using higher doses close to 35
J/cm2 with rectangular light guide
And when 56 J/cm is used and equal with 6mm light guide, three
pulses should be used.
When treating large or sense lesions or darker skin, choose a longer
pulse duration.
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Notes
Choosing the Advanced OPT (AOPT) mode allows you to tailor
A.7.3. Dose dose is the total amount of energy density transferred to skin,
measured in joules/square centimeter. The strong pulsed light of M22
universal IPL module is transferred through light guide and coupling gel,
and irradiates the skin of patients. Using a larger irradiation point can
reduce the scattering effect as much as possible, and form a stable dose
and deeper pThe higher the dose, the higher the temperature of the target
lesion, surrounding complaints and epidermis.
Generally speaking, the temperature mode is optimized by selecting the
correct time control parameters, and then the energy dose is gradely
incremented until the desired response is achived.
The cryogel and the ice water machine integrated in the device can reduce
the initial temperature of the skin, so the maximum temperature
accelerated duration the pulse injection can be reduced. The relatively
low dose is an important factor in the skin treatment of IPL and its non-
shutdown characters. However, when treating surface variable skin
conditions with light skin types, it may be necessities to turn off the ice
water machine and use room temperature gel to advance vasoconstriction.
Be sure to observe the skin during treatment to set the appropriate date, and
then make a successful IPL skin treatment plan.
A.7.4. The ice water machine button on the ice water machine treatment screen will show that the
ice water machine (continuous production cooling) is enabled or disabled.
Red button-ice water machine not working
Blue button-ice water machine in operation
When operating with a chiller, the following benefits will be added to the
treatment:
Improve the comfort of patients.
Strengthen epidermal protection to void verse
reactions.Notes
It is recommended to check the cooling of the light guide by
Touching before treatment.
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A.8.2. Coupling gel on skin the use of referenced (6-10 ℃) coupling gel can
allevate discomfort and can be used as a light-coupling medium between
the light guide and the skin surface.
A.9. Skin Therapy for Each treatment can cover the whole face, neck, test or hands. This
IPL-Basic can produce a lot more satifying cosmetic effect than some laser
Understanding treatments that need to be limited to separate problem areas.
The treatment time is short, usally less than twenty minutes.
According to the doctor's preference, IPL skin treatment has many
changes. This may invoke the selection of changes in IPL
parameters, or the combination of other different cosmetic treatment
functional modes into the course of treatment.
Skin therapy for IPL via M22 may use 560-nm, 590-nm, 640-nm
filters, visual filters (530-650nm & 900-1200nm) or acne filters
(400-600 to 800-1200nm).
The shorter wave 560nm cut-off filter is most commonly used for
surface lesions in light skin color (up to Freund's skin type III). To
treat surface lesions of darker skin types and deep lesions of all skin
types (I-IV), a 590nm cut-off filter is recommended. The intended
use of the 640nm cut-off filter is partially suitable for the treatment
of dark Er skin types (IV and V).
In addition, for deep penetration into the dermis of collagen in all
applicable skin types (I-V), 640nm filters are often used to offer
additional skin texture treatment.
M22IPL skin therapy can use 15x35mm, 8x15mm and 6mm round light
guides.
The most common used light-guiding crystal is the SapphireCool
light-guiding crystal 15x35 mm. It is especially suitable for fast area
coverage. For small areas where tomography is challenging, it is
recommended to use a light guiding crystal of about 8 x 15 mm or
6mm.
In addition, the 6mm round light guide allows you to choose higher
doses and treat a variety of stubborn diseases. You must strictly
abide by the small test protocol before you can use it.
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IPL skin therapy
should not be
used in patients
with Freund's
type VI
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After the first pulse, appropriate time (about 15 minutes or more for
skin morphology I-III and 24 to 48 hours for skin morphology IV-V)
should be given to observe the epidermal reaction (if any reaction
occurs).
A.10. Treatment can be started after clinical indications are input and treatment parameters are
selected.
Notes
During the first course of treatment, be sure to perform block test
in the area to be treated.
Make sure the patient lies down in a comfortable lying position and
wear approval eye protection equipment. Operators should always
wear approval eye protection equipment (see section a.2). Instruct
the patient to keep his eyes closed during the course of treatment.
Operators should have easy access to the treatment area and use M22
controls.
A beep will be hard when the system is ready. Press the trigger button to
transmit the pulse.
Physicians may want to select their own pulse duration and delay
values, edit user presets, and save them. In this way, if patients who
come to the clinic have similar characters, the operator can use these
user presets.
Setting parameters is an important part of clinical training. Lumenis
strongly recommended that first-time practitioners attendant
internship training specific for skin therapy using M22 IPL and
consult clinical experts when encounters differential cases.
As the course of treatment progress, when patients come back for
more treatment, the dose can be slightly incremented to achieve
higher curative effect. Be sure to do a local test to confirm the skin
reaction before starting treatment.
After treatment, the skin care program enhances the effectiveness of
IPL in smoothing skin tone, reducing pore size, and improving
pigmented lesions and photoaging.
Patients can immediately resume their daily life and rest, and at the
same time, they should observe postoperative preventive measures,
void sunshine or use sunscreen and supplement it frequently.
After IPL treatment, the color of pigmented lesions may soon
darken, and fade or peel off after a few days.
Vascular variants may so turn black quickly after IPL treatment, which
is the result of blood coagulation.
Acne may have more inflammatory symbols soon after IPL
treatment; This reaction will subside without hours to days after
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A.10.1. After the clinical indications are input and the treatment parameters are
selected, the treatment can be started.
1. Remove make up thoroughly before treatment, and thoroughly clean the
area with alcohol-free preparation liquid.
2. Be sure to have this area carefully, and remind patients that there
will be temporary hair removable in this area.
3. Operators can choose to use Lumenis default, custom user default, or
manually set parameters.
4. Start with inconspicuous parts of the body that need treatment.
Apply a layer (about 1-2mm thick) of referenced coupling gel to the
treatment site. This help the skin cool during the pulse sequence and
promotes the coupling of light into the skin.
5. Place the hand device vertically on the skin to ensure that the
SapphireCool light guiding crystal does touch the treatment area or
the coupling gel covering the area. Make sure that the tip is cooled
open by touching the light guide with the palm of your hand. Care
should be taken when aligning the light guide (used to transmit light
energy to the treatment So that it is the only object that touches the
treatment site. Do not press hard.
6. When applying the gel, gently spread the skin with the fingers of an
empty hand, or smooth the lines with a wooden stick so that the light
can penetrate evenly.
7. Press the trigger button on the hand to trigger the pulse; The system will
charge automatically.
8. Wipe off the gel and check the treatment site, paying attention to the
skin reaction. It is recommended to wait about 15 minutes or more.
Mild erythema is the expected effect, and pink indicates that the
penetration effect of light energy is very good.
9. If the skin exhibits the desired effect and there are no reverse actions,
the treatment is continued with a close pulse over the treatment area.
10. If the skin response is administrative, the intensity of treatment can
be improved by any of the following actions in the following order:
Increase the dose
Reduce pulse delay
Reduce pulse duration
Use filters with shorter waves
Reduce the number of pulses (from three pulses to two pulses)
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11. If erythema is too obvious, or there are signs of purple spot, adjust
the treatment parameters to reduce the treatment intention. You can
reduce the intention by any of the following actions in the following
order:
Dose reduction
Increase pulse delay
Increase pulse duration
Use filters with longer waves
Increase the number of pulses
Do not allow the treatment area to overlap by
more than 1mm.
12. To give full play to the cooling properties of the application gel, be
sure to start treatment immediately after applying the gel and only in
a limited range. After treatment, be sure to remove the gel from the
treatment area. Do not reuse the gel. Even if it is carefully removed,
charred hair may still accumulated in the gel.
13. After treatment, it is recommended to cool the treatment area
immediately (see section A.13).
A.10.2. The criteria are to start treatment with sample test pulses in inconspicuous
places.Use Lumenis defaults and record skin actions.
If there are no reverse actions, but the clinical results are not satisfactory,
please increase the dose by 1-
2 joules and the reaction was observed. If the change in dose still fails to
produce the desired results, the pulse parameters can be manually modified
(see section a.10, treatment).
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A.11. Alternative Technologies These suggestions can help you take advantage of three filter
options (560nm, 590nm, and
640nm).
Notes
It is proposed that before drawing up the second stage treatment
plan, we should be family with IPL skin treatment.
A.11. 1.1. Procedures 1. Complete the entire first stage with a 560nm
filter over the full face using patient-appropriate presuppositions
Course of treatment. The aim of this phase is to achieve the best results for
symptoms such as angiopathy and rosacea, brown pigment and senile
plaque, and inflammatory acne.
2.
Observe the skin reaction after the first stage. If the reaction is
severe, stop it. For mild to moderate skin reaction, use the second stage.
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3. After the first stage and before the second stage, it is recommended to cool the
treatment site.
War
ning
If the reaction in the first stage is too severe (erythema
and edema), please do not proceed to the second stage.
For dark skin (V-shaped) and sensitive areas (neck,
hands, chest), do not perform the second stage.
If you use a higher setting of a 6mm round light guide,
do not use the second stage.
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A.11.2. Special Skin type IV and V IPL skin treatment may require tuning some skills. Many
Techniques for patients with darker skin color have mild symptoms of blood vessels but
Optimizing Skin obvious symptoms of pigmentation. In this case, it is wise to start IPL skin
Types IV and V treatment with only a 640nm filter. This can not only remove the pigment
condition, but also provide deeper IPL penetration and protect the safety of
epidermis. Careful attention to parameters and use techniques can achieve the
maximum protection of dark skin rich in melanin. However, when there is
obvious vascular disease, 590nm filter can also be used. This filter will
transfer more energy in the wavelength range that can affect heme.
Follow all standard safety precautions regarding patient selection,
contraindications, and safe system operation.
A.11.2.1. Procedure 1. Similarly, in an inconspicuous area, such as the pre-ear area where facial treatment
is planned, trigger
Test pulse. Wait for at least 48 hours and observe the pulse site to
confirm that there are no signs of epidermal burns or other adverse
reactions.
2. Apply a layer of 1-2mm refrigerated coupling gel to the treated area, and
then start the treatment (you can choose other areas except the face).
When using IPL, gently spread the skin with the fingers of empty hands
to smooth the lines, so that the light can penetrate evenly.
Notes
IPL skin therapy for patients with skin type VI is prohibited.
A.11.2.2. Guidelines During continuous treatment, if only some vascular lesions and/or pigmented
lesions are cleared, more powerful treatment parameters should be used.
When the lesions spread across different skin layers (as may occur in
rosacea), the deeper part (in light skin morphology) is treated with a longer
wavelength filter first. Then, the shallow part is treated with a filter with
shorter wavelength. If the skin response is mild, two treatments can be
performed in the same course of treatment, but a few minutes of cooling time
should be left between pulses. If not, use a continuous course of treatment.
Long hairs on the face or arms should be shaved before treatment, because
although they are not aimed at, the hairs absorb light energy.
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A.12. Lumenis The following table lists the Lumenis default treatment parameters based on the
preset patient's skin type and underlying condition.
-Therapeutic
parameters
Table A-1: Lumenis Presupposition, IPL Skin Therapy: Rosacea, Using 8 x 15 and 15 x 35 mm Light
Guides
Pulse Pulse
Skin type Dose Filter Ice
Dise Depth of Pulse duration delay
(J/cm2) (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 20 560 III 3 15 Open
Table A-2: Lumenis Presupposition, IPL Skin Treatment: Erythema Rosacea, Using 8x15 and 15x35mm
Light Guides
Pulse Pulse
Skin type Dose Filter Ice
Dise Depth of Pulse duration delay
[J/cm2] (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 17 560 Double 4.5 10 Open
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Table A-3: Lumenis Presupposition, IPL Skin Therapy: Liver Spot, Using 8 x 15 and 15 x 35 mm Light
Guides
Pulse Pulse
Skin Dose Filter Ice
Dise Depth of Pulse duration delay
type (J/cm2) (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 13 560 Double 3 10 Open
Table A-4: Lumenis Presupposition, IPL Skin Therapy: Heterochromia of the skin, using 8 x 15 and 15 x
35 mm light guides
Pulse Pulse
Skin Dose Filter Ice
Dise Depth of Pulse duration delay
type (J/cm2) (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 16 560 Double 3.5 15 Open
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Table A-5: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/senile plaque (mild),
using 8x15 and 15x35mm light guides
Pulse Pulse
Skin Dose Filter Ice
Dise Depth of Pulse duration delay
type (J/cm2) (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 17 560 Double 3.5 10 Open
Table A-6: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/Senile Plaque (Severe),
Using 8x15 and 15x35mm Light Guides
Pulse Pulse
Skin Dose Filter Ice
Disea Depth of Pulse duration delay
type (J/cm2) (nm) water
se lesion numbe (ms) (ms
r machi
)
ne
preset
Shallow 15 560 Double 4 15 Open
layer
I
Middle 17 590 Double 4 25 Open
layer
Deep 20 640 III 3.5 25 Open
layer
Microvasodilatat
ion/senile plaque Shallow 15 560 Double 4 15 Open
layer
(severe) II
Middle 17 590 Double 4 25 Open
layer
Deep 20 640 III 3.5 25 Open
layer
Shallow 14 560 Double 4 20 Open
layer
III
Middle 16 590 Double 4 30 Open
layer
Deep 19 640 III 4 25 Open
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Table A-7: Lumenis Presupposition, IPL Skin Therapy: Microvasodilatation/senile plaque (non-facial),
using 8x15 and 15x35mm
Light guide
Pulse Pulse
Skin Dose Filter Ice
Dise Depth of Pulse duration delay
type (J/cm2) (nm) water
ase lesion numbe (ms) (ms
r machi
)
ne
preset
I 16 560 Double 3.5 15 Open
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Table A-8: Lumenis preset, IPL acne (notch filter 400-600 to 800-1200) treatment using 8 x 15 and 15
x 35 mm light guides
Pulse
Skin Dose Pulse delay Ice water
Dise Depth of Pulse duration
type (J/cm2) (ms) machi
ase lesion numbe (ms)
r ne
preset
I 16 2 3.5 15 Open
II 15 2 3.5 20 Open
V* 13 3 5 40 Open
I 16 2 3.5 20 Open
II 15 2 3.5 25 Open
V* 13 3 5 45 Open
I 15 2 3.5 25 Open
II 14 2 3.5 30 Open
V* 12 3 5 50 Open
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Table A-9: Lumenis Presupposition, IPL Acne (Notch Filter 400-600 to 800-1200) Treatment, 6mm for
solitary lesions only
Light guide
Pulse
Skin Dose Pulse delay Ice water
Disea Depth of Pulse duration
type (J/cm2) (ms) machi
se lesion number (ms)
ne
preset
I 22 2 3.5 15 Open
II 21 2 3.5 20 Open
V* 19 3 5 40 Open
I 22 2 3.5 20 Open
II 21 2 3.5 25 Open
V* 19 3 5 45 Open
I 21 2 3.5 25 Open
II 20 2 3.5 30 Open
V* 18 3 5 50 Open
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Table A-10: Lumenis Presupposition, IPL Skin Therapy: Limit, Use 8 x 15 and 15 x 35 mm Light Guides
Filter 515 560 590 615 640 695 Acne
Minimum 10 10 10 10 10 10 10
dose
Pulse duration Maximum
dose
2 - - - - - - -
2.5 - - - - - - -
3 - - - - - - -
3.5 - - - - - - -
4 15 14 12 10 - - 13
4.5 15 14 12 10 - - 15
5 15 14 12 10 - - 16
5.5 15 14 12 10 - - 18
6 26 22 20 19 17 14 19
6.5 27 24 22 20 18 15 20
7 28 25 23 21 19 15 22
7.5 30 26 24 22 20 16 23
8 32 28 25 23 21 17 24
8.5 32 29 26 24 22 18 25
9 32 30 28 25 23 19 27
9.5 32 31 29 26 24 20 28
10 32 32 30 27 25 21 29
10.5 35 32 31 28 26 21 29
11 35 32 32 29 27 22 29
11.5 35 32 32 30 28 22 30
12 35 35 34 31 29 23 30
13 35 35 35 32 29 23 31
14 35 35 35 32 30 24 31
15 35 35 35 33 30 24 31
16 35 35 35 34 31 24 31
17 35 35 35 34 31 25 32
18 35 35 35 34 31 25 32
19 35 35 35 34 31 25 32
20 35 35 35 35 32 25 32
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Table A-11: Lumenis IPL Presupposition, Skin Therapy: Minimum and Maximum Dose Limitation, Using
6 mm Circular Light Guide
Filter 515 560 590 615 640 695 Acne
Minimum 16 16 16 16 16 16 16
dose
Pulse duration Maximum
dose
2 - - - - - - -
2.5 - - - - - - -
3 - - - - - - -
3.5 - - - - - - -
4 24 22 19 16 - - 21
4.5 24 22 19 16 - - 24
5 24 22 19 16 - - 26
5.5 24 22 19 16 - - 29
6 42 35 32 30 279 22 30
6.5 43 38 35 32 29 24 32
7 45 40 37 34 30 24 35
7.5 48 42 38 35 32 26 37
8 51 45 40 37 34 27 38
8.5 51 46 42 38 35 29 40
9 51 48 45 40 37 30 43
9.5 51 50 46 42 38 32 45
10 51 51 48 43 40 34 46
10.5 56 51 50 45 42 34 46
11 56 51 51 46 43 35 46
11.5 56 51 51 48 45 35 48
12 56 56 51 50 46 37 48
13 56 56 56 51 46 37 50
14 56 56 56 51 48 38 50
15 56 56 56 53 48 38 50
16 56 56 56 54 50 38 50
17 56 56 56 54 50 40 51
18 56 56 56 54 50 40 51
19 56 56 56 54 50 40 51
20 56 56 56 56 51 40 51
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A.12. 1.1. Lumenis presupposition the following Lumenis presupposition is for the second stage of
skin therapy application for IPL. The parameters are only applicable to
microvasodilatation/age spots (severe) and must be entered manually.
A.13.1. Summarize the cold compress (non-ice compress) bag should be used to
cool the treatment site immediately after treatment to eliminate swelling
and make people feel comfortable. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. Another way is
to soak the 4x4 gauze pad with water in advance and put it in a small
plastic bag or plastic wrap, which can be used after treatment after
freezing.
In most cases, due to the nature of IPL skin therapy, all normal activity can
be restored.
A.13.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight exposure.
Sunbathing after the course of treatment may promote melanin
regeneration, which may lead to pigmentation.
A.13.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if they have any reaction.
A.13.4. Patients with tissue, vascular and pigmented lesions should be returned after about three
weeks, and patients with acne should be returned after at least about one
week for the next treatment until the whole four to six treatment
procedures are completed.
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A.13.5. Adverse reactions If any adverse reactions occur, the treatment should be
discontinued until the treatment site recovers and the causes of adverse
reactions are identified and solved.
A.14. Burton's acne Basis: Burton JL., Cunliffe WJ., Stafford I., Shuster L. "Universal Acne
area Prevalent in Adolescence". Br. J. Derm. 1971, 85: 119-126
Table A-13: Burton Acne Area
Level 0 Completely free of any lesions
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Pulse type Single Dou III Single Double III Single Double III Single Dou III Single Dou III Single Doubl III Single Doubl III Single Doubl III Single Double III
ble ble ble e e e
Minimum 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4
value
3 15 15 13 13 13 13 12 12 12 12 10 10 9 9 12 12 12 12
3.5 17 17 15 15 15 15 14 14 13 13 10 11 10 10 13 13 13 13
4 15 18 18 14 17 17 12 16 16 10 15 15 14 15 10 12 10 11 13 15 15 13 14 14
4.5 15 20 20 14 18 18 12 17 17 10 16 16 15 16 11 13 11 12 15 17 17 14 15 15
5 15 22 22 14 20 20 12 19 19 10 18 18 16 17 12 14 12 13 16 19 19 15 17 17
5.5 15 24 24 14 22 22 12 21 21 10 19 20 17 19 13 14 13 14 18 20 21 16 18 18
TotalP
ulseWi
6 26 26 26 22 23 23 20 22 22 19 20 21 17 18 20 14 14 15 14 14 15 19 22 22 17 19 19
dth
6.5 27 27 27 24 24 24 22 23 23 20 21 22 18 19 21 15 15 15 15 15 15 20 23 23 19 20 20
7 28 27 27 25 25 25 23 24 24 21 22 23 19 20 21 15 16 15 15 16 15 22 24 23 20 21 20
7.5 30 30 27 26 27 27 24 26 26 22 23 24 20 21 21 16 16 15 16 16 15 23 24 23 21 21 20
8 32 30 27 28 27 27 25 27 27 23 24 24 21 22 22 17 17 16 17 17 16 24 24 23 22 21 20
8.5 32 30 27 29 27 27 26 27 27 24 25 24 22 23 22 18 17 16 18 17 16 25 25 24 23 22 21
9 32 30 27 30 30 27 28 28 27 25 26 25 23 24 22 19 18 16 19 18 16 27 25 24 24 22 21
9 32 30 27 30 30 27 28 28 27 25 26 25 23 24 22 19 18 16 19 18 16 27 25 24 24 22 21
9.5 32 30 27 31 30 27 29 29 27 26 26 25 24 24 23 20 18 16 20 18 16 28 26 24 25 23 21
10 32 30 27 32 30 27 30 30 27 27 27 26 25 24 23 21 18 16 21 18 16 29 26 24 26 23 21
10.5 35 30 27 32 30 27 31 30 27 28 27 26 26 24 23 21 18 16 21 18 16 29 26 24 26 23 21
11 35 30 27 32 30 27 32 30 27 29 27 26 27 25 23 22 19 17 22 19 17 29 26 24 26 23 21
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Clinical
Guidelines: IPL Skin Therapy (ST) Lumenis ® M 22 ™
Pulse type Sing Double III Single Double III Single Double III Single Dou III Single Dou III Single Double III Single Double III Single Double III Single Double III
le ble ble
Minimum 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4
value
11.5 35 30 27 32 30 27 32 30 27 30 27 26 28 25 23 22 19 17 22 19 17 30 27 24 27 24 21
12 35 30 27 35 30 27 34 30 27 31 28 26 29 25 23 23 19 17 23 19 17 30 27 24 27 24 21
12.5 35 30 27 35 30 27 34 30 27 31 28 26 29 26 23 23 19 17 23 19 17 31 27 24 28 24 21
13 35 30 27 35 30 27 35 30 27 32 29 26 29 26 23 23 19 17 23 19 17 31 27 24 28 24 22
TotalP
ulseWi
dth
13.5 35 30 27 35 30 27 35 30 27 32 29 27 29 26 23 23 19 17 23 19 17 31 27 24 28 24 22
14 35 30 27 35 30 27 35 30 27 32 29 27 30 26 24 24 20 17 24 20 17 31 27 24 28 24 22
14.5 35 30 35 30 35 30 32 29 30 26 24 20 24 20 32 27 29 24
15 35 30 35 30 35 30 33 29 30 26 24 20 24 20 32 27 29 24
16 35 30 35 30 35 30 34 29 31 26 24 20 24 20 32 27 29 25
17 35 30 35 30 35 30 34 30 31 27 25 20 25 20 32 27 29 25
18 35 35 35 34 31 25 25 32 29
19 35 35 35 34 31 25 25 32 30
20 35 35 35 35 32 25 25 32 30
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Appendix B
Clinical guidelines: Vascular lesions (VL)
B.1. Brief introduction of vascular disease (VL) application will use universal
IPL module or Multi-Spot Nd: YAG module to treat large-scale vascular
disease of different depth and size. Generally speaking, the universal IPL
module is used to treat smaller and shallower blood vessels, while the
Multi-Spot Nd: YAG module is used to treat deeper and larger blood
vessels (especially leg varicose veins).
Regardless of which module is used, the following guidelines are mostly
applicable to various treatments of vascular diseases. Differences will be
specified.
B.2. Training requires that the M22 system should be operated only by
properly trained personnel who are familiar with control and use
methods, including doctors, nurses, technicians or other professional
staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
B.3.1. Indication M22 system for angiopathy application (and its matching, transmission
accessories for transmitting light energy) is suitable for cosmetic and
cosmetic applications requiring selective photolysis of soft tissue and
hemostasis in general surgery, plastic surgery and dermatology.
The intense pulsed light wavelength of 400-1200 nm is suitable for treating
benign epidermal angiopathy, including wine stain, hemangioma,
microvasodilatation of face, trunk and leg, rosacea, rosacea erythema,
hemangioma, spider hemangioma, Sivat skin heterochromia, leg varicose
veins and venous malformation.
The wavelength of 1064 nm produced by ND: YAG laser is suitable for
coagulation and hemostasis of vascular diseases and soft tissues, including
superficial and deep microvasodilation (varicose veins) and reticular veins of
legs
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B.3.2. Contraindicatio Before starting treatment, patients who have experienced problems during
ns (incomplete laser treatment should be carefully screened.
list) Patients suffering from any of the following diseases at the treatment site
shall not be treated on a trial basis:
Attack of infection
B.3.3. Preventive measures should be taken with care and in accordance with the
doctor's decision when treating patients with the following medical history or conditions:
Hemorrhagic coagulation disease.
Swollen crab foot scar.
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Systemic lupus erythematosus or purpura.
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Immunosuppressive drugs.
Herbal supplements, perfumes or cosmetics that may affect sensitivity
to light.
Oral isotretinoin (eg acne specific medicine).
Patients with the following conditions should be treated with caution and
according to the doctor's decision:
B.3.4. Caution As with any laser, appropriate measures must be taken to ensure
safe and proper use, and the full contents of this operation manual must
be thoroughly read and understood before operating the instrument.
Moreover, as discussed below, operators should attend laser training
courses before using the system.
Laser may cause skin damage. The higher the laser dose and the more severe
the skin pigmentation, the higher the risk:
Patients with darker skin types and residual tanning on the skin have a
higher risk of pigment changes in the treatment area. These patients
should strictly follow the treatment plan of the test location and be
treated carefully.
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Comply with all safety precautions described in the chapter "Safety
and Regulations" and other parts of this manual.
The light emitted by this module is enough to cause serious eye
damage or blindness. When the main power is turned on, all
personnel in the treatment room, including patients, operators and
any observers, must wear appropriate safety goggles.
Before starting comprehensive treatment, treatment should be carried
out at the patient's test site and skin reaction should be evaluated.
Side effects may not appear until several days after exposure. For
skin type V, wait 48-72 hours after treatment at the test site to
observe tissue reaction. Always allow sufficient time between test
treatment and actual treatment.
Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
B.4. Pre-
treatment
informati
on
B.4.1. Overview When a patient visits for the first time, the physician (or
authorized staff) should:
Record the patient's medical history (including previous
treatment methods) in detail, and judge whether it is suitable for
M22 system treatment.
Determine why patients want to seek treatment, and understand and
deal with patients' expectations.
Notes
Do not treat vascular lesions on pigmented lesions or tattoos. Hair
on vascular lesions should be removed before treatment.
When treating leg varicose veins, laser should not be considered as the first
option. Ensure that the request is purely for cosmetic purposes. Always
perform exfoliation and sclerotherapy when needed and accepted.
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B.4.2. When consulting a patient for an initial visit, the physician (or authorized staff
member) should inform the patient of the following information:
M22 treatment may include multiple treatments spanning several months.
Treatment may cause some discomfort or pain.
B.4.3. During IPL treatment, all people (patients and staff) in the treatment room
must wear goggles recommended by Lumenis or equivalent to protect
their eyes.
During treatment, all people (patients and staff) in the treatment room must wear it
Lumenis recommended goggles to protect the eyes. The optical density (OD) of
goggles is as follows:
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
B.4.4. Local anesthesia M22 module can be used for general skin treatment without local
anesthesia. However, because skin therapy generally treats a large area,
such as the whole face, many patients tend to use local anesthesia to
receive treatment, so that they will not feel uncomfortable during the
course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
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Because EMLA ® will have vasoconstrictive effect on the target site, it is not
recommended to use it. Generally, local anesthesia is applied some time
before treatment (as early as 1 hour before treatment). Be sure to completely
remove all local anesthetics before treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side
effects.
B.4.6. Photographing It is strongly recommended that photographs be taken before each treatment
to record the progress of the treatment (left, right and front of the
treatment site). Because progress will occur gradually, it is important to
leave a photo record for accurate evaluation and provide a stable basis for
patients to be satisfied with their progress. Because many patients cannot
objectively evaluate the progress of treatment, these photos can provide
concrete evidence.
Standard light conditions and similar shutter speeds, flashes, and focal lengths
should be used to objectively compare photographs taken at different times.
B.4.7.1. After the discomfort triggers the pulse, some patients will feel different degrees of
discomfort. Some people describe it as tingling, while others say it feels
like a rubber band bouncing. The burning sensation may last for up to an
hour after treating the larger deep veins. Most adults and older children
can tolerate this discomfort, but some patients may need local anesthesia.
Infants and younger children (especially those with hemangiomas) may
need general anesthesia.
After treatment of deep leg varicose veins, this area may be sore. If necessary,
prescribe analgesics. During menstruation, the pain may be more intense.
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B.4.7.2. For natural It may form scabs or blisters, and it takes five to ten days to recover.
skin
To cause
damage
B.4.7.3. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months. Pigment reduction may last for 12 to 24
months, but only a few cases are permanent.
B.4.7.4. There is little chance that scars (such as enlarged hypertrophic scars) will occur. In rare
cases, large bulges of abnormal crab foot swelling scars may appear. To
reduce the risk of scarring, be sure to carefully follow all post-treatment
instructions and exclude patients with hereditary scars.
Care should be taken to treat wine stains (PWS) in young children. If too
much light energy is absorbed, scarring may occur. In addition, the use of
high doses of ND: YAG on the face can also cause scarring, especially on the
nasal side. Therefore, it is recommended to use a low dose in areas other than
legs.
B.4.7.5. Excessive swelling After treatment, temporary swelling of the skin may occur
immediately, especially around the nose or eyes. Swelling usually
subsides within hours and no more than seven days at most.
B.4.7.6. Local inflammation is usually observed with temporary local inflammation and
a postoperative reaction of "cat scratches" along the vascular pathway.
B.4.7.7. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
B.4.7.8. The bruise treatment may cause blue-purple bruises in the treatment area, which may last
for five to fifteen days. After the bruise subsides, the skin in this area may
turn dark brown, which usually takes one to three months to subside. This
side effect is particularly common when using the Multi-Spot Nd: YAG
module because the applied pulse duration is too short.
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B.4.7.9. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
Do one more stage in the same treatment area during the first course of treatment
and whenever the treatment settings are changed
Before (if allowed), and when replacing the module, be sure to perform small
block tests in an inconspicuous part of the area to be treated.
B.5.1. There are small (< 0.5 mm) to moderate depth (0.5-4 mm) dilated blood
vessels under the epidermis of leg varicose skin. These blood vessels are
different in color, including red, green/blue.
B.5.2. PWS (Child Wine stains are flat, red or purple discoloration, which appears at birth.
Type) These large red blocks may grow as children grow up.
B.5.3. PWS (Adult Teenagers or adults may get wine stains, and trauma may be an influencing factor.
Type)
B.5.4. Facial A small red concentrated lesion on the face, caused by the curvature of
microvasodilation dilated blood vessels, usually around the nose, cheeks and chin of the face.
B.5.5. Trunk Small dilated blood vessels near the skin surface, usually only a few
microvasodilation millimeters in size, may grow anywhere in the body. They may contain
abnormal hyperplasia of arterioles, capillaries or veins.
B.5.6. Hemangioma Benign tumors are usually spherical, but sometimes flat masses, consisting of a
collection of dilated blood vessels in a certain area. Because in thin
smooth muscle cells, vascular cells are usually transparent, the color of
hemangioma is usually the color of blood flowing in it. If blood contains
a lot of oxygen or belongs to arteries, the color is usually bright red. If the
color is darker, the blood oxygen content is usually low, which belongs to
vein or is blocked.
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B.5.7. Generally, hemangiomas include dense congenital benign skin lesions, usually
convex masses that dilate blood vessels.
B.5.8. Nodular hemangioma is a small tissue mass or cell proliferation with nodular
shape.
B.5.9. Cherry hemangioma A bright red cherry hemangioma is vascular hyperplasia, which first
appears in adolescence or youth. These hemangiomas will become larger
and more with time. This lesion is composed of deep red or cherry red
papules, ranging in size from 1 mm to several mm, with obvious
protrusions on the surface.
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Definition
B.6.1.1. Pulse parameters angiopathy application can be operated using three pulse
parameters: pulse number, pulse time length and pulse interval delay (see
Figure B-1):
Number of pulses:
The energy of each pulse can be transferred as single pulse, double pulse
(divided into two sub-pulses) or triple pulse (divided into three sub-
pulses).
This unique system allows the target tissue to absorb all pulse energy, and
at the same time provides the cooling time required by the epidermis
between sub-pulses to protect the epidermis from damage.
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B.6. Advanced Selecting this mode allows the physician to adjust the required pulse
1.2. OPT module parameters for dose and pulse duration
Equation Different in pulse sequence. This function helps doctors to make special
(AOPT) customized treatment according to the needs of patients.
Please refer to the complete ADOPT flux limit table in table B-17.
B.6. Dose Energy density output in joules/square centimeter, by the operator for each
1.3. case
Make settings. The dose is divided by the total energy (measured in joules) of
the number of pulses you choose by the zone
The area of the domain (measured in square centimeters) is obtained.
B.6. Spectrum/filter The universal IPL module of M22 will emit optical pulses with broad
1.4. spectrum (400-1200 nm). Use
The cut-off filter can adjust the spectrum, and the filter will block the
transmission wavelength shorter than the filter indicates
All light waves, only transmit the spectrum from above this wavelength to 1200
nm.
For vascular filters, specific notch filters transmit only the following
wavelengths of light: 530-650 and
900-1200.
The Multi-Spot Nd: YAG module of M22 will emit laser pulses with a
wavelength of 1064 nm.
B.6. Size of The size of the irradiation point is the diameter or area of the ND: YAG
1.5. irradiation point laser beam (measured in millimeters).
It will judge the size of the treatment area and dose range.
The M22 Universal IPL Module is equipped with three SapphireCool light
guides (8x15, 15x35 mm moments)
Shape and 6mm circle). Each light guide determines the size of the treatment area and dose range.
B.6. Continuous Ice water machines are used in general surgery, plastic surgery and
1.6. cooling dermatology before/during phototherapy
Between/after, it is used to cool the epidermis of the treatment site. The
purpose is to:
Minimize burns and scalds during or related to phototherapy or laser
therapy (package
Including thermal necrosis), thus reducing possible complications such as
scars, scars and pigmentation
Or pigment reduction, etc.
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B.7. Setting Therapy Parameters the M22 system comes with Lumenis presets for various clinical
indications for vascular therapy, which you can use or enter your own
user presets. This chapter explains the meaning of each parameter and
provides guidelines on how to set parameters to achieve a successful
treatment outcome.
The operation mode of setting parameters is explained in detail in Chapter 5.
B.7.1. Spectral With Lumenis preset, cut-off filters for vascular therapy are 515, 560,
parameter 590, 615 nm or vascular filters (530-650 and 900-1200 nm). Each filter
(filter) will intercept
The wavelength of the filter is shorter than the number indicated on the filter, while
the wavelength of the vascular filter is 650-
It is cut off when it is within 900. By replacing the filters in the module,
different filters can be used for the same treatment.
The main component of light absorption in blood is heme. Heme has specific
absorption peaks in the visible and near infrared spectral range. The
absorption coefficient of heme is extremely high, which can be as high as
600nm wavelength, which means that the thin blood layer will absorb most
light energy. For small blood vessels below 0.1 nm, the range of 500 to 600
nm can penetrate the main part of blood vessels, and for large or deep blood
vessels above 0.4 nm, a longer wavelength in the visible range can be used
(the longer wavelength can penetrate deeper skin), while most of the light
energy still accumulates in blood vessels. Therefore, short wavelengths can
effectively bind to small blood vessels, while longer wavelengths can
effectively bind to larger blood vessels.
Melanin is the main absorption pigment in skin, and its absorption and
scattering coefficients decrease with the increase of wavelength. Therefore, the
heating effect of long wavelength on epidermis and dermis is lower than that of
short wavelength.
Another factor in choosing the correct filter is related to the skin color of the
patient. The darker the skin color, the more melanin in the skin. Melanin will
compete with the target lesion to absorb light waves. Because the light wave
absorbed by melanin decreases with the increase of wavelength, a longer
wavelength should be selected to reduce the possibility of light wave
absorption by skin pigment and the opportunity of burning skin.
Nd: YAG laser pulses at 1064 nm can penetrate deeper into the skin, and the
absorption of heme and melanin at this wavelength is suitable. Therefore, the
Multi-Spot Nd: YAG module is more effective in dealing with large blood
vessels with a large amount of heme.
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B.7.1.1. For shallow and small blood vessels, please choose to use shorter
wavelength filters and vascular filters
Devices (530-650 and 900-1200nm) are used as general IPL modules.
When dealing with deeper and larger blood vessels, filters with longer
wavelengths should be selected.
For patients with dark skin, please use a filter with longer wavelength instead.
Vascular filters can only be selected when treating small vessels with clear
boundaries.
For deeper and larger vessels, select the Multi-Spot Nd: YAG module.
War
ning
Using strong AOPT settings (short pulse duration and high
dose) may lead to unexpected adverse events. It is
recommended to choose parameters carefully and follow strict
test point protocols.
B.7.2. Pulse parameter Choosing correct pulse parameters is a necessary condition to achieve the best
(time control) treatment effect.
The main problem in treating patients with light energy is to heat the target
lesion to a temperature enough to destroy it, while avoiding damaging the
surrounding tissues and epidermis. The epidermis contains melanin, which
absorbs pulsed light, which increases the temperature of the epidermis and
causes negative side effects.
Higher doses are needed to treat deeper and larger lesions, because light
energy weakens as it penetrates deeper into the skin. Using this high dose to
warm the epidermis may cause injury or adverse reactions. The problem of
treating deep lesions without damaging the epidermis can be controlled by
considering thermal selectivity (more pulses, longer pulse duration and
delay).
The cooling time of an object is proportional to its area, and smaller objects
will cool faster than larger objects. Therefore, when the object area is similar
to the diameter of epidermal thickness (60-100 microns), the cooling time of
small lesions will be shorter than that of large lesions. The cooling time of
large area lesions is longer than that of small area lesions.
The design of M22 can take advantage of this thermal selectivity, for
example, the cooling time of relatively large lesions is longer, while the
cooling time of thinner epidermis is shorter. This can be achieved by
dividing the total energy delivered during treatment into several sub-pulses
(double pulses or triple pulses).
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Pulse duration is the duration of each sub-pulse light exposed to the lesion.
This means that the pulse length should be shorter than the cooling time of
the target.
The delay between sequential neutron pulses (pulse delay) should be long
enough for the skin to dissipate heat through cryogenic gel between pulses to
achieve the cooling effect. However, the delay time should also be shorter
than the cooling time of the target lesion, so that heat energy can be retained
and the temperature will increase with each continuous pulse. Darker skin
color will absorb more light and heat energy, which will make the
temperature higher. Therefore, this kind of skin needs a long delay time to
cool down.
B.7.2.1. Criterion If the energy source is divided into multiple sub-pulses, the pulse
interval delay duration of larger blood vessels
It should be longer, while small blood vessels should be shorter.
Dark skin types require longer pulse delays.
Notes
Choosing the Advanced OPT (AOPT) mode allows you to tailor
your treatment to the patient's needs.
B.7.3. Dose (energy Dose is the density of the total amount of light or laser energy transmitted to
density the skin, measured in joules/square centimeter. The powerful pulsed
) light/laser of M22 is transmitted through the light guide and coupling gel and
enters the skin of the patient. The larger the irradiation point, the smaller the
scattering effect and the deeper the tissue can be penetrated. The higher the
dose, the higher the temperature of the target lesion, surrounding tissues and
epidermis.
When treating hemangioma with relatively concentrated blood vessels or
adult-type wine stains, please use the universal IPL or Multi-Spot Nd: YAG
module at a relatively low dose.
Because of the low heme absorption rate at 1064 nm, the multi-Spot Nd:
YAG module uses a higher dose than IPL (up to 600 J/cm2 using a 1.5 mm
circular light guide). This is also permissible and still safe for the skin,
because melanin still has a lower absorption coefficient of 1064 nm, which is
the opposite of IPL, and therefore has a deeper target of penetrating the skin.
Generally speaking, the temperature pattern is optimized by selecting the
correct time control parameters, and then the dose is gradually increased until
the positive reaction is achieved.
Be sure to observe the skin during treatment to set the appropriate dose, and
then make a successful IPL skin treatment plan.
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B.7.4.2. Multi-Spot The Multi-Spot Nd: YAG module has two interchangeable irradiation point sizes
ND: YAG (2x4 nm and diameter)
Module 6 mm).
When treating large and shallow lesions, the epidermis may overheat
due to heat conduction at the lesion location, thus causing epidermis
damage. Therefore, if the depth of the aorta is very shallow, or when
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B.7.6. The ice water machine button on the ice water machine treatment screen will show that the
ice water machine (continuous conduction cooling) is enabled or
disabled.
Red button-ice water machine not working
Blue button-ice water machine in operation
When operating with a chiller, the following benefits will be added to the
treatment:
Strengthen epidermal protection to avoid adverse reactions
When using the SapphireCool tip, make sure that the tip cooling
function is turned on after touching the light guide on the palm
of your hand.
B.8.1. Therapeutic parameters for evaluating vascular lesions vary according to skin type and depth
and size of blood vessels to be treated. Therefore, the first step is to
evaluate the skin type and estimate the size and depth of blood vessels.
On the blood vessels to be treated, pre-evaluation is made by manually
pressing blood reflex before laser treatment.
In principle, priority should be given to the treatment of larger blood
vessels, and smaller blood vessels can only be treated after the treatment
of large blood vessels, so as to avoid repeated blood injection into smaller
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B.8.2. Quasi-work of If the lesion is smaller than the area covered by the light guide, a template
lesion treatment can be used to protect healthy tissue around the lesion. To prepare the
template, cut the proper gap or crack in the self-adhesive white label pure
white cardboard to expose only the diseased area. Before treatment, please
place the template on the treatment site and cover it with gel. After treatment,
please carefully remove the template.
B.8.3. Before triggering the light pulse, apply a thin layer (usually 1-2 mm thick) to
the treatment side for refrigeration
(6 deg.-10 deg. C) Coupling gel. If it is ND: YAG, it is enough to apply a thinner
layer of gel.
Notes
After the surface blood vessels have been treated, it is
recommended to use room temperature gel and place light guide,
and the related process does not need to be squeezed on the skin.
B.9. After inputting clinical indications and selecting treatment parameters before
treatment, treatment can be started.
Notes
During the first course of treatment, be sure to perform block test in the
area to be treated.
1. Apply a layer (usually about 1-2 mm thick) of refrigerated coupling
gel to the treatment site. This helps the skin cool during the pulse
sequence and promotes the coupling of light into the skin.
2. Place the module vertically on the skin.
IPL places the module (always in cooling mode) vertically on the skin to
ensure that the light guide plate is in contact with the treatment area or
the coupling gel covering the area. Care should be taken when aligning
the light guide (used to transmit light energy to the treatment site) so
that it is the only object that touches the treatment site.
Do not press hard.
Do not allow the treatment area to overlap more than 1mm!
Multi-Spot Nd: YAG: Contact the light guide with the gel. Slightly
apply pressure to the skin (refer to the depth of blood vessels),
adjoining but not overlapping.
During the same course of treatment, the same site can be treated twice
or even three times. Please wait for a few minutes until the site cools
before successive pulse therapy on the same site. If the skin or lesion
overreacts, please avoid treating the area multiple times.
3. IPL: Press the trigger button on the handpiece to trigger the pulse.
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Multi-Spot Nd: YAG: Before pressing the laser trigger, press the safety
switch (do not press it at the same time). The safety switch allows the
laser to be emitted only at a specified time interval (34 seconds). The
safety switch contains an orange indicator light, which will light up
when the laser trigger is enabled. If the specified time is exceeded, the
safety switch must be pressed again.
4. Erase the gel and make a careful diagnosis.
Remember, dark skin types take longer to react than light skin types.
5. The expected response is that the blood vessels become darker due to blood
coagulation and erythema appears along the blood vessels
/edema, and the surrounding epidermis does not change, which indicates that
the immune response has been stimulated.
Sometimes, blood vessels disappear because of vasoconstriction, either
permanently or only temporarily. You can feel blood coagulation by
pressing varicose veins. When loosened, there should be no blood reflex
action in this part.
6. If a good vascular response is accompanied by adverse reactions
(such as excessive redness or redness in the shape of light guide),
please adjust the treatment parameters to reduce the treatment
intensity. You can reduce the intensity by any of the following
actions in the following order:
Dose reduction
Increase pulse delay
Increase pulse duration
8. If there is an adverse skin reaction and the target lesion has not
changed, the dose can be increased by 10% at a time, but not more
than 20% than Lumenis preset. In addition, any of the following
actions can be performed simultaneously in the following order to
reduce the treatment intensity:
Increase pulse delay
Increase pulse duration
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B.9.1. Criteria in continuous treatment, if only part of vascular lesions are diluted
and whitened, stronger treatment should be used
The parameter of the effect. This is due to the reduction of the absorptive
capacity of the target.
If there are two types of lesions at the same site, both of which need
to be treated: for leg varicose veins with different depths, treat the
deeper site with ND: YAG 6 mm radiation point size first, and then
treat the surface site with ND: YAG or IPL with 2x4 mm radiation
point size.
It can be treated in the same course of treatment or in succession. If
the waiting time is too long, capillary regeneration may be caused
by growth factor secretion.
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B.10. Lumenis The following table lists the Lumenis default treatment parameters based on the
Default- patient's skin type and underlying condition.
Therapeutic
Parameters
Table B-1: Lumenis presupposition: IPL angiopathy, PWS children type
Angiopat Pulse
Skin Dose Filter Pulse delay Ice water
hy Pulse duration
type (J/cm2) (nm) (ms) machi
number (ms)
Type Depth ne
preset
I 15 515 Double 3.5 10 Open
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™ Diseases(VL)
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Table B-5: Lumenis Presupposition: IPL Vasculopathy, Facial Microvasodilatation, Use of IPL Vasculature
(Notch Filters 530-650 and
900-1200)
Angiopat Pulse Pulse
Skin Dose Filter Ice
hy Pulse duration delay
type (J/cm2) (nm) water
number (ms) (ms
Type Depth machi
)
ne
preset
I 18 Bloo Double 3.5 10 Open
d
vesse
l
Shallow
layer II 18 Bloo Double 3.5 15 Open
d
vesse
l
Facial
microvasodilation III 17 Bloo Double 3.5 20 Open
d
vesse
l
IV 16 Bloo Double 4 30 Open
d
vesse
l
V 15 Bloo Double 4.5 40 Open
d
vesse
l
I 19 Bloo Double 4 15 Open
d
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Lumenis ® M 22 Clinical Guidelines:
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vesse
l
Middle
layer II 19 Bloo Double 4 20 Open
d
vesse
l
III 18 Bloo Double 4 25 Open
d
vesse
l
IV 17 Bloo Double 4.5 35 Open
d
vesse
l
V 16 Bloo Double 5 45 Open
d
vesse
l
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Table B-6: Lumenis Presupposition: IPL Vasculopathy, Facial Microvasodilatation, Use of IPL Vasculature
(Notch Filters 530-650 and
900-1200) and 6mm light guide
Angiopat Pulse
Skin Dose Filter Puls Pulse time Ice water
hy delay
type (J/cm2) (nm) e length (ms) machi
(ms
Type Depth nu ne
)
mb preset
er
I 28 Blood Doubl 3.5 10 Open
vessel e
II 28 Blood Doubl 3.5 15 Open
Shallo vessel e
w layer III 27 Blood Doubl 3.5 20 Open
vessel e
IV 26 Blood Doubl 4 30 Open
Facial vessel e
microvasodilation
V 25 Blood Doubl 4.5 40 Open
vessel e
I 29 Blood Doubl 4 15 Open
vessel e
II 29 Blood Doubl 4 20 Open
Middle vessel e
layer III 28 Blood Doubl 4 25 Open
vessel e
IV 27 Blood Doubl 4.5 35 Open
vessel e
V 26 Blood Doubl 5 45 Open
vessel e
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Table B-8: Lumenis Presupposition: IPL Vasculopathy, Trunk Microvasodilatation, Use of IPL Vasculature
(Notch Filters 530-650 and
900-1200)
Angiopat Pulse time Pulse
hy Skin Dose Filter Ice
Pulse length delay
type (J/cm2) (nm) water
number (ms) (ms
Type Depth machi
)
ne
preset
I 17 Blood Double 3.5 15 Open
vessel
II 17 Blood Double 3.5 20 Open
Shallow vessel
layer III 16 Blood Double 3.5 25 Open
vessel
IV 15 Blood Double 4 35 Open
vessel
V 14 Blood Double 4 45 Open
vessel
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Table B-9: Lumenis Presupposition: IPL Vasculopathy, Trunk Microvasodilatation, Use of IPL Vasculature
(Notch Filters 530-650 and
900-1200) and 6 mm light guide
Angiopat Pulse time Pulse
hy Skin Dose Filter Ice
Pulse length delay
type (J/cm2) (nm) water
number (ms) (ms
Type Depth machi
)
ne
preset
I 27 Blood Double 3.5 15 Open
vessel
II 27 Blood Double 3.5 20 Open
Shallow vessel
layer III 26 Blood Double 3.5 25 Open
vessel
IV 25 Blood Double 4 35 Open
Trunk vessel
microvasodilation
V 24 Blood Double 4 45 Open
vessel
I 28 Blood Double 4 20 Open
vessel
II 28 Blood Double 4 25 Open
Middle vessel
layer III 27 Blood Double 4 30 Open
vessel
IV 26 Blood Double 4.5 40 Open
vessel
V 25 Blood Double 5 50 Open
vessel
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Table B-11: Lumenis Presupposition: Nd: YAG Angiopathy, Size of Irradiation Spot 6 mm in Diameter
Angiopat Dose (J/cm2) Pulse
hy Skin Pulse time Ice
Irradiation point Pulse delay
type length (ms) water
number (ms
Path Depth with diameter of 6 machi
ologi )
mm ne
cal
preset
chan
ges
I, II 90 Singl 7 - Open
e
Shallow time
layer
III, IV 90 Singl 7.5 - Open
e
time
Microvasodilatation V, VI 90 Singl 8 - Open
e
time
I, II 110 Singl 11 - Open
e
Middle time
layer
III, IV 110 Singl 11.5 - Open
e
time
V, VI 110 Singl 12 - Open
e
time
I, II 120 Double 6.5 10 Open
I, II 90 Singl 11 - Open
e
Middle time
layer
III, IV 90 Singl 11.5 - Open
Hemangioma e
time
V, VI 90 Singl 12 - Open
e
time
I, II 100 Double 6.5 20 Open
I, II 90 Singl 9 - Open
e
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Shallow time
layer
Vein of leg III, IV 90 Singl 9.5 - Open
0.5-1.0 mm e
time
V, VI 90 Singl 10 - Open
e
time
I, II 100 Singl 11 - Open
e
Middle time
layer
III, IV 100 Singl 11.5 - Open
e
time
V, VI 100 Singl 12 - Open
e
time
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Table B-11: Lumenis Presupposition: Nd: YAG Angiopathy, Size of Irradiation Spot 6 mm in Diameter
(Continued)
Angiopat Dose (J/cm2) Pulse
hy Skin Pulse time Ice
Irradiation point Pulse delay
type length (ms) water
number (ms
Path Depth with diameter of 6 machi
ologi )
mm ne
cal
preset
chan
ges
I, II 100 Singl 11 - Open
e
Shallow time
layer
III, IV 100 Singl 11.5 - Open
e
time
Vein of leg
V, VI 100 Singl 12 - Open
1.0-2.0 mm e
time
I, II 110 Singl 12 - Open
e
Middle time
layer
III, IV 110 Singl 12.5 - Open
e
time
V, VI 110 Singl 13 - Open
e
time
I, II 120 Double 6.5 20 Open
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Table B-13: Lumenis Presupposition: Nd: YAG Angiopathy, 1.5 mm Size of Irradiation Spot *
Pulse
Dose (J/cm2) Pulse time Ice
Angiopat Skin type Pulse delay
1.5 mm irradiation length (ms) water
hy numbe (ms
point r machi
)
ne
preset
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(*) Increase by 10 J/cm2 each time until the end point is reached (vasoconstriction)
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Table B-14: Lumenis Presupposition, IPL Angiopathy: Minimum and Maximum Dose Limits, Using 8 x 15
and 15 x 35 mm Light Guides
Filter 515 560 590 615 640 695 Bloo
d
vesse
l
Minimum 10 10 10 10 10 10 10
dose
Pulse duration Maximum
dose
2 - - - - - - -
2.5 - - - - - - -
3 - - - - - - -
3.5 - - - - - - -
4 15 14 12 10 - - 13
4.5 15 14 12 10 - - 14
5 15 14 12 10 - - 15
5.5 15 14 12 10 - - 16
6 26 22 20 19 17 14 17
6.5 27 24 22 20 18 15 19
7 28 25 23 21 19 15 20
7.5 30 26 24 22 20 16 21
8 32 28 25 23 21 17 22
8.5 32 29 26 24 22 18 23
9 32 30 28 25 23 19 24
9.5 32 31 29 26 24 20 25
10 32 32 30 27 25 21 26
10.5 35 32 31 28 26 21 26
11 35 32 32 29 27 22 26
11.5 35 32 32 30 28 22 27
12 35 35 34 31 29 23 27
12.5 35 35 34 31 29 23 28
13 35 35 35 32 29 23 28
13.5 35 35 35 32 29 23 28
14 35 35 35 32 30 24 28
14.5 35 35 35 32 30 24 29
15 35 35 35 33 30 24 29
16 35 35 35 34 31 24 29
17 35 35 35 34 31 25 29
18 35 35 35 34 31 25 30
19 35 35 35 34 31 25 30
20 35 35 35 35 32 25
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Table B-15: Lumenis Presupposition, IPL Angiopathy: Minimum and Maximum Dose Limitation, Using 6
mm Circular Light Guide
Filter 515 560 590 615 640 695 Bloo
d
vesse
l
Minimum 16 16 16 16 16 16 16
dose
Pulse duration Maximum
dose
2 - - - - - - -
2.5 - - - - - - -
3 - - - - - - -
3.5 - - - - - - -
4 24 22 19 16 - - 21
4.5 24 22 19 16 - - 22
5 24 22 19 16 - - 24
5.5 24 22 19 16 - - 26
6 42 35 32 30 27 22 27
6.5 43 38 35 32 29 24 30
7 45 40 37 34 30 24 32
7.5 48 42 38 35 32 26 34
8 51 45 40 37 34 27 35
8.5 51 46 42 38 35 29 37
9 51 48 45 40 37 30 38
9.5 51 50 46 42 38 32 40
10 51 51 48 43 40 34 42
10.5 56 51 50 45 42 34 42
11 56 51 51 46 43 35 42
11.5 56 51 51 48 45 35 43
12 56 56 54 50 46 37 43
13 56 56 56 51 46 37 45
14 56 56 56 51 48 38 45
15 56 56 56 53 48 38 46
16 56 56 56 54 50 38 46
17 56 56 56 54 50 40 46
18 56 56 56 54 50 40 48
19 56 56 56 54 50 40 48
20 56 56 56 56 51 40 48
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Table B-16: Lumenis Presupposition, Nd: YAG Angiopathy: Minimum and Maximum Dose Limitations
Light guide plate 6 mm ø 2 x 4 mm ø 1.5 mm ø 9 mm ø
Time Minimu Maximum Minimu Maximu Minimu Maximu Minimu Maximu
[millisecon m dose dose m dose m dose m dose m dose m dose m dose
ds]
2 20 29 75 97 300 450 10 15
3 20 42 75 143 300 600 10 21
4 20 56 75 188 300 600 10 28
5 20 69 75 225 300 600 10 34
6 20 81 75 225 300 600 10 40
7 20 92 75 225 300 600 10 45
8 20 103 75 225 300 600 10 51
9 21 113 75 225 300 600 10 56
10 20 122 75 225 300 600 10 60
11 22 131 75 225 330 600 11 66
12 25 140 85 225 360 600 12 70
13 25 140 85 225 360 600 12 70
14 27 150 92 225 390 600 13 70
15 28 150 96 225 420 600 14 70
16 30 150 100 225 480 600 15 70
17 32 150 108 225 480 600 16 70
18 34 150 113 225 510 600 16 70
19 35 150 120 225 540 600 17 70
20 37 150 125 225 540 600 18 70
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B.11.1. Summarize the cold compress (non-ice compress) bag should be used
immediately after treatment to cool the treatment site to eliminate
swelling and relieve discomfort. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. You can use
frozen 4x4 gauze blocks soaked in water in advance and put in small
plastic bags.
In the first four or five days after treatment, the treatment area should be
carefully maintained to prevent trauma: please avoid hot bath, aerobic exercise,
massage, etc.
B.11.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight exposure.
Sunbathing after the course of treatment may promote melanin
regeneration, which may lead to pigmentation.
B.11.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if the treatment site is enlarged or lumped.
Other doctors take a more conservative approach, advising patients not to use
cosmetics for several days after treatment. During this period, the skin will
be sensitive, which may damage the skin during makeup removal (especially
when cosmetics are not easy to remove) and make the treatment site
susceptible to infection.
To avoid damage or damage to the skin, some doctors recommend that their
patients add clothing to the treated area to reduce the risk of trauma or
infection in the first four or five days after treatment.
B.11.4. Other post-treatment recommendations are to cover the site with clothing for 10
days if the site is exposed to bacteria.
Patients should be advised not to take part in strenuous exercise or similar
activities for several days after treatment until the skin returns to normal
condition, otherwise it will lead to excessive sweating and/or skin tightening.
B.11.4.1. Leg vein compression should be left to doctors' discretion. After treatment of deep leg
varicose veins, you can wear stockings for support.
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If the lesion does not change, the dose should be increased by at least
10%, and the patient should be returned for examination three weeks
later.
When partial clearance occurs, the interval between each treatment is set to
three to six months.
When satisfactory results are achieved, the treatment is declared complete.
B.11.6. Adverse reactions If any adverse reactions occur, the treatment should be
discontinued until the treatment site recovers.
If there are indications for clearing the lesion after the treatment site is restored,
the dose should be reduced and the pulse parameters should be adjusted during
the next treatment. Patients should return for examination after three weeks.
If adverse reactions are observed and the lesions are not cleared, the patient
should wait another two to four weeks before returning for additional
examination. At that time, if partial clearance effect is found, the dose can be
reduced, the pulse duration and pulse delay can be increased, and the
treatment can be continued.
During the second examination, if the lesion has not been cleared, it should be
judged whether the adverse reaction is caused by factors such as skin
exposure and sunlight. If so, wait for the tanned part to subside before
resuming treatment. If the adverse reaction is not caused by sunlight exposure,
the treatment should be stopped.
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Clinical Guidelines: Vascular Disease (VL)
Pulse type Single Dou III Single Double III Single Double III Single Dou III Single Dou III Single Doubl III Single Doubl III Single Doubl III Single Double III
ble ble ble e e e
Minimum 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4 10 5 4
value
3 15 15 13 13 13 13 12 12 12 12 10 10 9 9 12 12 12 12
3.5 17 17 15 15 15 15 14 14 13 13 10 11 10 10 13 13 13 13
4 15 18 18 14 17 17 12 16 16 10 15 15 14 15 10 12 10 11 13 15 15 13 14 14
4.5 15 20 20 14 18 18 12 17 17 10 16 16 15 16 11 13 11 12 15 17 17 14 15 15
5 15 22 22 14 20 20 12 19 19 10 18 18 16 17 12 14 12 13 16 19 19 15 17 17
5.5 15 24 24 14 22 22 12 21 21 10 19 20 17 19 13 14 13 14 18 20 21 16 18 18
TotalP
ulseWi
6 26 26 26 22 23 23 20 22 22 19 20 21 17 18 20 14 14 15 14 14 15 19 22 22 17 19 19
dth
6.5 27 27 27 24 24 24 22 23 23 20 21 22 18 19 21 15 15 15 15 15 15 20 23 23 19 20 20
7 28 27 27 25 25 25 23 24 24 21 22 23 19 20 21 15 16 15 15 16 15 22 24 23 20 21 20
7.5 30 30 27 26 27 27 24 26 26 22 23 24 20 21 21 16 16 15 16 16 15 23 24 23 21 21 20
8 32 30 27 28 27 27 25 27 27 23 24 24 21 22 22 17 17 16 17 17 16 24 24 23 22 21 20
8.5 32 30 27 29 27 27 26 27 27 24 25 24 22 23 22 18 17 16 18 17 16 25 25 24 23 22 21
9 32 30 27 30 30 27 28 28 27 25 26 25 23 24 22 19 18 16 19 18 16 27 25 24 24 22 21
9 32 30 27 30 30 27 28 28 27 25 26 25 23 24 22 19 18 16 19 18 16 27 25 24 24 22 21
9.5 32 30 27 31 30 27 29 29 27 26 26 25 24 24 23 20 18 16 20 18 16 28 26 24 25 23 21
10 32 30 27 32 30 27 30 30 27 27 27 26 25 24 23 21 18 16 21 18 16 29 26 24 26 23 21
10.5 35 30 27 32 30 27 31 30 27 28 27 26 26 24 23 21 18 16 21 18 16 29 26 24 26 23 21
11 35 30 27 32 30 27 32 30 27 29 27 26 27 25 23 22 19 17 22 19 17 29 26 24 26 23 21
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Guidelines: Vascular Disease (VL) Lumenis ® M 22 ™
14.5 35 30 35 30 35 30 32 29 30 26 24 20 24 20 32 27 29 24
15 35 30 35 30 35 30 33 29 30 26 24 20 24 20 32 27 29 24
16 35 30 35 30 35 30 34 29 31 26 24 20 24 20 32 27 29 25
17 35 30 35 30 35 30 34 30 31 27 25 20 25 20 32 27 29 25
18 35 35 35 34 31 25 25 32 29
19 35 35 35 34 31 25 25 32 30
20 35 35 35 35 32 25 25 32 30
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Lumenis ® M 22 Clinical Guidelines:
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Appendix C
Clinical guidelines: Use of IPL for pigmented lesions (PL)
C.2. Training requires that the M22 system should be operated only by
properly trained personnel who are familiar with control and use methods,
including doctors, nurses, technicians or other professional staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
C.3.1. Indications: The application of M22 system for pigmented lesions (and its matching
transmission accessories for transmitting light energy) is suitable for
cosmetic and cosmetic applications requiring selective photolysis of soft
tissues and hemostasis in general surgery, plastic surgery and
dermatology.
400-1200 nm intense pulsed light wavelengths are suitable for the treatment
of benign epidermal lesions, including heterochromia, pigmentation, liver
spots and freckles.
C.3.2. Contraindication Before treatment, patients with previous IPL treatment problems must be
s (non- carefully screened. Patients suffering from any of the following diseases at
exhaustive list) the treatment site shall not be treated on a trial basis:
Attack of infection
Dysplastic maternal plaque
Tattoo
Severe complicated skin condition or any inflammatory skin condition.
Cold sores, open tears or abrasions.
Chronic or epidermal viruses, fungal or bacterial viruses.
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C.3.3. Preventive measures should be taken with care and in accordance with the
doctor's decision when treating patients with the following medical history or conditions:
Hemorrhagic coagulation disease.
Swollen crab foot scar.
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Systemic lupus erythematosus or purpura.
Gold therapy.
Radiotherapy.
Collagen, fat injection or other skin filling methods have
been used before. Patients who have used any of the following drugs
should be treated with care and in accordance with the doctor's
decision:
Anticoagulant; Avoid taking anticoagulants before treatment, which is
at the discretion of doctors.
Immunosuppressive drugs.
Herbal supplements, perfumes or cosmetics that may affect sensitivity
to light.
Oral isotretinoin (eg acne specific medicine).
Patients with the following conditions should be treated with caution and
according to the doctor's decision:
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Treatment in the edge of eye socket: Patients should wear intraocular
eye protection to protect their eyes from direct or indirect laser
exposure.
C.3.4. Caution As with any IPL, appropriate measures must be taken to ensure
safe and proper use, and the full contents of this operation manual must
be thoroughly read and understood before operating the instrument.
Moreover, as discussed below, operators should attend laser training
courses before using the system.
IPL may cause skin damage. The higher the dose and the more severe the
skin pigmentation, the higher the risk:
Patients with darker skin types and residual tanning on the skin
have a higher risk of pigment changes in the treatment area.
These patients should strictly follow the treatment plan of the
test location and be treated carefully.
Exposing the treatment area to sunlight immediately after
treatment or within one month after treatment may also increase
the risk of pigment changes in the treatment area. Patients
should be instructed to use broad-spectrum sunscreen
(minimum SPF 30) every day and reuse it every 2 hours. Avoid
direct sunlight.
Comply with all safety precautions described in the chapter
"Safety and Regulations" and other parts of this manual.
The light emitted by this hand device is enough to cause serious
eye damage and even blindness. When the main power is turned
on, all personnel in the treatment room, including patients,
operators and any observers, must wear appropriate safety
goggles.
Before starting comprehensive treatment, treatment should be
carried out at the patient's test site and skin reaction should be
evaluated. Side effects may not appear until several days after
exposure. For patients with V-shaped skin, wait 48-72 hours
after treatment at the test site to observe the tissue reaction.
Always allow sufficient time between test treatment and actual
treatment.
Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
C.4.1. Overview When a patient visits for the first time, the physician (or
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authorized staff) should:
Record the patient's medical history (including previous
treatment methods) in detail, and judge whether it is suitable for
M22 system treatment.
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Discuss the course of treatment with patients.
Warning
If it is a malignant lesion or in the early stage of malignant lesion,
please do not try to use M22 system for treatment. If you have
doubts about the benign nature of the lesion, please consult a
dermatologist or have a biopsy.
C.4.2. When consulting a patient for an initial visit, the physician (or authorized
staff member) should inform the patient of the following information:
Treatment may cause some discomfort or pain.
C.4.3. Eye protection equipment must be worn by all people (patients and staff) in
the treatment room during treatment
Lumenis recommended goggles to protect the eyes. The optical density (OD) of
goggles is as follows:
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
C.4.4. Local anesthesia M22 module can be used for general skin treatment without local
anesthesia. However, because skin therapy generally treats a large area,
such as the whole face, many patients tend to use local anesthesia to
receive treatment, so that they will not feel uncomfortable during the
course of treatment.
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When using local anesthesia, please follow the manufacturer's instructions.
Generally, local anesthesia is applied some time before treatment (as early as
1 hour ago). Be sure to completely remove all local anesthetics before
treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side effects.
C.4.5. It is recommended to take photos before and after treatment to record the
progress of treatment. Because many patients can't objectively evaluate
the progress of treatment, these photos can provide concrete evidence.
For all patients, use standard conditions and similar shutter speed, flash and
focal length. In this way, we can objectively compare the photos taken in
different periods.
C.4.6. Possible side The following are the most common possible side effects of treatment:
effects of
treatment
C.4.6.1. After the discomfort triggers the pulse, some patients will feel different degrees of
discomfort. Some people describe it as tingling, while others say it feels
like a rubber band bouncing. The burning sensation may last up to an
hour after treatment. Most adults and older children can tolerate this
discomfort, but some patients may need local anesthesia.
C.4.6.2. For natural It may form scabs or blisters, and it takes five to ten days to recover.
skin
To cause
damage
C.4.6.3. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months. Pigment reduction may last for 12 to 24
months, but only a few cases are permanent.
C.4.6.4. Scar scarring (e.g. enlarged hypertrophic scars) on dark skin is rare, or in rare cases, large
raised abnormal crab foot swelling scars may appear before and after
treatment. To reduce the chance of scarring, please carefully follow all
post-treatment instructions.
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C.4.6.5. Excessive swelling After treatment, temporary swelling of the skin may occur
immediately, especially around the nose or eyes. Swelling usually
subsides within hours and no more than seven days at most.
C.4.6.6. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
C.4.6.7. Blue-purple bruises (purple spots) may appear in the bruise treatment area, which may last
for five to fifteen days. After the bruise subsides, the skin in this area may
turn dark brown and subside within one to three months.
C.4.6.8. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
Do one more stage in the same treatment area during the first course of treatment
and whenever the treatment settings are changed
Before (if allowed), and when replacing the module, be sure to perform small
block tests in an inconspicuous part of the area to be treated.
C.5.2. The growth or formation of keratinosis. These may be flat or raised. Only
colored flat formation will respond to pure IPL treatment.
C.5.3. Coffee milk spot is a lesion with the homogeneous color characteristics of coffee milk,
ranging from light brown to dark brown. It can occur in single lesion or
multiple lesions. The condition may be present at birth, but usually
develops in early childhood and expands with age.
C.5.5. The pigmented spots of Baker's mother spot are slightly raised, ranging from
brown to dark brown (with other hirsutism).
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C.5.6. Daejeon/Ito One-sided definition, the color ranges from blue to brown spot block,
mother spot including skin, sclera and mucous membrane. It mainly occurs in dark skin
types.
C.6.2. Definition
C.6.2.1. Pulse Parameters Universal IPL Module operates through three sets of pulse parameters:
pulse number, pulse time length, and pulse interval delay (see Figure C-
1):
Number of pulses:
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This unique system allows the target tissue to absorb all pulse
energy, and at the same time provides the cooling time required by
the epidermis between sub-pulses to protect the epidermis from
damage.
Pulse duration (T):
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C.6.2.2. The energy density output of the dose in joules/square centimeter is set by the operator for
each case. The dose is obtained by dividing the total energy of the
number of pulses you choose (measured in joules) by the area of the area
(measured in square centimeters).
C.6.2.3. The universal IPL module of spectrum/filter M22 will emit optical pulses with broad
spectrum (515-1200 nm). The frequency spectrum can be adjusted by
using a cut-off filter, which blocks all light waves whose transmission
wavelength is shorter than that indicated by the filter, and only transmits
the frequency spectrum from above this wavelength to 1200 nm.
C.6.2.4. The continuous cooling ice water machine is used to cool the epidermis of the treatment
site before/during/after phototherapy in general surgery, plastic surgery
and dermatology. The purpose is to:
Minimize burns (including thermal necrosis) during or related to
phototherapy or laser treatment, thus reducing possible
complications such as scars, scars, pigmentation or
pigmentation.
Reduce pain and discomfort during phototherapy or laser
therapy, and/or associated pain and discomfort caused by both
treatments (local anesthesia created by cooling).
For phototherapy or laser therapy, higher pulsed light or laser dose can be
used.
Reduce the potential side effects of pulsed light or laser therapy.
C.7. Setting treatment parameters M22 system is accompanied by Lumenis presupposition for
various clinical indications for the treatment of pigmented lesions in IPL.
You can use these defaults or enter your own user defaults. This chapter
explains the meaning of each parameter and provides guidelines on how
to set parameters to achieve a successful treatment outcome.
The operation mode of setting parameters is explained in detail in Chapter 5.
C.7.1. Spectral The cutoff filters available for the treatment of pigmented lesions using the
parameter M22 system are 515 nm, 560 nm, 590 nm, 615 nm, 640 nm, or 695 nm
(filter) filters, each of which truncates light waves with wavelengths shorter than
those indicated on the filters. The filter is located in the module and is
replaceable.
The components that absorb light waves in pigmented lesions are natural
pigments, such as melanin (which appears in brown pigmented lesions) and
heme residues in brown heme staining.
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Melanin is the main absorption pigment in skin, and its absorption and
scattering coefficients decrease with the increase of wavelength. The higher the
density of melanin, the more light waves it can absorb.
According to the physical principle of interaction between light waves
and tissues, longer wavelengths can penetrate deeper tissues. Therefore,
they will be used to treat deeper lesions.
Another factor in choosing the correct filter is related to the skin color of the
patient. The darker the skin color, the more melanin is contained in the skin.
Melanin in skin will compete with target lesions to absorb IPL light waves.
Because the light wave absorbed by melanin decreases with the increase of
wavelength, it is suggested that the filter with longer wavelength should be
used for patients with darker skin color.
C.7.1.1. The filter with shorter wavelength should be selected for shallow lesions.
For deeper pigmented lesions and lesions with higher density
(density of lesions/regions and internal pigment density of lesions),
filters with longer wavelengths should be selected.
For patients with dark skin types or darker lesions, filters with longer
wavelengths should be used instead.
Using strong AOPT settings (short pulse duration and high dose)
may lead to unexpected adverse events. It is recommended to choose
parameters carefully and follow strict test point protocols.
C.7.2. Pulse parameter Choosing correct pulse parameters is a necessary condition to achieve the best
(time control) treatment effect.
The main problem in treating patients with light energy is to heat the target
lesion to a temperature enough to destroy it, while avoiding damaging the
surrounding tissues and epidermis. The epidermis contains melanin, which
absorbs pulsed light, which increases the temperature of the epidermis and
causes negative side effects.
Higher doses are needed to treat deeper lesions, because light energy will
weaken as it penetrates deeper into the skin. Using this high dose to warm the
epidermis may cause injury or adverse reactions.
The cooling time of an object is proportional to its area, and smaller objects
will cool faster than larger objects. Therefore, when the object area is similar
to the diameter of epidermal thickness (60-100 microns), the cooling time of
small lesions will be shorter than that of large lesions. The cooling time of
large area lesions is longer than that of small area lesions. Similarly,
pigmented lesions with low density pigment cool faster than those with high
density pigment.
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The design of M22 can take advantage of this thermal selectivity, for
example, the cooling time of relatively large lesions is longer, while the
cooling time of thinner epidermis is shorter. This design is achieved by
dividing the total energy transmitted during treatment into several sub-pulses
(double pulses or triple pulses) in order to adjust the delay between pulses.
Pulse duration is the duration of each sub-pulse light exposed to the lesion.
The pulse duration should be shorter than the cooling time of the target.
The delay between sequential neutron pulses (pulse interval delay), the time
to allow the skin to dissipate heat through cryogenic gel between pulses, thus
achieving the cooling effect. However, the delay time should also be shorter
than the cooling time of the target lesion, so as to retain heat energy and the
target temperature will increase with continuous pulses. Most patients are
suitable for shorter delay time. Dark skin type will absorb more light and heat
energy, which will make the temperature higher. Therefore, people with
darker skin color need a longer delay time to cool down.
C.7.2.1. Criteria for surface (epidermal) lesions, please choose monopulse; For
lesions at the junction, please select
Choose double pulses. For deep lesions, please choose three pulses.
Once the energy is divided, the pulse delay time should be longer for
deeper and denser lesions or for patients with dark skin types.
Notes
Choosing the Advanced OPT (AOPT) mode allows you to tailor
your treatment to the patient's needs.
C.7.3. Dose (energy Dose is the total amount of light energy transmitted to the skin, measured in
density joules/square centimeter. The intense pulsed light of the universal IPL
) module of M22 system is transmitted through the light guide and coupling
gel, and irradiates the skin of the patient. Using a larger size of the
illumination point can minimize the scattering effect, resulting in a stable
dose and deeper penetration (as opposed to the smaller illumination point
when using lasers). The higher the dose, the higher the temperature of the
target lesion, surrounding tissues and epidermis.
Generally speaking, the temperature pattern is optimized by selecting the
correct time control parameters, and then the dose is gradually increased until
the positive reaction is achieved.
Be sure to observe the skin during treatment to set the appropriate dose.
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C.7.4.1. Universal IPL Module Universal IPL Module has 3 interchangeable
SapphireCool light guides: 8x15, 15x35
Mm rectangular and 6 mm round.
C.7.5. Guidelines When starting treatment, representative test sites should be treated
and skin reactions should be examined.
If there are no adverse skin reactions and the clinical response is insufficient,
increase the dose and treat other areas. If the response is good, the whole area
should continue to be treated with these parameters.
If the response is still insufficient, please increase the dose again. Please
increase the dose by 10%, but do not exceed the Lumenis preset 20%.
Please reduce the dose (1-2 joules per square centimeter) when treating the
following parts:
C.7.6. The ice water machine button on the ice water machine treatment screen
will show that the ice water machine (continuous conduction cooling) is
enabled or disabled.
Red button-ice water machine is not working.
Blue button-ice water machine in operation.
When operating with a chiller, the following benefits will be added to the
treatment:
Strengthen epidermal protection to avoid adverse reactions.
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Improve the comfort of patients.
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C.8. Before treatment
C.8.2. Preparation for If the lesion is smaller than the light guide point, a template can be used to
treatment of protect healthy tissue around the lesion. To prepare the template, cut the
pathological proper gap or crack in the pure white cardboard to expose only the diseased
changes area. Before treatment, please place the template on the treatment site and
cover it with gel. After treatment, please carefully remove the template.
C.8.3. Coupling gel Before triggering the light pulse, a thin layer of refrigerated
(6 ℃-10 ℃) coupling gel should be applied to the treatment site. The
thickness should usually be 1-2 mm, and the thickness of dark skin type is
3 mm.
C.8.4. When treating pigmented lesions on dark skin types before cooling, the
treatment area should be cooled before triggering the pulse.
C.9. Treatment can be started after clinical indications are input and treatment
parameters are selected.
Notes
During the first course of treatment, be sure to perform block test in the
area to be treated.
1. Apply a layer of low temperature gel (usually about 1-2 mm thick
and 3 mm thick for dark skin types) to the treatment site. This helps
the skin cool during the pulse sequence and promotes the coupling of
light into the skin.
2. Place the module (all in cooling mode) vertically on the skin to
ensure that the sapphire low-temperature light guide really touches
the treatment area or the coupling gel covering the area. Care should
be taken when aligning the light guide (used to transmit light energy
to the treatment site) so that it is the only object that touches the
treatment site.
Make sure that the tip cooling function is turned on after touching the
light guide on the palm of your hand.
Do not press hard.
Do not allow treatment areas to overlap by more than 1 mm!
3. Press the trigger button on the handpiece to trigger the pulse.
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4. Erase the gel and make a careful diagnosis.
Keep in mind that dark skin types take longer to react than light skin types
5. Color change (brown pigment turns gray or dark) or subtle scab appears,
but the surrounding epidermis does not change, which means that the
therapeutic effect meets the expectation.
8. If there is an adverse skin reaction and the target lesion has not
changed, the dose can be increased by 10% at a time, but not more
than 20% than Lumenis preset. In addition, any of the following
actions can be performed simultaneously in the following order to
reduce the treatment intensity:
Increase pulse delay
Increase pulse duration
Use filters with longer wavelengths
Increase the number of pulses
In this way, a higher dose can affect the lesion and be transmitted in a
milder way, thus protecting the skin.
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10. After treatment, it is recommended to cool the treatment area immediately
(see section 0).
C.9.1. Criteria During continuous treatment, if only some pigmented lesions have
dilution effect, they should be used
More powerful parameters. This is due to the reduction of the absorptive
capacity of the target. If the parameters increase with the 15x35/8x15
mm light guide and the results are still unsatisfactory, you can try a
6mm round light guide.
Hair covering pigmented lesions-Hair should be removed before
treatment, which may cause temporary loss of hair in pigmented
treatment areas of patients.
C.10. Lumenis The following table lists the Lumenis default treatment parameters based on the
Default- patient's skin type and underlying condition.
Therapeutic
Parameters
Table C-1: Lumenis presupposition, treatment of pigmented lesions: freckles
Path Pulse
ologi Skin type Dose Filter Pulse delay Ice
Pulse duration
cal (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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Table C-2: Lumenis Presupposition, Pigmented Lesion Treatment: Freckles, Using 6 mm Light Guide
Path Pulse
ologi Skin type Dose Filter Pulse delay Ice
Pulse duration
cal (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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Table C-4: Lumenis Presupposition, Pigmented Lesion Treatment: Coffee Milk Spot
Path Pulse
ologi Skin Dose Filter Pulse delay Ice
Pulse duration
cal type (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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Table C-5: Lumenis Presupposition, Treatment of Pigmented Lesions: Blood Iron
Path Pulse
ologi Skin Dose Filter Pulse delay Ice
Pulse duration
cal type (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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Table C-6: Lumenis Presupposition, Treatment of Pigmented Lesions: Beck's Maternal Plaque
Path Pulse
ologi Skin Dose Filter Pulse delay Ice
Pulse duration
cal type (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
Table C-7: Lumenis presupposition, treatment of pigmented lesions: Daejeon/Ito maternal plaque
Path Pulse
ologi Skin Dose (J/cm2 Filter ( Pulse delay Ice
Pulse duration
cal type ) Nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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Table C-8: Lumenis Presupposition, Treatment of Pigmented Lesions: Pigmentation
Path Pulse
ologi Skin Dose Filter Pulse delay Ice
Pulse duration
cal type (J/cm2) (nm) (ms) water
number (ms)
chan machi
ges ne
preset
Type Depth
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IV 18 615 III 3 35 Open
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Table C-9: Lumenis Presupposition, Pigmented Lesions: Minimum and Maximum Dose Limitations Using
8 x 15 and 15 x 35 mm Light Guides
Filter 515 560 590 615 640 695
Minimum dose 10 10 10 10 10 10
Pulse duration Maximum
dose
2 - - - - - -
2.5 - - - - - -
3 - - - - - -
3.5 - - - - - -
4 15 14 12 10 - -
4.5 15 14 12 10 - -
5 15 14 12 10 - -
5.5 15 14 12 10 - -
6 26 22 20 19 17 14
6.5 27 24 22 20 18 15
7 28 25 23 21 19 15
7.5 30 26 24 22 20 16
8 32 28 25 23 21 17
8.5 32 29 26 24 22 18
9 32 30 28 25 23 19
9.5 32 31 29 26 24 20
10 32 32 30 27 25 21
10.5 35 32 31 28 26 21
11 35 32 32 29 27 22
11.5 35 32 32 30 28 22
12 35 35 34 31 29 23
13 35 35 35 32 29 23
14 35 35 35 32 30 24
15 35 35 35 33 30 24
16 35 35 35 34 31 24
17 35 35 35 34 31 25
18 35 35 35 34 31 25
19 35 35 35 34 31 25
20 35 35 35 35 32 25
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Table C-10: Lumenis Presupposition, Pigmented Lesions: Minimum and Maximum Dose Limits, Using 6
mm Circular Light Guide
Filter 515 560 590 615 640 695
Minimum 16 16 16 16 16 16
dose
Pulse duration Maximum
dose
2 - - - - - -
2.5 - - - - - -
3 - - - - - -
3.5 - - - - - -
4 24 22 19 16 - -
4.5 24 22 19 16 - -
5 24 22 19 16 - -
5.5 24 22 19 16 - -
6 42 35 32 30 27 22
6.5 43 38 35 32 29 24
7 45 40 37 34 30 24
7.5 48 42 38 35 32 26
8 51 45 40 37 34 27
8.5 51 46 42 38 35 29
9 51 48 45 40 37 30
9.5 51 50 46 42 38 32
10 51 51 48 43 40 34
10.5 56 51 50 45 42 34
11 56 51 51 46 43 35
11.5 56 51 51 48 45 35
12 56 56 54 50 46 37
13 56 56 56 51 46 37
14 56 56 56 51 48 38
15 56 56 56 53 48 38
16 56 56 56 54 50 38
17 56 56 56 54 50 40
18 56 56 56 54 50 40
19 56 56 56 54 50 40
20 56 56 56 56 51 40
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C.11. Post-treatment maintenance
C.11.1. Summarize the cold compress (non-ice compress) bag should be used
immediately after treatment to cool the treatment site to eliminate
swelling and relieve discomfort. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. You can use
frozen 4x4 gauze block soaked with water in advance and put in small
plastic bags.
In the first four or five days after treatment, the treatment area should be
carefully maintained to prevent trauma: no soaking or skin massage should be
carried out on the laceration area.
C.11.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight exposure.
Sunbathing after the course of treatment may promote melanin
regeneration, which may lead to pigmentation.
C.11.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if the treatment site is enlarged or lumped.
Other doctors take a more conservative approach, advising patients not to use
cosmetics for several days after treatment. During this period, the skin will
be sensitive, which may damage the skin during makeup removal (especially
when cosmetics are not easy to remove) and make the treatment site
susceptible to infection.
C.11.4. Other post-treatment recommendations are to cover the site with clothing for
10 days if the site is exposed to bacteria.
Patients should be advised not to take part in strenuous exercise or similar
activities for several days after treatment until the skin returns to normal
condition, otherwise it will lead to excessive sweating and/or skin tightening.
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If the lesion does not change, the dose should be increased by at least
10%, and the patient should be returned for examination three weeks
later.
When partial clearance occurs, the interval between each treatment is set to
three to six months.
When satisfactory results are achieved, the treatment is declared complete.
C.11.6. Adverse reactions If any adverse reactions occur, the treatment should be
discontinued until the treatment site recovers.
If there are indications for clearing the lesion after the treatment site is restored,
the dose should be reduced and the pulse parameters should be adjusted during
the next treatment. Patients should return for examination after three weeks.
When returning for examination three weeks after treatment, if adverse
reactions are observed and the lesions are not cleared, the patient should wait
for another two to four weeks, and then return for additional examination. At
that time, if partial clearance effect is found, the dose can be reduced, and the
pulse duration and pulse delay can be increased to continue the treatment.
During the second examination, if the lesion has not been cleared, it should be
judged whether the adverse reaction is caused by factors such as skin
exposure and sunlight. If so, wait for the tanned part to subside before
resuming treatment. If the adverse reaction is not caused by sunlight exposure,
the treatment should be stopped.
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Appendix D
Clinical Guidelines: IPL Hair Removal (HR)
D.1. Introduction This chapter describes the application of hair removal (HR) when
using the general IPL module.
D.2. Training requires that the M22 system should be operated only by
properly trained personnel who are familiar with control and use methods,
including doctors, nurses, technicians or other professional staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
D.3.1. Indication IPL depilation application of M22 system (and its matching transmission
accessories for transmitting light energy) is suitable for removing excess
hair of all skin types, and can produce stable long-term or permanent
depilation effect on skin types I-V by selecting target melanin in hair
follicles.
Notes
Permanent hair removal is defined as a long-term, steady reduction
in the amount of hair regrown after the treatment plan is adopted at
6 months, 9 months and 12 months.
D.3.2. Contraindicatio Before treatment, patients with previous IPL treatment problems must be
ns (non- carefully screened. Patients suffering from any of the following diseases at
exhaustive list) the treatment site shall not be treated on a trial basis:
Attack of infection
Dysplastic maternal plaque
Tattoo
Severe complicated skin condition or any inflammatory skin condition.
Cold sores, open tears or abrasions.
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Chronic or epidermal
viruses, fungal or
bacterial viruses.
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D.3.3. Preventive measures should be taken with care and in accordance with the
doctor's decision when treating patients with the following medical history or conditions:
Hemorrhagic coagulation disease.
Swollen crab foot scar.
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Systemic lupus erythematosus or purpura.
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D.3.4. Caution As with any IPL, appropriate measures must be taken to ensure
safe and proper use, and the full contents of this operation manual must
be thoroughly read and understood before operating the instrument.
Moreover, as discussed below, operators should attend laser training
courses before using the system.
IPL may cause skin damage. The higher the dose and the more severe the
skin pigmentation, the higher the risk:
Patients with darker skin types and residual tanning on the skin
have a higher risk of pigment changes in the treatment area.
These patients should strictly follow the treatment plan of the
test location and be treated carefully.
Exposing the treatment area to sunlight immediately after
treatment or within one month after treatment may also increase
the risk of pigment changes in the treatment area. Patients
should be instructed to use broad-spectrum sunscreen
(minimum SPF 30) every day and reuse it every 2 hours. Avoid
direct sunlight.
Comply with all safety precautions described in the chapter
"Safety and Regulations" and other parts of this manual.
The light emitted by this module is enough to cause serious eye
damage or blindness. When the main power is turned on, all
personnel in the treatment room, including patients, operators
and any observers, must wear appropriate safety goggles.
Before starting comprehensive treatment, treatment should be
carried out at the patient's test site and skin reaction should be
evaluated. Side effects may not appear until several days after
exposure. For patients with V-shaped skin, wait 48-72 hours
after treatment at the test site to observe the tissue reaction.
Always allow sufficient time between test treatment and actual
treatment.
Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
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D.4.1. Overview When a patient visits for the first time, the physician (or authorized
staff) should:
Record the patient's medical history (including previous
treatment methods) in detail, and judge whether it is suitable to
use M22 system for IPL hair removal.
Determine why patients want to seek treatment, and understand and deal
with patients' expectations.
D.4.2. When consulting a patient for an initial visit, the physician (or authorized staff
member) should inform the patient of the following information:
Treatment may cause some discomfort or pain.
D.4.3. Eye protection equipment must be worn by all people (patients and staff) in the
treatment room during treatment
Lumenis recommended goggles to protect the eyes. The optical density (OD) of
goggles is as follows:
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D.4.4. When taking photos and using M22 module for general skin treatment, local anesthesia is not
needed. However, because skin therapy generally treats a large area,
many patients tend to use local anesthesia to receive treatment, so that
they will not feel uncomfortable during the course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
Generally, local anesthesia is applied some time before treatment (as early as
1 hour ago). Be sure to completely remove all local anesthetics before
treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side effects.
D.4.5. Possible side It is recommended to take photos before and after treatment to record the
effects of progress of treatment. Because many patients can't objectively evaluate the
treatment progress of treatment, these photos can provide concrete evidence.
For all patients, use standard conditions and similar shutter speed, flash and
focal length. In this way, we can objectively compare the photos taken in
different periods.
D.4.6. Possible side The most common side effects of treatment are:
effects of
treatment
D.4.6.1. After the discomfort triggers the pulse, some patients will feel different degrees of
discomfort. Some people describe it as tingling, while others say it feels
like a rubber band bouncing. The burning sensation may last up to an
hour after treatment. Most patients can tolerate this discomfort, but some
people may need local anesthesia
(Especially when treating large areas).
D.4.6.2. The most common side effects of erythema are erythema and edema (redness, swelling),
which usually occur immediately after phototherapy and usually heal
within 24 to 48 hours.
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D.4.6.3. For natural In some cases, scabs or blisters may form, and it takes five to ten days to recover.
skin
To cause
damage
D.4.6.4. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months, but in some rare cases (mainly cases of
pigment reduction), the pigment change will last longer or become
permanent.
D.4.6.5. There is little chance that scars (such as enlarged hypertrophic scars) will occur. In rare
cases, large bulges of abnormal crab foot swelling scars may appear. To
reduce the risk of scarring, be sure to carefully follow all post-treatment
instructions and exclude patients with hereditary scars.
D.4.6.6. Excessive swelling After treatment, temporary swelling of skin may occur immediately.
Swelling usually subsides within hours and no more than seven days at
most.
D.4.6.7. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
D.4.6.8. Bruises in very rare cases, the treatment area may have blue-purple bruises (purple spots),
which may last for five to fifteen days. After the bruise subsides, the skin
in this area may turn dark brown and subside within one to three months.
D.4.6.9. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
Do one more stage in the same treatment area during the first course of treatment
and whenever the treatment settings are changed
Before (if allowed), and when replacing the module, be sure to perform small
block tests in an inconspicuous part of the area to be treated.
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D.5.2. Definition
D.5.2.1. Pulse parameters When using IPL module, M22 system can operate with three parameters:
pulse number, pulse duration and pulse delay (see Figure D-1):
Number of pulses:
In HR mode, the energy of each IPL pulse can be transferred into two
pulses (divided into two sub-pulses) or three pulses (divided into three
sub-pulses).
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D.5.2.2. The energy density output of the dose in joules/square centimeter is set by the operator for
each case. The dose is obtained by dividing the total energy of the
number of pulses you choose (measured in joules) by the area of the area
(measured in square centimeters).
D.5.2.3. The spectrum/filter IPL module emits optical pulses with a broad spectrum (515-1200
nm). The spectrum can be adjusted by using a cut-off filter. This filter
will block all light waves whose wavelength is shorter than that indicated
by the filter, and only transmit the spectrum from above this wavelength
to 1200 nm.
D.5.2.4. The continuous cooling ice water machine is used to cool the epidermis of the treatment
site before/during/after phototherapy in general surgery, plastic surgery
and dermatology. The purpose is to:
Minimize burns (including thermal necrosis) during or related to
phototherapy or laser treatment, thus reducing possible
complications such as scars, scars, pigmentation or pigmentation.
Reduce pain and discomfort during phototherapy or laser therapy,
and/or associated pain and discomfort caused by both treatments
(local anesthesia created by cooling).
For phototherapy or laser therapy, higher pulsed light or laser dose can be
used.
Reduce the potential side effects of pulsed light or laser therapy.
D.6. Set Treatment Parameters M22 comes with Lumenis presets for various clinical indications of
skin treatment, which you can use or enter your own user presets. This
chapter explains the meaning of each parameter and provides guidelines
on how to set parameters to achieve a successful treatment outcome.
The operation mode of setting parameters is explained in detail in Chapter 5.
D.6.1. Spectral When a specific color base absorbs light energy and converts it into heat
parameter energy, it will heat the tissue. Only absorbed photons can heat tissue.
(filter) Because melanin absorbs, hair that absorbs light pulses will transmit heat
energy to cells in hair follicles, which will affect hair follicle cells.
Melanin is the main pigment of hair, hair follicle and skin, which has higher
absorption rate at shorter wavelength and lower absorption rate at longer
wavelength. When the optical properties of these tissues are combined,
longer wavelengths can reach the whole hair structure.
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When the melanin concentration in hair is higher than that in epidermis, the
light energy absorbed by hair will be higher than that absorbed by skin. As a
result, hair follicles can be effectively damaged by heat without major
damage to the epidermis above them and the surrounding dermis. Therefore,
when treating hair lighter than skin, side effects (such as burns and scalds)
cannot be avoided.
For hair removal using a universal IPL module, one of the cut-off filters can
be used to adjust the spectrum: 640, 695, and 755 nm. These filters will
truncate light waves with shorter wavelengths than indicated by the filters.
For example, a 695 nm filter will truncate all light waves shorter than 695
nm. 695 filter is the most commonly used filter.
Darker skin types contain more melanin and compete with the target hair to
absorb the light emitted by the system. When the universal IPL module is
used, a cutoff filter with longer wavelength (for example, 755 nm) is more
suitable for patients with darker skin color. This filter is also suitable for
treating extremely dark hair, such as hair on male shoulders.
When treating fine or light-colored hair, it needs more powerful parameters
than coarse hair because of its low melanin content and low absorption rate.
When using IPL modules, it is recommended to use shorter filters (640 nm if
skin type permits), higher doses and stronger pulse parameters.
If the hair is thick and thick, it is recommended to use milder parameters to
protect the skin from being damaged by the heat energy generated by higher
light energy absorption rate.
D.6.1.1. If the criteria are light skin type and fine/light hair, please select a filter
with shorter wavelength and a filter with higher wavelength
A high dose.
For dark skin types and thick or even thick hair, choose a longer
wavelength filter and a lower dose.
D.6.2. Pulse parameter Choosing correct pulse parameters is a necessary condition to achieve the best
(time control) treatment effect.
The cooling time of an object is affected by its size, so the shorter the time
required for small objects, the longer the time required for larger objects.
The design of M22 system can take advantage of this thermal selectivity, that
is, relatively large hair follicles have longer cooling time and thinner
epidermis have shorter cooling time.
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D.6.2.1. Pulse duration should be shorter than the cooling time of the target, so as to limit all heat
energy to the target range, otherwise, some energy will be wasted due to
heat conduction to the surrounding tissues, and the risk of thermal
damage to the surrounding tissues may also be caused. When using the
universal IPL module, use two or three successive sub-pulses. If it is dark
skin and thick and/or thick hair, the total duration will be longer.
Criteria for patients with dark skin types: increase the number of pulses,
pulse duration and decrease the dose.
D.6.2.2. Pulse delay When using general IPL module, the delay duration should be enough for the
skin to dissipate heat through gel between sub-pulses to achieve the
cooling effect. However, the delay time should also be shorter than the
cooling time of hair follicles, so that hair follicles can retain heat energy
and the temperature will increase with each continuous pulse. Dark skin
types will absorb more light and heat energy, resulting in higher
temperatures. Therefore, a longer delay time (80 to 120 milliseconds)
should be selected.
Criteria for patients with dark skin types: increase the number of pulses,
pulse duration and decrease the dose.
D.6.3. Dose (energy Dose is the total amount of light energy transmitted to the skin, measured in
density joules/square centimeter. The strong light pulse of M22 system is transmitted
) through sapphire light guide and coupling gel, and irradiates the skin of
patients. Using a larger illumination point size can reduce the scattering
effect as much as possible and form a deeper penetrating force. The higher
the dose, the higher the temperature of the target hair, but the temperature of
the surrounding tissues and epidermis will be higher.
Some treatment guidelines include:
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D.6.3.1. When starting treatment, it is best to start with Lumenis presupposition at a representative
test site and record skin reaction.
If there are no adverse reactions and the clinical results are not satisfactory,
please increase the dose by 1-2 joules per square centimeter and observe the
reaction. If changing the dose still fails to produce satisfactory results, please
modify the pulse parameters.
If adverse reactions occur, please reduce the dose by 1-2 joules per square
centimeter. If adverse reactions still occur, after reducing the dose, please
increase the delay between pulses or switch to a filter with a longer
wavelength.
In the following cases, the dose is reduced:
Hair is thick.
The part adjacent to the bone (such as tibia and chin).
Sensitive parts of human body structure (such as under eyes, ankles and
behind knees).
D.6.4. The ice water machine button on the ice water machine treatment screen will show that the
ice water machine (continuous conduction cooling) is enabled or
disabled.
Red button-ice water machine not working
Blue button-ice water machine in operation
When operating with a chiller, the following benefits will be added to the
treatment:
D.7.1. Evaluation of treatment parameters varies depending on the type of skin, thickness, and hair
type to be treated, so the first step is to evaluate these factors.
D.7.2. Preparation of Shave the treatment area and remove all surface hair that may hinder the
treatment site treatment. Use pure white eyeliner to protect dark spots (moles). Stick to the
skin surface with adhesive tape or dust roller brush to remove all shaved hair.
D.7.3. Coupling gel Before triggering the light pulse, a thin layer (1-2 mm thick)
of refrigerated (6 ℃-10 ℃) coupling gel should be applied to the
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D.8. Treatment can be started after clinical indications are input and treatment
parameters are selected.
Notes
During the first course of treatment, be sure to perform block test in the
area to be treated.
1. Stick the adhesive surface of adhesive tape to the skin surface to remove all
shaved hair.
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D.9. Lumenis default The following table lists the Lumenis default treatment parameters for
value- universal IPL Modular Hair Removal (HR) applications.
Therapeutic
parameters
Table D-1: Lumenis preset, IPL hair removal
Skin Hair Filter Pulse time Pulse delay Dose Ice water
Hair color Pulse length
type textu (nm) (ms) (J/cm2) machi
numbe
re (ms) ne
r
preset
I Fine 640 Double 4.5 10 23 Open
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Notes
If the hair color is lighter than the skin color, the Lumenis default
value is not provided. Lumenis does not recommend treating hair
that is lighter than the surrounding skin.
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Table D-2: Lumenis Preset, IPL Hair Removal: Minimum and Maximum Dose Limits
Filter 640 695 755
Minimum dose 10 10 10
Pulse duration Maximum
dose
2 - - -
2.5 - - -
3 - - -
3.5 - - -
4 - - -
4.5 - - -
5 - - -
5.5 - - -
6 17 14 14
6.5 18 15 15
7 19 15 15
7.5 20 16 16
8 21 17 17
8.5 22 18 18
9 23 19 19
9.5 24 20 20
10 25 21 21
10.5 26 21 21
11 27 22 22
11.5 28 22 22
12 29 23 23
13 29 23 23
14 30 24 24
15 30 24 24
16 31 24 24
17 31 25 25
18 31 25 25
19 31 25 25
20 32 25 25
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D.10.1. Summarize the cold compress (non-ice compress) bag should be used
immediately after treatment to cool the treatment site to eliminate
swelling and relieve discomfort. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. You can use
frozen 4x4 gauze blocks soaked in water in advance and put in small
plastic bags.
In the first four or five days after treatment, the treatment area should be
carefully maintained to prevent trauma, skin abrasion or laceration: massage is
not allowed.
D.10.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight exposure.
Sunbathing after the course of treatment may promote melanin
regeneration, which may lead to pigmentation.
D.10.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if the treatment site is enlarged or lumped.
Other doctors take a more conservative approach, advising patients not to use
cosmetics for four to five days after treatment. During this period, the skin
will be sensitive, which may damage the skin during makeup removal
(especially when cosmetics are not easy to remove) and make the treatment
site susceptible to infection.
D.10.5. Follow-up course the following is Lumenis' suggestion for follow-up course. Doctors can
refer to it and make their own appropriate treatment plan.
Patients should return within four to eight weeks after treatment to check the
treatment site and receive additional treatment if necessary. Generally
speaking, the interval between upper cervical treatment is four weeks, and
the interval between lower cervical treatment is six to eight weeks. However,
the rate of hair growth varies depending on individual factors, body parts
treated, sex and hormones, physiological conditions and the season of
treatment.
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D.10.6. Adverse reactions If any adverse reactions occur, the treatment should be
discontinued until the treatment site recovers.
After the treatment site is restored, if there is an indication to remove hair, the
dose should be reduced and the pulse duration should be adjusted for the next
treatment. Patients should return for examination after three weeks.
If adverse reactions are observed and the hair is not removed during the
follow-up examination four weeks after treatment, the patient should wait
another two to four weeks before returning for additional examination. At
that time, if partial clearance effect is found, the dose can be reduced, the
pulse duration and pulse delay can be increased, and the treatment can be
continued.
During the second examination, if the hair has not been cleared, it should be
judged whether the adverse reaction is caused by factors such as skin
exposure and sunlight. If so, wait for the tanned part to subside before
resuming treatment. If the adverse reaction is not caused by sunlight exposure,
the treatment should be stopped.
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Appendix E
Clinical guidelines: Segmented non-peeling skin abrasion (ResurFX)
E.2. Training requires that the M22 system should be operated only by properly trained personnel
who are familiar with control and use methods, including doctors, nurses,
technicians or other professional staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
E.3.1. Indications 1565nm ResurFX laser module is suitable for skin surgery (I-VI skin type)
requiring the following items:
Soft tissue coagulation.
Skin changing procedure.
Heterochromia treatment, such as but not limited to liver plaque.
Treatment of acne scars and surgical scars.
Dermatoglyphic treatment.
Warning
Lasers can produce highly concentrated beams, which may cause
harm if used improperly. To protect the patient, yourself, and
theatre personnel, read and understand all operating manuals for
laser and appropriate delivery systems, including all safety and
regulatory sections, before operating. If you have any questions,
please contact the local representative of Lumenis.
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Notes
Except for applications that have been explicitly prohibited, the
application of laser instruments should be at the discretion of
doctors.
Skin that has been exposed to sunlight within 4-6 weeks before
the program or to artificial sunlight within 2-3 weeks before the
program, resulting in tanning, sunburn or artificial sunlight.
Tattoo
Permanent dermal transplantation
E.3.3. Pay attention to the treatment of patients with the following conditions
with caution and according to the doctor's decision.
Medical history or appearance:
Hemorrhagic coagulation disease
Complicated with inflamed skin symptoms (dermatitis, acne attack,
rosacea, etc.).
Swollen scar of crab foot
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Have a history of homomorphic diseases (vitiligo, psoriasis).
Uncontrolled systemic diseases, such as diabetes, epilepsy or heart
failure.
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E.3.4. Warning As with any laser, appropriate measures must be taken to ensure
safe and proper use.
This manual must be thoroughly read and understood before operating the
instrument, and the operator should attend laser training courses before
using the system.
Laser may cause skin damage. The higher the laser dose and the
more severe the skin pigmentation, the higher the risk:
Patients with darker skin types and non-recent tanning have a higher
risk of pigment changes in the treatment area.
These patients must be treated carefully according to strict small test
protocols.
Exposing the treatment area to sunlight immediately after treatment
or within one month after treatment may also increase the risk of
pigment changes in the treatment area.
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Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
E.4. Pre-
treatment
informati
on
E.4.1. Review and adjust expectations with patients for immediate and long-
term efficacy. Appropriate patient selection is necessary and
indispensable for ResurFX treatment. At the initial visit of a patient, the
physician (or authorized staff member) should:
Record the patient's medical history (including previous
treatment methods) in detail, and judge whether it is suitable to
receive the treatment of ResurFX module of M22 system.
Determine why patients want to seek treatment, and understand
and deal with patients' expectations. Patients with unrealistic
expectations should be identified during the negotiation process
and advised not to expect too much.
Discuss ResurFX skin replacement treatment plan with patients.
E.4.2. When consulting a patient for an initial visit, the physician (or authorized staff
member) should inform the patient of the following information:
Treatment may cause some discomfort or pain.
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E.4.3. When ResurFX module is used for eye protection appliances, doctors and all personnel near
the system should wear safety goggles with optical density OD > 3.1 and
protection levels D LB4 and I LB3 to avoid being injured by laser
radiation at 1565 nm.
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
E.4.4. Local anesthesia M22 module can be used for general skin treatment without local
anesthesia. However, because skin therapy generally treats a large area,
such as the whole face, many patients tend to use local anesthesia to
receive treatment, so that they will not feel uncomfortable during the
course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
Generally, local anesthesia is applied some time before treatment (as early as
1 hour ago). Be sure to completely remove all local anesthetics before
treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side effects.
E.4.5. It is recommended to take photos before and after treatment to record the
progress of treatment. Because many patients can't objectively evaluate
the progress of treatment, these photos can provide concrete evidence.
For all patients, use standard conditions and similar shutter speed, flash and
focal length. In this way, we can objectively compare the photos taken in
different periods.
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E.4.6. Possible side The most common side effects of treatment are:
effects of
treatment
E.4.6.1. After the discomfort triggers the pulse, some patients will feel different degrees of
discomfort. Some people describe it as tingling, while others say it feels
like a rubber band bouncing. After treatment, burning/itching may last for
up to one hour. Most patients can tolerate this discomfort, but some
people may need local anesthesia (especially when treating a large area).
E.4.6.2. The most common side effects of erythema are erythema and edema (redness and
swelling), which usually occur immediately after laser treatment and
usually heal within 24 to 48 hours.
E.4.6.3. For natural In rare cases, scabs or blisters may form, and it takes five to ten days to
skin recover. Discrete light brown particles may appear and last for about 10 days.
To cause They can be easily covered with light makeup.
damage
E.4.6.4. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months, but in some rare cases (mainly cases of
pigment reduction), the pigment change will last longer or become
permanent.
Attention
The incidence and duration of postoperative pigmentation in
patients with dark skin type (Freund's IV-VI) is higher than that in
patients with light skin type (Freund's I-III). The choice of
treatment parameters should be carefully considered to reduce
postoperative inflammatory reaction, and test repair should be
carefully performed according to each skin type in a long enough
period before operation.
E.4.6.5. There is little chance that scars (such as enlarged hypertrophic scars) will occur. In rare
cases, large bulges of abnormal crab foot swelling scars may appear. To
reduce the risk of scarring, be sure to carefully follow all post-treatment
instructions and exclude patients with hereditary scars.
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E.4.6.6. Excessive swelling After treatment, temporary swelling of the skin may occur
immediately, especially around the eyes or outside the face (such as the
neck or low neckline). Swelling usually subsides within hours and no
more than seven days at most.
E.4.6.7. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
E.4.6.8. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
During the first course of treatment, when the treatment settings are changed,
additional treatment is performed in the same treatment area
Before (if allowed), and when replacing modules, be sure to perform block
tests in an inconspicuous part of the intended treatment area.
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E.5.2. Definition
E.5.2.1. When the ResurFX module is used for pulse parameters, the M22 system can
operate with three parameters:
Scan shape:
Segmented scan pattern shapes can be transferred to the treatment
site in one of six user-selected shapes: straight line, rectangle,
square, ring, hollow circle and hexagonal.
Scan size:
The scan pattern size can be selected in increments of 1 mm between 5 and 18
mm.
Scanning density:
E.5.2.2. Energy (mJ) The energy density measured in microjoules, set by the operator for each
case, can be selected in increments of 1 microjoule in the range of 10 to
70 microjoules.
E.5.2.3. Module Tip ResurFX system has 2 gold plate metal tips that may be used during
treatment. The two tips transmit up to 18mm spot size:
SapphireCool Tip: The tip assembly includes a sapphire
window wrapped in a gold plate metal case and a transparent
window for viewing treatment modes. During the treatment,
sapphire can provide continuous contact cooling to improve the
safety and comfort of patients.
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Notes
Do not use any cooling method, as this may cause water to enter
the tissue
(E. G. ice, ice pack).
During treatment, it is necessary to combine a precise tip
perpendicular to the skin with external cooling.
E.5.3. The ice water machine button on the ice water machine treatment screen will show that the
ice water machine (continuous conduction cooling) is enabled or
disabled.
Red button-ice water machine is not operating
Blue button-ice water machine in operation
When operating with a chiller, the following benefits will be added to the
treatment:
Strengthen epidermal protection to avoid adverse reactions.
Improve the comfort of patients.
E.6. Set Treatment Parameters M22 comes with Lumenis presets for various clinical indications of
skin treatment, which you can use or enter your own user presets. This
chapter explains the meaning of each parameter and provides guidelines
on how to set parameters to achieve a successful treatment outcome, as
detailed in Chapter 5.
E.7.1. The evaluation of treatment parameters varies according to the skin type and skin condition
to be treated. Therefore, the first step is to accurately evaluate these
factors.
E.7.2. Preparation of If necessary, please shave off the hair at the treatment site before treatment.
treatment site
Bypass the mole that needs protection.
Make sure that the skin part to be treated has been thoroughly
cleaned and dried before treatment. If local anesthesia is used before
treatment, it is important to make sure that hair has been thoroughly
removed, cleaned and dried before treatment. Follow the guidelines
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of health care
production
experts to
decide the
dosage,
isolation and
time of drugs.
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Local anesthesia:
It must be used in medical facilities under the supervision of properly
licensed practitioners.
It should not be used in large areas because there is a potential risk of
systematic absorption.
Cooling:
When using the SapphireCool tip: Make sure to cool the tip
open by touching the light guide with the palm of your hand. If
water condenses at the tip of sapphire, please wipe it with dry
dust-free paper towel.
When using precision tips, make sure that external cooling is being used.
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E.8. Treatment can be started after clinical indications are input and treatment
parameters are selected.
Warning
Before operating ResurFX, it must be verified that the
aiming beam is visible, concentrated and undiffused.
It is strictly forbidden to operate ResurFX by placing the
tip on any non-skin medium. Testing on non-skin media
may result in irreversible damage to the tip and/or hand.
Do not use high density settings with high energy.
Notes
It is recommended that laser test repair be performed in an
inconspicuous position in the treatment area before treatment to
verify ideal parameters and prevent unexpected results.
When using external cooling for precision tips, make sure that
there is no condensation on the tissue. If so, please reduce the
external cooling force.
Before starting treatment, make sure that the tips are connected and
locked in place.
During treatment, it is very important to ensure that the
precision tip is perpendicular to the skin when using external
cooling.
Select the desired shape, shape size, density, and energy settings. The
energy readings must be checked before the laser is activated to verify that
the desired values are displayed on the screen.
Reset the pulse counter if necessary. To track the number of laser pulses
in the course of treatment, press the reset button on the left side of the
emission counter to clear the counter.
Please use the palm of your hand to make sure that the spike cooling is
turned on. If condensed water appears at the tip of sapphire, please dry it
with dust-free paper towel.
Work with the tip from end to end until traversing the whole treatment area.
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E.9. Lumenis Default- The following table lists the Lumenis default treatment parameters based on the
Therapeutic patient's skin type and underlying condition.
parameters
Table E-2: Lumenis Presupposition, Heterochromia Treatment: Freckles
Dise Skin type Depth Energy Density
ase [mJ] 1
I Epider 30 350
mis
II Epider 30 350
mis
Frec Epider
III 30 300
kles mis
IV Epider 25 250
mis
V Epider 20 250
mis
VI Epider 15 150
mis
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I Mod 40 350
erate
Sever 45 300
e
Mild 35 350
II Mod 40 350
erate
Sever 45 300
e
Mild 30 350
IV Mod 30 200
erate
Sever 35 200
e
Mild 20 250
V Mod 25 200
erate
Sever 30 200
e
Mild 15 200
VI Mod 20 150
erate
Sever 25 150
e
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I Mod 35 350
erate
Sever 40 300
e
Mild 30 350
II Mod 35 350
erate
Sever 40 300
e
Mild 25 350
IV Mod 25 350
erate
Sever 30 300
e
Mild 15 300
V Mod 20 300
erate
Sever 25 250
e
Mild 15 250
VI Mod 20 200
erate
Sever 25 200
e
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I Mod 35 350
erate
Sever 45 300
e
Mild 25 350
II Mod 35 350
erate
Sever 45 300
e
Mild 20 300
IV Mod 25 250
erate
Sever 30 200
e
Mild 20 250
V Mod 25 250
erate
Sever 30 200
e
Mild 15 200
VI Mod 20 200
erate
Sever 25 150
e
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I Mod 35 350
erate
Sever 40 300
e
Mild 30 350
II Mod 35 350
erate
Sever 40 300
e
Mild 30 300
IV Mod 30 250
erate
Sever 35 200
e
Mild 20 200
V Mod 25 150
erate
Sever 30 150
e
Mild 15 200
VI Mod 20 150
erate
Sever 25 150
e
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I Mod 30 300
erate
Sever 35 300
e
Mild 25 350
II Mod 30 300
erate
Sever 35 300
e
Mild 25 300
IV Mod 25 200
erate
Sever 30 200
e
Mild 15 200
V Mod 20 150
erate
Sever 25 150
e
Mild 15 150
VI Mod 20 150
erate
Sever 25 150
e
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I Mod 35 300
erate
Sever 40 250
e
Mild 30 350
II Mod 35 300
erate
Sever 40 250
e
Mild 30 300
IV Mod 30 200
erate
Sever 35 150
e
Mild 20 200
V Mod 25 150
erate
Sever 30 150
e
Mild 15 150
VI Mod 20 150
erate
Sever 25 150
e
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E.10.1. Summarize the cold compress (non-ice compress) bag should be used
immediately after treatment to cool the treatment site to eliminate
swelling and relieve discomfort. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. You can use
frozen 4x4 gauze blocks soaked in water in advance and put in small
plastic bags. You can also use cold toner spray.
In the first four or five days after treatment, the treatment area should be
carefully maintained to prevent trauma: if there is a strong reaction, it can be
applied with post-laser moisturizer.
E.10.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight exposure.
Sunbathing after the course of treatment may promote melanin
regeneration, which may lead to pigmentation.
E.10.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if the treatment site is enlarged or lumped.
Other doctors take a more conservative approach, advising patients not to use
cosmetics for four to five days after treatment. During this period, the skin
will be sensitive, which may damage the skin during makeup removal
(especially when cosmetics are not easy to remove) and make the treatment
site susceptible to infection.
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E.10.6. Adverse reactions If any adverse reactions occur, the treatment should be discontinued until
the treatment site is completely recovered and the cause of the adverse
reactions is understood. See the Side Effects section in this section (see
Section 0).
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Appendix F
Clinical Guidelines: Segmented Non-stripping Skin Replacement (ResurFX)
F.2. Training requires that the M22 system should be operated only by
properly trained personnel who are familiar with control and use methods,
including doctors, nurses, technicians or other professional staff.
The physician is responsible for contacting the local licensing authority to
determine whether any license is legally required for clinical use and device
operation.
Warning
Lasers can produce highly concentrated beams, which may cause
harm if used improperly. To protect the patient, yourself and the
program room personnel, read and understand all the operating
manuals of the laser and appropriate delivery systems, including all
safety and regulatory sections, before operating. If you have any
questions, please contact the local representative of Lumenis.
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Notes
Except for applications that have been explicitly prohibited, the
application of laser instruments should be at the discretion of
doctors.
Skin that has been exposed to sunlight within 4-6 weeks before
the program or to artificial sunlight within 2-3 weeks before the
program, resulting in tanning, sunburn or artificial sunlight.
Tattoo
Permanent dermal transplantation
F.3.3. Pay attention to the treatment of patients with the following conditions
with caution and according to the doctor's decision.
Medical history or appearance:
Hemorrhagic coagulation disease
Complicated with inflamed skin symptoms (dermatitis, acne attack,
rosacea, etc.).
Swollen scar of crab foot
Herpes simplex; Treatment may trigger herpes attack; Doctors can
prescribe preventive antiviral drugs at their own discretion.
Have a history of homomorphic diseases (vitiligo, psoriasis).
Uncontrolled systemic diseases, such as diabetes, epilepsy or heart
failure.
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F.3.4. Warning As with any laser, appropriate measures must be taken to ensure
safe and proper use.
You must thoroughly read and understand all the contents of this
operation manual before operating the instrument. Moreover, operators
should attend laser training courses before using the system.
Laser may cause skin damage. The higher the laser energy and density
and the more serious the skin pigmentation, the higher the risk:
Patients with darker skin types and residual tanning on the skin have
a higher risk of pigment changes in the treatment area.
These patients must be treated carefully according to strict small test
protocols.
Exposing the treatment area to sunlight immediately after treatment
or within one month after treatment may also increase the risk of
pigment changes in the treatment area.
The light emitted by this laser is strong enough to cause serious eye
damage or blindness. All personnel in the treatment room, including
patients, operators and any observers, must wear proper goggles
whenever the main power is turned on.
Treatment in the edge of eye socket: Patients should wear intraocular eye
protection to protect their eyes from direct or indirect laser exposure.
Notes
Lumenis has no clinical information about the safety of
phototherapy in pregnant or lactating women.
F.4. Pre-
treatment
informati
on
F.4.1. Review and adjust expectations with patients for immediate and long-
term efficacy. Proper patient selection is necessary and indispensable for
ResurFX treatment.
At the initial visit of a patient, the physician (or authorized staff member) should:
F.4.2. When consulting a patient for an initial visit, the physician (or authorized staff
member) should inform the patient of the following information:
Treatment may cause some discomfort or pain.
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F.4.3. When ResurFX module is used for eye protection appliances, doctors and all personnel near
the system should wear safety goggles with optical density OD > 3.1 and
protection levels D LB4 and I LB3 to avoid being injured by laser
radiation at 1565 nm.
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
F.4.4. Local anesthesia M22 module can be used for general skin treatment without local
anesthesia. However, because skin therapy generally treats a large area,
such as the whole face, many patients tend to use local anesthesia to
receive treatment, so that they will not feel uncomfortable during the
course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
Generally, local anesthesia is applied some time before treatment (as early as
1 hour ago). Be sure to completely remove all local anesthetics before
treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side effects.
F.4.5. It is recommended to take photos before and after treatment to record the
progress of treatment. Because many patients can't objectively evaluate
the progress of treatment, these photos can provide concrete evidence.
For all patients, use standard conditions and similar shutter speed, flash and
focal length. In this way, we can objectively compare the photos taken in
different periods.
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F.4.6. Possible side The most common side effects of treatment are:
effects of
treatment
F.4.6.1. After the discomfort triggers the pulse, some patients will feel different degrees of
discomfort. Some people describe it as tingling, while others say it feels
like a rubber band bouncing. After treatment, burning/itching may last for
up to one hour. Most patients can tolerate this discomfort, but some
people may need local anesthesia (especially when treating a large area).
F.4.6.2. The most common side effects of erythema are erythema and edema (redness and
swelling), which usually occur immediately after laser treatment and
usually heal within 24 to 48 hours.
F.4.6.3. For natural In rare cases, scabs or blisters may form, and it takes five to ten days to
skin recover. Discrete light brown particles may appear and last for about 10 days.
To cause They can be easily covered with light makeup.
damage
F.4.6.4. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients, or
because the treated area is exposed to sunlight before or after treatment.
For some patients, although measures have been taken to protect against
sunlight, pigmentation will still occur. This discoloration usually subsides
within three to six months, but in some rare cases (mainly cases of
pigment reduction), the pigment change will last longer or become
permanent.
Attention
The incidence and duration of postoperative pigmentation in
patients with dark skin type (Freund's IV-VI) is higher than that in
patients with light skin type (Freund's I-III). The choice of
treatment parameters should be carefully considered to reduce
postoperative inflammatory reaction, and test repair should be
carefully performed according to each skin type in a long enough
period before operation.
F.4.6.5. There is little chance that scars (such as enlarged hypertrophic scars) will occur. In rare
cases, large bulges of abnormal crab foot swelling scars may appear. To
reduce the risk of scarring, be sure to carefully follow all post-treatment
instructions and exclude patients with hereditary scars.
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F.4.6.6. Excessive swelling After treatment, temporary swelling of the skin may occur
immediately, especially around the eyes or outside the face (such as the
neck or low neckline). Swelling usually subsides within hours and no
more than seven days at most.
F.4.6.7. Sensitive and weak skin treatment site or surrounding skin may become very sensitive and
fragile. If this happens, please avoid makeup and do not rub the area, as it
may tear the skin.
F.4.6.8. Burns and scalds have a rare chance of causing burns and scalds on the
skin. To reduce the likelihood of burns and scalds, be sure to follow all
treatment instructions carefully, especially by performing block tests.
During the first course of treatment, when the treatment settings are changed,
additional treatment is performed in the same treatment area
Before (if allowed), and when replacing modules, be sure to perform block
tests in an inconspicuous part of the intended treatment area.
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F.5.2. Definition
F.5.2.1. When the ResurFX module is used for pulse parameters, the M22 system can
operate with three parameters:
Scan shape:
Segmented scan pattern shapes can be transferred to the treatment
site in one of six user-selected shapes: straight line, rectangle,
square, ring, hollow circle and hexagonal.
Scan size:
The scan pattern size can be selected in increments of 1 mm between 5 and 18
mm.
Scanning density:
F.5.2.2. Energy (mJ) The energy density measured in microjoules, set by the operator for each
case, can be selected in increments of 1 microjoule in the range of 10 to
70 microjoules.
F.5.2.3. Module Tip ResurFX system has 2 gold plate metal tips that may be used during
treatment. The two tips transmit up to 18mm spot size:
SapphireCool Tip: The tip assembly includes a sapphire
window wrapped in a gold plate metal case and a transparent
window for viewing treatment modes. During the treatment,
sapphire can provide continuous contact cooling to improve the
safety and comfort of patients.
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Notes
Do not use any cooling method, as this may cause water to enter
the tissue
(E. G. ice, ice pack).
During treatment, it is necessary to combine a precise tip
perpendicular to the skin with external cooling.
F.5.3. The ice water machine button on the ice water machine treatment screen will show that the
ice water machine (continuous conduction cooling) is enabled or
disabled.
Red button-ice water machine not working
Blue button-ice water machine in operation
When operating with a chiller, the following benefits will be added to the
treatment:
Strengthen epidermal protection to avoid adverse reactions.
Improve the comfort of patients.
F.6. Set the treatment parameter M22 system with Lumenis default values for various clinical
indications of skin treatment. You can use these presets, or enter your
own user presets. This chapter explains the meaning of each parameter
and provides guidelines on how to set parameters to achieve a successful
treatment outcome.
The operation mode of setting parameters is explained in detail in Chapter 5.
F.7.1. The evaluation of treatment parameters varies according to the skin type and skin condition
to be treated. Therefore, the first step is to accurately evaluate these
factors.
F.7.2. Preparation of If necessary, please shave off the hair at the treatment site before
treatment site treatment.
Make sure that the skin part to be treated has been thoroughly
cleaned and dried before treatment. If local anesthesia is used
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before
treatment, it
is important
to make sure
that hair has
been
thoroughly
removed,
cleaned and
dried before
treatment.
Follow the
guidelines of
health care
production
experts to
decide the
dosage,
isolation and
time of drugs.
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Local anesthesia:
It must be used in medical facilities under the supervision of properly
licensed practitioners.
It should not be used in large areas because there is a potential risk of
systematic absorption.
When using precision tips, make sure that external cooling is being
used. In addition, for other safety measures, the energy and density
limits of the tip are as follows:
The maximum density is 250 microbeams per square centimeter
The maximum energy is 40 mJ, and the following table summarizes
the comparison of energy range and depth and width of effect on
tissue:
Table F-1: Impact on tissues
Setti Single point energy Condensation Condensation
ng [microjoule] depth width
Low 10-20 327-417 87-103
Cooling:
When using the SapphireCool tip: Make sure the tip is cooled to
ON by touching the light guide with your palm. If there is
condensed water on the tip of SapphireCool, dry it with a non-
velvet paper towel.
When using precision tips: ensure that external cooling methods are
provided.
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F.8. Treatment can be started after clinical indications are input and treatment
parameters are selected.
Warning
Never operate ResurFX hand without confirming that the aiming
beam is visible.
Never place the tip on any medium other than skin when
operating ResurFX hand. Testing media other than skin can
cause irreversible damage to tips and/or hand tools.
Do not combine high energy and high density settings.
Notes
It is recommended that laser block testing be performed on
inconspicuous areas of the treatment site before treatment to
verify the required parameters and avoid unexpected results.
When using external cooling for precision tips, ensure that there
is no condensed water on the paper towels. If condensation
exists, it will weaken the effect of external cooling.
Before starting treatment, make sure that the tips are connected and
locked in place.
During treatment, it is necessary to combine a precise tip
perpendicular to the skin with external cooling.
Select the desired shape, shape size, density, and energy settings. The
energy readings must be checked before the laser is activated to verify that
the desired values are displayed on the screen.
Reset the pulse counter if necessary. To track the number of laser pulses
in the course of treatment, press the reset button on the left side of the
emission counter to clear the counter.
Work with the tip from end to end until traversing the whole treatment area.
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F.9. Lumenis Default- The following table lists the Lumenis default treatment parameters based on the
Therapeutic parameters patient's skin type and underlying condition.
I Mod 35 350
erate
Sever 45 300
e
Mild 25 350
II Mod 35 350
erate
Sever 45 300
e
Mild 20 300
IV Mod 25 250
erate
Sever 30 200
e
Mild 20 250
V Mod 25 250
erate
Sever 30 200
e
Mild 15 200
VI Mod 20 200
erate
Sever 25 150
e
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F.10.1. Summarize the cold compress (non-ice compress) bag should be used
immediately after treatment to cool the treatment site to eliminate
swelling and relieve discomfort. If the temperature of chemical cold
compress bag is lower than 4 ℃, it is not recommended. You can use
frozen 4x4 gauze blocks soaked in water in advance and put in small
plastic bags. You can also use cold toner spray.
In the first four or five days after treatment, the treatment area should be
carefully maintained to prevent trauma: if there is a strong reaction, it can be
applied with post-laser moisturizer.
F.10.2. For at least one month after sunlight exposure, patients should use high-coefficient (30-50
SPF) sunscreen and protect the treatment area from sunlight (natural or
artificial) exposure. Sunbathing after the course of treatment may
promote melanin regeneration, which may lead to pigmentation.
F.10.3. Cosmetics Most physicians allow patients to apply cosmetics immediately after treatment.
However, they will advise patients to notify their physician and stop
using cosmetics if the treatment site is enlarged or lumped.
Other doctors take a more conservative approach, advising patients not to use
cosmetics for four to five days after treatment. During this period, the skin
will be sensitive, which may damage the skin during makeup removal
(especially when cosmetics are not easy to remove) and make the treatment
site susceptible to infection.
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F.10.6. Adverse reactions If any adverse reactions occur, the treatment should be discontinued until
the treatment site is completely recovered and the cause of the adverse
reactions is understood. See the side effects section in this section (see
section f.4. 6).
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™ Diseases(VL)
Appendix G
Clinical Guidelines: Dark Tattoo and Pigmented Lesions (Q-Switched Nd:
YAG)
G.2. Training requires that the Q-Switched Nd: YAG module of M22 platform be designed to be
operated only by properly trained personnel who are familiar with control
and usage methods. This includes doctors, nurses, technicians or other
professional staff according to local laws and regulations.
The physician is responsible for contacting the local license issuing authority to
determine whether any license is required for clinical use and system operation
according to law.
G.3.1. The Q-Switched Nd: YAG laser module using the indicator M22 platform (and its matching
transfer accessories for transferring laser energy) is suitable for
applications requiring target color-based selective opto-
mechanical/photoacoustic effects in medical specialties of orthopedic
surgery and dermatology. The intended uses include:
Remove dark tattoos.
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G.3.3. Preventive measures Patients with the following medical history or conditions
should be treated with caution at the discretion of doctors:
Hemorrhagic coagulation disease.
Crab foot swelling scar disease.
Herpes simplex disease; Treatment may lead to herpes; Prophylactic
antiviral treatment can be given at the discretion of doctors.
Systemic lupus erythematosus or purpura.
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™ Switched ND: YAG)
Immunosuppressive drugs.
Herbal supplements, perfumes or cosmetics that may affect sensitivity to
light.
Oral isotretinoin (eg acne specific medicine).
Patients with the following conditions should be treated with caution and according
to the doctor's decision:
G.3.4. Warning that careful and appropriate measures must be taken when using
any laser to ensure safe and reasonable use. Before operating the
instrument, you must read and understand the whole operation manual
completely. In addition, as discussed below, operators should attend laser
training courses before using the system.
Laser may cause skin damage. With the increase of laser dose and skin
pigment content, the risk will also increase.
Dark skin types and treatment sites with residual tanning on the
skin will have a higher risk of pigment change. These patients
should strictly follow the treatment plan of the test location and
be treated carefully.
If the treatment site is exposed to sunlight immediately after
treatment and for one month after treatment, the treatment site
will also have a higher risk of pigment change. Patients should
be instructed to use broad-spectrum sunscreen (SPF 30) every
day to prevent direct sunlight.
Please observe all safety precautions listed in the "Safety and
Regulations" section and elsewhere in this manual.
Lasers emit enough light to cause serious eye damage or
blindness. When the main power is turned on, all personnel in the
treatment room, including patients, operators and any observers,
must wear appropriate safety goggles.
Notes
Lumenis has no clinical information about the safety of
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™ Switched ND: YAG)
G.4. Patient treatment Patient treatment is the responsibility of a licensed practitioner and therefore
the following information is provided as a general guideline only. All
users should be trained by authorized medical professionals, and have
consulted experienced practitioners and medical journals for more
detailed and up-to-date information.
For instructions, contraindications, precautions, warnings, complications, and
side effects, see the "Instructions for Use" section of this chapter (see Section
0).
Lumenis does not have any recommendations for medical practice. The
following guidelines are for reference only. Individual treatment should be
based on clinical training, clinical observation of the interaction between
laser and biological tissues, and appropriate clinical efficacy indicators.
G.5.1. Overview When a patient visits for the first time, the physician (or authorized
staff) should:
Record a detailed patient history, including previous treatment modes.
Determine why patients want to seek treatment, and understand and deal with
patients' expectations.
Discuss the course of treatment and post-treatment maintenance with patients.
Special attention should be paid to contraindications.
Inform the patient that the existing hair at the treatment site must be shaved or
removed before treatment.
G.5.2. When consulting a patient for an initial visit, the physician (or authorized staff
member) should inform the patient of the following information:
G.5.2.1. Treatment of Q-Switched Nd: YAG treatment may require multiple treatments at
dark tattoo intervals of 6-10 weeks over several months.
Therapy
Treatment may cause some discomfort or pain. Local anesthetics may be used.
After treatment, transient whitening, erythema, edema and skin bulging
usually occur immediately. In rare cases, bleeding or bleeding may occur.
It takes several months to gradually clear the lesions. Some professional
tattoos may take more than one year to remove.
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G.5.2.2. Treatment of Q-Switched Nd: YAG treatment may require multiple treatments at
pigmented intervals of 2-4 weeks over several months.
venereal
disease Treatment may cause some discomfort or pain. Local anesthetics may be used.
Change Transient erythema, edema and tiny bleeding spots. In rare cases,
urticaria, acne rash and transient pigmentation.
It may take several months to clear pigmented lesions and improve
skin color. Maintenance treatment may be needed.
G.5.4. All people (patients and staff) in the treatment room must wear safety goggles (OD > 4)
recommended by Lumenis or equivalent equipment to prevent retinal
damage during the treatment of eye protection equipment as long as the
Q-Switched Nd: YAG module of M22 system is used. Goggles must be
fully protected from 1064 nm laser radiation.
Warning
When receiving facial treatment, patients must wear completely
isolated eye protectors (metal goggles).
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™ Switched ND: YAG)
G.5.5. Local anesthesia M22 module can be used for general skin treatment without local
anesthesia. However, because skin therapy generally treats a large area,
such as the whole face, many patients tend to use local anesthesia to
receive treatment, so that they will not feel uncomfortable during the
course of treatment.
When using local anesthesia, please follow the manufacturer's instructions.
Generally, local anesthesia is applied some time before treatment (as early as
1 hour ago). Be sure to completely remove all local anesthetics before
treatment.
Warning
Large-scale use of local anesthesia may lead to unexpected side effects. .
G.5.6. Photographing It is strongly recommended that photographs be taken before each treatment
to record the progress of the treatment (left, right and front of the
treatment site). Because progress will occur gradually, it is important to
leave a photo record for accurate evaluation and provide a stable basis for
patients to be satisfied with their progress. Because many patients cannot
objectively evaluate the progress of treatment, these photos can provide
concrete evidence.
Standard light conditions and similar shutter speeds, flashes, and focal lengths
should be used to objectively compare photographs taken at different times.
G.5.7. Possible side The following potential side effects may occur after treatment to remove dark
effects of tattoos or pigmented lesions:
treatment
G.5.7.1. When discomfort triggers pulse, it may cause discomfort to varying degrees. Some people
have a burning sensation on their skin, while others have dull pain. After
treatment, burning and pain may last for 10 minutes or several hours. In
some cases, local anesthesia may be required.
G.5.7.2. For natural Skin may be injured by treatment, and scabs or blisters may form, which
skin takes five to ten days to recover. During the period of injury, cosmetics
To cause should not be used at the treatment site. Moisturizing products must be
damage gently applied to skin.
G.5.7.3. Purple spot and petechia treatment may cause blue-purple bruises in the treatment area,
which may last for five to fifteen days. After the purple spot or petechia
subsides, the skin in this area may turn dark brown, which usually takes
one to three months to subside.
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G.5.7.4. Erythema and edema After treatment, the skin may turn red immediately and/or temporary
swelling occurs. Redness and swelling usually subside within 3 to 7 days.
G.5.7.5. Pigment changes the pigment in the treatment area may change. Most cases of decreased
pigmentation or pigmentation occur in darker-skinned patients or as a
result of exposure to sunlight or other sunburns in the treated area before
or after treatment. For some patients, although measures have been taken
to protect against sunlight, pigmentation will still occur. This
discoloration usually subsides within three to six months, but in some
rare cases (mainly cases of pigment reduction), the pigment change will
last longer or become permanent.
G.5.7.6. There is little chance that scars (such as enlarged hypertrophic scars or swollen crab feet)
will occur. In rare cases, large bulges of abnormal crab foot swelling
scars may appear on the skin with genetic factors. To reduce the chance
of scars, please carefully follow all post-treatment instructions.
G.5.7.7. Infection and inflammation in some cases, inflammation may occur. For example, open
wounds caused by burns or ruptured epidermis may cause infection.
Antibiotic ointment should be used. Some doctors regularly use antibiotic
ointment as a preventive measure after treatment.
G.5.7.8. Itching may occur within 2-4 days after treatment of itchy pigmented lesions and within
one week after tattoo removal. This could last 4-10 days. Scratching
should be avoided.
G.5.7.9. Whitening at the same time of treatment, the upper part of the treated tattoo may turn
white, which indicates that the treatment is effective. This reaction is
usually extremely short and lasts for a few minutes at most.
G.5.7.10. After epidermal protrusion treatment, the upper part of the treated tattoo may protrude,
which usually subsides within a few days, indicating that the treatment is
effective.
G.5.7.11. Microhemorrhage Because the shock wave causes mechanical damage to the local
microvascular system, bleeding may occur from time to time above the
treated tattoo. This condition will only occur during and immediately
after treatment.
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G.5.7.12. Due to the damage to the integrity of epidermis, tissue fluid may ooze above the treated
tattoo; The condition usually subsides within 72 hours.
G.5.7.13. Anaphylaxis in rare cases, when broken/dispersed tattoo ink particles are released into the
lymphatic or circulatory system, immediate or delayed anaphylaxis may
occur. Doctors should prescribe treatment.
G.5.7.14. Tattoo ink deepens part of tattoo material, such as iron oxide or titanium oxide, which may
permanently deepen after exposure to laser energy.
G.5.7.15. Removing partial tattoos in some cases, the treated tattoos cannot be completely removed.
Other modes, such as camouflage, should be used at this time.
Notes
It is recommended that all skin types be tested before the first
treatment, mainly to prevent allergic reactions, scarring and pigment
changes.
G.6.1. Q-Switched Nd: YAG module of M22 platform uses photoacoustic effect
and photothermal action principle, aiming at removing dark tattoos and
treating benign pigmented lesions. During the treatment of these lesions
with phototherapy, tattoo/melanin particles are the main body that
absorbs radiation light, and the light energy will be quickly converted into
heat, causing damage to the target lesions. In addition, the nanosecond
pulse of Q-switched laser will bring acoustic vibration at the target site,
so as to break the particles (which can especially impact the target with
more dense particles). Because of the rapidity and selectivity of the
process, adjacent normal tissues are not affected by these effects, thus
avoiding additional damage.
The Q-Switched Nd: YAG module of M22 can flexibly adjust treatment
parameters according to patient and lesion characteristics to achieve the best
clinical effect. The treatment parameters displayed by the user interface
include:
Dose (energy density) derived from the size of irradiation point.
Pulse frequency (number of pulses per second) matched with the user's
specialty.
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G.6.2. Definition
G.6.2.1. The energy output of Q-switched Nd: YAG laser is constant. Therefore, the energy density
output (dose) measured in joules/square centimeter is larger than that
transmitted through a smaller irradiation point size. The point size is
measured in millimeter diameters (2, 2.5, 3.5, 5 and 6 mm, corresponding
to doses of 14 to 1.6 J/cm2, respectively) and can be set by the operator to
indirectly set the selected dose.
G.6.2.2. There are two pulse frequency modes for pulse parameters: single pulse
frequency mode or repeated pulse frequency mode.
In repetitive mode, the user can select different pulse frequencies, up to 5
Hz.
G.7.1. The following table is used as the criterion for determining the dose at the exposure point:
Size of irradiation Dose [J/cm2]
point [mm]
2 14
2.5 9
3.5 4.6
4 3.5
5 2.25
6 1.6
8 0.9
Notes
Plastic tips (irradiation point sizes 2, 2.5, 3.5 and 5) are
disposable.
Metal tip of gold plate (all irradiation point sizes) is not disposable.
Only the metal tip of the gold plate provides illumination point
sizes of 4, 6 and 8 mm.
G.7.2. Radiation point size criteria for dark lesions, the use of lower doses for
light lesions, the use of higher doses.
Before using irradiation point size 2 (maximum dose), it is
recommended to test at a lower dose before treatment.
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G.7.3. The pulse frequency criterion selects a single pulse when performing tests
or treating small lesions.
When several pulses are needed to treat sensitive parts, the repeated
pulse mode is selected, and the pulse frequency is adjusted according
to convenience and experience.
G.8.1. Evaluation of treatment parameters depends on lesion type and color intensity and skin type.
Therefore, the first step is to estimate the color intensity of lesions (for
tattoos) or lesion type, intensity and depth (for pigmented lesions) and
evaluate skin type.
G.9. Treatment 1. Ensure that patients, operators and anyone in the treatment
room must wear proper safety
Full goggles (see section g.5. 4).
2. Any person performing treatment should wear a program mask and
gloves during the course of treatment (because of possible contact with
body fluids and smoke).
3. Enter the "Treatment" screen. Press the Reset button to reset the
pulse counter.
4. Select the illumination point size and verify that the selected dose is displayed
on the screen.
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7. Touch the treatment site with the treatment tip and apply slight pressure.
The lens assembly is not in contact with the skin due to the tip space.
8. Press the safety switch on the back of the module once. To release
the pulse, the trigger must be pressed within 34 seconds after the
safety switch light is on. The system will charge automatically.
9. Carefully diagnose and look for changes in color or shape of lesions, as well as
changes in skin color.
10. The immediate reaction of tattoo should be whitening, epidermis bulging
and subsequent color change. Sometimes, purple spots appear around the
tattoo line due to the rupture of small blood vessels.
The immediate reaction of pigmented lesions should be discoloration
(usually darkening), followed by small hard scabs and shedding. Both
types of lesions surrounding partial erythema and/or edema may indicate
stimulation of an immune response.
G.9.2. When starting treatment, use a larger irradiation point size and a lower
dose, preferably in the test section
Position, and observe the skin reaction. If there are no signs or adverse
reactions (after removing tattoos)
48 hours), the dose can be gradually increased by changing to a smaller
irradiation point size.
Treat carefully (reduce the dose) in areas with high density near bones, fat
or blood vessels.
Reduce the dose by increasing the size of the dot: when a positive
reaction occurs immediately and skin defects (such as excessive redness
or swelling) occur around the lesion.
If there is no adverse skin reaction and no unsatisfactory changes are
observed in the lesion, gradually increase the dose (decrease the size of
the point).
Notes
Please refer to section G.10 for recommended treatment
presuppositions.
When treating tattoos, it may be accompanied by bleeding and
exudation, so it is necessary to use a disposable therapeutic
head.
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G.10. Lumenis The following table lists the Lumenis default treatment parameters based on the
Default- patient's skin type and underlying condition.
Therapeutic
Parameters
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Dens 2.25 5
Amat e
eur
Thick 4.6 3.5
Dens Not Not
Speci e applica applica
alties ble ble
VI Thick Not Not
applica applica
ble ble
Dens Not Not
Trau e applica applica
ma ble ble
Thick Not Not
applica applica
ble ble
Dens Not Not
Amat e applica applica
eur ble ble
Thick Not Not
applica applica
ble ble
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G.11. The following table lists Lumenis default treatment parameters based on the patient's skin type
and basic condition.
Notes
Unless otherwise specified, the post-treatment maintenance
guidelines refer to the removal of dark tattoos and the treatment of
pigmented lesions.
G.11.1. Summary After treatment, the treatment site should be gently cleaned with disinfectant
immediately.
Immediately after treatment, use a cold compress (non-ice compress) bag to
cool the treatment site to eliminate swelling and relieve discomfort. If the
temperature of chemical cold compress bag is lower than 4 ℃, it is not
recommended. Another way is to soak the 4x4 gauze pad with water in
advance and put it in a small plastic bag or plastic wrap, which can be used
after freezing. Air cooling or any other cooling method can be used.
After the dark tattoo removal treatment:
Patients should be encouraged to drink 8-10 glasses of water every day to
enhance the discharge of ink to the lymphatic system.
In the first five to ten days after treatment, the treatment area should be
carefully maintained to prevent trauma: avoid hot bath, aerobic exercise,
massage, any form of pressing on the treatment site (such as placing a
bag belt), etc.
G.11.2. Ointment or cream use antibiotic ointment (oily ointment is better than water cream
because it will not "stick" tattoos), or a combination of mild steroids
and antibiotic ointment. You can also use Aloe Vera gel or
sunscreen, especially if only mild immediate reactions occur.
G.11.3. The oppression of tattoos should be left to doctors' discretion. It is recommended that
the silicone block be placed in the treatment area, especially the
treatment area to be stretched or stretched, for about 22 hours a
day, at the doctor's discretion, for a minimum of ten days or a
maximum of the whole treatment period. This may help prevent
abnormal crab foot swelling scars from forming in affected patients.
G.11.4. Sunexposed patients should avoid sunlight exposure or use of tanning devices for six
weeks before, during and after treatment. Patients should apply high-
coefficient sunscreen and protect the treatment area from tanning.
After treatment, tanning will increase the formation of melanin,
which may cause pigmentation.
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G.11.5. Cosmetics After treating facial skin lesions, some users allow their patients to use
cosmetics immediately after treatment (provided that the epidermis is
intact). However, they will advise patients to notify their physician
and stop using cosmetics if they have any reaction.
After dark tattoo removal: Some doctors advise their patients to add clothing
to the treated area to reduce the risk of trauma or infection in the first four or
five days after treatment.
G.11.6. Follow-up course the following is Lumenis' suggestion for follow-up course. Doctors should
refer to it and make their own appropriate treatment plan.
Patients should return after 6-10 weeks of tattoo treatment and 2-4 weeks of
pigmented treatment to check the treatment site, and receive additional
treatment if necessary.
If only some lesions are cleared (no adverse reactions), the treatment
should be continued with the same or higher parameters.
If there is no change in the lesion, the dose should be increased.
It is recommended that patients return to visit for follow-up examination after
the last treatment.
G.11.7. Adverse reactions If any adverse reactions occur, the treatment must be discontinued
until the treatment site completely recovers. After the dark tattoo
removal treatment:
If there are signs of dissolution after healing at the treatment site, the
dose should be reduced in the next treatment, and then gradually
increased in the subsequent course of treatment (if appropriate).
If adverse reactions are observed or the lesion does not disappear, the
patient should wait for another four weeks, and then return for
additional examination. If it is noted that the lesion has not completely
disappeared, the treatment should be continued as described above.
If the lesion does not disappear and adverse reactions occur during the
second examination, the physician should decide whether to continue
treatment or stop treatment at his discretion.
G.11.8. End-of-treatment physicians may decide when to end treatment at their discretion, or depending
on the patient's satisfaction with the treatment outcome.
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