User Manual Fotona

MANUFACTURER:
Fotona d.d.
Stegne 7
SI – 1210 Ljubljana, Slovenia
phone: + 386 1 500 91 00
fax: + 386 1 500 92 00
www.fotona.com
OPERATOR MANUAL
Dynamis Line
(SP Dynamis, XS Dynamis, XP Dynamis)
(Fotona SP Plus, Dualis XS, Dualis XP Plus)
Model: M021-4AF/3, M002-2A, M001-12F

85928 CE 4.0
Please note that while every effort has been made to ensure that the data given in this manual is accurate.
The information, figures, illustrations, tables, specifications, and schematics contained herein are subject to
change without notice.
Copyright © 2009 Fotona d.d. Printed in Slovenia. All rights reserved.

The contents of this publication may not be reproduced in any form without the
explicit permission of Fotona d.d.
Page 2/103 85928_OM_Dynamis_Line_CE_4.0.doc

Effective date: 02.02.2010
Foreword
Dear customer,
Thank you for purchasing a Fotona laser system and placing your trust in our brand. We are certain that
your Fotona system will be an asset to your practice and will provide you with significant advantages in
many different areas of your daily work. With over 40 years of experience we have a deep understanding
of today’s modern physicians’ needs and aim to provide laser-based solutions that excel in quality and
reliability.
Fotona medical laser systems have been developed and are manufactured according to the most
stringent international quality and safety requirement and standards. All Fotona laser systems are
authorized to carry the CE mark.
Fotona medical laser systems provide the modern physician with the opportunity to offer their patients
precise, gentle and effective treatments. We believe the following advantages will benefit your practice:
• Greater patient comfort and satisfaction.

• Quicker, more efficient procedures.
• Higher precision and control.
• Superior clinical results.
• New challenges and procedures.
The purpose of this Operator Manual is to provide regulatory required information on particular
characteristics of the laser system and its operation. We strongly recommend carefully reading and
studying the entire content of this manual before attempting to operate the device. Please take note of the
various warnings and notes that are provided to ensure a maximum life-span of your system and to
safeguard the safety of the patient, medical personnel and yourself.
In the event you should have any questions or comments regarding the Fotona laser system, we invite you
to contact us by email at info@fotona.com . Alternatively, we can be contacted through the contact details
provided on the cover page.
To ensure that we can be of optimal service, we kindly recommend registering your Fotona device online
at www.fotona.com .
We hope you will enjoy your Fotona laser system and the added value and advantages it will bring to your
work.
Fotona Sales &

Marketing Department
85928_OM_Dynamis_Line_CE_4.0.doc 3/103
Content
INTRODUCTION AND SYSTEM

SYSTEM CHARACTERISTICS ...............................................9
1.1 GENERAL.............................................................................................................................9
1.2 SYSTEM CHARACTERISTICS ..........................................................................................10
Laser system.........................................................................................................................10
Laser Beam Delivery Unit .....................................................................................................10
Compatible Handpieces for the Er:YAG laser source ...........................................................11
Compatible Scanners for the Er:YAG laser source...............................................................11
Compatible Handpieces for the Nd:YAG laser source ..........................................................12
Compatible Scanners for the Nd:YAG laser source..............................................................12
INDICATIONS
INDICATIONS FOR USE ...................................................................................................13
2.1 INTENDED USE .................................................................................................................13
2.2 INDICATIONS, CONTRA-INDICATIONS AND SIDE EFFECTS .......................................14
Er:YAG Laser Indications ......................................................................................................14
Nd:YAG Laser Indications .....................................................................................................15
SAFETY AND REGULATOR
REGULATORYY COMPLIANCE..............................................................19
COMPLIANCE
3.1 OCULAR PROTECTION ....................................................................................................19
Safety eyewear .....................................................................................................................19
Er:YAG wavelength ...............................................................................................................19
Nd:YAG wavelength ..............................................................................................................19
Aiming beam .........................................................................................................................20
Nominal Ocular Hazard Distance (NOHD)............................................................................20
3.2 ELECTRICAL HAZARDS ...................................................................................................21
3.3 EXPLOSION AND FIRE HAZARDS ...................................................................................21
3.4 PROTECTING NON-TARGET TISSUES...........................................................................22
3.5 SAFETY FEATURES..........................................................................................................22
Emergency-Off Push Button .................................................................................................22
Keylock Switch ......................................................................................................................22
Laser Emission Indicator .......................................................................................................22
Doorswitch Interlock..............................................................................................................23
Protective Housing ................................................................................................................23
Safety Interlocks....................................................................................................................23
Location of Controls ..............................................................................................................23
Safety Shutter........................................................................................................................23
Manual Reset ........................................................................................................................23
Microprocessor Controlled Fault Detection ...........................................................................24
Energy Feedback Control Technology..................................................................................24
3.6 REGULATORY COMPLIANCE ..........................................................................................25
List of standards ....................................................................................................................25
3.7 ELECTRO-MAGNETIC COMPLIANCE STATEMENT.......................................................26
THE LASER SYSTEM IN OPERATION .........................................................................29
4.1 PREPARATIONS FOR USE...............................................................................................29
4.2 FOOTSWITCH AND INTERLOCK CONNECTION............................................................29
4.3 LASER BEAM DELIVERY SYSTEMS AND HANDPIECE CONNECTION ........................30
Er:YAG Laser Beam Delivery System and Handpiece Connection ......................................30
Sterilization of Er:YAG handpieces and beam delivery systems .........................................31
Nd:YAG Laser Beam Delivery System and Handpiece Connection .....................................31
Sterilization of Nd:YAG handpieces and beam delivery systems ........................................32
4.4 ATTACHING AND SETTING UP THE FOTONA S-11 SCANNER ....................................34
4.5 ATTACHING AND SETTING UP THE FOTONA ER:YAG F-RUNNER OR S-RUNNER
SCANNER ................................................................................................................................34
4.6 BALANCING THE ARTICULATED ARM............................................................................35
4.7 SWITCHING THE SYSTEM ON AND OFF........................................................................36
Switching the System On ......................................................................................................36
Switching the System Off ......................................................................................................36
Emergency Off-Switch ..........................................................................................................36
Restarting the System After an Emergency Stop..................................................................36
4.8 WELCOME WINDOW AND LASER TYPE SELECTION...................................................37
Description of the Control Keys.............................................................................................37
Selecting the Laser................................................................................................................37
4.9 ND:YAG OPERATION MODE ............................................................................................38
Nd:YAG Operation Mode Menu ............................................................................................38
Monitoring Total and Procedure Shots Fired.........................................................................38
Nd:YAG QCW Operation mode ............................................................................................39
Nd:YAG Pulse Operation Mode ............................................................................................41
Nd:YAG S-11 Scanner Operation Mode ...............................................................................43
4.10 ER:YAG OPERATION MODE ..........................................................................................47
Initial Er:YAG Screen ............................................................................................................47
Er:YAG Pulse Mode ..............................................................................................................48
Er:YAG F-Runner Operation Mode ......................................................................................56
Er:YAG S-Runner Operation Mode ......................................................................................60
4.11 INTRA-OPERATIVE INSTRUCTIONS .............................................................................65
System READY and STANDBY States.................................................................................65
Storing and Recalling Values from Memory ..........................................................................66
Starting the Treatment...........................................................................................................68
During the Treatment ............................................................................................................68
After the Treatment ...............................................................................................................68
4.12 MOVING THE SYSTEM ...................................................................................................69
4.13 ADVISORY MESSAGES ..................................................................................................69
MAINTENANCE ...................................................................................................................73
5.1 GENERAL ...........................................................................................................................73
Er:YAG Laser (applies to SP/XS Dynamis).........................................................................73
Nd:YAG Laser (applies to SP/XP Dynamis)..........................................................................73
5.2 TROUBLESHOOTING GUIDE ...........................................................................................74
5.3 OPERATOR MAINTENANCE ............................................................................................75
Cleaning the Laser Console External Surface ......................................................................75
Cleaning the Cooling Air Filter...............................................................................................75
Electrical power supply .........................................................................................................76
Water Utilities ........................................................................................................................76
Evacuation (Suction) Utilities.................................................................................................76
Regular Inspection of Laser Safety Related Features ..........................................................77
SPECIFICATIONS ...............................................................................................................79
6.1 LASER: ...............................................................................................................................79
Dynamis Er:YAG laser ..........................................................................................................79
Dynamis Nd:YAG laser .........................................................................................................79
6.2 GENERAL: ..........................................................................................................................79
LABELING .............................................................................................................................79
STORAGE AND SHIPMENT .............................................................................................79
WARRANTY ..........................................................................................................................79
9.1 WARRANTY SHIPMENTS, RETURNS AND ADJUSTMENTS .........................................79
9.2 DECONTAMINATION OF RETURNED EQUIPMENT .......................................................79
ENERGY METERS CALIBRATION PROCEDURE.................................................................79
10.1 ENERGY METER CALIBRATION PROCEDURE FOR THE ER:YAG LASER................79
10.2 ENERGY METER CALIBRATION PROCEDURE FOR THE ND:YAG LASER................79

Table of Figures
Figure 1 Articulated arm and balance. In scanner position (Top) and in handpiece position (Bottom) . 35
Figure 2 Dynamis Welcome Screen with control panel keys................................................................. 37
Figure 3 The Laser Selection Menu....................................................................................................... 37
Figure 4 The Nd:YAG Operation Mode Menu ....................................................................................... 38
Figure 5 Cumulative shots fired ............................................................................................................. 38
Figure 6 The QCW Mode Screen .......................................................................................................... 39
Figure 7 Nd:YAG QCW Mode Personal Settings Screen: custom memory slot renamed to ‘Custom-
#’, the default slot will not have a name.......................................................................................... 40
Figure 8 Cumulative QCW reset screen................................................................................................ 40
Figure 9 Nd:YAG PulseOperation Mode Basic Menu ............................................................................ 41
Figure 10 Nd:YAG Pulse Mode Personal Settings. (Top) for Basic menu ............................................ 42
Figure 11 Display appearance for Nd:YAG S-11 Scanner Operation mode basic menu. ..................... 43
Figure 12 The Nd:YAG Scanner Mode Personal Settings Screen ........................................................ 46
Figure 13 Er:YAG Initial Screen............................................................................................................. 47
Figure 14 Er:YAG Pulse Operation Mode Basic menu in energy mode, mJ displays (top) and fluence
2
mode, J/cm displayed (bottom) ..................................................................................................... 48
Figure 15 Er:YAG Pulse Mode Personal Settings Screen. (Top) default memory slot with fluence
display off (Middle) Custom memory slot named ErPULS2 with fluence display on. (Bottom)
Custom Memory slot named ErPULS2 with fluence ON and Fturbo displayed.............................. 51
Figure 16 Er:YAG Pulse Operation mode Basic menu with DC tissue effect indicator displayed ......... 52
Figure 17 Er:YAG Pulse Mode with Turbo Selected.............................................................................. 54
Figure 18 Er:YAG Pulse mode with smooth mode selected.................................................................. 54
Figure 19 Er:YAG Pulse Operation Mode Ablation and Coagulation Depth Indicator ........................... 55
Figure 20 The Er:YAG F-Runner Scanner Operation Mode Basic Menu .............................................. 56
Figure 21 Er:YAG Pulse Operation Mode Ablation Depth Indicator ...................................................... 57
Figure 22 The Er:YAG F-Runner Personal Settings Screen ................................................................. 57
Figure 23 Typical Representative Scan Pattern F-22 (F-Runner) Er:YAG Scanner.............................. 58
Figure 24 Er:YAG S-Runner Scanner Operation Mode Basic menu Screen......................................... 60
Figure 25 Er:YAG S-Runner Personal Settings Screen ........................................................................ 61
Figure 26 Er:YAG S-Runner Operation Mode Ablation and Coagulation Depth Indicator..................... 62
Figure 27 The S-Runner operation mode screen in V-SMOOTH pulsewidth mode.............................. 62
Figure 28 Adjusting the brightness of the aiming beam ........................................................................ 63
Figure 29 Typical Representative Scan Pattern of the S-22 (S-Runner)............................................... 63
Figure 30 F-Runner Operation mode basic menu with its settings........................................................ 66
Figure 31F Runner Memory Slot Screen (the names of memories on this screen may be other than
shown, they can be edited – customized to suit your applications)................................................ 66
Figure 32 Personal settings screen of ErFrun2 memory settings........Napaka! Zaznamek ni definiran.
Figure 33 Changing the name of the saved settings ............................Napaka! Zaznamek ni definiran.
Figure 34 The changed memory name after saving appears also in F-Runner memories menu ......... 67
1
I N T RO DU CT I O N AN D S YS T E M CH ARACT E RI S T I CS
1.1 General
The Fotona Dynamis laser systems line incorporates treatment lasers that operate
in the invisible near- and mid-infrared ranges of the electromagnetic spectrum,
and an aiming beam laser that operates in the visible range.
The incorporated lasers and their handpieces were developed for soft and hard
tissue surgery and for aesthetic and dermatology procedures. Please refer to
Section 2 for more detailed information on indications for use.
Fotona’s unique Variable Square Pulse (VSP) Technology integrated in the laser
systems allows ultimate control of laser energy and laser pulse length. This
ensures treatment precision, patient comfort, safety and ease-of-use in all
treatments.
There are three different types of laser systems within the Dynamis Line; each
incorporates a different combination of laser sources:
SP Dynamis (Fotona SP Plus):

• Er:YAG laser, with a wavelength of 2940 nm
• Nd:YAG laser, with a wavelength of 1064 nm
XS Dynamis (Dualis XS):
• Er:YAG laser, with a wavelength of 2940 nm
XP Dynamis (Dualis XP Plus):
• Nd:YAG laser with a wavelength of 1064 nm
The aiming laser is a semiconductor diode laser with a wavelength of 650 nm.
Both treatment laser types are pulsed solid-state lasers and generate high-energy
concentrated light, which may cause serious injury if used improperly.
For this reason, the operator must carefully read this manual before attempting to
operate the device.
CAUTION !
Laser systems should be used only by physicians trained
in the operation of laser devices.
CAUTION !
Use of controls, adjustments or performance of
procedures other than those specified herein may result
in hazardous laser radiation exposure.
CAUTION !
Portable and mobile RF communications equipment can
affect medical electrical equipment.
WARNING !
This document is the only source of instructions that can
ensure the safe operation of this laser system. Safe
operation of this laser system depends on full
compliance with these instructions.
1.2 System Characteristics

Laser system
Nd:YAG laser Er:YAG laser

Laser type
(SP and XP Dynamis) (SP and XS Dynamis)
Wavelength 1064 nm 2940 nm
2 2
Max. fluence 600 J/cm 95 J/cm
Max. pulse energy 50 J 3J
Pulse width range 0.1 – 50 ms 0.1 – 1.5 ms
Max. frequency 100 Hz 50 Hz
65 W in PULSE operating 20 W
mode
Max. power
65 W in QCW operating
mode
Laser Beam Delivery Unit
Nd:YAG laser Er:YAG laser

Beam delivery type Fiber-optic 7-mirror articulated arm

1
Compatible Handpieces for the Er:YAG laser source
(Note: Applicable to the SP/XS Dynamis Systems)
Model Description
R-04 Dermatological, straight handpiece, with 5 different spacers for 3, 5,
7, 10 and 12 mm spot sizes. Recommended for skin resurfacing,
removal of skin lesions and scars.
R08 Surgical, straight handpiece, 0.45 mm (0.3 mm) spot size at the
distance indicated by spacer. Recommended for cutting in skin and
mucosa. Special spacer available for hair transplant procedures.
R09-2 Multi-functional, collimated straight handpiece, 4 mm spot size for a
2 to 10 cm distance from the target. Recommended for skin
resurfacing and removal of leukoplakia.
R09-3 Multi-functional, collimated straight handpiece, 5 mm spot size for a
2 to 10 cm distance from the target. Recommended for skin
resurfacing and removal of leukoplakia.
R09-2G Multifunctional, collimated straight handpiece with a tube for
gynaecology. Recommended for the removal of genital warts.
R11 Dermatological, straight handpiece with variable focus, for spotsizes
from 2 to 7 mm. Recommended for skin resurfacing and removal of
skin lesions and scars.
PS01 Dermatological, fractional, straight handpiece, with integrated
adjustable spacer. 5, 7, 10, 12 mm spot sizes. Recommended for
skin resurfacing.
PS02 Dermatological, fractional, straight handpiece, with 5 different
spacers for 3, 5, 7, 10, 12 mm spot sizes. Recommended for skin
resurfacing.
PS03 Dermatological fractional, collimated straight handpiece with variable
spot size adjustment in the range of 2 to 7 mm. Recommended for
skin resurfacing.
Compatible Scanners for the Er:YAG laser source

(Note: Applicable to the SP/XS Dynamis Systems)
Model Description
Er:YAG F-Runner Scanner Model High speed fractal scanner with
F22 0.25 mm pixel size and 12x14 mm scan
area.
Er:YAG S-Runner Scanner Model High speed scanner with 4 mm spot
S22 size and 40x40 mm scan area.
Compatible Handpieces for the Nd:YAG laser source
(Note: Applicable to SP/XP Dynamis systems)
Model Description
R27 Reusable handpiece for laser-assisted lipolysis with 600 µm bare
600 µm Bare fiber. Compatible with QCW operation mode. This handpiece cannot
Fiber be directly selected in the QCW mode screen, instead select the
600 µm fiber. See Nd:YAG QCW Operation mode on page 39 for
details.
R31 Aesthetics and dermatological, straight handpiece with variable
spotsizes from 2 mm to 10 mm. Recommended for permanent hair
reduction, treatment of vascular and pigmented lesions and wrinkle
reduction. Recommended for laser hair removal, photocoagulation,
hemostasis of vascular and pigmented lesions, rosacea, wrinkles,
and acne. Compatible with the PULSE mode of operation.
R33 Aesthetics and dermatological straight handpiece with spot sizes of
2 to 10 mm in 1 mm increments using exchangeable optics.
Recommended for laser hair removal, hemostasis of vascular and
pigmented lesions, rosacea, wrinkles, and acne. Compatible with the
PULSE mode of operation.
Carefully read the respective Handpiece Operator Manuals before attempting to

use the handpieces or contact your Fotona representative for further information
regarding the specific applications and specifications for handpieces.
Compatible Scanners for the Nd:YAG laser source

(Note: Applicable to the SP/XP Dynamis Systems)
Model Description
S-11 Scanner High speed scanner with 3, 6, 9 mm
spot size, adjustable scan patterns and
a maximum scan area of 42 cm².

2
I N DI CAT I O N S F O R U S E
2.1 Intended use

In dermatology and surgery the Er:YAG laser (in the SP Dynamis and XS
Dynamis), and its accessories, are intended for surgical incision/excision,
vaporization and coagulation of soft and hard tissue. All soft tissue is included,
such as skin, subcutaneous tissue, striated and smooth tissue, cartilage meniscus,
muscle, mucous membrane, lymph vessels and nodes, organs and glands.
The Nd:YAG laser (in the SP Dynamis and XP Dynamis), and its accessories, are
indicated for use in surgical and aesthetic applications requiring selective
photothermolysis of target chromophores in soft tissue in the medical specialties of
general and plastic surgery and dermatology.
CAUTION !
Do not treat any suspicious lesion; biopsy (multiple
biopsies) any suspicious lesions.
Consult a specialist for cancer screening before initiating
ablative laser therapy.
WARNING !
Do NOT attempt any laser treatments if the patient shows
clear signs of having hyper-sensitive or abnormally
sensitive skin.
2.2 Indications, Contra-indications and Side effects
Er:YAG Laser Indications
Indications
Dermatology and Plastic Surgery General Surgery Indications:
Indications - Surgical incision/excision
- Epidermal nevi - Vaporization and coagulation of soft
- Telangiectasiae tissue during any general surgery
- Spider veins application where skin incision,
- Actinic sheilitis tissue dissection, excision of lesions,
- Keloids complete or partial resection of
- Verrucae internal organs, lesions, tissue
- Skin tags ablation and vessel coagulation in
- Anal tags necessary.
- Keratoses
- Scar revision Podiatry Indications:
- Decubitis ulcers - Warts
- Skin resurfacing - Plantar verrucae
- Large mosaic verrucae
ENT Surgery Indications: - Matrixectomy
- ENT lesions
- Cysts
- Polyps
- Hyperkeratosis
- Oral leukoplakia
Ophtalmology Indications:
- Soft tissue surrounding the eye and
orbit
- Anterior capsulotomy
Contra-indications (relative and absolute)

• Abnormal scarring • A history that may cause photosensitiviy
• Scarring or infection of treatment area • Pregnancy
• Excessive sun exposure (tanned skin) • Diabetes
• Use of iron supplements or an • Herpes simplex infection in the treatment
anticoagulant therapy area

2
Nd:YAG Laser Indications
PULSE Mode Operation in Dermatology

Indications
• Permanent reduction of unwanted • Reticular veins
hair in Fitzpatrick skin types I-VI • Haemangioma
• Skin rejuvenation • Cherry (senile) angioma
• Non-ablative wrinkle reduction • Rosacea
• Photocoagulation of pigmented • Telangiectatic matting
lesions to reduce lesion size • Verrucae and warts
• Leg veins • Venous lake
• Telangiectasias • Pyogenic granuloma
o Facial
o Nasal
o Truncal
Contra-indications
• History of keloid scarring • Pregnancy
• Scarring or infection of treatment • Irradiation in the region of the
area gonads
• Excessive sun exposure (tanned • Herpes simplex infection in the
skin) treatment area
• Use of iron supplements or an
anticoagulant therapy
• A history of a photosensitivity
disorder or use of photosensitizing
medication
Possible Undesired side effects

• Light redness that may persist for a few days. This can be easily covered by
applying make-up.
• Superficial burns, sometimes with blistering.
• Transient hypo- or hyper-pigmentation
Nd:YAG Laser Indications (continued)
QCW Mode Operation in Endovenous Laser Therapy
Indications
• Varicose veins (with or without • Large tributaries
sapheno-femoral or sapheno- • All veins that are not extremely
popliteal junction insufficience) tortuous
• Truncal varicose veins • Perforator vein insufficiency
• Large branch veins
Contra-indications
• Active thrombophlebitis or DVT • Hypertension
• Infection or inflammation in the • Epilepsy
treatment area • Use of iron supplements or an anti-
• Febrile state coagulant therapy
• Clotting disorders • A history of a photosensitivity
• Diabetes disorder or use of photosensitizing
• Heart or lung disease medication
• Vascular problems (including • Pregnancy
common circulation problems) • Herpes simplex infection in the
treatment area

• Bruising
• Soreness
• Non-specific inflammatory response (thermal effect)
• Skin burn
• Infection
• Oedema
• Discoloration
• Paresthesia
• Erythema
• Vein perforation
• Thrombophlebitis or DVT

2
Nd:YAG Laser indications (continued)
QCW Mode Operation in Laser-Assisted lipolysis
Indication
• Laser-assisted lipolysis
Contra-indications
• Collagen, scarring and connective • Wound heeling disorders
tissue disorders • Epilepsy
• Significant stretch marks • Infection or inflammation in the
• Clotting disorders treatment area
• Lupus • Febrile state
• Diabetes • Use of iron supplements or an anti-
• Heart or lung disease coagulant therapy
• Vascular problems (incl. common • A history of a photosensitivity
circulation problems) disorder or use of photosensitizing
• Endocrine disorders medication
• Hypertension • Pregnancy
• Morbid obesity • Herpes simplex infection in the
treatment area

• Bruising • Discoloration
• Soreness • Paresthesia
• Tenderness • Erythema
• Non-specific inflammatory • Skin thinning
response (thermal effect) • Irregular contour deformities
• Skin burn • Hematoma
• Infection • Fat & tissue necrosis
• Oedema • Pulmonary thromboembolism
• Fat embolism
3
S AF E T Y AN D RE G U L AT O RY CO M P L I AN CE
WARNING !
Severe and/or permanent eye damage may occur.
Never look directly into the treatment or aiming laser

beam or scattered laser light from reflective surfaces.
Never look directly into the laser aperture, optical fiber
tip, articulated arm exit aperture or handpiece exit when
power is applied to the laser, even when laser safety
eyewear is worn.
3.1 Ocular Protection

• Appropriate eye protection (see below) must be worn by the patient and all
operating personnel to prevent inadvertent exposure to the eyes.
• The treatment room door should be kept closed at all times while operating the
laser system.
• Warning signs in prominent places at all entrances to the laser treatment room
should alert all personnel they are entering a controlled area.
• The use of door interlocks that automatically disable the laser, when the
treatment room door is opened, is recommended
Safety eyewear
• Ensure that all personnel wear appropriate safety eyewear whenever the laser
system is switched on.
• Never look directly into the laser beam even when wearing protective eyewear.
• Never allow the laser beam to be directed at anything other than the target
area.
Er:YAG wavelength
Laser safety eyewear is required with Er:YAG 2940 nm wavelength.
The laser safety eyewear recommended for use with the Er:YAG wavelength laser
should the following minimum specification: for 2940 I R 2940 L4 (OD 4).
Nd:YAG wavelength
Laser safety eyewear is required with Nd:YAG 1064 nm wavelength.
The laser safety eyewear recommended for use with the Nd:YAG wavelength
laser should have the following minimum specification: for 1064 I R 1064 L7
(OD 7).
Aiming beam
A low power visible aiming beam is used to aim the treatment beam at the target
tissue. The aiming beam shines coaxial with the treatment beam.
The power of the visible aiming beam, with a wavelength of 650 nm, does not
exceed 1 mW, and therefore additional ocular protection for this laser is not
needed.
Nominal Ocular Hazard Distance (NOHD)

The following table specifies the minimum distances at which laser light emitted
from the Fotona laser systems are not considered harmful (NOHD – Nominal
Ocular Hazard Distance).
Er:YAG Laser
Handpiece Divergence (mrad) NOHD (m)

Articulated arm exit 7 40.7
R04-Ti, R04F 163 1.8
R08 110 2.7
R09-2 (G) 10 29
R09-3 14 20.6
R11 20 14.6
PS01 163 1.8
PS02 163 1.8
PS03 20 14.6
F-Runner scanner 59 1,6
S-Runner scanner 15.6 18.7
Nd:YAG Laser
Handpiece Divergence (mrad) NOHD (m)

Fiber-optic delivery unit 176 178
(945um fiber) - distal end
R31 2- 10mm spot 168 185
R33 – 2mm spot 128.6 242
R33 – 3mm spot 98.6 316
R33 – 4mm spot 90.2 345
R33 – 5mm spot 85.2 365
R33 – 6mm spot 83.6 372
R33 – 7mm spot 85.2 365
R33 – 8mm spot 83.6 372
R33 – 9mm spot 86.8 358
R33 – 10mm spot 90.2 345
600um bare fiber (with or
164 190
without R27 handpiece)
175 178
176 177
S-11 Scanner 3mm spot 55.5 561
S-11 Scanner 6mm spot 31 1004
S-11 Scanner 9mm spot 30.7 1014

3
3.2 Electrical Hazards
WARNING !
Never attempt to open the laser system’s protective
housing due to the realistic risk of being exposed to high
voltage components and excessive laser exposure.
Only qualified service personnel, authorized by Fotona,
should perform work inside the laser system console.
• Fotona strongly recommends that the area around the laser system and
footswitch is kept dry.
• Do not place fluid filled containers on the top of the laser system console.
• Do not operate the laser system if any of the cords are considered faulty or
frayed.
• The laser system should undergo routine inspection and maintenance
according to Fotona’s recommendations and institutional standards.
3.3 Explosion and Fire Hazards
WARNING !
Fire and explosion hazard.
Do not use the laser in the presence of flammables or
explosives, such as volatile anesthetics, alcohol, certain
surgical preparation solutions, and other such
substances.
Do not use the laser system before ensuring that surgical

drapes and gowns made of flame-retardant material and
towels or gauze sponges moistened with a sterile saline
solution or sterile water are available in the operating
field.
WARNING !
Do not use the laser system with the attached fiber-optic
delivery unit, if you cannot see the red aiming beam.
The fiber-optic delivery unit's optical fiber may be
damaged.
Using a damaged fiber may result in accidental laser
exposure to operating room personnel or the patient
and/or may cause fire in the operating room.
3.4 Protecting Non-Target Tissues
WARNING !
The system should always be kept in STANDBY mode
except during actual treatment to minimize the risk of
accidental laser exposure if the footswitch is
inadvertently pressed.
• Before removing the laser-optic delivery unit or the handpiece, always put the
device in STANDBY mode.
• Do not place hands or other objects in the laser beam path.
• Only the operator of the device, directing the laser beam at the target tissue,
should have access to the laser footswitch.
• Use caution pressing the laser footswitch, when it is in proximity to footswitches
for other equipment. Always ensure that the pressed footswitch is the correct
one, to avoid accidental laser exposure.
3.5 Safety Features
Emergency-Off Push Button

The laser system shuts down immediately, when the red emergency-off push
button (located on the front panel) is pressed.
Keylock Switch
The correct key must be inserted into the keylock switch to be able to switch on
the laser system.
The key can only be removed in the vertical OFF position and the laser can only
operate with the key in the horizontal ON position.
To prevent unauthorized use of the laser system, always remove the key from the
keylock switch when the treatment session has been completed.
Laser Emission Indicator

The message “EMISSION” is displayed on the control panel display in READY
mode and during laser operation. Additionally, the red led light in the upper right
hand corner of the READY key will be lit.
An audio signal indicates laser emission when the laser is activated by pressing
the footswitch.

3
Doorswitch Interlock
A remote interlock outlet (doorswitch) is provided to disable the laser system, if the
operating room door has been opened.
When the doorswitch is activated, the laser stops immediately, the shutter closes,
and the system reverts to STANDBY mode.
To resume treatment, the operating room door must be closed and the operator
must press the READY key again.
If the doorswitch interlock plug is removed from the system, the system becomes
inoperable.
Protective Housing
The protective housing of the instrument prevents unintended access/exposure to
laser radiation above Class I limits.
The protective housing can only be opened using special tools and should only be
attempted by qualified service personnel, authorized by Fotona.
Safety Interlocks
The system cannot deliver a treatment beam unless the fiber-optic delivery unit is
properly inserted and attached in its port on the system. If the Nd:YAG fiber-optic
delivery unit is removed from its port on the system, the laser is disabled and the
shutter closes. An advisory message will be shown on the system’s touch screen:
Nd:YAG FIBER NOT ATTACHED.
Location of Controls
All the controls of the laser system are located on the front panel of the device for
easy and safe access during operation. Except for the main power switch and the
wireless footswitch
Safety Shutter
Each treatment laser incorporates a safety shutter of which the positions are
monitored by the system.
The safety shutter for the corresponding treatment laser is open during laser
treatment only.
Manual Reset
If the laser treatment is interrupted externally (for example opening the operating
room doors), the system will stop the laser immediately and revert to STANDBY
mode, the safety shutter will close, and an advisory message will appear on the
system’s touch screen.
To resume laser operation, close the operating room door and press the READY
key.
Microprocessor Controlled Fault Detection
The laser system is a computer-controlled device with several built-in monitoring
and fault detection circuits and procedures.
If the system detects any fault, which it cannot correct, it will immediately disable
the laser, close the safety shutter, block the footswitch and keyboard, and issue an
advisory or system inconsistency message with code on the display. Additionally, it
will switch off the power supply and discharge the energy storing capacitors.
The operator can remedy advisory messages pertaining footswitch, doorswitch,
fiber, overheating coolant related failures.
In case the system is blocked and displays a "System Inconsistency Code XX"
message, immediately notify the technical service.
Energy Feedback Control Technology

The laser system incorporates a sophisticated double channel safety structure for
energy regulation. Each laser pulse is measured and energy is regulated
according to a prescribed algorithm in the microprocessor.
The laser output energy is constantly regulated by a signal from a feedback energy
meter. A second energy meter also monitors the energy of the laser. Should the
readings of both energy meters differ for more than a prescribed value; the system
will shut down, the laser will disable, the safety shutter will close, and an
appropriate inconsistency message will be displayed.

3
3.6 Regulatory Compliance
Systems in the Fotona Dynamis Line fully comply with all the requirements of
MDD 93/42/EEC.
List of standards
The following standards and their requirements as well as regulatory issues have
been used and implemented in the Fotona laser systems:
IEC 60601-1 Ed 2.0/1988+A1:1991+A2:1995
- Medical electrical equipment
Part 1: General requirements for safety
IEC 60601-1-2 Ed 2.1/2004

Part 1: General requirements for safety.
Part 2: Collateral standard: Electromagnetic compatibility – Requirements and
tests.
IEC 60601-1-4 Ed 1.1/2000

Part 1: General requirements for safety.
Part 4: Collateral standard: Programmable electric medical systems.
IEC 60601-2-22 Ed 2.0/1995

Part 2: Particular requirements for safety diagnostic and therapeutic laser
equipment.
IEC 60825-1/2007
- Safety of laser products.
Part 1: Equipment classification, requirements and user′s guide.
ISO 14971/2000
- Medical devices – application of risk management to medical devices
3.7 Electro-Magnetic Compliance Statement
The medical/electrical equipment present in Dynamis Line laser systems requires
that special precautions be taken in regard to EMC. Every system should be
installed and put into service according to the EMC information provided below.
ELECTROMAGNETIC EMISSION
Emission Test Compliance Electromagnetic Environment - Guidance
RF emissions Group 1 Every Dynamis Line laser system uses RF energy only for its
CISPR 11 internal function. Therefore the RF emissions are very low
and are not likely to cause any interference in nearby
equipment.
RF emissions Class B Every Dynamis Line laser system is suitable for use in all
CISPR 11 establishments, including domestic establishments and those
Harmonic emissions N/A directly connected to the public low-voltage power supply
IEC 61000-3-2 network that supplies buildings used for domestic purposes.
Voltage fluctuations / flicker N/A
emissions
IEC 61000-3-3
ELECTROMAGNETIC IMMUNITY
Immunity test IE 61000 test level Compliance level Electromagnetic Environment - Guidance
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. If floors
discharge are covered with synthetic material, the relative humidity
(ESD) ± 8 kV air ± 8 kV air should be at least 30%.
IEC 61000-4-2
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be that of a typical
transient/burst supply lines supply lines commercial hospital environment.
IEC 61000-4-4 ± 1 kV for input / ± 1 kV for input /

output lines output lines
Surge ± 1 kV differential ± 1 kV differential Mains power quality should be that of a typical
mode mode commercial hospital environment.
± 2 kV common ± 2 kV common
mode mode
Voltage dips, <5% UT <5% UT Mains power quality should be that of a typical
short (>95% dip in UT) (>95% dip in UT) commercial hospital environment.
interruptions for 0.5 cycle for 0.5 cycle If the operator of the Dynamis line laser system requires
and voltage continuous operation during power mains interruption, it
variations on 40% UT 40% UT is recommended that the system be powered from an
power supply (60% dip in UT) (60% dip in UT) uninterruptible power supply or battery.
input lines for 5 cycles for 5 cycles
IEC 61000-4-11 70% UT 70% UT

(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles
<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
NOTE UT is the ac mains voltage prior to application of the test level

3
ELECTROMAGNETIC IMMUNITY
Immunity test IE 61000 test level Compliance level Electromagnetic Environment - Guidance
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications equipment
150 kHz to 80 MHz 150 kHz to 80 MHz should be used no closer to any part of the Dynamis
IEC 61000-4-6 Line laser systems, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Radiated RF 3 V/m 3 V/m Recommended separation distance

80 MHz to 2.5 GHz 80 MHz to 1.5 GHz d = (3.5/V1)√P
IEC 61000-4-3
d = (3.5/E1)√P 80 MHz to 800 MHz
d = (3.5/E1)√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m)
Field strength from fixed RF transmitters, as determined
by an electromagnetic survey,a should be less than the
compliance level in each frequency range. b
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHZ, the higher frequency range applies.
NOTE 2:These guidelines not apply in all situations. Electromagnetic propagation is affected by absorption, reflection
from structures, objects and people.
a
Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If measured field strength in the location in which the above mentioned Fotona laser systems are used
exceeds the applicable RF compliance level above, the laser systems should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the laser
device.
b Over the frequency range 150 kHz to 80 MHz, field strength should be less then (V1) V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS

EQUIPMENT AND THE FOTONA LASER SYSTEMS
Dynamis Line laser systems are intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The operator can prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communication equipment (transmitters) and the laser system as recommended bellow,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter
power of transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d=(3.5/V1)√P d=(3.5/E1)√P d=(7/E1)√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3
10 3.7 3.7 7.4
100 12 12 23
For transmitters rated at maximum output power not listed above, the recommended separation distance d is meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures objects and people.
4
TH E L A SER SY STEM IN O PER A TIO N
WARNING !
After unpacking, and before installing and operating the
laser system, it should be brought to normal room
temperature (above dew point), for at least 4 hours, in a
thermally stabile environment (above 18ºC).
This is especially important when moving the laser system
into the laser room from outdoors when outside temperatures
are low.
4.1 Preparations for Use

• Inspect and assure yourself that the device’s cooling air inlet and outlet are
not blocked or hindered in any way, for efficient cooling.
The device should be placed in the laser treatment room so that a minimum
1 meter distance is left between the rear side of the device and any obstacle
(e.g. wall, other devices, etc.).
• Inspect and assure yourself that the device’s power cord is properly inserted
in the mains electrical supply outlet.
• Inspect and assure yourself that the main switch (located at the rear of the
device) is switched off.
• Verify that the mains electrical power supply is switched on.
4.2 Footswitch and Interlock Connection

• Connect the footswitch connector to its respective port at the rear of the
device.
If the footswitch is not properly connected, an advisory message appears on
the system’s touch screen after switching on the system.
The message will remain on-screen and the laser will remain inoperable, until
the footswitch is properly connected.
• A remote interlock plug is supplied with the laser system.
If the plug is removed, the laser will not operate and an advisory message
appears on the system’s touch screen after switching on the system.
To set up a doorswitch interlock connection in the laser procedure room, please

consult your dealer for assistance.
The doorswitch interlock port, designated as "DOORSWITCH", is located at the
rear of the device. When properly set-up, the interlock will disable laser operation
immediately, if the laser procedure room door is opened. The system closes the
safety shutter, and reverts to STANDBY mode. An advisory message appears on
the system’s touch screen. To resume operation, close the laser procedure room
door and press the READY key.
4.3 Laser Beam Delivery Systems and Handpiece Connection
CAUTION !
Since the aiming beam passes down the same laser beam
delivery systems as the treatment beam it provides a good
method of checking the integrity of the laser beam delivery
system.
If in READY mode, the aiming beam spot is not visible at the

distal end of the delivery unit, its intensity is reduced or it
appears diffused, then this could be an indication of damage
to the laser delivery system.
Er:YAG Laser Beam Delivery System and Handpiece

Connection
(Note: Applies to XS and SP Dynamis only)
The laser system is equipped with a 7-mirror articulated arm, which is permanently
attached to the laser system.
The articulated arm must be attached and aligned during installation of the
laser system onsite. Only skilled and trained personnel, authorized by
Fotona, may perform the attachment and alignment procedure. Contact
Fotona or your local Fotona representative to obtain a list of qualified and
Fotona authorized service personnel.
A variety of handpieces can be attached to the articulated arm (see the list of
compatible handpieces in the “Specifications” section).
WARNING !
Do not switch on the laser system without attaching a
handpiece to the articulated arm.
WARNING !
Carefully inspect the Er:YAG handpiece for any eventual
damage before attaching it to the articulated arm.
The exit window and the proximal input lens must be
clean.
Do not use a damaged handpiece. This may result in
accidental fracture of the lens or exit window, lead to
excessive laser exposure to the operating room
personnel and/or patient, and cause fire in the operating
room.

4
Before switching the system on, select and attach the most appropriate handpiece
considering the intended therapeutic application.
Follow the instructions contained in the handpiece’s Operator Manual to assemble
and connect the handpiece before use. Additionally, follow the instructions to set the
handpiece type on the control panel before use (see the "Selecting the Laser
Treatment Parameters" section).
NOTE
The balancing weight located on the arm should be readjusted for each handpiece type.
To adjust arm balance, turn the adjusting knob under the balancing weight. The articulated
arm is balanced differently for the scanner and the handpiece. For instructions refer the
section Balancing the articulated arm below.
Sterilization of Er:YAG handpieces and beam delivery systems
When delivered the handpieces, the F-Runner and S-Runner scanners are non-
sterile.
CAUTION !
Note that the supplied handpieces and Scanners are not
sterile.
They should be sterilized before use according to the
instructions in the handpiece’s and corresponding
Scanner Operator Manual.
Nd:YAG Laser Beam Delivery System and Handpiece Connection

(Note: Applies to XP and SP Dynamis only)
The Nd:YAG laser incorporated into the laser systems can be coupled to different
fiber-optic delivery units with different fiber diameters. Each fiber-optic delivery unit
has a SMA905 fiber connector at its proximal end.
Before switching the system on, select and attach the most appropriate handpiece
considering the intended therapeutic application.
Before switching on the system, make sure that the fiber-optic delivery unit is
properly attached to the fiber-coupling port on the system console. The laser system
automatically detects if the fiber is properly attached. The laser system disables the
laser and displays an advisory message in the event that a fiber is not inserted and
attached in the fiber-coupling port.
CAUTION !
Fibers used with the R27 handpiece for endovenous

treatments and bare fibers used for lipolysis treatments
are single use fibers delivered in sterile condition. Please
follow the instructions in R27 handpiece operator manual
as well as application notes for handling the sterile fibers
for endovenous and lipolysis treatments.
The fiber-optic delivery units for handpieces R31, R33
and the S11 Scanners should NOT be sterilized.
Sterilization of Nd:YAG handpieces and beam delivery systems

• For Endovenous applications:
Endovenous application are performed with 600 µm bare single-use
sterile fibers without any handpiece
WARNING!
Use proper aseptic technique when removing single-use
600 µm sterile fibers from their original sterile packaging.
Do not reprocess fibers that are intended for single-use!
• For laser lipolysis applications:

Laser lipolysis is performed with the reusable R27 handpiece and a
600 µm bare single-use sterile fiber. The supplied handpiece is not sterile.
To sterilize the reusable R27 handpiece follow the instruction in the R27
handpiece operator manual
CAUTION
Note that the R27 handpiece is not sterile. It should be
sterilized before use according to the instructions in the
handpiece’s Operator Manual. Reprocess the handpiece
in accordance with the instructions given in the
handpiece operator manual

4
WARNING
Use proper aseptic technique when removing single-use
600 µm fibers from their original sterile packaging. Also
use proper aseptic technique when removing the R27
handpiece from its sterilization pouch after sterilization.
Do not reprocess the 600 µm fibers that are intended for
single-use.
Assemble the fiber-optic beam delivery unit with the handpiece according to the
handpiece’s Operator Manual.
Following the assembly, follow the instructions in this manual to select the laser
beam delivery type.
CAUTION !
The distal ends of sterile fiber-optic delivery units for
endovenous and laser lipolysis applications are bare
optical fibers.
The red aiming beam emerging from the distal fiber end
should be a regular, homogenous illuminated circular
shape.
Do not use the fiber-optic delivery unit if the red aiming
beam is not visible.
CAUTION !
The fiber optic beam delivery unit used for R31, R33
handpieces and S11 Nd:YAG Scanner should be handled
in accordance with instructions in respective handpiece
operator manual.
Since the aiming beam passes down the same laser
beam delivery systems as the treatment beam it provides
a good method of checking the integrity of the laser
beam delivery system.
If the aiming beam spot is not visible at the distal end of
the delivery unit, its intensity is reduced or it appears
diffused, then this could be an indication of damage to
the laser delivery system.
Assemble the fiber-optic delivery unit with the handpiece according to the
handpiece’s Operator Manual.
Do not kink, step on, pull or catch the fiber on any equipment.
Any damage to the fiber beam delivery unit can cause accidental laser exposure to
operating room personnel and/or the patient or may cause fire in the operating
room.
Follow the instructions to select the laser beam delivery type (see the "Selecting the
Laser Treatment Parameters" section).
4.4 Attaching and Setting Up the Fotona S-11 Scanner
Carefully read the Operator Manual for the Fotona S-11 Scanner before attaching
the scanner to the host Fotona XP/SP Dynamis laser system.
1. Detach the fiber-optic beam delivery system used for the Nd:YAG single or
multi spot handpieces.
2. Attach the scanner fiber-optic beam delivery system to the fiber-coupling
port.
3. Attach the scanner electrical connector to the Nd:YAG scanner port on the
Fotona XP/SP Dynamis front panel.
4. Attach the optics for a 3, 6, or 9 mm spot size to the Fotona S-11 scanner
according to the instructions in the Fotona S-11 scanner Operator Manual.
5. To correctly set the operating parameters see section Nd:YAG S-11
Scanner Operation Mode on page 43.
NOTE
When using the Fotona S-11 scanner, three different spot sizes can be selected: 3mm,
6mm and 9mm.
Attach the optics for the desired spot size to the Fotona S-11 scanner head. The laser
system automatically recognizes the attached spot size optics and displays the selection
on the system’s display. The displayed fluences will then correspond with the selected
spot size.
4.5 Attaching and Setting Up the Fotona Er:YAG F-Runner or S-Runner

Scanner
Carefully read the Operator Manuals of the Fotona F-Runner and S-Runner
Scanner before attaching the scanner to the host Fotona SP/XS Dynamis laser
system.
1. Attach the optical input of the scanner to the optical output of the
SP/XS Dynamis articulated arm by screwing the two together.
2. Attach the scanner cable to the Er:YAG scanner port on the Fotona
SP/XS Dynamis front panel and to the scanner connector on the scanner
body.
3. To correctly set the parameters refer to section Er:YAG F-Runner
Operation Mode on page 56 for the F-Runner and to section Er:YAG S-
Runner Operation Mode on page 60 for the S-Runner scanner.
CAUTION
The system should be in Er:YAG laser operation modes
menu while attaching the F-Runner or S-Runner scanner to
the laser system.

4
4.6 Balancing the Articulated Arm
The articulated arm can be balanced and adjusted according to user preference.
The articulated arm weight pivot has an orange spot and a black screw counter
balance adjustment. The articulated arm balance weight has two orange spots -
one for balancing the handpiece the other for balancing the scanner.
When using a handpiece rotate the balance weight so that the white part of the
balancing weight is closer to the articulated arm holder and align the orange spot
on the weight with the orange spot on articulated arm (as in Figure 1 Bottom),
when using a scanner rotate the weight 180 degrees (as in Figure 1 Top). The
black counter balance screw can be adjusted according to user preference.
Figure 1 Articulated arm and balance. In scanner position (Top) and in handpiece position
(Bottom)
4.7 Switching the System On and Off
Switching the System On
• Inspect and verify that the "Laser in Use" warning sign has been switched on
outside the treatment room.
• All personnel present in the treatment room must wear appropriate laser safety
eyewear (see the "Ocular Protection" section).
• Switch on the main power switch located at the rear of the device. The welcome
screen with Fotona logo appears on the system’s touch screen.
• Insert the key in the keylock switch and turn it to the horizontal ON position. An
advisory message will appear indicating the status of the system’s self test
procedure. During the self test procedure the system checks the complete device
for proper operation.
After completing the self test, the system enters the Laser selection menu.
If during the system self test any inconsistencies are encountered, an advisory
message or a system inconsistency message with code will appear on the system’s
touch screen. Please refer to the "Troubleshooting" section and/or “Advisory
Messages” section for more information.
Switching the System Off

• If the laser system is in READY mode, indicated by a red led light in the top right
corner of the READY key, press the STANDBY key on the control panel to put
the system into STANDBY mode.
NOTE
The laser system automatically reverts to STANDBY mode after 3 minutes without any
action in READY mode.
• When the system is in STANDBY mode, turn the key in the key-lock switch to the
vertical OFF position.
• Remove the key to prevent unauthorized use of the laser system.
• Switch off the main switch.
Emergency Off-Switch
To switch off the laser system in an emergency situation:
• Press the Emergency Stop push button (located on the front panel of the device).
• The message "EMERGENCY STOP" will appear on the system’s touch screen.
• Turn the key in the keylock switch to the vertical OFF position and switch off the
main switch.
Restarting the System After an Emergency Stop

To restart the laser system:
• Wait at least 1 minute after having performed an Emergency Off procedure.
• Rotate the Emergency Stop push button to the left to release.
• Switch on the main switch.

4
4.8 Welcome Window and Laser Type Selection
The welcome window appears on the system’s screen after the laser system has
completed the selftest during the start-up procedure: the laser system logo will be
written on the display for a short time.
Figure 2 Dynamis Welcome Screen with control panel keys
Description of the Control Keys

The laser system control panel (Figure 2) consists of 8 soft keys: 4 along each side
of the display; and 6 keys below the display. The soft keys next to the display allow
for the selection of of menu items that appear next to them in the display. For
convenience the keys are referred to throughout this manual as soft
key (K1) through (K8) as labeled in Figure 2. The Store key is used to store laser
parameters for later recall (see section Storing and Recalling Values from Memory
on page 66). The Plus and Minus keys are used to increase and decrease of
parameters appearing on the display. The Standby key is used to put the laser into
STANDBY state. In STANDBY state the laser will not fire and its safety shutter will
be closed. The Back key can be used at any time to return to the previous screen.
Selecting the Laser

After start-up and self test the system enters the laser selection menu shown on
Figure 3.
Figure 3 The Laser Selection Menu
In the The Laser Selection Menu the Er:YAG soft key (K3) and the Nd:YAG soft
key (K7) are displayed. Choose the laser type you wish to work with by pressing the
soft touch window key. Descriptions of the operating modes are presented in the
sections that follow.
4.9 ND:YAG Operation Mode
Nd:YAG Operation Mode Menu
Figure 4 The Nd:YAG Operation Mode Menu
If the Nd:YAG Laser was selected from the Laser selection menu (Figure 3) then
the Nd:YAG Operation Mode menu will appear (Figure 4). Five menu items will be
displayed, selecting them causes the following:
- Pulse (K2): Enters Pulse operating mode. See section Nd:YAG Pulse Operation
Mode, on pg. 41 for more details.
- QCW (K3): Enters Quasi Continuous Wave Operation mode. See section
Nd:YAG QCW Operation mode page 39 for more details.
- Scanner (K6): Enters Scanner Operation mode, in which the Fotona Nd:YAG
Scanner can be used. See section Nd:YAG S-11 Scanner Operation Mode on
page 43.
- Statistics (K4): Displays a procedure and total laser pulse counter status for
Nd:YAG laser (see section Monitoring Total and Procedure Shots Fired below).
- Sleep (K8): Puts the laser into Sleep mode (energy saving mode).
Monitoring Total and Procedure Shots Fired

If the Statistics soft key was selected from the Nd:YAG Operation Mode menu
(Figure 4) the Nd laser shots screen will appear (
Figure 5).
The total number of shots fired by the Nd:YAG laser since the last flashlamp
replacement is recorded on the Nd laser shots screen next to the label Total. There
is also a resetable counter that can be used to track shots fired during a laser
procedure or over an arbitrary length of time: it appears next to the label Procedure.
To reset this counter press the ClearProcedure soft key (K8). This procedure will
not reset the total number of shots.
Figure 5 Cumulative shots fired

4
Nd:YAG QCW Operation mode
Figure 6 The QCW Mode Screen

To fire a continuous stream of Nd:YAG laser pulses use Nd:YAG QCW mode.
If the QCW soft key was selected from the Nd:YAG Operation Mode menu (Figure
4) the QCW Operation Mode Basic menu will appear (Figure 6).
Properly setting QCW parameters
Because of the interactions between parameters the following standardized method

is recommended for setting the parameters of QCW Mode. After pressing each soft
key adjust the selected parameter with the Plus and Minus keys on the control panel
keyboard
1. If the parameters you wish to use have been stored in memories press the
M soft key (K1) select the saved parameters as described in section
Storing and Recalling Values from Memory and skip to step 9.
2. Adjust the aiming (pilot) beam intensity appropriately by selecting the P soft
key (K5) and following the steps in section Nd:YAG QCW Operation mode
Personal Settings on page 40.
3. Select the fiber type using soft key (K6).
4. Select the pulsewidth (ms) using soft key (K7)
5. Select the power (W) using soft key (K2)
6. Select the frequency (Hz) using soft key (K3)
7. Select the treatment time (seconds) using soft key (K4). When operating at
low Hz this setting may not be available.
8. The settings can be stored by pressing the Store Key. For details see
section Storing and Recalling Values from Memory on page 66.
9. Press the Ready Key to ready the laser.
10. The system will prompt you to confirm any values that changed
automatically or the fiber type, when all values have been confirmed, press
the Ready Key again.
11. The cumulative energy (J) output during treatment can be monitored with
soft key (K8). See section Monitoring and reset of the Cumulative Energy
output in QCW mode below for more details.
12. Fire the laser by depressing and holding the footswitch: the laser will fire
continuously. An *E* (which stands for emission) will appear in the center of
the screen indicating that the laser is firing.
When changing the parameters in QCW mode, be aware of the following:
- Any automatically changed parameters will flash on the system display when
the Ready Key is pressed. The system will request confirmation of these
automatically changed parameters.
- When the fiber size is changed, the power, frequency as well as pulsewidth
settings may automatically change.
- When the pulsewidth setting is changed the power and frequency settings
may automatically change.
- When the power setting is changed the frequency setting may automatically
change.
- The available frequency range depends on the previously selected power
setting.
- Treatment time selection is not available for frequency settings under 10 Hz.
The cumulative energy is calculated and displayed at all times while the
footswitch is pressed.
Nd:YAG QCW Operation mode Personal Settings
Figure 7 Nd:YAG QCW Mode Personal Settings Screen: custom memory slot renamed to
‘Custom-#’, the default slot will not have a name.
To change the pilot light brightness use the Nd:YAG QCW Mode Personal
Settings Screen, shown in Figure 7. This screen will appear if the P soft key was
selected from The QCW Mode Screen shown in Figure 6. To brighten or darken
the pilot light select the plus soft key (K2) or the minus soft key (K5).
Monitoring and reset of the Cumulative Energy output in QCW mode

The cumulative energy that has been delivered in QCW mode is calculated and
displayed on the control panel in units of Joules.
Figure 8 Cumulative QCW reset screen

To reset the cumulative energy counter press the soft key (K8).
Then select the YES soft key (K2) to clear the cumulative energy delivered
during QCW mode; select the NO soft key (K6) to return to the previous screen
without erasing the cumulative energy.

4
Nd:YAG Pulse Operation Mode
Figure 9 Nd:YAG PulseOperation Mode Basic Menu

If the Pulse soft key was selected from the Nd:YAG Operation Mode menu
(Figure 4) the Nd:YAG PulseOperation Mode Basic Menu will appear (Figure
9).
Properly setting Pulse Mode parameters
The Plus and Minus keys on the control panel are used to change the
parameters. To properly set the pulse mode parameters follow these steps:
1. If the parameters you wish to use have been stored in memory press
the M soft key (K1) select the appropriate memory slot as described in
section Storing and Recalling Values from Memory on page 66 and
skip to step 6.
2. Adjust the pilot beam appropriately by selecting the P soft key (K5)
and following the steps given in section Nd:YAG Pulse Operation Mode
Personal Settings below.
3. Select the handpiece by pressing soft key (K2).
4. Select the spotsize (mm) by pressing soft key (K7).
5. Select the fluence (J/cm²) by pressing soft key (K3).
6. Select the frequency (Hz) by pressing soft key (K4).
7. The settings can be stored by pressing the Store Key. See section
Storing and Recalling Values from Memory on page 66 for details.
8. Select the Ready key.
9. You will be asked to confirm the spotsize and the values of the other
parameters. After insuring that the selected spotsize is equivalent to
the handpiece spotsize and after reviewing all other parameters press
the Ready key again.
10. The system will calibrate the laser for selected parameters and enter
the READY state indicated by emission mnemonics *E* in the center of
the screen as well as a red aiming beam emerging from the handpiece
or fiber selected.
Be aware of the following things when changing the pulse mode parameters:
- Any automatically changed parameters will flash on the system display
when the Ready Key is pressed. The system will request confirmation of
these automatically changed parameters.
- When the spotsize is changed, the fluence and frequency settings may
automatically change.
- When the pulsewidth is changed, the fluence and frequency settings may
- When the fluence is changed, the frequency settings may automatically
change.
Nd:YAG Pulse Operation Mode Personal Settings
Figure 10 Nd:YAG Pulse Mode Personal Settings. (Top) for Basic menu
(Bottom) Personal settings in a custom memory slot named ‘Custom-#’.
To change the intensity of the pilot beam select the Minus soft key (K3) or the
Plus soft key (K7). Press the Back key to return to the previous screen. To
change the name of a custom memory slot, as in Figure 10 (Bottom), refer to
section Storing and Recalling Values from Memory pg 66.

4
Nd:YAG S-11 Scanner Operation Mode
Figure 11 Display appearance for Nd:YAG S-11 Scanner

Operation mode basic menu.
To apply Nd:YAG laser shots in a pattern across a rectangular region use the
Nd:YAG scanner mode together with the S-11 scanner.
If the SCANNER soft key was selected from the Nd:YAG Operation Mode Screen
(Figure 4) the Mode Screen will appear (similar to Figure 11).
Properly setting Scan Mode parameters
The Plus and Minus keys are used to change the parameters. To properly use
the scanner mode take the following steps:
1. Setup and connect the scanner to the system according to the instructions
in section 4.4 Attaching and Setting Up the Fotona S-11 Scanner of this
manual and in the scanner operator manual.
2. Select the SCANNER soft key from the Nd:YAG operation mode screen.
The scanner self test will run, if an error message occurs refer to the
scanner operator manual.
3. If the settings you wish to use for the currently attached Scanner spot size
have been stored in memory press the M soft key (K1) select the saved
memory as described in section Storing and Recalling Values from
Memory on page 66 and skip to step 9.
NOTE:
If different spot size than attached to the Nd:YAG scanner is to be used return to
Nd:YAG Operation Mode menu, detach the current spot size optics, attach the
desired spot size optics to the scanner and enter the Nd:YAG Scanner operation
mode and follow step 3.
4. Adjust the personal settings by selecting the P soft key (K5) and following
the steps in the section Adjusting the Nd:YAG Scanner Mode Personal
Settings below.
5. Since the Nd:YAG Scanner spotsize is automatically recognized by the
scanner and displayed on the control panel display it cannot be selected
through the corresponding soft key.
6. Select the fluence (J/cm²) by pressing soft key (K3).
7. The overlap is adjusted on the scanner itself (see the note below)
8. Select the scan pattern by pressing soft key (K6), see section Nd:YAG S-
11 Scanning Patterns below for a description of each scan pattern.
9. Select the pulsewidth by pressing soft key (K8).
10. Change the autorepeat settings by selecting the P soft key (K5) and
following the directions in section Autorepeat Functionality below.
Press the Ready key. The system will prompt you to check any
parameter settings that were changed automatically.
11. If all of the parameters are correct press the Ready key again. The scan
size should be outlined in red.
12. Change of scan size is performed by the joystick on the scanner. For
details see Operation Manual of S11 Nd:YAG Scanner.
13. Fire off one scan by depressing the Footswitch. To fire off more than
one scan depress and hold the Footswitch; to adjust the time for
repositioning the scanner after each complete scan to a new position
(Autorepeat time) see section Autorepeat Functionality below.
14. The settings can be stored by pressing the Store Key. For details see
section Storing and Recalling Values from Memory on page 66.
NOTE
The Overlap parameter is not shown on the display of the system but on the S11
scanner control panel. Please refer to S11 Scanner operator manual for details on
overlap selection.
If scanner overlap control has been enabled through the personal settings then the
density can be selected using the joystick on the scanner. The overlap between
adjacent spot sizes is a measure of scanning density, the following overlap can be
selected: 13%, 20%, or 30%. Please refer to the scanner operator manual for details.
If the scanner overlap control is disabled in the personal settings menu the overlap is
fixed to current setting on the scanner and cannot be changed with the joystick on
the scanner.
Be aware of the following things when changing the Nd:YAG Scanner Operation
mode parameters:
- Any automatically changed parameters will flash on the system display when
the Ready Key is pressed. The system will request confirmation of these
automatically changed parameters.
change.
CAUTION !
If the 3mm, 6mm or 9mm inlet optics are not properly
inserted into the S-11 Scanner the system displays an
advisory message to check the inlet optics. This
message will be displayed until the inlet optics have
been properly inserted. Pressing any key on the
keyboard while this advisory message is displayed will
force the system to revert to the Nd:YAG Operation
mode menu.

4
Nd:YAG S-11 Scanning Patterns
Sequential Scanning Pattern
The SE or SEquential scanning sequence performs a single, uninterrupted, line-by-

line scan across the entire scan area. This scanning sequence is useful when the
practitioner wants to cover a smaller scan area than the entire scan area, without
changing the scan area size during the treatment.
Optimal Scanning Pattern

The OP or OPtimal scanning sequence performs a scan across the entire scan area
chosen by the practitioner in which neighboring and successive spot deposition is
avoided. The complete scanning sequence is completed in four passes across the
entire scan area. The OP scanning sequence is recommended for performing
scanner treatments that require high fluence levels be delivered to the skin at high
repetition rates.
Partial Scanning Pattern

The PR or PaRtial scanning sequence is based on the same non-successive spot
deposition principles as the OP scanning sequence with the addition of an Autorepeat
time between successive passes. Autorepeat time is a variable, configurable pause
that can be set by the practitioner in the P soft key (K5). The Autorepeat time pauses
provide additional cooling in the treatment site, which make the PR scanning
sequence particularly useful when treating patients with a low pain threshold.
Autorepeat Functionality
Between each complete scans, during the Autorepeat pause, a temporary outlining
shape will be visible, indicating the Autorepeat pause. The Autorepeat pause outline
is shown as follows:
During this Autorepeat time the scanner has to be moved to next position.
Between each pass in PR scanning sequence during the Atoprepeat time the outline
shown below will appear.
To adjust the length of the autorepeat pause adjust the Autorepeat in Personal
settings soft key (K5) on the NdScanner Screen (see Figure 11); the length of the
pause ranges from 0.5 to 3.0 seconds. When all four passes are finished in PR
scanning sequence the outlining shape will again be visible in the following shape:
Please note that the Autorepeat time between each pass in PR scanning sequence is
equal to Atorepeat time between consecutive complete scans.
Adjusting the Nd:YAG Scanner Mode Personal Settings
Figure 12 The Nd:YAG Scanner Mode Personal Settings Screen
Use the Nd:YAG Scanner Mode Personal Settings to change the Pilot light
brightness with soft key (K1), change the Autorepetion rate with soft key (K2),
enable overlap with soft key (K3).
WARNING !
If, in READY mode, the red aiming beam does not outline
the selected scanning pattern, DO NOT use the scanner.
Contact technical service immediately!

4
4.10 Er:YAG Operation Mode
Initial Er:YAG Operation Modes Menu Screen
Figure 13 Er:YAG Initial Screen
If the Er:YAG soft key was selected from the Laser Type Selection Screen
(Figure 3) then the Er:YAG Initial Screen will appear (Figure 13). Five menu
items will be displayed, selecting them causes the following:
- Pulse (K2): Enters pulse operating mode, in which the laser fires a
stream of discrete pulses.
- Statistics (K4): Displays the procedure laser shot counter and total laser
shot counter
- S-runner (K6): Enters the S-runner Scanner Operation mode
- F-runner (K7): Enters the F-runner Scanner Operation mode
- Sleep (K8): Puts system in sleep mode (energy saving mode) - press the
READY key to go out of sleep mode.
WARNING !
If the red aiming beam is not visible in ready mode, do

not use the laser system.
The articulated arm beam delivery unit or optical
handpiece may be damaged.
Using a damaged beam delivery unit or handpiece may result
in accidental laser exposure to the operating room personnel
or the patient and/or may cause fire in the operating room.
Er:YAG Pulse Operation Mode
To fire a stream of individual Er:YAG laser pulses while manually controlling
the spot deposition pattern use Er:YAG Pulse Mode.
Figure 14 Er:YAG Pulse Operation Mode Basic menu in

2
energy mode, mJ displays (top) and fluence mode, J/cm
displayed (bottom)
If the Pulse soft key was selected from the Er:YAG Operation Mode Menu
Screen (Figure 4) the Er:YAG PulseOperation ModeBasic Menu will appear
(Figure 14).
Soft key (K3) will shown either energy (J) or fluence (J/cm²) depending upon
the saved Personal settings (see section Er:YAG Pulse Operation Mode
Personal Settings below).
Properly setting Er:YAG Pulse Operation Mode parameters
The Plus and Minus keys are used to change the parameters. To properly
set the pulse mode parameters follow these steps:
1. If the parameters you wish to use have been stored in memory press
the M soft key (K1) select the saved parameters as described in
section Storing and Recalling Values from Memory on page 66, and
skip to step 10.
2. Select a compatible handpiece by pressing soft key (K2). The
handpiece types, in their order of appearance are as follows: R04,
R11, PS01, PS02, PS03, R09-2, R09-3, R08.
3. Select either basic or one of the turbo modes by pressing soft
key (K6), see section Er:YAG Pulse Mode with Turbo Mode below for
details on the use of turbo mode.
4. Adjust the pilot light, the fluence display and the frequency of laser
pulses (fturbo) of turbo mode by selecting the P soft key (K5) and
following the steps in section Er:YAG Pulse Operation Mode Personal
Settings found below.
5. Select the spotsize (mm) by pressing soft key (K7).
6. Select the fluence (J/cm²) or energy (J) by pressing soft key (K3).
Holding this soft key down will temporarily display the calculated
fluence or energy.
7. Select the pulse length by pressing soft key (K8). Descriptions of the
pulse lengths are listed in section Specifications pg. 79.

4
8. Select the frequency (Hz) in by pressing soft key (K4).
NOTE
When TurboX spot deposition mode is activated the frequency displayed in the
operation mode menu is the frequency of complete turbo pulse repetition, while the
frequency of laser pulses is adjusted in personal setting mode as menu item fturbo.
9. The settings can be stored at any time by pressing the Store Key. For
details see section Storing and Recalling Values from Memory on page
66.
10. Select the Ready key.
11. You will be asked to confirm the handpiece and spotsize and any values
that changed automatically. After ensuring that the selected spotsize is
equivalent to the attached handpiece spotsize press the Ready key
again.
12. Fire the laser by depressing the footswitch. One pulse (in Basic Pulse
Deposition Mode) or a burst of pulses (in Turbo Pulse Deposition Mode)
will be delivered with a selected frequency. The pulse frequency within
the burst of pulses in Turbo pulse deposition mode is selected in
Personal settings. A Tissue Effect Indicator (TEI) may appear on the
bottom center of the screen as shown in Figure 14. For a description of
the TEI see below.
13. Keep the footswitch depressed to continue to fire pulses or burst of
pulses with selected repetition rate.
WARNING !
The operator is solely responsible for properly selecting
and confirming the handpiece and the spot size on the
system console according to the intended application.
The delivered energy per pulse can differ significantly
from the intended energy per pulse, and can potentially
damage the handpiece, if an incorrect handpiece is
selected on the control panel.
NOTE
For the R04, R09, R11, PS01, PS02, PS03 handpieces, the Spotsize parameter must
also be selected.
For the R08 handpiece the spotsize is fixed and cannot be changed. The R08
handpiece cannot be selected if Fluence display menu is used since the R08
handpiece is supported only in Energy display menu.
CAUTION !
When changing the Spotsize, the Energy/Fluence setting

will remain the same until the system is capable to
realize the changed parameters. When the system is
incapable to perform the same setting of Fluence/energy
for the changed spot size, then the Energy/Fluence will
change.
The Tissue Effect Indicator may also change, since the
tissue effect depends on the Spotsize as well as the
Energy and the Mode.
NOTE
Please note, that since the transmission values vary for different handpiece types,
the range of selectable energies/Fluences may differ between handpiece types.
For example, when an R08 handpiece is selected, the Energy setting might be
changed automatically by the system computer if the currently set value is not
available with the R08 handpiece. The new value will be the closest match to the
previous energy setting.
Be aware of the following things when changing the pulse mode parameters:
- Any automatically changed parameters will flash on the system display
when the Ready Key is pressed. The system will request confirmation of
these automatically changed parameters.
- When the spotsize is changed, the fluence and frequency settings may
change.

Er:YAG Pulse Operation Mode Personal Settings
4
Figure 15 Er:YAG Pulse Mode Personal Settings Screen. (Top) default memory slot with
fluence display off (Middle) Custom memory slot named MedPL with fluence display on.
(Bottom) Custom Memory slot named MedPL with fluence ON and Fturbo displayed.
To change the pilot light brightness, switch between fluence and energy displays
use the Er:YAG Pulse Mode Personal Settings Screen.
If the P soft key was selected from the Er:YAG Pulse Mode Screen (Figure 14)
then one of the Er:YAG Personal Settings Screens will appear (Figure 15).
The Plus and Minus soft keys should be used to change the Pilot level; + and –
keys on the control panel are used for changing the Turbo mode Autorepeat
time. Use this general procedure to set the personal settings, skip steps if the
options are unavailable:
1. If a memory slot is being used its name can be changed using the
menu keys (K1) and (K5) and the Plus and Minus keys, see section
Storing and Recalling Values from Memory on page 66.
2. To brighten or darken the pilot light select the minus soft key (K2) or
the plus soft key (K5).
3. To switch between energy and fluence on the
Er:YAG Pulse Mode Screen (Figure 14) change the ON/OFF soft
key (K8).
4. If TurboN mode has been enabled then the Fturbo parameter can be
changed with the menu keys (K3) and (K7). Details can be found in the
Er:YAG Turbo section below.
CAUTION !
When you use the personal mode settings screen to switch
between fluence and energy, the fluence/energy setting will
revert to the last SAVED value; the value WILL NOT be
calculated from the current value. The Spot size,
Turbo/Basic, Pulsewidth (Mode) and TEI indicator may also
change. Check all parameters before you begin operating.
NOTE
Please note, that since the transmission values vary for different handpiece types, the
range of selectable energies/Fluences may differ between handpiece types.
For example, when an R08 handpiece is selected, the Energy setting might be changed
automatically by the system computer if the currently set value is not available with the
R08 handpiece. The new value will be the closest match to the previous energy setting.
Er:YAG Pulse Operation Mode Tissue Effect Indicator
Figure 16 Er:YAG Pulse Operation mode Basic menu with DC tissue effect indicator
displayed
The TEI indicator displays the nature of interaction of laser beam with tissue.
TEI is displayed only in BASIC Pulse deposition mode.
The TEI indicator is not displayed when R08 handpiece is selected or when
TurboN or Smooth Modes are selected.

4
Pulse width: MSP
Fluence (flu) [J/cm2] TEI Meaning
f lu < 1 NH Non Ablative Hot
1 ≤ flu ≤3 LC Light Peel Cold
3 < flu ≤10 MC Medium Peel Cold
flu > 10 DC Deep Peel Cold
Pulse width: SP in LP
1 ≤ flu ≤ 3 LW Light Peel Warm
3 < flu ≤ 10 MW Medium Peel Warm
flu > 10 DW Deep Peel Warm
Pulse width: VLP in XLP

1 ≤ flu ≤ 3 LH Light Peel Hot
3 < flu ≤ 10 MH Medium Peel Hot
flu > 10 DH Deep Peel Hot
Table 1 Tissue Effect Indicators Arranged in three tables according to pulsewidth
The tissue effect indicator is displayed regardless of whether the spot fluence or
energy is displayed on the screen.
When Energy menu is selected in personal setting menu (i.e. Fluence menu
OFF), the system calculates the fluence from selected energy and spot size and
displays the TEI mnemonic.
The TEI indicator is displayed in the middle of last row on the system screen (see
Figure 16 Er:YAG Pulse Operation mode Basic menu with DC tissue effect
indicator displayed on page 52).
Er:YAG Pulse Mode with Turbo Mode
Figure 17 Er:YAG Pulse Mode with Turbo Selected
TurboN is used to fire a burst of up to 6 shots on the same position, the

frequency with which each burst occurs can be set with the frequency
soft key (K4). The frequency of the laser shots within the burst train can be
controlled with the FTurbo soft key (K4) through the Er:YAG Pulse Operation
Mode Personal Settings (see Figure 15).
Er:YAG Pulse Operation mode with Smooth Mode
Figure 18 Er:YAG Pulse mode with smooth mode selected
Smooth mode is similar, but distinct from Turbo spot deposition mode. The
SMOOTH Mode delivers a four SP pulses to the same spot.
When the SMOOTH Mode pulsewidth is selected, the system displays a short
message stating that only spotsizes of 5 mm and above are supported. The
system will also display a message when the user leaves smooth mode.
When leaving SMOOTH mode and entering XLP pulsewidth the default
parameters will be displayed for XLP pulsewidth.
SMOOTH Mode pulsewidth operates with the following handpieces and
spotsizes:
• R04 with 5, 7, 10 or 12 mm spotsizes
• R09-3 with 5mm spotsize
• R11 with 5, 6 and 7 mm spotsizes
SMOOTH mode pulsewidth imposes several limitations on the parameters
that can be selected:
• Fluence delivered in the SMOOTH pulse. This is a cumulative fluence
taken over the entire pulse.
• Handpiece type (R04, R09-3, R11,PS01, PS02, PS03)
• Spotsize – must be greater or equal to 5mm
• Frequency (repetition rate) – from 0.5 to 2Hz.
NOTE: The Er Pulse Operation mode in SMOOTH mode pulsewidth is

available only in Er:YAG Pulse operation mode.

4
CAUTION !
When switching to or from SMOOTH mode the system
will reset the parameter values of XLP mode to the
values. Always check the parameters before you begin
operating.
Er:YAG Pulse Mode Ablation and Coagulation Depth Indicator
Figure 19 Er:YAG Pulse Operation Mode Ablation and Coagulation Depth Indicator
Pressing and holding the frequency soft key (K8) (see Figure 14 on page 48)
causes the calculated ablation depth and coagulation depth to appear in basic
mode and only the calculated ablation depth to appear in TurboN spot
deposition mode( see figure Figure 19). These are approximate values and will
vary depending upon the skin type and characteristics.
Er:YAG F-Runner Operation Mode
Figure 20 The Er:YAG F-Runner Scanner Operation Mode Basic Menu

Use Er:YAG F-Runner Operation Mode to use the the F-Runner Scanner with
the SP/XS Dynamis system.
If the F-Runner soft key was selected from the Er:YAG Operation Mode
Menu (Figure 4) the Er:YAG F-Runner Scanner Operation Mode Basic Menu
(Figure 20) will appear.
NOTE
The Er:YAG F-Runner Scanner must be attached to the laser system in order to
enter the F-Runner Mode Screen. Otherwise the system will issue a message
explaining that the F-Runner is not connected to the system and then will revert to
the Er:YAG operation mode menu.
Properly setting Er:YAG F-Runner Mode parameters
1. Attach the F-Runner Scanner to the system per the instructions given
in this manual (section 4.5 Attaching and Setting Up the Fotona
Er:YAG F-Runner or S-Runner Scanner) and in the F-Runner
scanner operator manual.
2. If the parameters you wish to use have been stored in memory, press
the M soft key (K1) select the saved parameters as described in
section Storing and Recalling Values from Memory on page 66, and
skip to step 10.
3. Select the Spot deposition mode (either basic or a turbo mode) by
pressing soft key (K6). For details on turbo mode see section Using
Turbo Spot deposition mode with the F-Runner Scanner below.
4. Select the scanning pattern by pressing soft key (K7). For a list of
the available scanning patterns see section Er:YAG Scan Patterns of
the Fotona F-Runner.
5. Select the coverage percentage of the scan by pressing soft
key (K2). (2,5,10,20,40,60%)
6. Select the Pulsewidth (either MSP, SP, or LP) by pressing soft
key (K8).
7. Select the frequency of the laser pulses by pressing soft key (K4).
Changing the Hz may lower the Energy automatically.
8. Select the fluence/energy delivered in each pulse by pressing the soft
key (K3). The display of fluence or energy can be toggled in the
Personal settings

4
9. Alter the brightness of the pilot light and the autorepetition settings by
pressing the P soft key (K5).
10. Press the Ready key
11. Fire one scan by depressing and holding the footswitch, if Autorepetition
is engaged press and hold the footswitch throughout the procedure.
Er:YAG F-Runner Operation Mode Ablation Depth Indicator
Figure 21 Er:YAG Pulse Operation Mode Ablation Depth Indicator
causes the calculated ablation depth to appear, as in Figure 21. These are
approximate values and will vary depending upon the skin type and
characteristics.
Er:YAG F-Runner Personal Settings
Figure 22 The Er:YAG F-Runner Personal Settings Screen
To change the pilot light brightness or modify the auto-repeat interval (the interval
between scans) use the Er:YAG F-Runner Personal Settings Screen (Figure 22).
If the P soft key was selected from the Er:YAG F-Runner Mode Screen (Figure
20) then one of the Er:YAG Personal Settings Screens will appear.
Use this general procedure to set the personal settings; skip steps if the options
are unavailable:
1. To brighten or darken the pilot light select the plus soft key (K2) or the
minus soft key (K5).
2. To modify the pause interval between scans change the
Autorepeat soft keys (K4) and (K8). From 0.5 seconds to 1,2 seconds,
in 0.1 second increments.
3. Press the back button to go back to the previous menu.
Er:YAG Scan Patterns of the Fotona F-Runner
The entire scan shape of Fotona F-Runner Er:YAG scanner is shown in Figure
23. Three parameters fully specify the shape of the scan: coverage, scan width
X and height Y. The steps necessary to modify scan width X and scan heightY
are discussed in the F-Runner operator manual; coverage is modified on the
system control panel as discussed above.
X
Pixel Triangle of pixels Red outlining frame
Figure 23 Typical Representative Scan Pattern F-22 (F-Runner) Er:YAG Scanner
The order in which the individual pixels are visited in the scan is called the scan
pattern. Three different scan patterns are available.
The SE or SEquential scanning sequence performs a single, uninterrupted, line-

by-line scan across the entire scan area. This scan sequence can be particularly
useful when the practitioner wants to cover a smaller area than the entire scan
area without changing the scan area size mid-treatment.

4
The OP or OPtimal scanning sequence performs a scan across the entire scan
area chosen by the practitioner in which neighboring and successive spot
deposition is avoided. The complete scanning sequence is completed in four
passes across the entire scan area. The OP scanning sequence is
recommended for performing scanner treatments that require high fluence levels
be delivered to the skin at high repetition rates.

The PR or PaRtial scanning sequence is based on the same non-successive
spot deposition principles as the OP scanning sequence with the addition of an
Autorepeat time between successive passes. Autorepeat time is a variable,
configurable pause that can be set by the practitioner in the P soft key (K5). The
Autorepeat time pauses provide additional cooling in the treatment site; the PR
scanning sequence is useful when treating patients with a low pain threshold.
Autorepeat Functionality
Between each complete scans, during the Autorepeat pause, a temporary

outlining shape will be visible, indicating the Autorepeat pause. The Autorepeat
pause outline is shown as follows:
Between each pass in PR scanning sequence during the Atoprepeat time the
outline shown below will appear.
To adjust the length of the autorepeat pause select the Auto soft key (K5) on
the ErScanner Screen (see Figure 22). When all four passes are finished in PR
scanning sequence the outlining shape will again be visible in the following
shape:
Please note that the Autorepeat time between each pass in PR scanning
sequence is equal to Atorepeat time between consecutive complete scans.
Using Turbo Spot deposition mode with the F-Runner Scanner
The F-Runner Scanner has two pixel deposition modes: Basic and Turbo
When a scan is done in basic mode each point in the scan pattern is fired upon
only once.
Turbo mode has level settings 2 through 6. In Turbo mode, each point in the
scan pattern is fired upon multiple times. For example, when Turbo mode level 5
is selected, each point in the scan pattern will be fired upon five times before the
scanner moves to the next point.
The effect of pulse stacking in Turbo mode is to increase ablation depth
Er:YAG S-Runner Operation Mode
Figure 24 Er:YAG S-Runner Scanner Operation Mode Basic menu Screen
Use Er:YAG S-Runner Mode to use the S-Runner Scanner with the
SP/XS Dynamis system.
If the S-Runner soft key was selected from the Er:YAG Initial Screen (Figure 4)
the Er:YAG S-Runner Scanner Mode Screen (Figure 24) will appear.
NOTE
The Er:YAG S-Runner Scanner must be attached to the laser system in order to enter
the S-Runner Mode Screen. Otherwise the system will issue a message explaining that
the S-Runner is not connected to the system and will revert to the Er:YAG Operation
mode menu.
Properly setting Er:YAG S-Runner Mode parameters

1. Attach the S-Runner Scanner to the system per the instructions given in
this manual (4.5 Attaching and Setting Up the Fotona Er:YAG F-Runner or
S-Runner Scanner on page 34) and in the S-Runner scanner operator
manual
2. If the parameters you wish to use have been stored in memory press the
M soft key (K1) select the saved parameters as described in section
Storing and Recalling Values from Memory on page 66 and skip to step
10.
3. Select the Spot deposition mode (either Basic or a TurboN, or ScanN
mode) by pressing soft key (K6), for details see section Using Turbo and
ScanN Spot Deposition modes with the S-Runner Scanner on pg. 62.
4. Select the scanning pattern by pressing soft key (K7). For a list of the
available scanning patterns see section Er:YAG Scan Patterns of the
Fotona S-Runner pg. 63.
5. Select the overlap with soft key (K2).
6. Select the energy or fluence delivered in each pulse with soft key (K3).
7. Select the frequency with soft key (K3).
8. Select the pulsewidth with soft key (K8).
9. Alter the brightness of the pilot light and the Autorepetition settings by
pressing the P soft key (K5).
10. Press the ready key. The system will prompt you to confirm the
parameters.
11. Press the ready key again to confirm the parameters.
12. Fire one scan by depressing and holding the footswitch, if auto repetition is
engaged press and hold the throughout the procedure.

4
Er:YAG S-Runner Operation Mode Personal Settings
Figure 25 Er:YAG S-Runner Personal Settings Screen
To change the pilot light brightness, switch between fluence and energy on
the display or modify the auto-repeat interval (the interval between scans) use
the Er:YAG S-Runner Personal Settings Screen (Figure 25).
If the P soft key was selected from the Er:YAG S-Runner Mode Screen
(Figure 24) then one of the Er:YAG S-Runner Personal Settings Screens will
appear.
Use this general procedure to set the personal settings, skip steps if the
options are unavailable:
1. To rename the memory slot see section Storing parameters into a
user memory slot on page 66.
2. To brighten or darken the pilot light select the minus soft key (K2) or
the plus soft key (K5).
3. To switch the display between fluence and energy settings press the
ON/OFF soft key (K7).
4. Modify the Autorepeat time (the pause interval between scans) with
the Autorepeat soft key (K8).
CAUTION !
When you use the personal mode settings screen to
switch between fluence and energy, the fluence/energy
setting will revert to the last SAVED value; the new value
will not be calculated from the current value. The Spot
size, Turbo/Basic, Pulsewidth (Mode) andTEI indicator
may also change. Always check all parameters before
you begin operating.
Er:YAG S-Runner Operation Mode Ablation and Coagulation Depth
Indicator
Figure 26 Er:YAG S-Runner Operation Mode Ablation and Coagulation Depth Indicator
causes the calculated ablation depth and coagulation depth to appear, as in
Figure 26. When VSmooth mode pulsewidth or TurboN spot deposition mode is
selected only the ablation depth will appear. These are approximate values and
will vary depending upon the skin type and characteristics.
Er:YAG V-Smooth Pulsewidth Mode
Figure 27 The S-Runner operation mode screen in V-SMOOTH pulsewidth mode.
V-Smooth can be used with the Er:YAG S-Runner scanner with Basic mode
ONLY. V-Smooth mode is similar, but distinct from Turbo mode. V-Smooth
Mode is an operational modality that delivers a train of six MSP pulses on a
same spot. The time duration of a pulse train is controlled by soft key (K4)
and can be adjusted from 0.1s up to 0.5s.
When 0.1s time duration of pulse train is selected each spot receives 6 laser
shots with selected cumulative fluence and then the next spot is being treated
and so on until the scan is completed.
When 0.2s time duration of pulse train is selected two spots are treated
simultaneously until each spot receives 6 laser shots. Then the next two spots
are being treated and so on until the scan is completed.
Again with 0.5s time duration of pulse train five spots are treated
simultaneously until each spot receives 6 laser shots. Then the next five spots
are being treated and so on until the scan is completed.
The selectable scan sizes are therefore limited to discrete set of sizes for
each pulse train duration.
Using Turbo and ScanN Spot Deposition modes with the S-Runner
Scanner
The S-Runner Scanner has three spot deposition modes of operation: Basic,
Turbo, and Scan.
When a scan is done in Basic spot deposition mode each point in the scan
pattern is fired upon only once.

4
Turbo mode has level settings 2 through 6. In Turbo spot deposition mode,
each point in the scan pattern is fired upon multiple times. For example, when
turbo mode level 5 is selected, each point in the scan pattern will be fired
upon five times before the scanner moves to the next point.
Like Turbo mode, Scan spot deposition mode also has level settings 2
through 6. In Scan spot deposition mode the entire scan is repeated multiple
times. For example, when Scan spot deposition mode level 4 is selected, the
complete scan will be repeated four times (all the points in the pattern will be
fired upon in sequence, and then again three more times).
Changing the Aiming Beam Parameters
Figure 28 Adjusting the brightness of the aiming beam
Adjusting the pilot beam is accomplished in a similar manner across all

operating modes. To change the intensity of the pilot beam select the
Minus soft key (K3) or the Plus soft key (K7) in the personal settings
screen.
Er:YAG Scan Patterns of the Fotona S-Runner
The entire scan shape of Fotona S-Runner Er:YAG scanner is shown in

Figure 29. Three parameters fully specify the shape of the scan: Overlap,
scan width X and scan height Y. The steps necessary to modify these
parameters are discussed in the S-Runner operator manual.
x
y
a
Spot Triangle of spots Red outline frame
Figure 29 Typical Representative Scan Pattern of the S-22 (S-Runner)
The scan width X and height Y can be changed in steps of ∆X and ∆Y. The
steps ∆X and ∆Y depend on the selected overlap. The higher the overlap, the
denser the spots will be.
The order in which the individual spots are visited in the scan is the scan
pattern. Three different scan patterns are available:
The SE or SEquential scanning sequence performs a single, uninterrupted,

line-by-line scan across the entire scan area. This scanning sequence can be
particularly useful in situations when the practitioner wants to cover a smaller
scan area than the entire scan area, without having to change the scan area
size during the treatment.

The OP or OPtimal scanning sequence performs a scan across the entire
scan area chosen by the practitioner in which neighboring and successive
spot deposition is avoided. The complete scanning sequence is completed in
four passes across the entire scan area. The OP scanning sequence is
recommended for performing scanner treatments that require high fluence
levels be delivered to the skin at high repetition rates.

The PR or PaRtial scanning sequence is based on the same non-successive
spot deposition principles as the OP scanning sequence with the addition of
an Autorepeat time between successive passes. Autorepeat time is a
variable, configurable pause that can be set by the practitioner in the P soft
key (K5). The Autorepeat time pauses provide additional cooling in the
treatment site, which makes the PR scanning sequence particularly useful
when treating patients with a low pain threshold.
V-Smooth Scanning Pattern

The V-Smooth scan pattern is used automatically when V-Smooth mode is
selected. Each spot in a group of up to five spots is visited in consecutive
order. Then the process is repeated until each spot has been visited a total of
six times. This is then repeated with the next group until the entire scan area
is covered.

4
4.11 Intra-Operative Instructions
System READY and STANDBY States
The system state is controlled by the STANDBY and READY keys. If the
system is in STANDBY state, pressing the READY key will start the
calibration of the selected laser parameters.
When the READY key the system requests confirmation of the set spots size
and parameters. To confirm press the READY key again. Then the system
calibrates the laser using the selected parameters. The safety shutter is
closed during the calibration of the laser.
After the calibration is completed, and a safety timeout of 2 seconds has been
terminated the *E* emission indicator is displayed, the red light inside the
READY key is lit and the safety shutter opens. This indicates that the system
is in READY state. In READY state the aiming beam emerges from the
handpiece.
In READY state the footswitch is enabled. By pressing the footswitch, the
treatment laser beam with the selected parameters is delivered from the
handpiece.
While the footswitch is pressed, an audio signal indicates that the laser is
delivering laser energy from the handpiece.
NOTE
If the footswitch is pressed during the calibration process, an advisory message will
appear. After the footswitch is released, the system will switch to STANDBY mode.
To complete the calibration enter the READY state as described above.
If the system is in READY state, pressing the STANDBY key reverts the
system to the STANDBY state. The safety shutter closes.
The system automatically reverts to STANDBY state, if the parameters are
changed during operation.
The system also reverts to standby state if it is not fired for 3 minutes while in
READY state. This is a safety feature.
Storing and Recalling Values from Memory
The procedure for storing settings in memory is similar across all operating
modes.
The M soft key in all Operation mode basic menus allows for two-touch recall
of custom settings. Simply press the M soft key and then the soft key
corresponding to the appropriate memory slot.
Each operation mode has 8 memory slots which can be renamed and
customized. In addition there is for every operation mode a basic menu with its
settings whose name cannot be changed; custom settings of each basic menu
can however be stored using the same procedure.
Storing parameters into the default memory slot
The procedure is described for Er:YAG F-Runner operation mode. It is the
same for any other operation mode.
1. After pressing the F-Runner key in Er:YAG laser operation mode menu
the F-Runner operation mode basic menu appears. Change the
necessary parameters according to the instructions given in section
2. Properly setting Er:YAG F-Runner Mode parameters on page 56.
3. After the parameters have been set press the STORE key. The top of
the screen will say ErFrun as in Figure 30.
4. The next time you enter Er:YAG F-Runner Operation mode the stored
parameters will be automatically loaded.
Figure 30 F-Runner Operation mode basic menu with its settings
Storing parameters into a user memory slot
1. Select the M soft key (K1) in F-runner operation mode basic menu to
reach the F-Runner memory menu shown in Figure 31.
Figure 31F Runner Memory Slot Screen (the names of memories on

this screen may be other than shown, they can be edited –
customized to suit your applications)
Select the memory you wish to recall or change by pressing soft
keys (K1) through (K8). The selected memory settings will be
displayed
2. Change the necessary parameters according to the instructions given
in section Properly setting Er:YAG F-Runner Mode parameters on page
56.

4
3. To change the name of the memory press the P soft key (K5) to go to
the Personal settings screen as shown in Figure 32.
Figure 32 Personal settings screen of ErFrun2 memory settings
4. From this screen the name of the memory slot can be adjusted by
selecting the character position with soft keys (K1) and (K5) and
adjusting the character with the Plus and Minus Keys.
Figure 33 Changing the name of the saved settings
The memory name length is 7 characters max. If the name is shorter

than 7 characters, it must end with “#” character.
NOTE
The name editor’s character set includes both upper and lower case English alphabets,
including numbers from 0 to 9 and special characters “_”, “–” and “#”. Names cannot be
any longer than 7 characters. Any new name entry must end with the “#” character (see
Fig. 7). The “#” is only displayed in the name change editor and will not be displayed in
the S-Runner memory menu.
5. Adjust the other personal settings as described in section Properly

setting Er:YAG F-Runner Mode parameters on page 56.
6. Press the Store Key. The saved name should now appear on the
Memory menu screen as in Figure 34.
Figure 34 The changed memory name after saving appears also in F-Runner
memories menu
Recalling Settings from the memory menu
1. Select the M soft key (K1) from any operation mode menu. The
memory menu screen will be displayed as in Figure 31.
2. Select the memory slot.
The stored settings in the selected memory will be displayed on screen.
CAUTION !
The system must be kept in STANDBY mode at all times,
except during the actual laser treatment.
Keeping the system in STANDBY mode prevents
accidental laser exposure if the footswitch is
inadvertently pressed.
Starting the Treatment

• Press the READY key to enter READY mode, if the system is in
STANDBY mode.
• Aim the aiming beam at the target tissue.
• Press the footswitch to activate the treatment beam with the selected
parameters.
While the footswitch is pressed, an audio signal indicates that the treatment
beam is emerging from the fiber beam delivery unit or handpiece.
During the Treatment

(Note: Applies to SP and XP Dynamis only)
Always revert the system to the STANDBY state and place the Nd:YAG
handpiece in its holder on the system console if surgery is interrupted for any
reason (e.g. to change the fiber-optic delivery unit or handpiece).
After the Treatment

After the treatment, the following steps should be performed:
• If the system is in READY mode, press the STANDBY key to enter
STANDBY mode.
• Turn the key in the keylock switch to the vertical OFF position.
• Switch off the main switch at the rear of the device.
• If desired, disconnect the fiber-optic delivery unit or handpiece.
• Clean the system console and keyboard as instructed in the "Cleaning the
Laser Console External Surface" section.
• If desired, remove the footswitch plug from its port at the rear of the
device.
• If desired, unplug the power cord of the device from mains electrical
supply outlet.

4
4.12 Moving the System
Before moving the system:
• Switch off the main power switch (located at the rear of the device).
• Lock the articulated arm using the strap with press-buttons on the rear
system handlebars and remove the fiber-optic delivery unit from its port on
the device.
• Disconnect the power plug from the mains electrical supply outlet.
• Disconnect the footswitch from its port on the device and securely attach
the footswitch to the magnet on the rear of the system. It is advisable to
wind the footswitch connection cord around the rear handlebar when
moving the system.
• If the doorswitch interlock is used, detach its connector from its port at the
rear of the device.
4.13 Advisory Messages

The laser system displays several advisory messages during normal laser
operation and functioning, besides also displaying advisory messages in the
event of any irregularities during operation.
The table below lists the different advisory messages displayed by the
system, including a description and clarification where thought necessary.
For further information, in the event an advisory message or the
circumstances surrounding the advisory message may not be fully
understood, we strongly recommend contacting your local Fotona
representative.
Advisory message Description / Explanation

Appears when switching the device on after
the system had been switched off at the main
Key Switch is ON. switch, but the keylock switch had been left in
Turn it OFF and the horizontal ON position.
then ON again
Turn the key in the keylock switch to the
vertical OFF position and switch the system
on again.
Indicates that the key in the keylock switch is
in the vertical OFF position.
Key Switch is OFF
Turn the keylock switch to the horizontal ON
position to start up the laser system.
Wait, POST test Indicates that the system is performing the
in progress Power-On Self Test during the start-up
procedure.
BOOT done Indicates that the system’s main computer

has been successfully booted.
Indicates, during the system’s start up
Integrity Checking procedure, that the system is checking the
in progress! integrity of all programs used for the safe
operation of the laser system.
Appears only if the system has detected an
error while checking the integrity of the
programs used for the safe operation of the
laser system.
Integrity ERROR
The system’s functions will be blocked
immediately, and no laser operation will be
possible.
Contact technical service immediately.
Indicates, after switching on the system by
Wait, turning the key in the keylock switch to the
selftest in progress horizontal ON position, that a complete system
self test is taking place.
Selftest PASSED! Indicates that the system’s selftest was

successfully completed.
Footswitch not Indicates that the footswitch is not connected.

Connected! Connect the footswitch to the device.
Indicates that the Nd:YAG fiber-optic delivery
unit is not (properly) connected to its port on
Nd:YAG fiber the laser system.
NOT attached
Attach the Nd:YAG fiber-optic beam delivery
unit to the system.
Indicates that the Nd:YAG fiber-optic delivery
unit has become disconnected during laser
Nd:YAG fiber operation.
NOT attached
Release Footswitch Release the footswitch and check that the
Nd:YAG fiber-optic delivery unit is connected
to the laser system.
After pressing the READY key the system
requests the operator to confirm the selected
Check Spot spotsize on the control panel and to check that
8 mm the same spotsize has been physically
and press READY selected on the handpiece.
Confirm by pressing the READY key
WAIT, calibration Indicates that the laser is performing the
in PROGRESS calibration procedure.
Indicates that the selected fluence and
corresponding energy settings cannot be
achieved. Normal laser operation is possible at
Can't calibrate lower fluence settings (i.e. smaller fluence with
Try lower setting same spotsize, or same fluence but smaller
spotsize).
Notify technical service.
Indicates the 2 second time delay between the
WAIT 2 seconds completion of the calibration procedure and
the safety shutter being opened.

4
Indicates that the doorswitch interlock plug is
not (properly) inserted in the doorswitch
interlock port on the system, OR if the
doorswitch interlock connection was installed
Door OPEN! on the laser operating room door, that the door
has been opened.
Insert the doorswitch interlock plug into the
doorswitch interlock port at the rear of the
system, OR close the door.
Indicates that the system cooling liquid has
overheated, possibly due to the ambient
Please WAIT temperature being too high.
Coolant Stop the treatment. Do not switch off the
Overheated system. Wait at least 10 minutes for the
system to cool down and/or until the message
disappears. Resume normal operation.
Indicates that the footswitch has been pressed
when the system is not ready for laser
Release Footswitch operation.
Release the footswitch
Indicates that, while the laser was operating,
the doorswitch interlock plug has been
removed from the system, OR the laser
operating room door has been opened.
DOOR OPEN !
Release footswitch Release the footswitch, insert the doorswitch
interlock plug OR close the laser room door.
The system will revert to Standby.
Press the READY key to resume normal laser
operation.
Emergency switch Indicates that the Emergency-Off Push Button

PRESSED! was activated.
Turn main switch Follow the “Restarting the System” procedure
OFF immediately.
described in this Operator Manual.
After turning the key in the keyswitch to the
vertical OFF position, the system switches off
WAIT, turning its peripheral subsystems.
instrument OFF
Wait to allow the system to properly complete
the switching off procedure.
Indicates that the system has been switched
off by turning the key in the keylock switch to
the OFF vertical position and that the main
Key Switch is OFF switch at the rear of the device has remained
Turn OFF in the ON position.
instrument Switch the main switch at the rear of the
device to the OFF position to completely
switch off the system.
Indicates that the laser system is in
sleep mode energy saving sleep mode.
press READY Press the READY key to leave sleep
mode.
Indicates that the selected laser
operation settings have been saved.
In normal operation, the Nd:YAG
laser settings are saved after each
Settings SAVED! successful calibration.
If laser settings are to be saved
without entering READY mode, then
select the laser settings and press the
STORE key.
Indicates that the system’s computer
has successfully de-energized all the
peripheral subsystems and that the
Now it is safe to main switch can now be switched off.
turn main switch OFF If the main switch is switched off
before this message appears, you
should wait 1 minute before switching
on the main switch again.
Indicates that the scanner cable is not
properly connected to the laser
SCANNER system or to the scanner (S11,
Disconnected! F-Runner or S-Runner).
Check that the cable is connected
properly
This message appears if a scanner is
WRONG Scanner selected which is not attached to the
Use Model F22 (S22 or S11) system. Check if the proper scanner
type is connected to the system.

5
M A IN TEN A N C E
5.1 General
The Fotona laser systems have been designed to provide years of trouble-
free operation.
The built-in computer processor performs self-diagnostics and initiates
corrective actions when necessary, as well as automatic calibrations to
ensure a properly functioning system.
If a non-correctable inconsistency is detected, the laser system will disable
and a message including a inconsistency code will be displayed on the
screen.
Er:YAG Laser (applies to SP/XS Dynamis)

A dirty window or lens on the handpiece are the most common cause of
reduced transmission of the Er:YAG laser beam.
In this case, it is advisable to clean the window or lens.
If the handpiece lenses or misalignment of the articulated arm cause the
failure, they should be replaced or aligned by technical service.
Nd:YAG Laser (applies to SP/XP Dynamis)

If no visible aiming beam emerges from the fiber when the laser system is in
ready mode, it is advisable to replace the fiber or fiber-optic delivery unit
assembly.
Replacement fibers can be purchased from the local Fotona distributor.
CAUTION !
It is the user’s sole responsibility to ensure safe and
problem-free operation of the laser system by means of
regular preventive maintenance and periodical testing as
described in this section. The user is held responsible
for all eventual problems and unsafe operation of the
laser system arising from failing to perform or organize
the preventive maintenance and/or periodical testing
procedures prescribed in this section.
5.2 Troubleshooting Guide
All laser systems are rigorously, environmentally and mechanically tested.
In the unlikely event that the laser system fails to operate properly most errors
are detected and displayed by the system itself.
If the system displays a message, which advises you to call technical service,
do not attempt to repair the device yourself or to open the console.
Because of high voltages in the device, any unqualified repair attempt may be
life threatening.
Before switching on the system, always verify:

• that the mains electrical power supply is on.
• that the main switch on the rear side of the laser system is in the OFF
position and all electrical connections are correct and intact.
• that the doorswitch interlock plug is inserted in the doorswitch interlock
port, if the doorswitch interlock is used in conjunction with a remote switch.
Close the interlock protected door.
• that the beam delivery system is properly connected.
• that the footswitch is properly connected.
CAUTION !
Do not use the device if the system display on
control panel remains blank, after switching on the
main switch at the rear of the device and after
turning the key in the keylock switch to the
horizontal ON position
Switch the system off and notify the technical
service.
NOTE
If an inconsistency is detected and the device does not display any advisory
messages, switch the system off.
Wait for 1 minute and then switch the system on again.
In case the error repeats, notify the technical service.
System inconsistencies with advisory messages can be remedied by the user.

All other inconsistencies detected by the system and displayed with an
identification error code, need the intervention of the technical service. In such
cases, please notify your Fotona representative and/or notify the technical
service.

5
5.3 Operator Maintenance
Cleaning the Laser Console External Surface
After each treatment session, wipe the external surface of the laser console
and the control panel with a cloth dampened with a non-caustic cleaning
solution, such as soap and water, isopropyl alcohol, or a “hospital-grade”
disinfectant, in order to maintain cleanliness and hygiene.
Dry the console with a clean cloth.
Do not spray or pour cleaning agents on the laser system console.
Cleaning the Cooling Air Filter

There are four air filters used to filter incoming cooling air.
The first one is located behind the laser front panel. The air filter cartridge can
be easily removed by pushing down the handle, which is accessible from the
bottom part of the front panel.
The second air filter is at the bottom of the laser device. The air filter cartridge
can be easily removed by pulling backward the handle on the rear bottom side
of the laser device.
The two side filters on the lower part of the laser console are accessible from
inner side of the the laser system console lower part. First the rear cover that
holds the two additional heat exchangers is to be removed .
After removal, clean each air filter or replace it. New air filters are available
from the local Fotona distributor.
Reassemble the air filter cartridges in reverse order.
A dirty and blocked air filter may reduce the cooling capacity of the system,
which may lead to overheating of the laser.
The air filters should be cleaned at least twice a year.
CAUTION !
The Fotona Dynamis Line laser systems are a permanently
installed devices. Electrical power must therefore be
supplied from a permanently installed mains electrical outlet
that must comply with all applicable local, state and/or
national electrical regulations and codes.
It is strongly recommended to carefully review the electrical
specifications contained herein, in the “Specifications”
section.
Electrical power supply
Electrical power must be supplied from a 230VAC ±10%, single phase,
50/60Hz, 25A outlet with a grounding. The system comes with a power cord
that cannot be detached from the device. An adequate plug and electrical
power supply outlet must be provided and all electrical requirements must be
fulfilled prior to installing the system onsite.
The system has been designed to provide allowable leakage currents for
Class I, Type B devices in accordance with the requirements of EN 60601-1
(IEC 60601-1) and UL 544; an additional isolation transformer is not required.
For safety reasons, periodical testing of the onsite electrical power supply
utilities on a yearly basis, including measurements of leakage currents, is
recommended. It is advisable to have the testing done by a qualified and
certified technical service.
Water Utilities
The Fotona Dynamis Line lasers incorporate an internal self-contained
cooling system.
No water utilities for cooling purposes are required for system operation.
Evacuation (Suction) Utilities

The customer must provide an efficient evacuation utility to be used for
suction of the remains of ablated and vaporized tissue.
The filters in this evacuation utility must be checked and replaced regularly by
the customer according to its manufacturer’s instructions.
CAUTION !
High speed evacuation of the laser smoke plume is
required when lasing herpes and other lesions that
may contain viral entities. Virus particles may rise in
the laser plume and can re-infect the patient in other
anatomical areas (e.g. lungs) and possibly infect the
laser operator and other operating room personnel.

5
Regular Inspection of Laser Safety Related Features
Energy meters calibration
The laser system incorporates two energy meters per laser source; they
should be checked for calibration on a yearly basis.
NOTE
The energy meters should only be calibrated by qualified service personnel,
authorized by Fotona. Contact Fotona or your local Fotona representative to obtain a
list of qualified and Fotona authorized service personnel.
Leakage currents and grounding impedance of the laser system

measurements
This procedure should be performed on a yearly basis. The earth leakage

current and patient leakage current, as well as the grounding impedance of
the laser system should be measured during the procedure.
NOTE
Leakage currents and grounding impedance should only be measured , according to
the instructions in the system’s Service Manual, by qualified service personnel,
authorized by Fotona. Contact Fotona or your local Fotona representative to obtain a
list of qualified and Fotona authorized service personnel.
6
S P E CI F I CAT I O N S
6.1 LASER: Dynamis Er:YAG laser
Laser wavelength: 2940 nm
Output energy per pulse: 30 to 3000 mJ in PULSE and S-Runner

operation modes
2
6 to 300 J/cm in F-Runner operation
modes
2
Fluence Range 0.13 – 95 J/cm
Pulse repetition rate (frequency): 2 to 50 Hz
Max. average power: 20 W
Pulse width: Variable in 5 steps:

MSP Mode: 100 microseconds
SP Mode: 300 microseconds
LP Mode: 600 microseconds
VLP Mode: 1000 microseconds
XLP Mode: 1500 microseconds
SMOOTH mode: 250 milliseconds (with
equally-spaced SP pulses)
V-SMOOTH mode with S-Runner

Scanner: 100-500 ms
Dynamis Nd:YAG laser

PULSE Operation Mode
Laser wavelength: 1064 nm
2
Fluence range: 10 to 600 J/cm
Pulse repetition rate (frequency) Adjustable from 0.5 to 75 Hz
Average power: Up to 65 W
Pulse width: Variable from 0.1 up to 50 ms
Spotsizes supported R31 andR33 handpiece 2, 3, 4, 5, 6, 7,

8, 9, 10 mm
S11 Nd:YAG Scanner 3, 6 and 9 mm
Applied part type: Type B
Sterilization: Autoclave (handpiece spacers and R27

handpiece)
QCW mode of operation
Available in XP or SP Dynamis
Laser wavelength & type 1064 nm Nd:YAG
Maximum power: 65 W
Pulsewidth range: 0.1 to 2 ms
Frequency (pulse repetition rate) 0.5 Hz to 100 Hz

range:
Beam delivery system • 600 µm and 1000 µm

(945 µm) core-size, bare
optical fiber with SMA905
connector on proximal end
• 945 µm core-size optical fiber
with SMA905 connector on
both ends
Compatible handpieces • R27 (for 600 µm and

1000 µm)

6
Laser system classification:
6.2 GENERAL: (according to IEC 60825-1 Ed Class IV
2/2007)
Classification according to Class IIb, Rule 9
MDD93/42/EEC, Annex IX:
Classification according to CMDR Class III, Rule 9
Power requirements: - rated supply voltage: 220-240 VAC

- number of phases: 1
- rated frequency: 50/60 Hz ± 2%
- rated current: 19 A
Electrical connection: non-detachable power supply cord (permanent connection)
Class of equipment: Class I equipment
Type of equipment: Type B equipment
Protect. earth impedance < 200 mΩ
Leakage currents: - earth leakage currents NC/SFC < 5mA/10mA

- patient leakage currents NC/SFC < 100 µA / 500 µA
- enclosure leakage currents NC/SFC < 100 µA / 500 µA
Circuit breaker: 25A
Fuses On Relay Board:

F1 T 6,3A H / 250V (5x20mm)
On 24VDC Auxiliary Power Supply:

F1 F 7A H / 250V (6x30mm)
On the Fotona S-22 scanner adapter board:

F1 T 1.25A L / 250V (5x20mm)
Aiming Beam: - semiconductor diode laser at a wavelength of 650 nm

- Power 1 mW max.
- adjustable in 7 steps from 0 to max.
- Laser Classification: Class II (according to IEC 60825-1 Ed
1.2/2001)
Safety interlocks: - remote door switch interlock connector

- fiber attachment interlock
Emergency laser stop: - emergency stop according to IEC 947-3
Footswitch - to operate the treatment laser
Controls - main switch

- keylock switch (key removable in vertical OFF position only)
Indicators:
VFD 4 x 20 characters with the - Fluence in J/cm2 , Energy in J, Power in W

following displays: - Frequency in Hz
- Pulsewidth in ms for Nd:YAG, MODE for Er:YAG
- Handpiece type
- Spotsize in mm and Scanning pattern type
- Spot deposition mode (Basic, Turbo, Scan)
- System STANDBY and READY states
- Laser status: E when in READY mode
Control panel keys:

K1 – K8 - soft keys
+ - to increase the selected parameter
- - to decrease the selected parameter
BACK - to return to the previous menu
STORE - to save the settings
Status keys:
STANDBY - to enter the standby state
READY - to enter the ready state
Safety goggles: To operate the device in accordance with IEC

60825-1 Ed 1.2/2001 safety goggles with the
following minimum safety levels are prescribed (
in accordance with EN 207:1998/ A1:2002):
- 2940 nm 2940 I L4 (OD 4)
- 1064 nm 1064 I L7 (OD 7)
Mechanical:
Construction: mobile equipment
Degree of protection: IPX0 (IEC 529)
Cooling: internal water-to-air
Dimensions 60 x 33 x 103 cm: (Length x Width x Height)
Weight: Console 112 kg without articulated arm
Environmental conditions:
Operation: - ambient temperature range +10 oC to +29 oC; must be
above dew point
- relative humidity range of 30% to 75% - non condensing
- atmospheric pressure range of 700 hPa to 1060 hPa
Storage and transport: - ambient temperature range -40 oC to +70 oC (without

cooling water)
- relative humidity range of 10% to 100% (incl.
condensation)
- atmospheric pressure range of 500 hPa to 1060 hPa
Compatible beam deliveries:
For Er:YAG laser: 7-mirror articulated arm permanently attached to the

system
For Nd:YAG laser: 945 µm core fiber-optic beam delivery unit with SMA 905
connectors on both ends - length 2m, NA=0.22
600 µm single use sterile bare fiber
Compatible handpieces:
For Er:YAG laser :
Handpieces PS01, PS02, PS03, R04Ti, R04-F, R08, R09-2, R09-2G,
R09-3, R11
Scanner compatibility F-Runner (Model F22), S-Runner (Model S22)
For Nd:YAG laser :

Handpieces R33 with removable optics for 2, 3, 4, 5, 6, 7, 8, 9, 10
mm
R31 with variable spot sizes for 2 to 10 mm in steps of
1mm
Scanner compatibility Fotona S-11 Nd:YAG Scanner
External connections:
- Potential equalization terminal
- Doorswitch connector (NC contact)
- Footswitch connector (NC & ON contact)
- Fiber optic SMA 905 port
- Scanner connector S11
- Scanner connector F-Runner/S-Runner
Footswitch cable length: 3m
Power cord length: 5m

7
L A B EL IN G
According to IEC 60825-1 Ed 2/2007 standard, the Fotona laser systems have
warning labels on specific locations to indicate conditions under which the
operator could be subjected to laser radiation.
For the label locations, refer to the figures below.
SP Dynamis Front View (The numbers refer to labels which appear after the picture series)
The XS, and XP Dynamis have different front panels as shown below.
3
SP Dynamis
XP Dynamis
XS Dynamis
Front Panel Details

7
7 12, 13, 14
15
16, 17, 18
8
10
11
SP Dynamis Rear View
19
SP Dynamis Side view

7
SP Dynamis – Side View (XS Dynamis is similar but dos not have a holder for the S-11 scanner)
Label 1 Label 2 Label 3

7
Label 12
Label 13
Label 14
Label 15
Label 16
Label 17
Label 18
Label 20

8
STO R A G E A N D SH IPM EN T
The laser system has been designed for long-term storage in a normal office
environment.
Protect the system from adverse conditions such as extreme temperature and
condensing moisture.
In no case should the laser system be exposed to temperatures below 0°C.
Cooling system damage, as well as moisture induced damage to the electronics of
the system could ensue under such circumstances.
If long-term storage is anticipated, enclosing a package with fresh silica-gel
desiccant will protect the console from condensed water.
W A R R A N TY 9
The laser system is warranted to be free from defects in components and
workmanship for 12 months from the date of shipment from the manufacturer’s
site.
The warranty expires if personnel, not authorized by Fotona, take part in any
attempted repairs to the system. The warranty does not apply in the event of
misuse, negligence or accidental damage.
Note that certain limitations apply to Fotona's warranty; optical parts,
components and handpieces are warranted for 90 days. Optical parts (such as,
but not limited to, lenses, sapphire windows, fiber tips) and components that
come in contact with the operator or patient while operating the laser system,
and consumables are not under warranty.
9.1 Warranty Shipments, Returns and Adjustments

Any warranty claim must be made promptly and must be received by Fotona
within the applicable warranty period.
In the event that the device must be returned for repair and/or adjustment,
authorization from Fotona must be obtained. Instructions on how and where
the device should be shipped will be provided by Fotona. Any system or
component, returned for examination and/or repair under warranty, should be
shipped insured and prepaid via the means of transportation specified by
Fotona. Shipping charges for all systems or components, replaced or repaired
under warranty, shall be the sole responsibility of the purchaser.
In all cases Fotona has sole responsibility for determining the cause and nature
of the failure, and Fotona's determination with regard thereto will be final.
The foregoing warranty is exclusive and in lieu of all other warranties, whether
written or oral or implied and shall be purchaser's sole remedy and Fotona's
sole liability under contract or warranty or otherwise for the product. Fotona
disclaims any implied warranty or merchantability or fitness for a particular
purpose.
In no event can Fotona be held liable for any incidental or consequential
damages arising from or in connection with the use or performance of the
goods delivered hereunder.
The primary purpose of this provision is to limit Fotona's potential liability
arising from this sale.
9.2 Decontamination of Returned Equipment

Equipment sent back to Fotona or authorized service facilities for repair, must
be properly decontaminated in order to comply with transportation laws.
The decontamination must be performed with a chemical germicide approved
for use as a "Hospital Disinfectant".
A Decontamination Certificate (provided in this Manual) must be enclosed with
the shipment.
If equipment is received without a Decontamination Certificate, Fotona will
assume that the equipment is contaminated and will charge the customer with
the cleaning costs.
10
EN ER G Y M ETER S C A L IB R A TIO N PR O C ED U R E
NOTE
Only qualified service personnel, authorized by Fotona, should perform the calibration
procedure. Contact Fotona or your local Fotona representative to obtain a list of qualified
and Fotona authorized service personnel.
NOTE
A calibrated energy/power meter with measurement accuracy of at least ± 7 % at
wavelengths 2940 nm and 1064 nm should be used to perform the calibration procedure.
Do not attempt to calibrate the energy meters if calibrated external energy meters are not
available – this may cause serious damage to the laser system.
CAUTION
During the adjustment, alignment and calibration
procedures, appropriate safety goggles must be used by
the service technician and all personnel present in the
laser room.
The purpose of the calibration procedure is to check whether the output energy
corresponds to the energy set by the operator and displayed on the control panel
screen within an accuracy range of ± 20 percent.
For Er:YAG laser in Dynamis laser systems there are two energymeters - monitor
and feedback. Each energymeter has two ranges LO and HI that can be calibrated
separately.
For Nd:YAG laser in Dynamis laser systems there are two pairs of energymeters.
One pair for monitor the other for feedback. Both the feedback and monitor
energymeters have a channel for LO and HI energies. Each channel can be
separately calibrated.
The feedback energy meters are used to regulate the output energy with a digital
closed-loop feedback loop. The monitor energy meters reading must match the
corresponding feedback energy meter reading. This forms a double safety
condition.
If the readings of corresponding monitor and feedback energy meters differ by
more then a prescribed value, the system will disable the respective laser, close
the safety shutters, block the entire system and display an energy meters
mismatch message.
The laser system uses laser beam delivery systems which inherently give rise to
certain losses in the transmitted laser beams.
To ensure the system displays the treatment energy accurately, these losses are
compensated by the system itself through transmission factors for each handpiece
and fiber.
10.1 Energy Meter Calibration Procedure for the Er:YAG Laser
NOTE
Carefully inspect the attached handpiece for damage before the calibration procedure.
The exit window or fiber tip and the proximal input lens must be clean.
It is advisable to use a new exit window or fiber tip for the calibration procedure.
NOTE
Before attempting the Er:YAG energy meter calibration procedure it is advisable to check if
the Er:YAG beam is centered on the articulated arm exit aperture.
If it is, then proceed with the calibration of energy meters.
If it is not, then first align of the articulated arm as described in the Service manual.
The Er:YAG laser energy meter calibration procedure is as follows:

• Remove the hand piece and then the articulated arm
• Remove the laser system’s upper cover and laser head cover to gain access
to the energy meter assembly
• Place the external energy meter approx. 15 cm from the arm socket (from the
beam coupling lens)
• Switch on the system and enter the service firmware for Er:YAG laser
(described in service manual)
• Select mode SP, frequency of 5Hz and after entering the READY mode
measure and subsequently adjust voltage to get a reading of approx. 150 mJ
on the external energy meter
• Observe the readings of FL (Feedback) and ML (Monitor) energy meters on
the display.
• Locate the FErLO feedback energy meter trimpot
• Use a suitable screwdriver to turn the trimpot.
• Press the footswitch and measure the energy continuously with the external
energy meter
• Slowly adjust the FErLO trimpot until the reading of the FL energy meter
coincides with the reading of the external energy meter
• With the footswitch pressed, adjust the MErLO trimpot until the readings of the
ML (monitor) energy meter match the readings of the FL (Feedback) energy
meter
• Repeat the procedure at different modes VSP, SP, LP, VLP and XLP and
different frequencies but with voltages that realize energies between 30 mJ
and less than or equal to 250 mJ. Make small corrections where necessary.
The FL (Feedback) energy meter should match the reading of the external
energy meter within ±10% for all energies between 30 to 250 mJ. The ML
(Monitor) energy meter should match the reading of the FL (Feedback) energy
meter within ±15% for all energies between 30 and 250 mJ at all frequencies
and pulse widths.
• This completes the FErLO and MErLO energy meter calibration
• Now select SP mode, 5Hz, and select a voltage to get a reading of approx
700mJ on the external energy meter.

10
• Observe the readings of FH (Feedback) and MH (Monitor) energy meters on
the display.
• Locate the FErHI feedback energy meter trimpot
• Use a suitable screwdriver to turn the trimpot.
• Press the footswitch and measure the energy continuously with the external
energy meter
• Slowly adjust the FErHI trimpot until the reading of the FH energy meter
coincides with the reading of the external energy meter
• With the footswitch pressed, adjust the MErHI trimpot until the readings of the
MH (monitor) energy meter matches the readings of the FH (Feedback)
energy meter
• Repeat the procedure at different modes VSP, SP, LP, VLP and XLP and
different frequencies but with such voltages that are realizing energies
between 500 mJ and 1500 mJ. Make small corrections where necessary. The
FL (Feedback) energy meter should match the reading of the external energy
meter within ±10% for all energies between 500 to 1500 mJ. The ML (Monitor)
energy meter should match the reading of the FL (Feedback) energy meter
within ±15% for all energies between 500 and 1500 mJ at all frequencies and
pulse widths.
• This completes the FErHI and MErHI energymeters calibration
• Exit service mode.
• Then turn off the laser system
• Wait for 30 seconds and turn it on again
In normal operation of Er:YAG laser measure the laser energy emitted from the
selected hand piece at different settings. The readings of the external energy
should match the selected energies on the display within ± 20%.
NOTE
Please note that the energy measured at the arm socket with the reference energy meter
in normal operating mode differs form the energy selected on the display by the
transmission factor of the selected hand piece.
For example:
If handpiece R04 is selected, then its transmission is typically 0.93.
If the selected energy on the display is 1000 mJ then the energy measured with
the external energy meter should be 1000/0.93 = 1075 mJ.
10.2 Energy Meter Calibration Procedure for the Nd:YAG Laser
NOTE
Before starting the energy meter calibration procedure, check that the red aiming beam
emitted from the hand piece is a regular, circular shape.
If it is not, the fiber-optic delivery unit may be damaged at the proximal or distal end, or the
fiber coupling optics may be misaligned.
To check the alignment of the fiber coupling optics, please refer to the Service Manual.
If the fiber coupling optics are aligned, but the emerging aiming beam is still not a regular
circular shape, then replace the complete fiber-optic delivery unit.
Proceed with the calibration procedure described below once the shape of the aiming
beam is regular.
NOTE
Energy measurements for the Nd:YAG laser should be performed on a single pulse,
since there are currently no commercial energy meters on the market that can measure
high energies from pulse to pulse at higher repetition rates..
For this reason, measure the energy for every fifth laser pulse. To perform this correctly,
with a suitable absorber, close the beam path to the energy meter probe and open the
path on every fifth pulse.
The Nd:YAG energy meter in the Fotona SP Plus laser system consists of two
pairs of laser beam energy sensors. In each pair, one sensor is used for
measuring LOW energies the other for measuring HIGH energies. For this reason
there are four trimpots for trimming the response of the energy sensor. Therefore
the feedback energy sensors are designated as FNdLO and FNdHI. The same
holds for the Monitor energy sensors – MNdLO and MNdHI.
LOW energies are energies up to 2 J, HIGH energies are energies higher than
2 J.
The Nd:YAG laser energy meter calibration procedure is as follows:
Calibration of LOW Energy sensors

• Switch off the system and disconnect it from the mains electrical supply.
• Remove the laser system’s upper cover as well as the laser head cover to
gain access to the energy meter assembly.
• Disconnect the fiber-optic beam delivery unit from the system.
• Place the external energy meter approx. 15 cm from the fiber coupling
assembly port (to get a red aiming beam of approx. 15 mm diameter).
• Switch the system on and enter the NdVolts service firmware.
• After the self test is completed, select the Nd:YAG laser.
• Select a 0,6 ms pulsewidth and a repetition rate of 1 Hz.
• Make trial shots and subsequently adjust the voltage to a reading of 1 J on
the external energy meter.
• Then locate the FNdLO (Feedback) energy meter for low energies and adjust
the FL reading to match the reading on the external energy meter.

10
• Repeat the same procedure with the MNdLO (Monitor) energy meter but now
with MNdLO trimpot and ML reading
• Then make measurements at approx. 0.5 J and also at energies close to (but
less than) 2 J by adjusting the voltage.
• Then check the matching of FL reading with an external energy meter at
different pulse width from 0.1 to 50 ms and at different frequencies for
energies not greater than 2 J.
• The Feedback energy meter reading should match the external energy meter
reading within ±10%.
• The Monitor energy meter should match the reading of the Feedback energy
meter within ±15%.
This completes the FNdLO and MNdLO energy meters calibration.
Calibration of HIGH energy sensors

• The High energy energy meters measure energies greater than or equal to
2 J.
• The procedure is the same as for low energies, except that in this case the
potentiometers to be adjusted on the energy meter assembly are FNdHI and
MndHI.
• Adjust the pulsewidth to 2 ms and the repetition rate to 1 Hz.
• Adjust the voltage to get a reading of approx. 10 J on the external energy
meter.
• Then adjust the FNdHI trimpot until the reading FH on the system’s display
matches the reading on the external energy meter.
• Adjust the MNdHI trimpot to match the reading MH on the system’s display to
the value of the F energy meter reading.
• Then make measurements at energies close to (but greater than) 2 J and at
different pulse widths ranging from 0.3 to 50 ms. Perfrom the same tests at
the highest energy settings of 50J.
• The Feedback energy meter reading should match the external energy meter
reading within ±10%.
• The Monitor energy meter should match the reading of the Feedback energy
meter within ±15%.
• Exit service mode.
• Wait for 30 seconds and then switch the system on in normal operating
mode.
• Attach the fiber beam delivery unit and the hand piece.
• Measure the laser energy emitted from the selected hand piece at different
settings. The readings of the external energy should match the selected
energies on the display within ± 20%.
Waste Electric & Electrical Equipment (WEEE)
Do not dispose of WEEE as unsorted municipal waste; WEEE should be
collected separately by the relevant local authorities.
Contact your local Fotona representative in order to collect and return a
disused Fotona laser system. With this you will contribute to the reuse,
recycling and/or other forms of WEEE recovery.
WEEE can potentially have negative effects on the environment and human
health as a result of the presence of hazardous substances in electrical and
electronic equipment if disposed of improperly.
Decontamination Certificate
The undersigned certifies that the Fotona device being returned herein by
____________________________________ _________________________________
Individual/Institution City, State, Country
has been cleaned and is free from biohazards, including - but not limited to - human or animal blood, tissue or
fluids or components thereof.
The undersigned also agrees to reimburse Fotona for any costs incurred in cleaning the enclosed equipment,
in the event said item(s) are received by Fotona in a contaminated condition.
_____________________________________ _________________________________
Model Model
_____________________________________ _________________________________
Serial No. Serial No
_____________________________________ _________________________________
Typed/Printed Name Position/Title
_____________________________________
Signature and Date

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MANUFACTURER:

Model: M021-4AF/3, M002-2A, M001-12F

Copyright © 2009 Fotona d.d. Printed in Slovenia. All rights reserved.

Page 2/103 85928_OM_Dynamis_Line_CE_4.0.doc

• Greater patient comfort and satisfaction.

Fotona Sales &

INTRODUCTION AND SYSTEM

STORAGE AND SHIPMENT .............................................................................................79

Page 6/103 85928_OM_Dynamis_Line_CE_4.0.doc

SP Dynamis (Fotona SP Plus):

1.2 System Characteristics

Nd:YAG laser Er:YAG laser

Laser Beam Delivery Unit

Nd:YAG laser Er:YAG laser

Page 10/103 85928_OM_Dynamis_Line_CE_4.0.doc

Compatible Scanners for the Er:YAG laser source

Carefully read the respective Handpiece Operator Manuals before attempting to

Compatible Scanners for the Nd:YAG laser source

Page 12/103 85928_OM_Dynamis_Line_CE_4.0.doc

2.1 Intended use

Er:YAG Laser Indications

Contra-indications (relative and absolute)

Page 14/103 85928_OM_Dynamis_Line_CE_4.0.doc

PULSE Mode Operation in Dermatology

Possible Undesired side effects

Possible Undesired side effects

Page 16/103 85928_OM_Dynamis_Line_CE_4.0.doc

Possible Undesired side effects

Severe and/or permanent eye damage may occur.

Never look directly into the treatment or aiming laser

3.1 Ocular Protection

Nominal Ocular Hazard Distance (NOHD)

Handpiece Divergence (mrad) NOHD (m)

Handpiece Divergence (mrad) NOHD (m)

Page 20/103 85928_OM_Dynamis_Line_CE_4.0.doc

3.3 Explosion and Fire Hazards

Do not use the laser system before ensuring that surgical

3.5 Safety Features

Emergency-Off Push Button

Laser Emission Indicator

Page 22/103 85928_OM_Dynamis_Line_CE_4.0.doc

Energy Feedback Control Technology

Page 24/103 85928_OM_Dynamis_Line_CE_4.0.doc

IEC 60601-1-2 Ed 2.1/2004

IEC 60601-1-4 Ed 1.1/2000

IEC 60601-2-22 Ed 2.0/1995

IEC 61000-4-4 ± 1 kV for input / ± 1 kV for input /

IEC 61000-4-11 70% UT 70% UT

NOTE UT is the ac mains voltage prior to application of the test level

Page 26/103 85928_OM_Dynamis_Line_CE_4.0.doc

Radiated RF 3 V/m 3 V/m Recommended separation distance

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS

4.1 Preparations for Use

4.2 Footswitch and Interlock Connection

To set up a doorswitch interlock connection in the laser procedure room, please

If in READY mode, the aiming beam spot is not visible at the

Er:YAG Laser Beam Delivery System and Handpiece

Page 30/103 85928_OM_Dynamis_Line_CE_4.0.doc

Sterilization of Er:YAG handpieces and beam delivery systems

Nd:YAG Laser Beam Delivery System and Handpiece Connection

Fibers used with the R27 handpiece for endovenous

Sterilization of Nd:YAG handpieces and beam delivery systems

• For laser lipolysis applications: