Dynamis User Manuel

MANUFACTURER:
Fotona d.d.
Stegne 7
SI – 1000 Ljubljana, Slovenia
phone: + 386 1 500 91 00
fax: + 386 1 500 92 00
www.fotona.com
OPERATOR MANUAL
Dynamis Pro Line
(SP Dynamis, XS Dynamis, XP Dynamis, SP Spectro, XP Spectro)
Model: M021-4AF/3, M002-2A, M001-12F

87009 USA ENG 13
Please note that while every effort has been made to ensure that the data given in this manual is accurate, the
information, figures, illustrations, screenshots, tables, specifications, and schematics contained herein are
subject to change without notice.
Copyright © 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 2/123 87009 OM Dynamis Pro Line USA ENG 13

Date of issue/Latest revision: 2. July 2015
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 50 years of experience we have a deep understanding of the
modern physician’s 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 physicians 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 treatment possibilities.
The purpose of this Operator Manual is to provide regulatorily required information on particular
characteristics of the laser system and its operation. We strongly recommend carefully reading and studying
the entire contents of this manual before attempting to operate the device. Please take note of the various
warnings and notes that are provided to ensure the 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 your 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.
The Fotona Team
87009 OM Dynamis Pro Line USA ENG 13 Page 3/123

Content
1. INTRODUCTION AND SYSTEM CHARACTERISTICS.....................................................7

1.1 GENERAL ................................................................................................................................7
1.2 BASIC SYSTEM CHARACTERISTICS ...........................................................................................9
Compatible Handpieces for the Er:YAG Laser Source .........................................................10
Compatible Scanners for the Er:YAG Laser Source .............................................................10
Compatible Handpieces for the Nd:YAG Laser Source ........................................................11
Compatible Scanners for the Nd:YAG Laser Source ............................................................11
2. INDICATIONS FOR USE .....................................................................................................12
2.1 INTENDED USE ......................................................................................................................12
2.2 INDICATIONS FOR USE, CONTRA-INDICATIONS AND SIDE EFFECTS ...........................................12
3. SAFETY AND REGULATORY COMPLIANCE ...................................................................21
3.1 OCULAR PROTECTION ...........................................................................................................21
Safety Eyewear .....................................................................................................................21
Er:YAG Wavelength ..............................................................................................................21
Aiming Beam .........................................................................................................................22
Nominal Ocular Hazard Distance (NOHD)............................................................................22
3.2 ELECTRICAL HAZARDS...........................................................................................................23
3.3 EXPLOSION AND FIRE HAZARDS .............................................................................................24
3.4 PROTECTING NON-TARGET TISSUES ......................................................................................24
3.5 SAFETY FEATURES ................................................................................................................25
Emergency-Off Push Button .................................................................................................25
Keylock Switch ......................................................................................................................25
Laser Emission Indicator .......................................................................................................25
Door Switch Interlock ............................................................................................................25
Protective Housing ................................................................................................................25
Safety Interlocks ....................................................................................................................25
Location of Controls ..............................................................................................................26
Safety Shutter .......................................................................................................................26
Connection Terminal for Potential Equalization Conductor ..................................................26
Microprocessor Controlled Fault Detection ...........................................................................26
Energy Feedback Control Technology ..................................................................................26
3.6 ELECTRO-MAGNETIC COMPLIANCE STATEMENT......................................................................27
4. THE LASER SYSTEM IN OPERATION ..............................................................................30
4.1 PREPARATIONS FOR USE .......................................................................................................30
4.2 FOOT SWITCH AND INTERLOCK CONNECTION..........................................................................31
4.3 LASER BEAM DELIVERY SYSTEMS AND HANDPIECE CONNECTION ............................................31
Er:YAG Laser Beam Delivery System and Handpiece Connection ......................................31
Sterilization of Er:YAG Handpieces and Beam Delivery Systems ........................................32
Nd:YAG Laser Beam Delivery System and Handpiece Connection .....................................32
Sterilization of Nd:YAG Handpieces and Beam Delivery Systems .......................................34
4.4 ATTACHING AND SETTING UP THE FOTONA S-11 SCANNER .....................................................35
4.5 ATTACHING AND SETTING UP THE FOTONA ER:YAG F-RUNNER OR S-RUNNER SCANNER ........36
4.6 BALANCING THE ARTICULATED ARM .......................................................................................38
4.7 EXPECTED POSITION OF THE OPERATOR AND PATIENT...........................................................38
4.8 SWITCHING THE SYSTEM ON AND OFF ...................................................................................39
Switching the System On ......................................................................................................39
Switching the System Off ......................................................................................................40
Stopping the Laser System in Case of Emergency ..............................................................40
Restarting the System After an Emergency Stop .................................................................41
4.9 GRAPHICAL USER INTERFACE (GUI) ......................................................................................41
4.9.1. Dynamis and Spectro User Interface Features ...........................................................41
4.9.2 Treatment Group Selection ..........................................................................................41
4.9.3 Settings menu ..............................................................................................................42
4.9.4 Selecting the Laser Source ..........................................................................................44
4.9.5 Selecting a Treatment Group with a Selected Laser Source .......................................44

4.9.6 Application Libraries of the Selected Treatment Group ...............................................46
4.9.7. Application Screens: an Introduction ..........................................................................50
4.9.8 Application Screens with the Er:YAG Laser and Settings Adjustment ........................50
4.9.9 Application Screens for the Nd:YAG Laser and Settings Adjustment .........................62
4.9.10 Saving Options Overview ...........................................................................................73
4.9.11. Description of Icons and Buttons used in the GUI ....................................................73
4.10 INTRA-OPERATIVE INSTRUCTIONS ........................................................................................80
System READY and STANDBY States ................................................................................80
Starting the Treatment ..........................................................................................................81
During the Treatment ............................................................................................................81
After the Treatment ...............................................................................................................82
4.11 MOVING THE SYSTEM ..........................................................................................................82
4.12 ADVISORY MESSAGES .........................................................................................................82
5. MAINTENANCE ...................................................................................................................87
5.1 GENERAL ..............................................................................................................................87
Er:YAG Laser (applies to models M021-4AF/3 and M002-2A) .............................................87
Nd:YAG Laser (applies to models M021-4AF/3 and M001-12F) ..........................................87
5.2 TROUBLESHOOTING GUIDE ....................................................................................................87
5.3 OPERATOR MAINTENANCE .....................................................................................................88
Cleaning the Laser Console External Surface ......................................................................88
Cleaning the Cooling Air Filter ..............................................................................................88
Electrical power supply .........................................................................................................89
Water Utilities ........................................................................................................................89
Evacuation (Suction) Utilities ................................................................................................90
Regular Inspection of Laser Safety Related Features ..........................................................90
6. SPECIFICATIONS................................................................................................................91
6.1 LASER ................................................................................................................................91
6.2 GENERAL ...........................................................................................................................92
7. LABELING ...........................................................................................................................95
8. STORAGE AND SHIPMENT .............................................................................................119
9. WARRANTY .......................................................................................................................120
9.1 W ARRANTY SHIPMENTS, RETURNS AND ADJUSTMENTS .........................................................120
9.2 DECONTAMINATION OF RETURNED EQUIPMENT.....................................................................120
10. CALIBRATION PROCEDURE FOR ENERGY METERS ...............................................121

1. INTRODUCTION AND SYSTEM CHARACTERISTICS
1.1 General
The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in
the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as
well as an aiming beam laser that operates in the visible range.
The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser
systems allows control of laser energy and laser pulse length.
There are three basic models in the Fotona Dynamis Pro Line (M021-4AF/3,
M002-2A, M001-12F), each incorporating a different combination of laser sources
and graphical user interface possibilities:
SP Dynamis, SP Spectro, M021-4AF/3:
• Er:YAG laser, with a wavelength of 2940 nm
• Nd:YAG laser, with a wavelength of 1064 nm
XS Dynamis, M002-2A:
XP Dynamis, XP Spectro, M001-12F:
• Nd:YAG laser with a wavelength of 1064 nm
The aiming laser in all models is a semiconductor diode laser with a wavelength
of 650 nm.
Both treatment laser types are pulsed solid-state lasers that 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.
WARNING!
Only qualified service personnel, authorized by Fotona,
should perform the installation of the system. Contact
Fotona or your local Fotona representative to obtain a
list of qualified and Fotona-authorized service personnel.
CAUTION!
Federal law restricts the sale of this device by or on the
order of a physician or any other practitioner who is
licensed by the law of the State in which he or she
practices to use or order the use of the device.
WARNING!
Laser systems should be used only by physicians
trained in the operation of laser devices.

WARNING!
Use of controls, adjustments or performance of
procedures other than those specified herein may result
in hazardous laser radiation exposure.
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.
WARNING!
No modification of this equipment is allowed.
WARNING!
No service or maintenance shall be performed during
patient treatment.

1.2 Basic System Characteristics
Laser Source Specifications for the Dynamis Laser Family
Laser source type Er:YAG laser Nd:YAG laser

Wavelength 2940 nm 1064 nm
2 2
95 J/cm (1550 J/cm for 2
Max. fluence 600 J/cm
R08-Ti handpiece)
Max. pulse energy 3J 50 J
Pulse width range 0.1 – 1.5 ms, 250 ms 0.1 – 50 ms, 0.3-60 s
Max. frequency 50 Hz 100 Hz
Max. average power 20 W 80 W
Beam delivery type 7-mirror articulated arm Fiber-optic
Laser Source Specifications for the Spectro Laser Family
Laser source type Er:YAG laser Nd:YAG laser

Wavelength 2940 nm 1064 nm
2 2
95 J/cm (1550 J/cm for 2
Max. fluence 600 J/cm
R08-Ti handpiece)
Max. pulse energy 3J 50 J
0.1 – 50 ms, (optional
Pulse width range 0.1 – 1.5 ms, 250 ms
0.3-60 s)
Max. frequency 50 Hz 100 Hz
Max. average power 20 W 35 W
Beam delivery type 7-mirror articulated arm Fiber-optic

Compatible Handpieces for the Er:YAG Laser Source
Model Description
R-04 Non-collimated Er:YAG handpiece, with 5 different spacers for 3, 5,
7, 10 and 12 mm spot sizes.
R08-Ti Non-collimated Er:YAG handpiece, 0.45 mm (0.3 mm) spot size at
the distance indicated by the spacer.
R09-2 Collimated Er:YAG handpiece, 4 mm spot size for a 2 to 10 cm
distance from the target.
R09-3 Collimated Er:YAG handpiece, 5 mm spot size for a 2 to 10 cm
distance from the target.
R09-2G Collimated Er:YAG handpiece with a tube for gynecology.
R11 Collimated Er:YAG handpiece with variable spot sizes from 2 to

7 mm.
When used with a GA adapter, the spot size at the GA adapter's exit
is variable but larger, by a factor of 1.28, than the setting on the R11
handpiece.
The 7 mm spot size setting must be used with GC adapters.
PS02 Non-collimated, patterned Er:YAG handpiece, with 5 different
spacers for 3, 5, 7, 10 and 12 mm spot sizes.
PS03 Collimated, patterned Er:YAG handpiece with variable spot size
adjustment in the range of 2 to 7 mm.
When used with a GA adapter, the spot size at the GA adapter's exit
is variable but larger, by a factor of 1.28, than the setting on the
PS03 handpiece.
The 7 mm spot size setting must be used with GC adapters.
FS01 Non-collimated, fractional handpiece with a matrix of 9x9 equidistant
pixels arranged in an 8.8 x 8.8 mm square.
Compatible Scanners for the Er:YAG Laser Source

Model Description
Er:YAG F-Runner Scanner Model High speed fractional 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.
Carefully read the scanner Operator Manuals before attempting to use the
scanner handpieces or contact your Fotona representative for further information
regarding the specific applications and specifications for scanner handpieces.

Compatible Handpieces for the Nd:YAG Laser Source
Model Description
R27 Reusable Nd:YAG handpiece for laser-assisted lipolysis for holding
600 or 1000 µm a 600 µm (R27-600) or 1000 µm (R27-1000) sterile bare fibers.
Bare Fiber
Fiber 600 600 µm Sterile bare fiber for endovenous laser treatments.
Fiber 1000 1000 µm Sterile bare fiber for endovenous laser treatments.
R33 Nd:YAG handpiece with spot sizes of 2 to 10 mm in 1 mm
increments using exchangeable optics.
R33-T Nd:YAG handpiece with spot sizes of 2 to 10 mm in 1 mm
increments, using exchangeable optics compatible with the
non-contact skin temperature sensor assembly.
R34 Nd:YAG handpiece with spot sizes of 15 and 20 mm using
exchangeable optics.
R34-T Nd:YAG handpiece with spot sizes of 15 and 20 mm using

exchangeable optics compatible with the non-contact skin
temperature sensor assembly.
Note: this handpiece should be used with jumper Fiber beam
delivery code: 93941 or 93942.
Compatible Scanners for the Nd:YAG Laser Source

Model Description
S-11 Scanner High speed scanner with 3, 6, 9 mm
spot size with standard 945 µm fiber,
adjustable scan patterns and a
maximum scan area of 42 cm².
Optional 2 mm spot size and patterned
treatments with 600 µm fiber and 3 mm
scanner optics
Carefully read the scanner Operator Manual before attempting to use the
scanner handpiece or contact your Fotona representative for further information
regarding the specific applications and specifications for the scanner handpiece.

2. INDICATIONS FOR USE
2.1 Intended Use

The Dynamis laser system family is intended to be used in the field of
dermatology, aesthetic medicine, gynecology, genitourology and surgery.
2.2 Indications for Use, Contra-indications and Side Effects

For indications for use, contra-indications, side effects and detailed procedural
guidelines, refer to the current versions of the following Fotona Application
Manuals:
- Application Manual: USA ENG 85874 Nd:YAG Lasers – 1064 nm and Er:YAG
Lasers 2940 nm Dermatology, Aesthetic Medicine, Gynecology, Genitourology
and Surgery
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.

Er:YAG Laser Indications
The Fotona Dynamis Er:YAG laser is intended for surgical incision/excision,
cutting, ablation, vaporization and coagulation of soft and hard tissue. All soft
tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated
and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph
vessels and nodes, organs, and glands.
Indications
Dermatology and Plastic Surgery General Surgery Indications:
Indications - Surgical incision/excision
- Epidermal nevi - Vaporization and coagulation of
- Actinic cheilitis soft tissue during any general
- Verrucae surgery application where skin
- Skin tags incision, tissue dissection,
- Keratoses excision of lesions, complete or
- Soft tissue resurfacing partial resection of internal
organs, lesions, tissue ablation
Dermatological procedures requiring and vessel coagulation is
resurfacing of soft tissue with necessary
fractionated handpiece
ENT Surgery Indications: Podiatry Indications:

- ENT lesions - Warts
- Cysts - Plantar verrucae
- Polyps - Large mosaic verrucae
- Hyperkeratosis - Matrixectomy
- Oral leukoplakia
Gynecology Indications
- Herpes simplex
Oral/Maxillofacial Indications:
- Endometrial adhesion
- Oral and glossal lesions
- CIN (Cervical Intraepithelial
neoplasia
Intra-oral soft tissue incision, excision,
- Cysts
ablation, coagulation
Condiloma
Ophtalmology Indications:
Genitourinary Indications:
- Soft tissue surrounding the eye
lesions of the external genitalia,
urethra and anus, penis, scrotum and
urethra, vulvar lesions, polyps and
familial polyps of the colon

Contra-indications
• Abnormal scarring • Vascular problems (incl. common
• Infection or inflammation of circulation problems)
treatment area • Endocrine disorders
• Excessive sun exposure (tanned • Hypertension
skin) • Morbid obesity
• A history of a photosensitivity • Wound healing disorders
disorder or use of photosensitizing • Epilepsy
medication • Febrile state
• Pregnancy • Use of iron supplements or an
• Irradiation in the region of the anticoagulant therapy
gonads • Retin-A and similar products 3 days
• Diabetes before and 7 days after treatment
• Insulin-dependent diabetes (need a • Accutane (Roaccutane) within 6
written release from their family months
physician) • Systemic antifungal, oral antifungal
• Cancer in the area to be treated therapy, or isotretinoin within 6
• Autoimmune disorders, such as months
Lupus • Use of vasodilators
• History of seizures • Gold therapy
• Herpes simplex infection in the • An inability to visualize the area to
treatment area be treated
• Collagen, scarring and connective • Preoperative histology findings
tissue disorders indicative of malignancy
• Clotting disorders • Anatomic findings not consistent
• Heart or lung disease with the diagnosis
Possible side effects

• Scarring (hypertrophic, atrophic), • Bruising
• Delayed healing • Soreness
• Persisted ulcerated areas, • Tenderness
• Bleeding • Infection
• Light redness that may persist for a • Oedema
few days. • Discoloration
• Superficial burns, sometimes with • Paresthesia
blistering. • Erythema
• Transient hypo- or hyper- • Irregular contour deformities
pigmentation • Partial skin erosion
• Mild to moderate discomfort or pain • Pulling sensation
during the treatment • Hemosiderin staining
• Burns, blistering, crusting (thermal
effect)
An informed consent from the patient is recommended.

Nd:YAG Laser Indications
The Fotona Dynamis Nd:YAG laser is intended for incision, ablation, vaporization
coagulation and hemostasis of vascular lesions and soft tissue in various
dermatological and surgical areas, and for permanent reduction of unwanted
hair in Fitzpatrick skin types I - VI.
PULSE Mode Operation in Dermatology

Indications
• Photocoagulation and hemostasis • Treatment of wrinkles
of pigmented and vascular lesions, • Treatment of mild to moderate
such as, but not limited to: inflammatory acne vulgaris
- Port wine stains • Removal of unwanted hair, for
- Hemangiomae stable long term or permanent hair
- Warts reduction and for treatment of PFB.
- Telangiectasie The laser is indicated for all skin
- Rosacea types, Fitzpatrick I-VI, including
- Venus lake tanned skin;
- Leg veins
- Spider veins
Contra-indications
• History of keloid scarring • Clotting disorders
• Scarring or inflammation or • Heart or lung disease
infection of treatment area • Vascular problems (incl. common
• Excessive sun exposure (tanned circulation problems)
skin) • Endocrine disorders
• A history of a photosensitivity • Hypertension
disorder or use of photosensitizing • Morbid obesity
medication • Wound healing disorders
• Pregnancy • Epilepsy
• Irradiation in the region of the • Febrile state
gonads • Use of iron supplements or an
• Diabetes anticoagulant therapy
• Insulin-dependent diabetes (need a • Retin-A and similar products 3 days
written release from their family before and 7 days after treatment
physician) • Accutane (Roaccutane) within 6
• Cancer in the area to be treated months
• Autoimmune disorders, such as • Systemic antifungal, oral antifungal
Lupus therapy, or isotretinoin within 6
• History of seizures months
• Herpes simplex infection in the • Use of vasodilators
treatment area • Gold therapy
• Collagen, scarring and connective
tissue disorders

• Light redness that may persist for a • Erythema
few days. • Irregular contour deformities
• Superficial burns, sometimes with • Hematoma
blistering. • Fat & tissue necrosis
• Transient hypo- or hyper- • Pulmonary thromboembolism
pigmentation • Partial skin erosion
• Delayed healing • Pulling sensation
• Mild to moderate discomfort or pain • Hemosiderin staining
during the treatment • Hair removal by lasers or intense
• Burns, blistering, crusting (thermal pulse light sources can cause
effect) increased hair growth in some
• Bruising individuals. Based upon currently
• Soreness available data, the highest risk groups
• Tenderness for this response are females of
• Non-specific inflammatory Mediterranean, Middle Eastern, and
response (thermal effect) South Asian heritage treated on the
• Infection face and neck.
• Oedema
• Discoloration
• Paresthesia
Nd:YAG Laser Indications (continued)

QCW Mode Operation in Podiatry
Indications
• Podiatry (ablation, vaporization, - Temporary increase of clear nail
incision, excision, and coagulation in patients with onychomycosis
of soft tissue) including: (e.g. dermatophytes,
- Matrixectomy Trichophyton rubrum and T.
- Radical nail excision mentagrophytes, and/or yeast
- Periungual and subungual Candida albicans, etc.)
warts
- Plantar warts
- Neuromas

Contra-indications
• History of keloid scarring • Morbid obesity
• Scarring or inflammation or • Wound healing disorders
infection of treatment area • Epilepsy
• Excessive sun exposure (tanned • Febrile state
skin) • Use of iron supplements or an
• A history of a photosensitivity anticoagulant therapy
disorder or use of photosensitizing • Retin-A and similar products 3 days
medication before and 7 days after treatment in
• Pregnancy periungual area
• Irradiation in the region of the • Accutane (Roaccutane) within 6
gonads months
• Diabetes • Systemic antifungal, oral antifungal
• Insulin-dependent diabetes (need a therapy, or isotretinoin within 6
written release from their family months
physician) • Use of vasodilators
• Cancer in the area to be treated • Gold therapy
• Autoimmune disorders, such as • Undiagnosed lesions of nail plate
Lupus and periungual area
• History of seizures • Permanent or semi-permanent
• Herpes simplex infection in the discoloration of the nail plate
treatment area • Subungual hematoma
• Collagen, scarring and connective • Nevoid subungual formation
tissue disorders • Concomitant nail disorders such as
• Clotting disorders psoriasis of nail plate, lichen planus
• Heart or lung disease and atopic dermatitis
• Vascular problems (incl. common • Tattoos in the treatment area or
circulation problems) presence of exogenous dies and
• Endocrine disorders nail lacquers in the nail plate
• Hypertension • Subungual pigment moles or
hemorrhagia
• Light redness that may persist for a • Skin burn
few days. • Infection
• Superficial burns, sometimes with • Oedema
blistering. • Discoloration
• Transient hypo- or hyper- • Paresthesia
pigmentation • Erythema
• Delayed healing • Skin thinning
• Temporary nail discoloration (color • Irregular contour deformities
changes to yellowish ) • Hematoma
• Mild to moderate discomfort or pain • Fat & tissue necrosis
during the treatment • Pulmonary thromboembolism
• Burns, blistering, crusting (thermal • Fat embolism
effect) • Partial skin erosion
• Bruising • Pulling sensation
• Soreness
• Tenderness
• Non-specific inflammatory response
(thermal effect)

QCW Mode Operation in Endovenous Laser Therapy
Indications
• Endovenous Laser Therapy of
superficial incompetent tributary
veins associated with varicose
veins and varicosities
Contra-indications
• Insulin-dependent diabetes (need a • Retin-A and similar products 3
written release from their family days before and 7 days after
physician) treatment
• Cancer in the area to be treated • Accutane (Roaccutane) within 6
Lupus • Systemic antifungal, oral antifungal
• History of seizures therapy, or isotretinoin within 6
• Herpes simplex infection in the months
treatment area • Use of vasodilators
• Collagen, scarring and connective • Gold therapy
tissue disorders • Active thrombophlebitis or DVT

• Light redness that may persist for a • Infection
few days. • Oedema
• Superficial burns, sometimes with • Discoloration
blistering. • Paresthesia
• Transient hypo- or hyper- • Erythema
pigmentation • Skin thinning
• Delayed healing • Irregular contour deformities
• Mild to moderate discomfort or pain • Hematoma
during the treatment • Fat & tissue necrosis
• Burns, blistering, crusting (thermal • Pulmonary thromboembolism
effect) • Fat embolism
• Bruising • Partial skin erosion
• Soreness • Pulling sensation
• Tenderness • Hemosiderin staining
• Non-specific inflammatory response • Vein perforation
(thermal effect) • Thrombophlebitis or DVT
• Skin burn

QCW Mode Operation in Laser-Assisted Lipolysis
Indication
• Laser-assisted lipolysis
Contra-indications
• Insulin-dependent diabetes (need • Retin-A and similar products 3
a written release from their family days before and 7 days after
tissue disorders • Significant stretch marks

• Mild to moderate discomfort or pain • Irregular contour deformities
during the treatment • Hematoma
• Burns, blistering, crusting (thermal • Fat & tissue necrosis
effect) • Pulmonary thromboembolism
• Bruising • Fat embolism
• Soreness • Partial skin erosion
• Tenderness • Pulling sensation
• Non-specific inflammatory response • Hemosiderin staining
(thermal effect)

QCW Mode Operation in General Surgery
Indication
• Surgical incision/excision,
vaporization and coagulation of • Treatment of Aphthous Ulcers
soft tissue. All soft tissue is
• Excision and Vaporization of
included: striated and smooth
Herpex Simplex I and II
tissue, muscle, cartilage,
meniscus, mucous, membrane, • Laser assisted uvulopaletoplasty
lymph vessels and nodes, organs (LAUP)
and glands, fibroma removal,
frenectomy and frenotomy;
Contra-indications
• Insulin-dependent diabetes (need • Retin-A and similar products 3
a written release from their family days before and 7 days after
tissue disorders • Significant stretch marks

• Mild to moderate discomfort or pain • Irregular contour deformities
during the treatment • Hematoma
• Burns, blistering, crusting (thermal • Fat & tissue necrosis
effect) • Pulmonary thromboembolism
• Bruising • Fat embolism
• Soreness • Partial skin erosion
• Tenderness • Pulling sensation
• Non-specific inflammatory response • Hemosiderin staining
(thermal effect)

3. SAFETY AND REGULATORY COMPLIANCE
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

• Appoint one person that will be responsible for laser controls during treatment.
• Appropriate eye protection (see below) must be worn by the patient and all
operating personnel to prevent inadvertent exposure to the eyes.
• Never look directly into the laser beam even when wearing protective eyewear.
• Never allow the laser beam to be directed to anything other than the targeted
treatment site.
• Never allow jewelry, mirrors or other reflective objects to intercept the laser
beam.
• 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 that they are entering a controlled area.
• It is recommended to use door interlocks that automatically disable the laser
when the treatment room door is opened.
• When the laser system is not in use, place it in STBY mode to prevent
accidental laser emission.
• When the laser system is unattended, remove the key from the key switch to
prevent the system from unauthorized use.
Safety Eyewear
• Ensure that the patient and 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 the Er:YAG 2940 nm wavelength.
The laser safety eyewear recommended for use with the Er:YAG laser
wavelength (2940 nm) should meet the following minimum specification: I 2940
LB4 (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 laser
wavelength (1064 nm) should meet the following minimum specification:
I 1064 LB7 (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 full angle NOHD (m)
(mrad)
Articulated arm exit 8.25 34.42
R04-Ti, R04F 163 1.78
R08-Ti 157.2 1.87
R09-2, R09-2G 13.62 21.32
R09-3 8.80 32.89
R11 9.31 31.04
PS02 163 1.8
PS03 22.25 12.96
FS01 252 1.17
F-Runner scanner 59.05 4.97
S-Runner scanner 15.55 18.72

Nd:YAG Laser
Handpiece Divergence full angle NOHD (m)
(mrad)
Fiber-optic delivery unit 175 190
(945um fiber) - distal end
Fiber-optic delivery unit 164 203
(600um fiber) - distal end
R33 (R33-T) – 2 mm spot 87.5 380
R33 (R33-T) – 3 mm spot 60.5 549
R33 (R33-T) – 4 mm spot 48.5 684
R33 (R33-T) – 5 mm spot 43.1 770
R33 (R33-T) – 6 mm spot 42.1 788
R33 (R33-T) – 7 mm spot 38.9 853
R33 (R33-T) – 8 mm spot 41.6 798
R33 (R33-T) – 9 mm spot 45.3 733
R33 (R33-T) – 10 mm spot 48.9 679
R34 – 15 mm spot 34.2 970
R34 – 20 mm spot 99.2 335
R34-T – 15 mm spot 22.6 1467
R34-T – 20 mm spot 42.2 786
600um bare fiber (with or
164 203
without R27 handpiece)
175 190
176 189
S-11 Scanner 3mm spot 55.5 598
S-11 Scanner 6mm spot 31 1070
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.
WARNING!
To avoid risk of electric shock, this equipment must only
be connected to a supply mains with a protective earth
connection.

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, see Figure 1) is pressed.
Laser Emission Ready Keylock Switch

Indicator key
Touchscreen The correct key must be inserted into the keylock switch to be able to switch on
the laser system (see Figure 1).
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 red Laser Emission Indicator on the front panel and the Ready key at the
bottom of the touchscreen (see Figure 1) will be lit when the laser system enters
the READY state.
An audio signal indicates laser emission when the laser is activated by pressing
Emergency-Off Keylock the footswitch.
Push Button Switch
Fiber and Scanner
connections
Figure 1
Door Switch Interlock

Doorswitch Mainswitch
A remote interlock outlet (door switch, see Figure 2) is provided to disable the
Footswitch Power supply laser system if the operating room door has been opened.
Cord
When the door switch 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 door switch 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.
Potential equalization Safety Interlocks

Terminal
The system cannot deliver a treatment beam unless the fiber-optic delivery unit is
Figure 2 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
(see Figure 1) for easy and safe access during operation, except for the main
power switch and the wireless foot switch (see Figure 2).
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.
Connection Terminal for Potential Equalization Conductor

A potential equalization terminal (see Figure 2) is provided on the rear side of the
laser system to facilitate connection with a potential equalization busbar of the
electrical installation in the laser room if available. For this purpose a separate
potential equalization conductor must be used that can be attached to this
terminal. The terminal complies with the IEC 60601-1 standard.
Microprocessor Controlled Fault Detection

The laser system is a computer-controlled device with many built-in monitoring
and fault detection circuits and procedures.
If the system detects any fault that 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 a corresponding code on the
touchscreen. Additionally, it will switch off the power supply and discharge the
energy storing capacitors.
The operator can remedy advisory messages pertaining to the foot switch, door
switch, fiber or overheating coolant related failures.
In case the system is blocked and displays an "ERROR 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 by 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.

3.6 Electro-Magnetic Compliance Statement
The medical/electrical equipment present in the 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 Pro Line laser system uses RF energy only
CISPR 11 for its 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 Pro 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
WARNING!
The Dynamis Pro Line of medical electrical equipment
should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, all
equipment should be observed to verify normal
operation in the configuration in which it will be used.
WARNING!
Portable and mobile RF communications equipment can
affect medical electrical equipment.
WARNING!
The use of accessories and scanner cables other than
those specified, with the exception of transducers and
cables sold by the manufacturer of the equipment as
replacement parts for internal components, may result in
increased emissions and decreased immunity of the
laser equipment.

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 mode ± 2 kV common

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
and voltage If the operator of the Dynamis Pro line laser system
variations on 40% UT 40% UT requires continuous operation during power mains
power supply (60% dip in UT) (60% dip in UT) interruption, it is recommended that the system be
input lines for 5 cycles for 5 cycles powered from an uninterruptible power supply or battery.
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.

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 the 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 FOTONA LASER SYSTEMS
Dynamis Pro 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 a maximum output power not listed above, the recommended separation distance d in 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. THE LASER SYSTEM IN OPERATION
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 stable 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
• Identify the laser room clearly. Place appropriate warning signs in prominent
locations at all entrances to the laser room.
• Cover windows, portholes, etc. with opaque material to prevent laser light
from escaping from the laser room.
• When the Fotona Dynamis/Spectro laser device is in operation, restrict entry
and limit laser room access to personnel that are booth essential to the
procedure and well trained in laser safety precautions.
• Make sure that all laser room personnel are familiar with the laser system
controls and know how to shut down the laser instantly in an emergency.
• The laser room environment above the laser system must be free from any
obstacles to allow free manipulation of the articulated arm in all operating
positions. Ensure that nothing can fall on the articulated arm.
• The patient must be placed on either side of the laser system in such a
position that he/she cannot reach the laser system console, the touchscreen
or the footswitch and rear side of the equipment.
• When sterile fibers and handpieces are to be used, the operator must appoint
a person who will control the laser (selecting and adjusting the settings for
treatment) on the system touchscreen.
• Inspect and ensure 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
of 1 meter distance is left between the rear side of the device and any
obstacle (e.g. wall, other devices, etc.).
The laser system is designed to operate with ambient temperatures not
exceeding 29°C. In case of higher ambient temperatures, the system may
report a “Coolant overheated” advisory message.
• Inspect and ensure that the main switch (located at the rear of the device,
see Figure 2) is switched off.
• Verify that the switch for the electrical supply outlet used for the laser device
is switched on.
• Inspect and ensure that the device’s power cord is properly inserted in the
mains electrical supply outlet.

4.2 Foot Switch and Interlock Connection
• Connect the foot-switch connector (see Figure 2) to its respective port at the
rear of the device.
If the foot switch 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 foot switch 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 door switch interlock connection in the laser procedure room, please
consult your dealer for assistance.
The door switch interlock port, designated as "DOORSWITCH", is located at the
rear of the device (see Figure 2). 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 or Spectro systems 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 its alignment checked during
installation of the laser system onsite. Only skilled and trained personnel,
authorized by Fotona, may perform the attachment and/or 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. All handpieces
for Er:YAG are displayed in the Dynamis and Spectro laser systems Graphical
User Interface, grouped into the following types:
• Full beam straight (R04-Ti, R08-Ti, R09-2, R09-2G, R09-3, R11)
• Full beam scanned (S-Runner Scanner)
• Fractional (FS01)
• Fractional scanned (F-Runner scanner)

(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 potential
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, or cause fire in the operating
room.
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 the 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 to the below section: Balancing the Articulated Arm.
Sterilization of Er:YAG Handpieces and Beam Delivery

Systems
Upon delivery, all handpieces and 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 or scanner’s Operator
Manual.
Nd:YAG Laser Beam Delivery System and Handpiece

Connection
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.
Some therapeutic procedures need only sterile bare optical fibers without any
handpiece.
There are also therapeutic procedures that require a sterile handpiece (like the
R27-400, R27-600 or R27-1000) to hold and manipulate the distal end of the
sterile fiber.
Some therapeutic procedures use a jumper fiber beam delivery that is connected
between the host laser system’s fiber coupling port and the optical handpiece
input (like the R33, R34, handpieces and S11 scanner). The jumper fiber beam
deliveries are not intended to be sterilized and are not intended to come in
contact with the patient.
The Nd:YAG handpieces in the Graphical User Interface of the Dynamis laser
systems are grouped according to the following types:
• Full beam straight (R33, R34)
• Full beam scanned (S11 Scanner)
• Bare fiber (Fiber 400, Fiber 600, Fiber 1000, R27-400, R27-600, R27-
1000)
Before switching the system on, select and attach the most appropriate fiber
beam delivery and handpiece considering the intended therapeutic application.
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.
The jumper fiber-optic delivery end-face on both the proximal and distal sides
should always be protected with the protective covers supplied with the fiber
when not in use. Before attaching the jumper fiber beam deliveries to the laser
system and handpiece, remove the protective cover on each side of the fiber
and inspect the fiber end-face. The fiber end-faces must be clean with no visible
damage on them. Dirty fiber end-faces will surely cause damage to the fiber
beam delivery as well as to the fiber coupling optics assembly of the host laser
system.
CAUTION!
Please note that the fiber beam deliveries used with R33
and R34 handpiece are different than fiber deliveries
used for all other Nd:YAG handpieces, including the S11
Nd:YAG scanner. Carefully read the R33 and R34
handpiece Operator Manual to properly choose and
attach the correct fiber beam delivery for the R33 and
R34 handpieces.
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 the R27 handpiece
Operator Manual as well as the Application Notes for
handling the sterile fibers for endovenous and lipolysis
treatments.
The jumper fiber-optic delivery units for the R33 and R34
handpieces and the S11 scanner should NOT be
sterilized.

Sterilization of Nd:YAG Handpieces and Beam Delivery
Systems
• For Endovenous applications:
Endovenous applications are performed with 600 µm bare single-use or
reusable sterile fibers without any handpiece.
WARNING!
Use proper aseptic technique when removing single-use
or reusable 600 µm sterile fibers from their original
sterile packaging.
Do not reprocess fibers that are intended for single-use!
Reusable fibers are delivered with the instructions
provided by the fiber manufacturer. Reprocess the
reusable fibers according to instructions given in the
manufacturer’s Instructions For Use.
• For laser lipolysis applications:

Laser lipolysis is performed with the reusable R27 handpiece and a 600
or 1000 µm bare single-use sterile fiber. The supplied handpiece is not
sterile. To sterilize the reusable R27 handpiece, follow the instructions in
the R27 handpiece Operator Manual.
CAUTION
Note that the R27 handpiece is not sterile. It should be
sterilized before each use according to the instructions
in the handpiece’s Operator Manual. Reprocess the
handpiece in accordance with the instructions given in
the handpiece’s Operator Manual.
WARNING
Use proper aseptic technique when removing single-use
400, 600 or 1000 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 400, 600 or
1000 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 jumper fiber optic beam delivery unit used for the
R33 and R34 handpieces and the S11 Nd:YAG scanner
should be handled in accordance with instructions in
respective handpiece’s 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, or if 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 or Spectro laser
system.
1. Detach the jumper fiber-optic beam delivery system used for the
Nd:YAG single or multi spot handpieces.
2. Attach the scanner jumper 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 or Spectro front panel.
4. With the supplied clamps attach the scanner cable to the fiber beam
delivery at 40-50 cm intervals along the scanner cable (see Figure 3
below). By doing so, the scanner cable or fiber beam delivery will not
come in contact with the patient.
5. 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.
6. To correctly set the operating parameters, see the section: Nd:YAG S-
11 Scanner Operation Mode.

Figure 3: Scanner cable together with fiber beam delivery.
NOTE
When using the Fotona S-11 scanner, three different spot sizes can be selected: 3 mm,
6 mm and 9 mm.
Attach the optics for the desired spot size to the Fotona S-11 scanner head. If the
attached optics does not match the selected spot size on the touchscreen, the system
will issue an advisory message to attach the correct optics.
If a 2 mm spot size is to be used with the S11 scanner, a 600 um fiber instead of the
standard 945 um jumper fiber delivery should be utilized together with 3 mm inlet and
outlet optics. The 945 um fiber is to be detached from the S11 scanner and laser system
and replaced by a 600 um jumper fiber beam delivery.
WARNING!
Never use the 600 um jumper fiber beam delivery for
3 mm, 6 mm or 9 mm spot size with the S11 scanner. The
fluences realized with 3 mm, 6 mm and 9 mm spot sizes
will be 2.5 times higher than that selected on the display,
which may cause serious injury.
The 3 mm, 6 mm and 9 mm spot sizes should always use
the standard 945 µm fiber.
WARNING!
Never use the jumper fiber beam delivery assembly

intended for the R33 or R34 handpieces with the S11
scanner or the R33 and R34 handpieces. This may cause
serious damage to S11 scanner or the R33 and R34
handpieces.
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 or S-Runner
Scanner before attaching the scanner to the host Fotona SP/XS Dynamis or SP
Spectro laser system.
1. Attach the optical input of the scanner to the host laser system’s
articulated arm exit.
2. Attach the scanner cable to the Er:YAG scanner port on the host laser
system’s front panel and to the scanner connector on the scanner body.
3. On the host laser system, select an application with the attached

scanner.
4. To correctly set the parameters, refer to the section Er:YAG F-Runner
Operation Mode for the F-Runner scanner and to the section Er:YAG S-
Runner Operation Mode for the S-Runner scanner.
NOTE
The scanner cable must be attached with the supplied clamps along the articulated
arm as shown in Figure 4 below.
Figure 4: The scanner cable attached to the articulated arm.

4.6 Balancing the Articulated Arm
The articulated arm can be balanced and adjusted according to the user’s
preference. The articulated arm’s weight pivot has red spots and a black screw
counterbalance adjustment. The articulated arm’s balance weight has two red
spots - one for balancing the handpiece and 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 red spot on
the weight with the red spot on the articulated arm (as in Figure 5 Bottom). When
using a scanner rotate the weight 180 degrees (as in Figure 5 Top). The black
counterbalance screw can be adjusted according to the user’s preference.
Figure 5: Articulated arm and balance. In scanner position (Top) and in handpiece position (Bottom).
4.7 Expected Position of the Operator and Patient

Patients must be placed on either side of the laser system in such a position that
they cannot reach the laser system console, the touchscreen, foot switch or the
rear side of the equipment, so that they cannot reach any controls of the laser
device during the procedure.
In cases where sterile fibers and handpieces are used, the operator must
appoint a responsible person for selecting and adjusting the settings for the
treatment on the system touchscreen in order to keep the operating environment
sterile.

4.8 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 mains power switch located at the rear of the device. The
welcome screen with the Fotona logo appears on the system’s touch screen.
• When the “Turn key on” message appears on the touchscreen (see Figure 6
below), insert the key in the key-lock switch and turn it to the horizontal ON
position. The system will now continue with a self-test and detect all the
installed technologies configured according to the end user order. The
progress of the self-test can be seen on the touchscreen. During the self-test
procedure the system checks the complete device for proper operation.
Figure 6: Welcome Screen for SP Dynamis.
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.
After completing the self-test, the system enters the Treatment group selection
menu (see Figure 7 below).

Figure 7: Dynamis/Spectro laser systems Treatment Group selection window for the Er:YAG laser
source.
NOTE
After choosing wavelength, treatment groups are presented on screen. Each
treatment group consists of different presets. For actual medical applications consult
the Applications manual.
Switching the System Off

• If the system is in the Treatment Group selection menu, turn the key-lock
switch to the vertical OFF position. The system will revert to the Welcome
window (detected technologies window), in which the laser cooling system
and power supply are turned off. To completely de-energize the system, turn
the main switch off on the rear side of the system.
• If the laser system is in the READY state, indicated by a red led light on the
host laser system’s front plate, touch the STANDBY key on the touchscreen
to put the system into the STANDBY state.
NOTE
The laser system automatically reverts to the STANDBY state after 3 minutes without
any action in the READY state.
• When the system is in the STANDBY state, turn the key in the key-lock
switch to the vertical OFF position. The system will revert to the Welcome
window (detected technologies window), in which the laser cooling system
and power supply are turned off.
• Remove the key to prevent unauthorized use of the laser system.
• To completely de-energize the laser system, switch off the main switch on the
rear side of the laser system.
Stopping the Laser System in Case of Emergency

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 laser system will be completely de-energized (turned-off) including the
touchscreen too.

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.
• Turn the main switch on the laser system’s rear side to the OFF position
• Perform the Switching the System ON procedure as previously described
above.
4.9 Graphical User Interface (GUI)
4.9.1. Dynamis and Spectro User Interface Features

Each laser source has a number of treatment groups, within which the user may
select from a number of pre-set treatments from a library. Many treatments can
be performed with different handpieces.
The Fotona Dynamis and Spectro laser systems support different handpieces for
the Er:YAG laser and for the Nd:YAG laser. During treatment selection, the
handpiece must also be selected. The user interface shows only those
handpieces that have been installed.
In laser systems that have two laser sources (Er:YAG and Nd:YAG), a dual-
wavelength TwinLight source can also be configured for groups of applications
that are multi-step treatments utilizing both the Er:YAG and Nd:YAG laser
wavelengths.
In model M001-12F only treatment groups that utilize the Nd:YAG laser source
are available.
In model M002-2A only treatment groups that utilize the Er:YAG laser source are
available.
For each laser source there is an Expert group (Expert Er or Expert Nd) in
which, rather than selecting an application (treatment), the user may select a
type of handpiece (like full beam straight, , full beam scanned, patterned beam
straight, , fractional , scanned fractional, bare fiber, etc..) and a particular
handpiece model.
The Expert group feature is intended for advanced users who are well
acquainted with Fotona handpieces and are capable of adjusting the settings
with the selected handpiece for the application they intend to perform.
4.9.2 Treatment Group Selection

After the laser system has completed the self-test, the Treatment Group
selection window (or HOME window) will be displayed on the touchscreen, with
the laser source last used highlighted and the corresponding selectable
treatment groups listed (see Figure 8 below).

Figure 8: Dynamis/Spectro laser systems Treatment Group selection window for the Nd:YAG laser
source.
NOTE
After choosing wavelength, treatment groups are presented on screen. Each
treatment group consists of different presets. For actual medical applications consult
the Applications manual.
In the Treatment Group selection window for the highlighted laser source, the
installed treatment groups can be selected by touching the treatment group
name on the touchscreen.
4.9.3 Settings menu
The Settings menu can be accessed from Home screen (Treatment group
selection menu):
Settings
button
Figure 9: Treatment groups selection screen with Settings button

NOTE
Please note that the Treatment groups shown on screen depend on the installed SW
Option.
• Touch the Settings button indicated on figure above.

• The Settings menu opens:
BACK
button
returns to
previous
screen
Figure 10: Settings menu
In Settings menu various programs and service firmware can be accessed to

support system settings and servicing:
• Language selection – after touching the Language button select the desired
language and confirm the selection.
• Counter – access to total laser shots counter for each laser. To reset each
lasers total shot counter a password is needed after touching the reset
button.
• TS Calibration – Touchscreen calibration
NOTE
This function should be used only if Fotona service staff will ask you to perform
touchscreen calibration.
When asked to do it:
After touching the TS calibration button touch each cross in center of circles
appearing successively in each corner of the screen until OK is displayed and
wait for calibration to end. For each corner of the screen 15 seconds are at
disposal to touch the cross in center of circle.

CAUTION!
Performing the calibration by touching the regions outside each circle with
cross will recalibrate the touchscreen in a way that it may not respond as
expected. In such cases calibration of the screen will be needed as
described above.
• History log – Access to error history log. 15 last detected ERROR Codes will
be displayed with a date and time stamp. By touching the ERROR Code row
a description of the ERROR Code will appear for several seconds.
• Welcome banner - (by default the factory set Welcome string is the
commercial name of the device) – if edited the factory set Welcome string will
be changed to the edited one.
• Info – This button currently has no function
• Group config – Accessible only with Custom Groups Code which is different
for each laser system. To be used only by trained service personnel.
• Er:YAG Service – Opens Er:YAG laser service menus – accessible only with
Service Code. To be used only by trained service personnel.
• Er:YAG Headpieces – opens Add/Remove Er:YAG handpieces menu
(enables/disables the display of installed handpieces for each application with
Er:YAG laser). To be used only by trained service personnel.
• Nd:YAG Service – Opens Nd:YAG laser service menus – accessible only
with Service Code. To be used only by trained service personnel.
• Nd:YAG Handpiece – opens Add/Remove Nd:YAG handpieces menu
(enables/disables the display of installed handpieces for each application with
ND:YAG laser). To be used only by trained service personnel.
4.9.4 Selecting the Laser Source

In the Treatment Group selection menu, the installed laser sources can be
selected by touching the desired laser source button on touchscreen. For each
laser source, a list of installed treatment groups is displayed on the screen.
Select a treatment group by touching its name on the touchscreen.
• For SP Dynamis and Spectro, both Er:YAG and Nd:YAG as well as the
combined (TwinLight) laser sources can be selected.
• For XP Dynamis and Spectro, only the Nd:YAG laser source can be
selected.
• For XS Dynamis, only the Er:YAG laser source can be selected.
4.9.5 Selecting a Treatment Group with a Selected Laser

Source
By touching the Treatment Group name button on the touchscreen, the last used
application from the selected group will be recalled and displayed on the
touchscreen.
4.9.5.1 Expert Er or Expert Nd Groups
The Expert groups are intended for skilled users who are well acquainted with
Fotona handpieces and their properties. Instead of selecting an application, the
user selects the handpiece type and then the handpiece itself.
Expert Er Group
In the Expert Er group the library of handpieces is shown in Figure 11

below.

Figure 11: Expert Er group handpieces library.
There are a number of different handpieces which are grouped by seven

types for the Er:YAG laser and three types for the Nd:YAG laser.
The handpiece types in the Expert Er group are:
• Full beam straight (R04-Ti, R08-Ti, R09-2, R09-2G, R09-3, R11)

• Full beam side firing (R11-GA, R11-GAc, R11-GC, R11-GCc)
• Full beam scanned (S-Runner scanner)
• Patterned beam straight (PS01, PS02, PS03, PS03-A)
• Patterned beam side firing (PS03-GA, PS03-GAc, PS03-GC, PS03-
GCc)
• Fractional beam straight (FS01)
• Fractional beam scanned (F-Runner scanner)
NOTE
Please note that only those handpieces will be displayed that are installed.
NOTE
Please note that when using GA and GC adapters with a glass speculum, you should
select the GAc or GCc options for the R11 and PS03 handpieces in the GUI.
When using a wire speculum, you should select the GA or GC options for the R11 and
PS03 handpieces in the GUI.
Expert Nd Group
The handpiece types in the Expert Nd group are:
• Full beam straight (R33, R34)

• Full beam scanned (S11 Scanner)
• Bare fiber (Fiber 600, Fiber 1000, R27-600, R27-1000)
NOTE
The appearance of the Expert Nd handpieces library is shown in Figure 12

bellow.

Figure 12: Appearance of the Expert Nd handpieces library.
NOTE
After selection of the handpiece type, the handpiece model must be selected
and confirmed. Instead of application names, the handpiece types and models
will be displayed.
The information line on the screen will display the last saved key settings for the
selected handpiece type and model.
After confirmation, the application screen with last-saved settings for the
selected handpiece type and model will be displayed.
4.9.6 Application Libraries of the Selected Treatment Group

The applications libraries can be accessed through the application screen. In the
application screen, the settings for the application are displayed and can be
adjusted. From the application screen the READY state can be entered.
There are two different applications libraries in the Graphical User Interface:
• Fotona’s pre-set library of applications

• The personal library of applications created, named and saved by the
user
Numerous pre-set applications are included in the libraries of the Dynamis and
Spectro laser systems.
Two toggle buttons on the touchscreen are provided in the GUI that allows for
switching between the applications library and application window (see Figure 13
below).

Toggles
between
Fotona pre-
set library and
application
screen
Toggles
between
Personal
library and
application
screen
Figure 13: Typical application screen for a pre-set Fotona application.
4.9.6.1 Fotona Pre-set Library of Applications

The application screen for Fotona pre-set applications is indicated with the
icon in the toggle button. By touching this button the screen will show the
pre-set applications library for the current application group.
The button icon will change to indicating that the system is now in the pre-
set applications library.
NOTE
The same action can be achieved also by touching the handpiece selection button,
since the selection of handpieces is available in the applications library screen.
Generally each application is defined by selecting the application name and the
handpiece model with which the application can be performed (see Figure 14
below).
Figure 14: Typical applications library screen for Fotona pre-set applications, where applications are
selected by the name of the application.
For some application groups, the applications are selected by pictograms (for
example, the Veins treatment groups with the Nd:YAG laser or Skin Resurfacing
groups with the Er:YAG laser), or by name if there are no pictograms (see Fig.

15).
Figure 15: Typical Applications library screen for Fotona pre-set applications, where the applications
are selected with pictograms.
After selection of an application, the handpiece selection is to be performed on

the left side of the screen by touching the handpiece name.
• The picture of the handpiece will be displayed after the selection.
• The key settings parameters will be displayed also in the info row
(handpiece type, fluence, spot size, pulsewidth, frequency, etc.)
• The confirmation button will be highlighted .
By touching the confirmation button the system enters the application screen for
the selected application with all application settings recalled from the library.
NOTE
Please note that only those handpieces that are installed will be available for
selection.
NOTE
The practitioner should be aware that the skin structure differs from person to person,
so treatment parameters and protocols will differ from case to case. Suggested
parameter ranges in the Applications Manual as well as pre-sets in Fotona laser
systems should be taken only as guidelines. The practitioner should adjust the laser
treatment procedure and selection of treatment parameters from case to case based
on the intended clinical end-point.
4.9.6.2 User-created (Personal ) Library of Applications

Each treatment group aside from the pre-set Fotona Library of applications also
has its own user-created Personal library of applications. Access to the library is
possible at any time by touching the button in the Fotona pre-set

application screens or applications library screens. At first installation of the laser
system, these libraries are empty as shown in Figure 16.

Toggles
between
Personal
applications
library
screen and
application
screen
Figure 16: Personal library appearance on a newly installed system.
The creation of personal applications in the personal library will be described

later in this manual. An example of a Personal applications library with two user-
created applications is shown in Figure 17.
Information
row
Figure 17: Appearance of a Personal applications library with

two user-created applications.
To select an application, simply touch the desired application. The key settings
for the selected application will be displayed on the info row (handpiece model,
operating mode, fluence, frequency, etc.
To confirm the selected application, touch the button. The application screen
with settings will be recalled and displayed on screen (see Figure 18).
Toggles
between
Personal
applications
library
screen and
Fotona
application
screen
Figure 18: User-created application screen appearance.

4.9.7. Application Screens: an Introduction
The applications screens are those screens where the settings of parameters for
treatment are displayed, and from which the user may enter the READY state
and start the treatment by pressing the foot switch.
All applications screens are similar but differ in appearance depending on the
handpiece type and operating mode used.
Each application screen has a More Settings screen that is accessed with the
button. In the More Settings screen, the aiming beam (pilot) intensity (and in
some cases additional settings) can be adjusted. In each More Settings screen
there is a session counter that displays the laser shot count and also a reset
button.
Fotona Pre-set Applications Settings

Pre-set Fotona settings are provided for applications in every treatment group.
These settings cannot be deleted and they are always at disposal to be recalled.
When original Fotona settings are used, this is indicated with an icon in the
settings indicator button in the form of a green star . If any parameter of the
settings is changed, this is indicated with an icon in the settings indicator

button.
A typical application screen appearance with an explanation of buttons and icons
is shown in Figure 19 below.
Home Burst Laser
Operation
button Save mode source and
mode
button selection wavelength
selection
button indicator
button
Toggles
between
Settings
application
indicator
screen and
button
application
library
More
Settings
Selected screen
handpiece button
and Ablation
handpiece and
selection coagulation
button depth
indicator
Energy/
Fluence
units button Frequency
slider and
adjustment
buttons
Fluence/
Energy
adjustment Spot size
slider slider
STBY/READY
Figure 19: Typical Application screen appearance.
4.9.8 Application Screens with the Er:YAG Laser and Settings

Adjustment
The appearance of the applications screen depends on the type of the
handpiece and the operation mode. There are applications screens for:
• Fotona pre-set applications and

• For user-created personal applications (see above).
The settings adjustment is the same for both user-created personal applications
and Fotona pre-set applications. The only difference is that for user-created
personal applications, a change of handpiece cannot be performed.

Application Settings with Full Beam Handpieces
The Operating modes of the Er:YAG laser are represented by the mnemonics
MSP, SP, LP, VLP and XLP. They are acronyms for the pulse widths of the
Er:YAG laser:
• MSP – Micro Short Pulse

• SP – Short Pulse
• LP – Long Pulse
• VLP – Very Long Pulse
• XLP – Extra Long Pulse
The shortest pulses have the highest peak power.
The application screen appearance when full beam, straight or side-firing

handpieces with MSP, SP, LP, VLP and XLP operation modes is shown in
Figure 20 below.

Burst mode Ablation and
Operation mode selection
Save selection button coagulation
button depths
button
indicator
Selected More Settings

handpiece menu button
and
handpiece
selection Frequency
button with slider
adjustment
buttons
Spot size
Fluence with slider
with slider adjustment
adjustment buttons
buttons
STBY/READY
button
Figure 20: Application screen appearance with full

beam handpieces.
For handpieces with fixed spot size (R08-Ti, R09-2, R09-2G, R09-3) the spot
size is not displayed in the application window since it cannot be adjusted. The
spot size for those handpieces is shown on the info row of the applications
library and handpiece selection menu.
Handpiece Selection:
By pressing the handpiece button, the selected group applications
library with the highlighted current application and handpiece will be
displayed (see Figure 21 below).
Information
row
Figure 21: Applications library in which the current application and

handpiece are highlighted.
Select the desired handpiece. In the Info row the pre-set key settings for
the desired handpiece for the current application are recalled and
displayed (handpiece model, operation mode, frequency, Burst mode,
fluence, spot size, ablation and coagulation depths per pulse). By
touching the settings indication button, choose between alternative or
the original Fotona settings.
Confirm the selection with the button. The application screen with the
selected handpiece will be displayed.

Operation Mode Selection:
By touching the operation mode button, a pop-down menu opens for
selecting the operation mode. MSP, SP, LP, VLP or XLP operation
modes can be selected if the current spot size is smaller than 5 mm. For
spot sizes greater than 5 mm, an additional Smooth burst mode will
appear in the pop-down menu.
Select the desired Operation mode.
NOTE
When changing the operation mode, the system keeps the spot size and handpiece
type the same, while the fluence and pulse width may change.
Burst Mode Selection (see Figure 22 below):
By touching the burst mode button, a pop-down menu opens offering a

choice between Basic, Turbo2, Trubo3,…, Turbo6 burst modes. The
TurboN burst mode means that N pulses are performed on the same
position. The Basic burst mode corresponds to delivering a single laser
pulse on a selected position with the fluence and repetition rate
displayed. When changing the burst mode form Basic to TurboN:
• The pulsewidth of the TurboN pulse, with an adjustment slider
and adjustment buttons, is displayed in the application screen.
• The fluence in the Basic operation mode is increased by a factor
N (N-times the fluence in BASIC Burst mode).
Fluence
More Settings
menu button
Fluence
slider
Frequency
with slider
and
Increase/ adjustment
Decrease buttons
adjustment
buttons
Spot size with
slider and
adjustment
Pulsewidth
buttons
of TurboN
pulse with
slider and
adjustment
buttons STBY/READY
button
Figure 22: Application screen with Stacking mode pulsewidth slider

and adjustment buttons.
Fluence Selection:
Fluence adjustment is performed by the slider or by touching the
decrease (<) or increase (>) adjustment buttons which decrease or
increase the fluence in discrete steps.
The red bar above the fluence shows the level of the current fluence to
the max available.

Frequency Selection:
The Frequency (repetition rate) adjustment is performed in the same
way as fluence, with the slider or adjustment buttons.
Spot Size Selection:

The spot size is displayed and can be adjusted only for handpieces with
variable spot size. The adjustment is performed with the slider or
adjustment buttons.
The More Settings Menu Screen:

By touching the More settings menu button in the application screen, the
More Settings menu opens (see Figure 23 below).
Figure 23: More settings menu appearance for full beam handpieces.
In the More Settings menu:

The aiming beam (pilot) intensity level can be adjusted with the
corresponding buttons on the screen (see figure above). The intensity
ranges from level 0 to 7. Level 0 corresponds to the lowest intensity.
The laser shots session counter indicates the delivered laser shots. To
reset the laser shots counter, touch the button.
Application Settings with Full Beam Straight in SMOOTH Mode
The SMOOTH operation mode can be selected through the Operation mode
drop-down menu button only when the spot size of the current handpiece is
5 mm or higher. The appearance of the application window is shown in Figure 24
below:

More Settings menu
button
SMOOTH
pulse
number
with slider
and
adjustment
buttons
Figure 24: Application screen for SMOOTH operation mode.

By touching the operation mode button, a drop-down menu opens for
selecting the operation mode. MSP, SP, LP, VLP, XLP and SMOOTH
operation mode can be selected. Select the desired Operation mode.
NOTE
When changing the operation mode, the system keeps the spot size and handpiece
type the same, while the fluence and frequency may change.
Fluence Selection:
Fluence adjustment is performed by the slider or by touching the
decrease (<) or increase (>) adjustment buttons, which decrease or
increase the fluence in discrete steps.
The red bar above the fluence shows the level of current fluence to the
max available.
The Frequency (repetition rate) adjustment is performed in the same
way as the fluence with the slider or adjustment buttons.

The spot size is displayed and can be adjusted only for handpieces with
variable spot size. The adjustment is performed with the slider or
adjustment buttons.

SMOOTH Pulse Number Selection:
The number of SMOOTH pulses delivered by each activation of the foot
switch can be limited by the selection of a SMOOTH pulse number.
When the selected number of SMOOTH pulses with the selected fluence
and repetition rate are delivered, the laser emission stops, the foot
switch must be released, the handpiece repositioned to a new position
and the foot switch activated again.
The number of SMOOTH pulses that will be delivered in a train, when
the foot switch is activated, can be set in a range from 1 to 9. The setting
is adjusted with the slider or adjustment buttons in discrete increments
of 1.
NOTE
The settings for the SMOOTH pulse number in a train can be disabled by
touching the SMOOTH pulse number. When the SMOOTH Pulse number setting
is disabled, this is indicated by a change of black number color to grey. When
the SMOOTH pulse number setting is disabled, a continuous train of SMOOTH
pulses will be delivered with the selected frequency while the foot switch is
pressed.
More Settings Menu Screen:

The More Settings menu screen appearance and items available for
selection is the same as for full beam handpieces in MSP, SP, LP, VLP
and XLP operation modes, as previously described above.
Application Settings with Full and Fractional Beam Scanners

In Fotona Dynamis/Spectro laser systems, the full beam scanned handpiece
used is the model S22 (S-Runner) scanner. The S-Runner scanner delivers
4 mm laser spots in patterns with adjustable size, overlap of laser spots and
method of scanning sequences (patterns). The application screen with S-Runner
scanner appearance is as shown in Figure 25 below:
Scanning
pattern
button
More Settings
menu button
Overlap of
laser spots
in a scan
pattern
Figure 25: Application screen with S-Runner scanner.
Since the S-Runner is delivering fixed laser spots with a diameter of 4 mm, its
spot size is not shown in the application screen.

By touching the Operation mode button a pop-down menu opens where
the operation mode can be selected from MSP, SP, LP, VLP and XLP
options.

NOTE
When changing the operation mode the system may change the fluence and
frequency.
The S-Runner does not support SMOOTH operation mode since the spot size is
smaller than 5 mm.
Burst Mode Selection:
By touching the Burst mode button, a drop-down menu opens in which

the Basic, Turbo1, Turbo2, …, Turbo6 burst modes can be selected.
When changing the stacking mode form Basic to TurboN:
• The pulsewidth of the TurboN pulse, with adjustment slider or

adjustment buttons, is displayed in the application screen.
• The fluence in Basic operation mode is increased by a factor N
(N-times the fluence in Basic stacking mode).
The Fluence and Frequency Selection:

With corresponding slider or adjustment buttons.
With corresponding sliders or adjustment buttons.
Laser Spots Overlap Selection:

With the corresponding slider and adjustment buttons, four discrete
overlaps can be adjusted: 0%, 13% 20% and 30%.
Scanning Pattern Selection:

By touching the scanning pattern button, a pup-down menu opens with
three options: Optimal, Sequential and Partial. Select the desired
scanning pattern.
The entire scan shape of the Fotona S-Runner Er:YAG scanner
is shown in Figure 26 below. 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.
Figure 26: Typical representative scan pattern of the S-Runner scanner.
Sequential Scanning Pattern

The 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.

Optimal Scanning Pattern
The 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 Optimal
scanning sequence is recommended for performing scanner treatments
that require high fluence levels to be delivered to the skin at high
repetition rates.
Partial Scanning Pattern
The Partial scanning sequence is based on the same non-successive

spot deposition principles as the Optimal 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 More Settings menu. The Autorepeat time pauses provide
additional cooling in the treatment site, which makes the Partial
scanning sequence particularly useful when treating patients with a low
pain threshold.
S-Runner Scanner Autorepeat Time Setting in the More Settings Menu
By touching the More Settings menu button in the application screen,
the More Settings screen for the S-Runner scanner will open, where in
addition to the aiming beam (pilot) intensity level, the Autorepeat time
can be adjusted as shown in Figure 27 below.
Aiming
beam
(Pilot)
instensity
adjustment
buttons
BACK button
Autorepeat
time setting
buttons
increase/
decrease
in steps of
0.1 s.
Reset
button for
laser shots
in session
counter
Figure 27: The More Settings menu that facilitates adjustment of the Autorepeat time and aiming
beam (Pilot) intensity. The laser shots Session counter displays the number of laser shots.
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!
Application Settings with the F-Runner Fractional Scanner

For Fotona Dynamis/Spectro laser systems, the Fractional beam scanned
handpiece used is the model F22 Scanner (F-Runner). It generates four pixels in
a single laser shot with each pixel having a diameter of 0.25 mm (see figures
below). The pitch between pixels was designed to realize adjustable coverages
of 5%, 10% and 20%. The fluence per pixels is adjustable. The application
screen with F-Runner scanner appearance is as shown in Figure 28 below:

Figure 28: Application screen for F-Runner fractional scanner.
Since the F-Runner delivers fixed laser spots (pixels) with a diameter of 0.25
mm, its spot size is not shown in the application screen.

By touching the Operation mode button, a drop-down menu opens
where the operation mode can be selected from: MSP, SP, LP, VLP and
XLP.
NOTE
When changing the operation mode, the system may change the fluence and
frequency.
The F-Runner does not support SMOOTH operation mode.

the Basic, Turbo1, Turbo2, …, Turbo6 Burst modes can be selected.
When changing the burst mode form Basic to TurboN:
• The pulsewidth of the TurboN pulse, with an adjustment slider
and adjustment buttons, is displayed in the application screen.
• The fluence in the Basic operation mode is increased by a factor
N (N-times the fluence in BASIC Burst mode).
The Fluence per Pixel and Frequency Selection:

Use the corresponding sliders or adjustment buttons.
The Coverage selection:

Use the corresponding slider or adjustment buttons. Three discrete
Coverages can be adjusted: 5%, 10% and 20%.
NOTE
Coverage means the percent of laser-treated surface per unit surface.
Use the corresponding slider or adjustment buttons.

By touching the scanning pattern button, a drop-down menu opens with
two options: OPTIMAL and NATURAL.
The NATURAL pattern is semi-random, while the OPTIMAL pattern is a
regular grid which is always the same. Each pattern is composed of 4
spot sub-units.
The entire scan shape of the Fotona F-Runner Er:YAG scanner is

shown in Figure 29 below. 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 F-Runner operator
manual.
Figure 29: Scan Patterns of the Fotona F-Runner Scanner (A) Optimal (B) Natural
The width, height and precent coverage of the scan can be changed.
The width and height are adjusted on the scanner keyboard. The
coverage is set with the laser system control panel. For 5% coverage
the scan is performed in a single pass, for 10% in two passes for 20% in
four passes. When F-22 is used in the non-fractionated manner the
handpiece is set to a single spot non-scanning pattern or to a scanning
pattern with 100% coverage.
Autorepeat Functionality
Between each complete scan, a temporary outlining shape will be
visible, indicating the Autorepeat pause. The Autorepeat pause outline is
shown as follows:
Adjust the length of the autorepeat pause in the More Settings menu as
in the case with the S-Runner scanner (described above).

The More settings menu screen appearance and selection items are the
same as for the S-Runner scanner as previously described above.
WARNING!
Application Settings with a Fractional Handpiece

The fractional handpiece used with Dynamis laser systems is the model FS01
handpiece. With diffractive optics, the handpiece generates a matrix of 9x9

pixels in a square of 8.8 x 8.8 mm. Each pixel has a diameter of 0.25 mm. The
pixel pitch was designed to assure a fixed coverage of 5%. The Application
screen appearance with the FS01 handpiece is shown in Figure 30 below for the
Basic Burst mode:
Figure 30: Application screen with the FS01fractional handpiece

in Basic Burst mode.
Since the FS01 handpiece delivers fixed laser spots (pixels) with a diameter of
0.25 mm, its spot size is not shown in the application screen.

By touching the Operation mode button, a drop-down menu opens
where the operation mode can be selected from: MSP, SP, LP, VLP and
XLP.
NOTE
When changing the operation mode, the system may change the fluence and
frequency.
The FS01 handpiece does not support SMOOTH operation mode.

the Basic, Turbo1, Turbo2, …, Turbo6 Burst modes can be selected.
When changing the Burst mode from Basic to TurboN:
• The pulsewidth of the TurboN pulse, with an adjustment
slider and adjustment buttons, is displayed in the application
screen.
• The fluence in the Basic operation mode is increased by a
factor N (N-times the fluence in BASIC Burst mode).
• The frequency changes to a repetition rate of TurboN pulses.
Fluence per Pixel:

Coverage Selection:
Fixed at 5% (not displayed in the application screen).
NOTE
Coverage means percent of laser-treated surface per unit of surface coverage.


By touching the More Settings menu button, the More Settings menu
screen opens. The appearance is the same as for full beam handpieces
previously described above.
When a Burst mode other than Basic is selected, the TurboN pulsewidth
appears on the screen with a slider and adjustment buttons as shown in Figure
31 below:
TurboN
Pulsewidth
with slider
and
adjustment
buttons
Figure 31: Application screen with FS01 fractional handpiece

when Turbo2 Burst mode is selected.
4.9.9 Application Screens for the Nd:YAG Laser and Settings

Adjustment
As with Er:YAG applications, the appearance of the applications screen depends
on the type of handpiece and the operation mode.
There are applications screens for:
• Fotona pre-set applications and
• User-created personal applications (see above).
The settings adjustment is the same for both user-created personal applications
and Fotona pre-set applications. The only difference is that for user-created
personal applications, a change of handpiece cannot be performed.
Operation Modes for the Nd:YAG Laser

In Fotona Dynamis/Spectro lasers, two basic operation modes are implemented:
Pulse (VERSA or FRAC3), and QCW.
The VERSA operation mode stands for medium duration laser pulses ranging
from 5 to 50 ms. Their distinct feature is their high energy (up to 50 J). .
For pulse durations below 2 msec FRAC3 mode pulses can be selected.
The QCW operation mode stands for a continuous laser pulse train. This is used
for surgical applications. The pulsewidth range for QCW pulses ranges from 0.1
to 2 ms, with repetition rates up to 100 Hz.
For better control of the delivery of laser energy during the burst of pulses to the
same treatment area a Piano burst mode can be pre-selected.

Application Settings with Full Beam Handpieces for VERSA Operation
Mode
In Fotona Dynamis/SPectro laser systems, the full beam handpieces for the
Nd:YAG laser are: Model R31, R33 and R34.
The appearance of the Application screen is shown in Figure 32 below:
Save button Operation modes button

Laser source and
Home button wavelength
indicator
Toggle button
for switching
between Settings indication
applications button
library and
application
screen More Settings
Handpiece Frequency with

selection slider and
adjustment buttons
Fluence with
slider and Spot size with slider
adjustment and adjustment
buttons buttons
Pulsewidth
with slider and STBY/READY button
adjustment
buttons
Figure 32: Application screen for Full beam handpieces

for VERSA operation mode.
By pressing the handpiece button, the selected group applications
Figure 33: The applications library with the handpiece selection screen.
Select the desired handpiece. In the Info row, the pre-set key settings for
the desired handpiece for the current application are recalled and
displayed (handpiece model, operation mode, frequency, , fluence,

spot size). By touching the settings indication button, choose either
alternative or the original Fotona settings.
Confirm the selection with the button. The application screen with the
selected handpiece will be displayed.

By pressing the operation mode button, a drop-down menu opens for
selecting the operation mode. Select the desired operation mode.
NOTE
When changing the operation mode, some of the settings may change they cannot be
supported by the system.
Fluence Selection:
Use the corresponding slider or adjustment buttons (see the application
screen above).
screen above).
Pulsewidth Selection:
screen above).
NOTE
Change of pulsewidth may cause an automatic change in fluence and/or frequency in
order to accommodate the settings to the capabilities of the laser.

screen above).
After selection of the spot size for the selected handpiece, always
ensure that the selected spot size corresponds to the spot size on the
handpiece.
NOTE
Change of spot size may cause an automatic change in fluence and/or frequency in
order to accommodate the settings to the capabilities of the laser.

By touching the More Settings menu button, the More Settings screen
will be displayed (see Figure 34 below).

Figure 34: Appearance of the More Settings screen when an R33 or R34
handpiece is used.
In the More Settings screen, the following settings are available:
The Aiming Beam (Pilot) Intensity Setting:

With the corresponding buttons (see figure above) the intensity level can
be adjusted from level 0 to level 7. Level 0 corresponds to the lowest
intensity.
Session Counter:
Indicates the total laser shots delivered in session. A reset button
for the laser shot counter is also provided.
Application Settings with Full Beam Handpieces for Piano Burst Mode
When Piano burst mode is selected, the application screen appears as shown in
Figure 35 below.
Fluence with slider PIANO pulse

and adjustment repetition time with
buttons slider and
adjustment
buttons
Spot size with

PIANO slider and
pulsewidth with adjustment
slider and buttons
adjustment
buttons
STBY/READY
button
Figure 35: Application screen for PIANO operation mode.
By touching the handpiece button, the selected group applications
displayed. Select the desired handpiece and confirm the selection as in
the case for the VERSA operation mode described above.

selecting the operation mode.
Select the desired Operation mode.
NOTE
When changing the operation mode, the handpiece and spot size remain the same,
The pulsewidth will change to max. The fluence, pulsewidth and frequency may also
change if any of these parameters cannot be supported by the system.
Fluence Selection:
screen above).
Piano Pulse Repetition Time Selection:

screen above).
Piano Pulse Width Selection:

screen above).
NOTE
A change of pulsewidth may cause an automatic change in fluence and/or frequency
to accommodate the system settings to the capabilities of the laser.
The max PIANO pulsewidth available depends on the selected fluence.

screen above).
After selecting the spot size for the chosen handpiece, always ensure
that the selected spot size corresponds to the spot size on the
handpiece.
NOTE
A change of spot size may cause an automatic change in fluence and/or frequency to
accommodate the system settings to the capabilities of the laser.

The appearance and settings in the More Settings screen are the same
as in the case of using VERSA operation mode with the same
handpieces, as described above.
Application Settings with the Scanned Beam Handpiece

In Dynamis/Spectro laser systems the scanned beam handpiece is the Model
S11 Scanner.
Please refer to the S11 scanner Operator Manual for details of the S11 scanner
operation, such as the adjustment of scan size and overlap of laser spots with
the S11 Scanner keyboard.
The appearance of the application screen with the S11 scanner is shown in
Figure 36 below:

Figure 36: Application screen with S11 Scanner.
By touching the handpiece button, the selected group applications
displayed. Select the desired handpiece and confirm the selection as
previously described above.

selecting the operation mode. There is only one option for the operation
mode: VERSA.
Select the desired operation mode in the drop-down menu.
NOTE
When changing the operation mode, the handpiece and spot size remain unchanged
while the fluence, frequency and pulse width may change.
Fluence Selection:
screen above).
screen above).
screen above). The range of pulsewidths for the VERSA operation mode
is from 5 to 50 ms in steps of 5 ms.
NOTE
Change of pulse width may cause an automatic change in fluence and/or frequency to
accommodate the system settings to the capabilities of laser.

screen above). The available spots are 2, 3, 6 and 9 mm.

NOTE
After selection of the spot size for the S11 scanner, insert the desired optics for the
selected spot size to the S11 scanner before touching the READY button.
In case that the S11 scanner optics do not match the selected spot size in the
Application screen, an advisory message will be displayed that requests the operator
to insert the correct optics in the S11 scanner that matches the selection on the
screen.
A change of spot size may cause an automatic change in the fluence and/or frequency
to accommodate the system settings to the capabilities of the laser.
2 mm Spot Size Selection with the S11 Scanner

When a 2 mm spot size is to be used on the Nd:YAG S11 scanner:
• Detach the standard 945 um fiber used for 3 mm, 6 mm or 9 mm
spots and attach the 600 um fiber to the S11 scanner and laser
system
• Setup and connect the scanner to the system according to the
instructions in the section Attaching and Setting up the Fotona
S-11 Scanner of this manual, and in the scanner operator
manual
• Attach the 3 mm inlet and outlet optics to the S11 scanner
• Select the 2 mm spot size in the application screen.
WARNING!
Optional 600 µm fiber beam delivery is to be used only with
3 mm inlet and output optics, and with the 2 mm spot size
selected on the keyboard. The optional 600 µm optical fiber
delivery is not to be used with the 6 mm or 9 mm inlet optics.
Never use the optional 600 µm fiber beam delivery when 3 mm,
6 mm or 9 mm spot sizes are selected in the Application
screen. When the optional 600 µm fiber beam delivery is used
in place of the standard 945 µm fiber beam delivery, and a
3 mm, 6 mm or 9 mm spot size is selected, the resulting output
fluence will be by factor of 2.5 times higher than that displayed
on the user interface screen. This may cause serious injury to
the patient.
Overlap Selection:
The Overlap of laser spots setting is performed with the keyboard on the
S11 scanner as described in Operator Manual of the S11 Nd:YAG
scanner. In the More Settings menu screen (see below) the overlap
selection on the S11 scanner can be only enabled or disabled. This
means that when the Overlap is disabled in the More settings menu, the
current overlap set on the S11 scanner cannot be changed.
Overlap settings of the S11 scanner can be adjusted with the keyboard
on the scanner in a range described in Operator manual of the S11
scanner.

More Settings Screen:
By touching the More Settings menu button, the More settings screen
opens (see Figure 37 below).
Figure 37: More Settings menu screen for the S11 scanner.
In the More settings screen, the following settings can be adjusted:

• Aiming beam (Pilot) intensity – in a range from level 0 to level 7
in steps of 1 using the corresponding buttons on the screen (see
figure above).
• Autorepeat time for repositioning the S11 scanner when the
complete scan has finished – in a range from 0.3 to 3 seconds
using the corresponding buttons on the screen (see figure
above).
• Overlap enable/disable – a toggle button on the
screen. If the disabled option is selected, the current overlap set
on the S11 scanner will be locked and cannot be changed with
the keyboard on the S11 scanner.
In addition, a session counter indicating the number of laser shots in the

session is provided. To reset the counter, touch the reset
button.

By touching the scanning pattern button, a drop-down menu opens with
three options: Optimal, Sequential and Partial. Select the desired
scanning pattern by touching the desired option in the drop-down menu.
Sequential Scanning Pattern

The 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 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 Partial scanning sequence is based on the same non-successive
spot deposition principles as the Optimal 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 More Settings menu screen. The Autorepeat time pauses provide
additional cooling in the treatment site, which makes the Partial
scanning sequence particularly useful when treating patients with a low
pain threshold.
Autorepeat Functionality
Between each complete scan, 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 should be moved to next

position.
Between each pass in the Partial scanning sequence during the

Autorepeat time, the outline shown below will appear:
To adjust the length of the autorepeat pause, adjust the Autorepeat time
in the More Settings menu screen. The length of the pause ranges from
0.3 to 3.0 seconds. When all four passes are finished in the Partial
scanning sequence, the outline will again be visible in the following
shape:
Please note that the Autorepeat time between each pass in the Partial
scanning sequence is equal to the Autorepeat time between consecutive
complete scans.
WARNING!

Applications Settings with Bare Fibers in QCW Operation Mode
NOTE
The selectable average power is limited:
For Dynamis laser systems, to 80 W with the Fiber 1000 or R27-1000 handpiece and
to 30 W with the Fiber 600 or R27-600 and R27-C handpieces.
For Spectro laser systems, to 35 W with the Fiber 1000 or R27-1000 handpiece and to
30 W with the Fiber 600 or R27-600 and R27-C handpieces.
In some applications, the sterile bare fiber is used without any handpiece. On the
other hand, there are other applications in which the sterile bare fibers need a
holding and guiding handpiece (R27-400, R27-600, R27-1000 or R27-C).
The appearance of the application screen in QCW operation mode is shown in
Figure 38 below:
Fiber or Cumulative delivered

handpiece energy counter
selection button
More Settings menu

Power with button
slider and
adjustment
buttons
Frequency with slider
and adjustment
buttons
Exposure time slider

Pulewidth with
and adjustment
slider and
buttons
adjustment
buttons
STBY/READY button
Figure 38: Application screen for QCW operating mode.
Fiber or Handpiece Selection:

Touch the fiber or handpiece button to open the fiber or handpiece
selection options for the current application. Select the handpiece and
confirm the selection with confirmation button . The settings for the
current application with the new handpiece will be recalled and
displayed in the application window.

The operation mode selection in the QCW operation mode application
screen is disabled since no other operation modes support treatments
with bare fibers. Therefore the operating mode cannot be changed.
Power Selection:
Use the slider or adjustment buttons to select the desired average
power.
Use the slider or adjustment buttons to select the desired frequency.

NOTE
The max frequency setting depends on the selected power and pulsewidth.
Use the slider or adjustment buttons to select the desired pulsewidth.
NOTE
During adjustment of the pulsewidth, the frequency may automatically change to
accommodate the system settings to the capabilities of the laser.
Exposure Time Selection:

The laser system will stop laser emission when the exposure time
expires following activation of the foot switch.
Use the slider or adjustment buttons to select the expected duration of
the treatment in seconds. The exposure time can be adjusted up to 990
seconds.
NOTE
The selection of exposure time can be disabled by touching the number above the
exposure time slider. When the exposure time selection is disabled, the number above
the slider is colored grey (shaded). With a disabled selection of exposure time, the
laser will deliver laser pulses with an unlimited exposure time as long as the foot
switch is activated.
Cumulative Delivered Energy Indicator:

The cumulative true delivered energy in units of Joule (J) on the target
tissue is continuously displayed on the application screen (see figure
above) while the foot switch is activated.
To reset the cumulative energy indicator, touch the cumulative energy
indicator button. A drop-down menu will appear in which a RESET
button will be shown. Touch the reset button and the cumulative energy
will be reset to 0 J.

By touching the More Settings menu button in the application screen,
the More Settings menu will open (see Figure 39 below).
Back button
Figure 39: More Settings menu screen for QCW operation mode.
In the More Settings screen:

The aiming beam (Pilot) intensity can be adjusted with the

corresponding buttons (see figure above).
The session counter indicates the laser shots delivered. To reset the
laser shot session counter, touch the reset button .
4.9.10 Saving Options Overview

In Figure 40 below, the structure of each Treatment group and the range of
saving options are shown.
Figure 40: Structure of each Treatment Group with saving options within the group.
4.9.11. Description of Icons and Buttons used in the GUI
HOME
By touching the HOME icon in any of the Applications or Applications library
screens, the system reverts to Treatment Group selection (or HOME) screen for
the last used laser source.
Save Button
Touching the Save icon opens the drop-down menu for the saving options
of the settings in the current application screen.
Saving options for applications from the pre-set Fotona applications library
The drop-down menu appearance (see Figure 41 below).
New personal application to

be named and saved to the
personal library

For saving alternative
settings for a Fotona factory-
set application
Figure 41: Drop-down menu appearance.

Alternative setting saving option:
When the alternative settings saving option is
selected, an advisory message will be generated on screen (see
Figure 42 below).
Figure 42: Advisory message for alternative settings.
The advisory message will be displayed for a while and will

disappear in the event of no action by the user.
If YES button is touched in an advisory message, the alternative
settings for a Fotona (factory set) application will be saved under
the same name but in a different memory slot indicated by the
icon next to the application name (see Figure 43 below).
Figure 43: Creating an alternative setting.
The original Fotona settings for the same application can be

recalled by touching the toggle button. The button will
change to the button, indicating that the original Fotona

application settings have been recalled.

New personal application saving option:
When the option of creating a new personal setting

is selected, the Personal application library screen will be
BACK button –
returns to previous
screen
Scroll Up/Down
Slider
Empty memory slots
Figure 44: The personal application library screen.
NOTE
In the figure above, the appearance of the screen with one previously created
application in the personal Library of applications for the Veins group is shown. In a
brand new laser system this library will be empty.
In the above screen, the position of an application (memory slot)

can be selected by touching the field of any memory place.
After selection, the new application name can be entered with
the help of the on-screen keyboard ) and confirmed with the
confirmation button (see Figure 45 below).
Confirmation button
BACK button –
returns to previous
screen
Backspace button
Upper/Lower case
button
Space bar
Figure 45: On-screen keyboard.
After confirmation, the system reverts to the saved application

screen.
NOTE
If an already occupied memory slot is touched, the name of selected memory slot will
be displayed as the application name. You can delete it with the use of backspace
button or edit a new name. After confirmation, the old settings in this memory will be
overwritten with new settings (and a new name if edited).

The appearance of the personal application window after saving
the new application with a new name (for example: Mr Smith leg
nd
veins 2 Tx) and accessing it is shown in Figure 46 below.
Figure 46: The personal application library screen after saving the new application with a new name.
Saving options for applications from the personal applications library

There is only one saving option for applications recalled from the personal library
(see Figure 47 below).
Figure 47: Personal Applications Library toggle button.
The procedure for saving is the same as described above for saving a new
personal application from the Fotona pre-set application screen.
Info button
Touching the Info icon displays information (if any) available on the current
screen.
Application Screen / Library and the Fotona Pre-set Applications Screen

Toggle Button
Button for toggling between the current Fotona application screen and the
Fotona pre-set applications library for the current application group.
Personal Application Screen / Personal Applications Library Toggle Button

Button for toggling between the current Personal application window and the
Personal applications library for the current application group.

Icon and Settings Indicator Button for Original Fotona Settings
Indicates that the current application settings are original Fotona factory settings.
By touching this button, the Alternative or changed-but-not saved settings will
subsequently be recalled and displayed.
NOTE
Please note that in brand new laser systems, all Alternative settings are the same as
Fotona factory settings.
Icon and Settings Indicator Button for Alternative Settings to Fotona

Applications
Indicates that the changed and saved settings for a Fotona application are
recalled and displayed.
Icon and Settings Indicator Button for Changed-but-Not-Saved Settings

Indicates that the settings have been changed but not saved. After saving, this
indicator is changed to or depending on if the setting was saved as an

Alternative setting in the Fotona library or a new application in the Personal
library.
More Settings Menu Button

Opens the More Settings menu screen for adjusting the aiming beam (Pilot)
intensity level and additional settings (if any) for the current application, and also
displays the session pulse counter (laser shots).
Operation Modes Button

When touched on screen, it opens a drop-down menu which enables selection of
the allowed operation modes for the current application and handpiece.
For the Nd:YAG laser the operation modes are VERSA, QCW and PIANO.
For the Er:YAG laser the operation modes are MSP, SP, LP, VLP, XLP and
SMOOTH.
For some applications the operation modes selection is limited..
NOTE
Please note that SMOOTH operation mode in the Er:YAG laser application windows
can be selected only with a handpiece of spot size greater or equal to 5 mm.
Burst Mode Button

Appears only in application windows for applications with the Er:YAG laser
source.
When touched on screen, it opens a drop-down menu that enables a selection of
Basic, Turbo1, Turbo2, Turbo3, Turbo4, Turbo5 and Turbo 6 Burst modes.
For a TurboN selection, N laser pulses are stacked on the same position.

Scan Pattern Button
The Scanner pattern button appears only in applications with the S11 Nd:YAG
scanner, S-Runner or F-Runner Er:YAG Scanner.
For applications with the S11 Nd:YAG or S-Runner Er:YAG scanners, a drop-
down menu opens which allows selection of the Sequential, Optimal and Partial
modes.
For the F-Runner scanner, the available scan patterns are Optimal and Natural.
Fluence / Energy Icon

In the application screen for the Er:YAG laser, the Fluence display (in units of
2
J/cm ) will change to the corresponding energy content of the laser beam in units
of mJ when this button is pressed.
By touching and holding this button the system will switch from displaying units
2
of J/cm to displaying units of mJ rounded to nearest selectable energy.
2
Switching from displaying units of mJ to J/cm is carried out in a similar manner
for the Er:YAG laser.
For the Nd:YAG laser, touching this icon will display the corresponding energy
for the selected spot size in Joules while the button is pressed.
Frequency (Repetition Rate) Icon

This icon represents the Frequency (repetition rate) of laser pulses for the
selected operation mode. The frequency is displayed in units of Hz.
Pulse Repetition Time for Piano burst mode Icon
This icon represents the Pulse repetition time for the Piano burst mode. It
indicates the time from the end of a Piano pulse to start of the next Piano pulse
(time for repositioning the handpiece from one to next position).
By touching the Time to next pulse icon, this setting is disables and a single
Piano pulse will be delivered each time the foot switch is pressed.
The pulse repetition time is displayed in units of s (seconds).
Pulsewidth Icon for VERSA and QCW Operation Mode
This icon represents the pulsewidth for the Nd:YAG laser for the VERSA and
QCW operation modes. The pulsewidth is displayed units of ms.
Pulsewidth for Piano burst mode
This icon represents the pulsewidth for the Nd:YAG laser in Piano operating
mode. The pulsewidth is displayed units of s (seconds).
Spot Size Icon
This icon represents the spot size for handpieces with variable spot sizes. Spot
sizes are displayed in units of mm.
NOTE
Please note that for handpieces with fixed spot sizes, the spot size is not displayed.
Please refer to the handpiece operator manual for information on the spot size of each
handpiece.
Exposure Time Icon

Appears only in application windows with the Nd:YAG laser in QCW operation
mode. After pressing the foot switch the laser will fire for the selected exposure
time. For initiating a new firing with the selected exposure time, the foot switch
should be released and pressed again.

By touching the exposure icon, the exposure setting can be disabled. A disabled
exposure time means that the laser will continuously fire laser pulses until the
foot switch is pressed.
Overlap Icon
Appears only in application windows for the S-Runner Er:YAG scanner, allowing
for the adjustment of laser-spots overlap. It is expressed in %.
Coverage Icon
Appears only in application windows for the F-Runner Er:YAG scanner, allowing
for adjustment of coverage. The coverage is expressed in % indicating the
percentage of the spot surface that is exposed to the fractional laser beam.
Number of Smooth Pulses Icon
Appears in application windows with Smooth burst mode of the Er:YAG laser. It
indicates the number of Smooth pulses that will be delivered after pressing the
foot switch with the selected frequency. To initiate a new burst of Smooth pulses
the foot switch should be released and pressed again.
Buy touching this icon the Burst adjustment will be disabled and Smooth pulses
with the selected frequency will be delivered until the foot switch is pressed.
READY/STBY Button
Shines red when the system is in READY state.
Shines grey when the system is in STBY mode.
Ablation and Coagulation Depth Icon for Full Beam Handpieces

Appears only in application windows using the Er:YAG laser. The upper icon and
number shows the ablation depth for the current settings. The lower icon and
number shows the coagulation depths per single pulse for the current settings.
Both depths are shown in units of micrometers (µm).
Cumulative Energy Button

Appears only in application windows using the Nd:YAG laser and when the
QCW operation mode is selected. It displays the actual cumulative energy in
units of Joules (J) while the foot switch is pressed.
By touching this button a drop-down menu offers a Reset button for resetting the
cumulative energy to 0.0 J.
Confirmation Button
When displayed on any screen, this must be touched to confirm the selection.
Back Button
If touched from any screen, the back button returns to the previous screen of the
GUI.

4.10 Intra-Operative Instructions
System READY and STANDBY States

The system state is controlled by the STANDBY and READY button. The system
is in STANBY state when the STANDBY/READY button is colored grey.
When the READY button is touched, the system requests confirmation of the
selected handpiece and spot size as well as all settings with an advisory
message (see Figure 48 below).
Figure 48: Appearance of an advisory message in the application screen.
Confirm by pressing the OK key on the touchscreen. 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 complete and a safety timeout of 2 seconds has
terminated, the emission indicator (red ready light on the system’s front panel)
turns on, the READY button color changes from GREY to RED, and the safety
shutter opens. This indicates that the system is in the READY state. In the
READY state, the aiming beam emerges from the handpiece.
In the READY state the foot switch is enabled. By pressing the foot switch, the
treatment laser beam with the selected parameters is delivered from the
handpiece.
While the foot switch is pressed, an audio signal indicates that the laser is
delivering laser energy from the handpiece.
NOTE
If the foot switch is pressed during the calibration process, an advisory message will
appear. After the foot switch 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 the READY state, pressing the READY button reverts the
system to the STANDBY mode and the READY button color changes to grey.
The safety shutter closes.
The system automatically reverts to STANDBY mode if the parameters are
changed during operation.
The system also reverts to standby mode if it is not fired for 3 minutes while in
the READY state. This is a safety feature.
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 foot switch is
inadvertently pressed.
Starting the Treatment

• Press the READY key to enter the READY state if the system is in STANDBY
mode.
• Aim the aiming beam at the target tissue.
• Press the foot switch to activate the treatment beam with the selected
parameters.
While the foot switch is pressed, an audio signal indicates that the treatment
beam is emerging from the fiber beam delivery unit or handpiece.
WARNING!
If the red aiming beam is not visible in the READY state,
do not use the laser system.
The articulated arm’s beam delivery unit or the 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.
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.
WARNING!
When sterile fibers and handpieces are to be used, the
operator must appoint a person that will control the laser
system’s touchscreen (selecting and adjusting the
settings for treatment).
During the Treatment

(Note: Applies to SP and XP Dynamis only)
Always revert the system to the STANDBY mode 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).

CAUTION!
When changing the spot size, the energy/fluence
setting will remain the same provided that the system is
capable of adjusting to the changed parameters. If the
system is incapable of delivering the same
fluence/energy for the changed spot size, then the
energy/fluence will change.
The ablation and coagulation depth may also change,
since the tissue effect depends on the spot size as well
as the energy and the mode.
WARNING!
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.
Severe and/or permanent eye damage may occur.
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.
4.11 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.
• If the doorswitch interlock is used, detach its connector from its port at the
rear of the device.
4.12 Advisory Messages

The laser system displays several advisory messages during normal laser
operation and functioning. In addition, it also displays 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 that 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
Turn keyswitch ON Appears in the Welcome screen or when the

system was turned OFF with the key switch in
any state of the device, and the system returned
to Welcome screen (sleep mode).
Turn keyswitch OFF Usually this message appears when the system
was turned ON with the key switch in the ON
position.
This message also appears in the Select
Treatments Group menu, indicating that
returning to the Welcome screen is possible by
turning the Key switch OFF.
When the key switch is turned OFF, the system
goes into a “sleep mode” in which the charger
and cooling system are turned off while the rest
of the system remains powered and operating.
The key switch can be turned OFF in any state
of the device.
Footswitch not connected Appears during self-tests if the foot switch is not
connected (or if it is faulty). Please check if the
foot switch is attached.
If the message persists during self-tests with the
attached foot switch – replace the foot switch.
Please release footswitch Appears if the foot switch is pressed during a
self-test. Please release the foot switch during
the self-test.
Do you want to create an When an alternative setting saving option is
alternative setting? selected in a Fotona factory set application.
Reverting to STBY state! If no activity with the laser in the READY state
(154) exceeds 3 minutes, the system reverts to
STANDBY mode.
Nd:YAG fiber not attached! If fiber is not attached to the fiber coupling
(156) assembly on the laser system when the READY
state is attempted with the Nd:YAG laser.
Attach fiber to the system.
Cooling liquid overheated! When room temperature exceeds 29°C and the
Do not turn key switch OFF! highest average power of Nd:YAG is used for a
Please wait a few minutes! long time, the cooling liquid may overheat. The
(157) system will stop the laser emission, close the
safety shutter and issue this advisory message.
Do not turn OFF the system with the key switch,
but wait approx. 5 minutes for cooling down and
then resume normal operation.
Please close the door or When the door switch is not properly connected
check door switch (158) to the laser system or if the door switch is in the

open state (if a door switch is installed in the
laser room door). Check if the door switch is
properly connected to the system on the rear
side.
Try lower setting! Flashlamp When due to aging of the flashlamp, the
replacement recommended! selected laser cannot calibrate the requested
(159) energy. Try operation at a lower setting if the
treatment can still be performed. Replacement
of the flashlamp is recommended.
Scanner error! Scanner did This message is actually an error message of
not move to 1st position! the attached scanner. It indicates that the
(160) selected scanner, after pressing the footswitch,
does not move to the starting position from
outlining when the footswitch is pressed.
Please notify your Fotona service. Operation
with other scanners and handpieces is possible.
Scanner error! (161) This advisory message indicates that the
selected scanner, when activated in the READY
state, generates an error message. The
message is always followed by a scanner Error
code containing two characters (XY).
Please notify your Fotona service. Normal
operation with other scanners and handpieces
is possible.
Scanner adapter does not This advisory message is actually an ERROR
respond! (163) message from the scanner adapter, through
which the laser system communicates with
scanners.
operation with any handpiece is possible.
Scanner adapter does not This advisory message is actually an ERROR
respond! (169) message from the scanner adapter, through
which the laser system communicates with a
scanner.
Scanner or adapter This advisory message is actually an ERROR
communication echo error! message from the scanner or scanner adapter,
(164) through which the laser system communicates
with a scanner.
Er Scanner disconnected! The selected scanner is not connected to the
(165) laser system or the scanner cable is faulty.
Please properly attach the scanner cable to the
laser system and also to the Er:YAG scanner.
Nd Scanner disconnected! The selected scanner is not connected to the
(168) laser system or the scanner cable is faulty.
Please properly attach the scanner cable to the
laser system and also to the Nd:YAG scanner.
Wrong scanner attached! This message is generated when the selected
Please attach selected scanner in the laser system does not match the
scanner! (166) scanner attached to the system (for example,

the S22 S-Runner scanner is selected in the
GUI and the F22 F-Runner scanner is attached
to the system).
Attach the selected scanner to the system.
Incompatible Nd scanner This message appears when an old S11
(167) Nd:YAG scanner with incompatible software is
attached to the laser system or if the Nd:YAG
scanner is faulty.
operation with other handpieces is possible.
Incorrect scanner adapter This is actually an error message of the scanner
version (170) adapter, though which the laser system
communicates with a scanner.
operation with other handpieces is possible.
Improper optics combination This appears in cases with the S11 scanner
attached to S11 Scanner. when:
Please check inlet and outlet 6 mm optics and a 3 mm exit lens are attached
optics (171) 9 mm optics and a 3 mm exit lens are attached
3 mm optics and NO exit lens is attached
Please attach the correct optics to the S11
scanner according to the instructions in the S11
scanner operator manual.
S11 scanner spot size If this message persists, this means that the
unknown! (172) S11 scanner is faulty. Please notify your Fotona
service.
Normal operation with other handpieces and
scanners is possible.
Spot size and attached The spot size selected in GUI and the actual
optics mismatch! Please spot size attached to the S11 scanner does not
check the attached scanner match.
optics! (173)
Match the selection on the laser system screen
with the attached optics on the scanner.
Scanner optics! Match the selection on laser system screen with
(173) attached optics on scanner
Please confirm correct After touching the READY button the system
handpiece and spot size asks for confirmation if the selected handpiece
(Rxx, Y mm) and spot size on laser system screen matches
the actual handpiece and spot size attached to
the system. After confirmation, the system starts
the calibration and enters the READY state.
This feature is implemented for safety reasons.
SMOOTH mode is available This advisory message is reported when
with spotsizes 5mm or higer! SMOOTH operation mode is selected with a
handpiece with spot size < 5mm. Select spot
size ≥ 5mm and re-enter SMOOTH operation
mode.
Wait Calibration in progress! This advisory message is displayed each time
before entering READY state. Wait for the
message to disappear and the red aiming beam
to emerge from the handpiece, scanner or fiber
to start the treatment by pressing the foot

switch.
Do not activate the footswitch during calibration!
S11 scanner disconnected If this message persists, it means that the S11
or scanner optics error! scanner is faulty.
(175)
Please contact your Fotona service. Normal
operation with other scanners and handpieces
is possible.
Synchronizing, please wait... If this message persists for more than 5
seconds, please contact your Fotona service.
Further operation with the system is not
possible.
System not configured! This message is intended for service personnel,
only during the configuration of new software
options in the laser system.

5. MAINTENANCE
5.1 General
Fotona laser systems have been designed to provide years of trouble-free
operation. The built-in computers perform self-diagnostics and initiate 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 that includes an inconsistency code will be displayed on the screen.
Er:YAG Laser (applies to models M021-4AF/3 and M002-2A)

A dirty window or lens on the handpiece is the most common cause of reduced
transmission of the Er:YAG laser beam. In such cases, it is advisable to clean
the window or lens.
If the handpiece lenses or a misalignment of the articulated arm cause the
failure, they should be replaced or aligned by technical service.
Nd:YAG Laser (applies to models M021-4AF/3 and M001-12F)

If no visible aiming beam emerges from the fiber when the laser system is in the
READY state, 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 that 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 and terminated with a
handpiece or scanner.
• that the foot switch is properly connected.
CAUTION!
Do not use the device if the system touchscreen
remains blank after switching on the main switch at
the rear of the device.
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 technical service. In such cases,
please notify your Fotona representative and/or notify the technical service.
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 system’s front panel. The air filter
cartridge can be easily removed by opening the door on the front side of the
system’s lower housing and pushing down the handle that 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 back the handle on the rear bottom side of the
laser device.
The two side filters are on the lower part of the laser console. Access to them
depends on the type of the system:
With models M002-2A Dynamis and M001-12F and M021-4AF/3 Spectro, they
are accessible from the inner side of the laser system console’s lower section.
First, the rear cover that holds the two additional heat exchangers is to be

removed. After removal, clean each air filter or replace it.
With models M021-4AF/3 and M001-12F Dynamis, the two side filters can be
removed from the system with their cartridges by gently lifting each cartridge
upward. 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.
Electrical power supply
CAUTION!
Fotona laser systems that operate at a rated current of 19 A should be
connected to an electrical mains supply with a grounded mains outlet
with a suitable plug that is certified for the rated current of the device.
The connection must comply with all local, state and/or national electrical
regulations for the rated current of the device.
For laser system that operate at a rated long-term current of 12 A, the

electrical power must be supplied from a grounded 16 A mains electrical
outlet.
Carefully review the electrical specifications in the “Specifications”
section.
For laser systems that operate at a rated current of 19 A, electrical power must
be supplied from a 220 – 240 V AC ±10%, single phase, 50/60 Hz mains with a
protective earth connection. The supply line must be provided with a dual pole
circuit breaker (Type C). The laser system comes with a power cord with free
wires that cannot be detached from the device. An adequate (for example IEC
309) electrical supply outlet that is certified for a rated current of at least 20 A
must be provided with a suitable plug. The distal part of the power cord must
therefore be connected to a properly prepared electrical mains outlet in
compliance with all applicable local, state and/or national electrical regulations
and codes which apply to electrical connections.
For laser systems that operate at a rated Long term current of 12 A, the
electrical power must be supplied from a 220 – 240 V AC ±10% single phase
50/60 Hz, 16 A outlet with a grounding. The laser system also 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.
All models of the Dynamis and Spectro familiy of lasers have 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. Testing should be performed by a qualified and certified
technical service.
Water Utilities

The Fotona Dynamis and Spectro 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.
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. SPECIFICATIONS
There are three models of Dynamis/Spectro laser systems
Model 1: M021-4AF/3 (Id: 92729) SP Dynamis:
• Nd:YAG laser, with a wavelength of 1064 nm with max average power of 80 W
Model 2: M021-4AF/3 (Id: 92731) SP Spectro:

• Nd:YAG laser, with a wavelength of 1064 nm with max average power of 35 W
Model 3: M002-2A (Id: 92733); XS Dynamis:

The system has a lower laser console.
Model 4: M001-12F (Id: 92730); XP Dynamis:

• Nd:YAG laser with a wavelength of 1064 nm with max Average power of 80 W
Model 5: M001-12F (Id: 92732); XP Spectro:

• Nd:YAG laser with a wavelength of 1064 nm with max Average power of 35 W
6.1 LASER
Er:YAG laser
Laser wavelength: 2940 nm
Output energy per pulse: 30 to 3000 mJ
2 2
Fluence range: 0.1 – 95 J/cm (9300 J/cm for R08-Ti
handpiece)
Pulse repetition rate (frequency): 2 to 50 Hz
Max. average power: 20 W
Pulse width: Variable in 6 steps:
MSP Operation mode: 100 microseconds
SP Operation mode: 300 microseconds
LP Operation mode: 600 microseconds
VLP Operation mode: 1000 microseconds
XLP Operation mode: 1500 microseconds
Smooth burst mode: five SP pulses in 250
milliseconds
Sterilization:
Autoclave (handpiece spacers and
Speculums)
Nd:YAG laser
Laser wavelength: 1064 nm
Max pulse energy: 50 J
Fluence range: 2
4 to 600 J/cm
Pulse repetition rate (frequency): Adjustable from 0.5 to 100 Hz

Average power: Up to 80 W – for Models 1 and 4
(Up to 30 W with 600 µm sterile bare fiber)
Up to 35 W - for Models 2 and 5

(Up to 30 W with 600 µm sterile bare fiber)
Pulse width: 5 – 50 ms for VERSA Operation mode

0.1 – 2 ms for FRAC3 and QCW Operation
mode
0.3 – 60 s for Piano burst mode

Beam delivery: 945 µm core step-index fiber with high poser
SMA 905 connectors on each side; NA=0.22
600 µm core step-index fiber with high poser

SMA 905 connectors on each side; NA=0.22
(for 2 mm spot generation with S11 scanner)
Spot sizes supported: R31 and R33 handpiece 2, 3, 4, 5, 6, 7, 8, 9,

10 mm
R34 handpiece 15 and 20 mm
S11 Nd:YAG scanner 2,3, 6 and 9 mm
Applied parts type: Type B
Sterilization: Autoclave (handpiece spacers and R27-400,

R27-600, R27-100 and R27-C handpiece)
6.2 GENERAL
Classification according to Class IIb, Rule 9

MDD93/42/EEC, Annex IX:
Classification according to CMDR Class III, Rule 9
Power requirements for:

• M021-4AF/3; SP Dynamis - rated supply voltage: 220-240 VAC
• M001-12F; XP Dynamis - number of phases: 1
- rated frequency: 50/60 Hz ± 2%
- rated current: 19 A
Power requirements for:

• M002-2A; XS Dynamis - rated supply voltage: 220-240 VAC
• M021-4AF/3; SP Spectro - number of phases: 1
• M001-12F; XP Spectro - rated frequency: 50/60 Hz ± 2%
- long-term input power: 2.3 kVA
- long-term current rating: 12 A
- momentary current rating: 19 A
- momentary input power: 4,4 kVA
Electrical connection for:

• M021-4AF/3; SP Dynamis non-detachable power supply cord, free wire
• M001-12F; XP Dynamis
Electrical connection for:

• M002-2A; XS Dynamis non-detachable power supply cord
• M021-4AF/3; SP Spectro
• M001-12F; XP Spectro
Class of equipment: Class I equipment

Type of equipment: Type B equipment
Protect. earth impedance < 200 mΩ
Leakage currents for all models: - earth leakage current NC/SFC < 5mA/10mA
- patient leakage current NC/SFC < 100 µA /
500 µA
- touch current NC/SFC < 100 µA / 500 µA
Circuit breaker for:

• M021-4AF/3; SP Dynamis 25 A
• M001-12F; XP Dynamis

Circuit breaker for:
• M002-2A; XS Dynamis 15 A
• M021-4AF/3; SP Spectro
• M001-12F; XP Spectro
Fuses: On TV Relay TS 1 Board:

F1 TR5 0.25A (Littelfuse 37202500431)
F2 T 6.3 A H /250V (5x20 mm)
F3 TR5 6.3A (372 Littelfuse 3721630431)
On TV TS S22 SCAN adapter board:

F1 TR5 2A (372 Littelfuse 37212000431
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 2:2007)
Safety interlocks: - remote door switch interlock connector

- fiber attachment interlock
Emergency laser stop: - emergency stop according to IEC60947-5-1,

-5-5
Foot switch: IPX1, IPX1 Wireless or IPX8 optional

footswitch
- to operate the treatment laser
Controls: - main switch

- keylock switch (key removable in vertical
OFF position only)
Laser system classification: Class 4

(according to IEC 60825-1 Ed 2/2007
Indicators: 8.4” TFT LCD color touchscreen

Ready warning light on front panel
Status buttons: On Touchscreen

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 LB4 (OD 4)
- 1064 nm 1064 I LB7 (OD 7)
Mechanical:
Construction: mobile equipment on wheels
Degree of protection: IPX0 (IEC 60529)
Cooling: internal water-to-air
Dimensions and weight for Model 1 and

Model 4: - 60 x 33 x 103 cm: (Length x Width x
Height)
- Weight: 125 kg for Model 1
- Weight: 117.6 kg for Model 4

Dimensions and weight for Model 2,
Model 3 and Model 5: - 60 x 33 x 82 cm (Length x Width x
Height)
- Weight: 115.9 kg for Model 2
108.9 kg for Model 3
102.3 kg for Model 5
Environmental conditions:
o o
Operation: - ambient temperature range +10 C to +29 C;
must be above dew point
- relative humidity range of 30% to 75% - non
condensing
- atmospheric pressure range of 700 hPa to
1060 hPa
o o
Storage and transport: - ambient temperature range -40 C to +70 C
(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 step-index fiber with high poser
SMA 905 connectors on each side; NA=0.22,
2m
600 µm core step-index fiber with high poser

SMA 905 connectors on each side; NA=0.22,
2m (for 2mm spot generation with S11
scanner)
Compatible handpieces:
For Er:YAG laser :
- Handpieces R04-Ti, R08-Ti, R09-2, R09-2G, R09-3, R11,
PS02, PS03, FS01
- Scanner compatibility F-Runner (Model F22), S-Runner

(Model S22)
For Nd:YAG laser:
- Handpieces R33 and R33-T with removable optics for 2, 3,
4, 5, 6, 7, 8, 9, 10 mm
R34 and R34-T with removable optics
for 15 and 20 mm
R27-600 (for supporting and guiding

the sterile 600 µm bare fiber),
R27-1000 (for supporting and guiding
the sterile 1000 µm bare fiber)
- Scanner compatibility Fotona S-11 Nd:YAG scanner with

optics for 3, 6 and 9 mm spot sizes
External connections: - Potential equalization terminal

- Door switch connector (NC contact)
- Foot switch connector (NC & ON contact)
- Fiber optic SMA 905 port
- Scanner connector S11
- Scanner connector F-Runner/S-Runner
Footswitch cable length: 3m

S11 Scanner cable length: 2 m, Part No.:71185
S22/F22 Scanner cable length: 2 m, Part No.:85301
Power cord length: 5 m for Model 1 and Model 4
3 m for Model 2, Model 3 and Model 5

7. LABELING
According to the IEC 60825-1 Ed 2/2007 standard, 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.
2, 31
3, 32
4, 33
SP Dynamis
Front View
NOTE: XP Dynamis has the same appearance except that it does not have an articulated arm and trays for
the S-Runner and F-Runner scanners.
The numbers refer to the labels which appear after the picture series.

59
60
XS Dynamis
Front View

16
17, 45
18, 46
19, 47
SP Spectro
Front View
NOTE: XP Spectro has the same appearance except that it does not have an articulated arm or trays for the
S-Runner and F-Runner scanners.

Front panel details for models M021-4AF/3 and M001-12F
2, 17, 31, 45
3, 18, 32, 46
4, 19, 33, 47, 60
NOTE: Model M002-2A does not have a connector for the Nd Scanner.

9, 34
5, 36
14, 43
6, 35 15, 44
13, 42
8, 38
10, 39
7, 37
SP Dynamis
Rear View
NOTE: XP Dynamis has the same appearance except that it has no articulated arm
or trays for the S-Runner or F-Runner scanner.

65
63
69
62 70
68
61
64 66
XS Dynamis
Rear View

22, 51
21, 49
29, 57
20, 48 30, 58
28, 56
23, 50
25, 52
24, 53
SP Spectro
Rear View
Note: XP Spectro variant has the same appearance except that Model M001-12F does not have an
articulated arm or trays for the S-Runner and F-Runner scanners.

11, 40
SP Dynamis
Side View
NOTE: XP Dynamis has the same appearance except that it has no articulated arm.

12, 41
SP Dynamis
Side View
NOTE: XP Dynamis has the same appearance except that it has no articulated arm or trays for the S-Runner
and F-Runner scanners.

XS Dynamis
Side View

67
XS Dynamis
Side View

26, 54
SP Spectro
Side View
Note: XP Spectro has the same appearance except that Model M001-12F does not have an articulated arm
or trays for the S-Runner and F-Runner scanners.

27, 55
SP Spectro
Side View
Note: XP Spectro has the same appearance except that Model M001-12F does not have an articulated arm
or trays for the S-Runner and F-Runner scanners.

Labeling M021-4AF/3 92729 SP Dynamis
Label 1 Label 2 Label 3
Label 10 Label 11
Label 12

Label 13
Label 14
Label 15

Labeling M021-4AF/3 92731 SP Spectro
Label 25 Label 26
Label 27

Label 28
Label 29
Label 30

Labeling M001-12F 92730 XP Dynamis
Label 40
Label 41

Label 42
Label 43
Label 44

Labeling M001-12F 92732 XP Spectro
Label 54
Label 55

Label 56
Label 57
Label 58

Labeling M002-2A 92733 XS Dynamis
Label 65 Label 66
Label 67

Label 68
Label 69
Label 70

Explanation of Labels
Optical fiber
applicator
Identification label together with the Type Laser Warning sign together with the
B applied part sign (see IEC60601-1) radiation pattern emitted from the device
Laser Warning
Potential equalization conductor: provides a direct connection between the equipment and the
potential equalization busbar of the electrical installation (see IEC60601-1).
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 Dynamis laser system.
With this you will contribute to 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.

8. STORAGE AND SHIPMENT
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.

9. WARRANTY
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 the 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. CALIBRATION PROCEDURE FOR ENERGY
METERS
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.
Calibration of the energy meters should be performed once per year.

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

Page 2/123 87009 OM Dynamis Pro Line USA ENG 13

• Greater patient comfort and satisfaction

The Fotona Team

87009 OM Dynamis Pro Line USA ENG 13 Page 3/123

1. INTRODUCTION AND SYSTEM CHARACTERISTICS.....................................................7

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Laser Source Specifications for the Dynamis Laser Family

Laser source type Er:YAG laser Nd:YAG laser

Laser Source Specifications for the Spectro Laser Family

Laser source type Er:YAG laser Nd:YAG laser

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R11 Collimated Er:YAG handpiece with variable spot sizes from 2 to

Compatible Scanners for the Er:YAG Laser Source

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R34-T Nd:YAG handpiece with spot sizes of 15 and 20 mm using

Compatible Scanners for the Nd:YAG Laser Source

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2.1 Intended Use

2.2 Indications for Use, Contra-indications and Side Effects

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ENT Surgery Indications: Podiatry Indications:

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Possible side effects

An informed consent from the patient is recommended.

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PULSE Mode Operation in Dermatology

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An informed consent from the patient is recommended.

Nd:YAG Laser Indications (continued)

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An informed consent from the patient is recommended.

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Possible side effects

An informed consent from the patient is recommended.

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Possible side effects

An informed consent from the patient is recommended.

87009 OM Dynamis Pro Line USA ENG 13 Page 19/123

QCW Mode Operation in General Surgery

Possible side effects

An informed consent from the patient is recommended.

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3.1 Ocular Protection

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Nominal Ocular Hazard Distance (NOHD)

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3.2 Electrical Hazards

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Do not use the laser system before ensuring that

Using a damaged fiber may result in accidental laser

3.4 Protecting Non-Target Tissues

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Emergency-Off Push Button

Laser Emission Ready Keylock Switch

Laser Emission Indicator

Door Switch Interlock

Potential equalization Safety Interlocks