a company of biolitec AG

LEONARDO®

INSTRUCTION MANUAL

Distribution by:

CeramOptec GmbH
Siemensstr. 44, 53121 Bonn
Germany
Tel: +49 (228) 97 967 – 0
Fax: +49 (228) 97 967 - 99
 LEONARDO®
INSTRUCTION MANUAL

TABLE OF CONTENTS

1 SAFETY PROVISIONS AND REGULATIONS ........................................................................................6

2 PRODUCT DESCRIPTION ......................................................................................................................7
2.1 INTENDED USE AND INDICATIONS ........................................................................................ 7
2.1.1 Recommended lasers for indications ......................................................................... 8
2.2 CONTRAINDICATIONS ......................................................................................................... 9
2.3 SIDE EFFECTS ................................................................................................................... 9
3 DESCRIPTION OF THE DEVICE.......................................................................................................... 10
3.1 CONTROLS AND CONNECTIONS ......................................................................................... 10
3.2 DESCRIPTION OF CONTROLS, DISPLAYS, CONNECTIONS ..................................................... 11
3.2.1 Controls ................................................................................................................... 11
4 OPERATION .......................................................................................................................................... 15
4.1 PREPARING THE LASER UNIT ............................................................................................ 15
4.1.1 Footswitch ............................................................................................................... 16
4.1.2 Door interlock connection scheme ........................................................................... 16
4.2 SWITCHING ON THE DEVICE .............................................................................................. 17
4.3 SETTINGS AND PARAMETERS FOR ALL TREATMENTS ........................................................... 19
4.3.1 Setting language ..................................................................................................... 19
4.3.2 Configuring the aiming beam ................................................................................... 20
4.3.3 Help system ............................................................................................................ 21
4.4 EXTRAS .......................................................................................................................... 23
4.4.1 Info screen .............................................................................................................. 23
4.4.2 User administration ................................................................................................. 24
4.4.3 4.4.3 Video display .................................................................................................. 27
4.5 TREATMENT .................................................................................................................... 28
4.5.1 Configuring the laser output..................................................................................... 28
4.5.2 Selecting a treatment mode ..................................................................................... 33
4.6 DESCRIPTION OF THE TREATMENT MODES ......................................................................... 34
4.6.1 Continuous mode CW ............................................................................................. 34
4.6.2 Pulse Mode ............................................................................................................. 37
4.6.3 ELVeS® segment mode ........................................................................................... 41
4.6.4 ELVeS® signal mode ............................................................................................... 43
4.6.5 Derma mode (for LEONARDO® Dual 45 only) ......................................................... 46
4.7 SWITCHING OFF THE LASER SYSTEM ................................................................................. 47
4.8 MESSAGES AND POSSIBLE CAUSES ................................................................................... 48
5 ACCESSORIES ..................................................................................................................................... 50
5.1 SALES PACKAGE FOR THE LASER INCLUDES ....................................................................... 50

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 5.2 LASER SAFETY EYEWEAR ................................................................................................. 50
6 APPLICATION SYSTEMS, FIBERS AND MEDICAL PROBES .......................................................... 52
6.1 APPLICATION FIBERS AND MEDICAL PROBES ...................................................................... 52
6.2 HANDLING AND USE OF APPLICATION SYSTEMS AND MEDICAL PROBES ................................. 52
7 SAFETY ................................................................................................................................................. 53
7.1 SAFETY ELEMENTS .......................................................................................................... 53
8 MAINTENANCE AND CARE ................................................................................................................ 54
8.1 ROUTINE MAINTENANCE ................................................................................................... 54
8.2 CLEANING ....................................................................................................................... 54
8.3 CHANGING FUSES ............................................................................................................ 54
8.4 TECHNICAL SAFETY CHECK............................................................................................... 54
9 TECHNICAL SPECIFICATIONS AND LABELING .............................................................................. 55
9.1 MODEL-SPECIFIC SPECIFICATIONS .................................................................................... 55
9.1.1 LEONARDO® DUAL 45 ........................................................................................... 55
9.1.2 LEONARDO® 1470.................................................................................................. 55
9.1.3 ..................................................................................................................................... 55
9.2 GENERAL SPECIFICATIONS FOR ALL LEONARDO® MODELS ............................................... 56
9.3 LABELING ........................................................................................................................ 57
9.3.1 Certification and power rating label.......................................................................... 57
9.3.2 Symbol key.............................................................................................................. 59
9.4 MANUFACTURER’S DECLARATION REGARDING ELECTROMAGNETIC COMPATIBILITY ............. 60
10 SERVICE POLICY ............................................................................................................................. 63
11 ENVIRONMENTAL PROTECTION ................................................................................................... 63
12 WARRANTY POLICY ........................................................................................................................ 64
12.1 IMPORTANT CONDITIONS ............................................................................................... 64
13 APPENDIX ......................................................................................................................................... 66
13.1 DEVICE MASTER DATA ............................................................................................................... 66
13.2 TRAINING RECORD........................................................................................................ 66
13.3 TECHNICAL SAFETY CHECK ........................................................................................... 67

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 List of illustrations
Figure 1: Front of the device ....................................................................................................... 10
Figure 2: Rear of the device........................................................................................................ 10
Figure 3: Subdivision of the operating interface .......................................................................... 11
Figure 4: Application fiber connection ......................................................................................... 15
Figure 5: Foldable footswitch ...................................................................................................... 16
Figure 6: Door interlock connection scheme ............................................................................... 16
Figure 7: Start screen 1 .............................................................................................................. 17
Figure 8: Start screen 2 (Selecting the language the first time the device is switched on)........... 17
Figure 9: Login screen. The device activates after entering the number code ............................. 18
Figure 10: An example of the monitor display when CW mode was the last active mode (for dual-
wavelength devices) ................................................................................................................... 18
Figure 11: An example of the monitor display when CW mode was the last active mode (for
single-wavelength devices) ......................................................................................................... 19
Figure 12: Menu item: language setting ...................................................................................... 19
Figure 13: Menu item: setting the aiming beam .......................................................................... 20
Figure 14: Setting the aiming beam in any application mode by using the PILOT box ................ 21
Figure 15: Controls for Help ........................................................................................................ 21
Figure 16: Help for Pulse mode .................................................................................................. 22
Figure 17: Help for 2D Power Control™ (not available in single-wavelength devices)................. 22
Figure 18: Information screen ..................................................................................................... 23
Figure 19: Navigating document display ..................................................................................... 23
Figure 20: Login screen .............................................................................................................. 24
Figure 21: User administration option menu ............................................................................... 24
Figure 22: Add user .................................................................................................................... 25
Figure 23: Edit user .................................................................................................................... 26
Figure 24: Remove user ............................................................................................................. 26
Figure 25: Setting the laser output for a dual-wavelength device ................................................ 28
Figure 26: Setting the laser output for a single-wavelength device.............................................. 28
Figure 27: Setting the laser output for devices that emit one or two wavelengths ....................... 29
Figure 28: Laser power setting for dual wavelength without 2D Power Control™ ....................... 29
Figure 29: Method 2: Setting the laser power using 2D Power Control™ .................................... 30
Figure 30: Setting output with constant total laser power output ................................................. 30
Figure 31: Setting the output with constant relation between two wavelengths ........................... 31
Figure 32: Fixing the power for the wavelength 1470 nm on the horizontal ................................. 31
Figure 33: Fixing the power for the wavelength 980 nm on the vertical axis................................ 32
Figure 34: Saving four power settings ......................................................................................... 32
Figure 35: Pop-up window for saving the power setting .............................................................. 33
Figure 36: New name for the button............................................................................................ 33
Figure 37: Selecting a treatment mode on the touchscreen ........................................................ 34
Figure 38: Screen display of Continuous mode CW in standby................................................... 35
Figure 39: Screen display of Continuous mode CW (for devices that emit one wavelength) ....... 35
Figure 40: Display of laser ready for emission ............................................................................ 36
Figure 41: Examples for continuous mode .................................................................................. 37
Figure 42: Screen display of Pulse mode.................................................................................... 37
Figure 43: Screen display of Pulse mode (for devices that emit one wavelength) ....................... 38
Figure 44: Screen display of Pulse mode, parameter settings .................................................... 38
Figure 45: Pulse duration zoom settings ..................................................................................... 39
Figure 46: Single-pulse mode ..................................................................................................... 40
Figure 47: Multi Pulse mode ....................................................................................................... 40

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Figure 48: Start screen of ELVeS® segment mode for setting .................................................... 41
Figure 49: Start screen of ELVeS® segment mode for setting parameters (for devices that emit
one wavelength) ......................................................................................................................... 41
Figure 50: Setting the parameters in ELVeS® segment mode .................................................... 42
Figure 51: Setting the parameters in ELVeS® signal mode ........................................................ 43
Figure 52: Setting the parameters in ELVeS® signal mode (for devices that emit one wavelength)
................................................................................................................................................... 44
Figure 53: Setting laser power .................................................................................................... 44
Figure 54: Defining the energy interval ....................................................................................... 45
Figure 55: Screen display of Derma mode, dual laser setting ..................................................... 46
Figure 56: Setting parameters for Derma mode .......................................................................... 47
Figure 57: Laser safety eyewear ................................................................................................. 50
Figure 58: Safety elements ......................................................................................................... 53
Figure 59: Label for devices that emit laser power of two wavelengths ....................................... 57
Figure 60: Label for devices that emit laser power of 15W at wavelength of 1470 nm ................ 58
Figure 61: Laser warning sign..................................................................................................... 59
Figure 62: Laser emergency stop button..................................................................................... 59
Figure 63: Laser aperture at distal end of fiber............................................................................ 59
Figure 64: ESD warning symbol ................................................................................................. 59
Figure 65: Year of manufacture .................................................................................................. 59
Figure 66: Fuse .......................................................................................................................... 59
Figure 67: Manufacturer ............................................................................................................. 59
Figure 68: Up .............................................................................................................................. 59
Figure 69: See user manual........................................................................................................ 59
Figure 70: Fragile goods ............................................................................................................. 59
Figure 71: Admissible temperature range ................................................................................... 59
Figure 72: Keep away from water and dampness ....................................................................... 59
Figure 73: Maximum admissible air humidity .............................................................................. 59
Figure 74: CE mark .................................................................................................................... 59
Figure 75: Atmospheric pressure limitation ................................................................................. 59
Figure 76: WEEE sign (see chapter 11) ...................................................................................... 59
Figure 77: Applied part type B .................................................................................................... 59

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1 Safety provisions and regulations
The LEONARDO® laser system may only be operated by appropriately qualified and trained
personnel in compliance with legislation and the safety regulations. This device may also only be
implemented in a clinical setting by qualified and trained doctors.
National legislation and safety regulations must be observed. In Germany, these are as follows:
• The German Medical Devices Operator Ordinance (MPBetreibV)
• The accident prevention regulation “Laser Radiation” (German Accident Prevention &
Insurance Association safety prevention regulation no. 93)
• Electrical installations in hospitals and locations for medical use outside hospitals: DIN
VDE 0107
The operator or a nominated laser safety officer is responsible for ensuring compliance with these
regulations.
The LEONARDO® laser is a class 4 medical laser according to Directive EN 60825-1:2003. Class
4 lasers can generate dangerous diffuse reflections. They can damage the eyes and skin, and
represent a fire hazard. Class 4 lasers may also ignite flammable materials.

Caution: Direct eye exposure to the laser light leads to irreversible eye damage!
The laser system is not suitable for ophthalmological applications.
To avoid damage to the eye and retina, doctors, surgical personnel, patients and any other
persons present in the room during treatment must wear appropriate protective eyewear.
Only use protective eyewear provided or approved by CeramOptec. Suitable protective eyewear
can also be obtained from CeramOptec (see also the recommendations in section 5.2).

Safe distance – NOHD (Nominal Ocular Hazard Distance):

The safe distances for the following devices are:

LEONARDO® Dual45: 410 cm

LEONARDO® 1470 : 63 cm

from the laser outlet or from the emitting fiber.

Note that a greater distance must be maintained when using certain handpieces in derma mode
(see section 4.6.5).

Caution: Do not look directly at the laser beam or a laser beam that is in use with optical devices
or instruments. Doing so may result in permanent damage to the eyes or to the instruments.
Avoid placing reflective material, such as metal and glass, into the path of the beam.

Caution: Accidental irradiation to tissue not intended as the target tissue may result in laser burn.

Attention: The LEONARDO® laser may only be used with the accompanying footswitch and the
specified application and light delivery systems.

When operating the device, ensure that it is evenly balanced on a stable surface and that a
distance of at least 25 cm is maintained between the ventilation fan and the walls. Position the
device so that there are no cables or optical fibers suspended in the air between the wall socket,
the device and the patient.
To avoid risk of electric shock, do not open the housing. Service and maintenance may only be
carried out by CeramOptec or by qualified personnel authorized by CeramOptec.
The equipment must be routinely inspected and maintained in accordance with the instructions
provided in the maintenance section of this manual. A technical safety check must be performed
on a two year basis (see section 8.4).

Unplug the device before cleaning (see section 8.2).

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Caution: Do not use this device in potentially explosive atmospheres. Avoid using flammable
anesthetic gases or oxidizing gases such as nitrogen oxide or oxygen. Certain materials
saturated with oxygen, such as cotton, may ignite even if the laser is used in accordance with the
regulations. Allow sufficient time for flammable disinfectant solutions to evaporate before you use
the laser. Note that bodily gases may also ignite.
Caution: Use of non-approved equipment or procedures when the device is in operation may
result in dangerous exposure to radiation.

Noncompliance with the safety and operating instructions provided in this manual will in all cases
invalidate warranty and liability on the part of CeramOptec.

Note: Ensure that the switch on the back of the unit is in the off position to prevent unauthorized
use of laser devices.

Note: Note also the manufacturer’s specifications regarding electromagnetic compatibility and the
relevant requirements (see section 9.4).

2 Product description
LEONARDO® is a laser system with functions and ergonomics specially developed for medical
applications. A touchscreen is used to set treatment parameters, such as laser power. User-
friendly menu navigation and microprocessor-supported control ensure reliable operation while
allowing physicians to concentrate on the essential aspects of treatment.
The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser
radiation with the wavelength of 980 / 1470 nm +/-30 nm (aiming beam 635 nm +/-10 nm and 532
nm +/-10 nm). Depending on the model, your LEONARDO® laser has a maximum laser output
power of 15 W (1470 nm) or 30 W (980 nm).
LEONARDO® is available as a device with two wavelengths (980 nm and 1470 nm) or as a
single-wavelength device with 1470 nm.
All LEONARDO® lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE.
Additional special treatment modes for specific treatment procedures or in combination with
corresponding application fibers are available, depending on the configuration of the unit. Special
treatment modes are available in combination with the corresponding application fibers for
dermatology ("Derma mode") and phlebology ("ELVeS signal mode" and "ELVeS segment
mode").
For safety reasons, the LEONARDO® laser is equipped with a system for automatic recognition of
the optical fibers used. Application fibers from CeramOptec have coding for communicating with
the laser device.
For delivery details, refer to section 5.1.

2.1 Intended use and indications

LEONARDO® is designed for delivering laser light to soft tissue in contact and non-contact
surgical procedures, including endoscopic procedures.
LEONARDO® is suitable for the following fields of application: incisions, excisions, vaporization,
ablation, hemostasis or coagulation of soft tissue in the following areas:

• ENT (turbinectomy, LAUPP, septum, paracentesis, tonsillotomy, laryngeal cancer,

hemangioma, adhesions, epistaxis, DCR)

• Pulmonology (coagulation and vaporization of endobronchial tumors)

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 • Colorectal surgery (laserhemorrhoidoplasty), anal fistulas (FiLaC), soft tissue tumors,
polyps (polyposis coli and/or villous adenoma), anal stenoses, condylomata accuminata,
fissures, mariscae, coccygeal fistulas)

• Endovenous ablation of surface veins (saphenous veins, magna and parva), tributaries,
perforant veins, recurrences, venous leg ulcers)

• Dermatology (DUAL 45): Telangiectases, spider naevi, hemangioma, spider veins,

vascular malformations, warts, lentigo

Intended user: Hospitals, Ops and set up physicians.

Patient population: Ages, weight and state of health: The attending physician decides here.

2.1.1 Recommended lasers for indications

Dermatology
Endovenous
Pulmono-
ENT / Otorhinolaryngology Colorectal surgery ablation of
logy
coagulation & vaporization of endobronchial tumors surface veins

Telangiectases, spider naevi, hemangioma, spider

veins, vascular malformations, warts, lentigo
coagulation & vaporization of endobronchial

saphenous veins (magna and parva)

(laserhemorrhoidoplasty)

condylomata accuminata
and/or villous adenoma
Indication
polyps (polyposis coli
anal fistulas (FiLaC)
soft tissue tumors

coccygeal fistulas

venous leg ulcers

laryngeal cancer

perforant veins
turbinectomy

anal stenoses
hemangioma
paracentesis
tonsillotomy

reccurences
tributaries
adhesions

mariscae
stenoses
epistaxis
septum

fissures
LAUPP

DCR

Laser model
®
LEONARDO
X X X X X X X X X - X Xx X X X X X X X X X X X X X -
1470
®
LEONARDO
X X X X X X X X X X X X X X X X X X X X X X X X X X X
Dual 45

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2.2 Contraindications
No contraindications are currently known for the LEONARDO® laser when used as intended.

2.3 Side effects

Burning of the target tissue may occur if the intensity of the laser is set too high. Swelling,
bleeding or fever may occur as a result of improper use of the laser.

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3 Description of the device
3.1 Controls and connections
[1] Screen
[2] Emergency stop button
[3] Laser outlet
[4] Laser warning light
[5] Standby button

Figure 1: Front of the device

[6] Power connection

[7] Footswitch port
[8] Door interlock
[9] On-off switch
[10] Service Port

Figure 2: Rear of the device

Note: Detailed descriptions of labeling are provided in section 0.

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3.2 Description of controls, displays, connections
3.2.1 Controls

Figure 3: Subdivision of the operating interface

1. Info area
2. Laser status button
3. Status messages
4. Treatment mode options
5. Function options
6. Main area

Screen [1] The display is subdivided into four main key fields and shows:
- Status of the device (Enable/Standby)
- Treatment mode (Continuous mode (Continuous Wave CW),
Pulse mode and additional programs (optional))
- Treatment parameters (duration, energy, pulse parameter)
- Power settings
- Fiber information
- Aiming beam settings
Settings can be changed via the key fields and the cursor on the
screen
screen.
Key fields on the screen - Switch between enable and standby status
[1] - Change treatment mode (Continuous mode, Pulse mode and
additional programs (optional))
- Select the parameter to be configured
- Aiming beam (Off, On, CW mode or Pulse mode with intensity
setting)
- Save changed treatment modes
- Select function

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 Key fields next to the screen
Emergency stop button Pressing the emergency stop button interrupts the power supply of
[2] the laser diodes and averts an emission of laser radiation.
Only press the laser stop button in case of emergency.
Laser standby [5] Pressing this button switches the laser to standby mode, from
which it can be reactivated. To enter standby mode, the on-off
switch on the rear of the device must be in the On position.
Selecting a function
Treatment modes
Here you can select and set the treatment mode.

Info screen
Instructions for use and additional information about using lasers
can be retrieved and read on screen.

Video area
Treatment videos provided by biolitec biomedical technology
GmbH can be viewed here (coming soon).

Online shop for accessories (coming soon).

User settings
Device version number, language version, aiming beam settings.

Feature settings
These settings are only to be used by the service staff of
CeramOptec or other authorized personnel.

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 Selecting treatment modes
Continuous mode (Continuous Wave mode, CW)

Pulse mode

ELVeS® signal mode

ELVeS® segment mode

Derma mode (for LEONARDO® Dual 45 only)

Header
PILOT ON / OFF
The pilot beam can turned on or off and indicates if it’s turned on.
Furthermore the color of the pilot beam is displayed.
PILOT beam settings
Pilotbeam color, intensity and operatinn mode (CW/Pulse) can be
adjusted
SYSTEM STATUS
In standby mode, the power connection is plugged in and the main
switch is in the On position. The device does not emit any laser
radiation in the standby mode even if the footswitch is pressed.
Pressing this button switches the device from standby mode to
ready mode.
If the status is switched from standby to ready, the laser device
prepares for use. Duration of the preparing phase is about 3
seconds.

Indication that the laser is now ready. The laser device now emits
laser radiation as soon as the footswitch is pressed.
By pressing this button, the status switches from ready to standby.

Laser warning signal [4] When laser radiation is emitted, the LED warning light comes on
and a warning signal is sounded.

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 Side of the device
Laser outlet [3] Fiber coupling for connecting application fibers. If the fibers are not
fully tightened or if they loosen/detach during treatment, the error
message "No fiber connected" is displayed. If this error message
occurs, the laser switches to standby and can no longer be
activated.
Caution: Only use approved application systems, fibers, and
medical probes (see section 6). The use of non-approved systems
may damage the unit and result in dangerous exposure to
radiation. Noncompliance invalidates the warranty.
Application fibers LEONARDO® is compatible with various application fibers. For the
minimum fiber core diameters permitted and possible power
restrictions, refer to the specifications for the different models in
section 9.1.
The use of application fibers with a smaller fiber diameter or
lower quality and the use of non-approved systems may
damage the unit and result in dangerous exposure to laser
radiation. Noncompliance invalidates the warranty.
Rear of the device
Power connection [6] The laser may only be used in the standard power supply
configuration. Proceed as described in section 4.1. Examine the
cable for visible damage prior to connecting the plug to the power
supply. If the cable is damaged, do not use the cable or replace it.
Footswitch [7] The footswitch must be connected to the device using the plug
connector at the rear of the device.
Treatment starts when you press the footswitch. The laser emits
radiation for the preselected time. Treatment can be interrupted at
any time by releasing the footswitch.
The laser emits radiation only as long as the footswitch is
pressed.
Laser emission continues once you press the footswitch again.
Door interlock [8] A door interlock can be connected using the port on the rear of the
device. The device can only be operated if the door interlock is
closed or if the blanking plug supplied is connected to the port. To
ensure a correct connection, refer to section 4.1.2.
Caution: You must ensure that no voltage is connected to this
port.
On-off switch [9] For setting the laser system into operating state, press the switch
on the rear of the device. If the switch is in the On position, it is
possible to switch the laser to standby mode and back by pressing
the standby button (see page 10 and 12 [5]).
Sevice Port [10] Using the service port is reserved for persons who are authorized
by CeramOptec.

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4 Operation
4.1 Preparing the laser unit
Check the device for any obvious signs of damage after unpacking the laser. Do not use the
device if any damage is detected.
Before starting the laser, connect the footswitch cable to the footswitch port on the rear of the
device [7]. The red markings on the plug and the socket must line up.
Then connect the cable of the door interlock or the interlock connector with the port on the rear of
the device [8].
Connect the power cable [6]. You must use a power cable with Earth Ground (included in
delivery) and a power outlet with an approved earth ground.
After that insert the application fiber approved by the
manufacturer together with its plug (figure 4) into the fiber
coupling of the laser outlet [3] on the side of the device.
When the fiber is connected correctly, the message "No fiber
connected" disappears on the display.
The device is equipped with a system for automatic
recognition of application fibers. If an application fiber has
coding, information about the fiber is read from the coding
once the fiber is connected to the device. Figure 4: Application fiber
connection

If the message "Not a valid biolitec® fiber" appears, this means that the device did not recognize
the coding on the fiber or identified the fiber as unsuitable for the laser unit based on the data
defined for the device. Only approved application fibers may be used with this device (see
section 6). Please contact our service department if further information is required.

Caution: All operating steps after preparation of the laser unit may only be performed when all
persons in the room are wearing appropriate laser safety goggles.
Use of the operating controls or configuration options of the LEONARDO® in a manner other than
that described here in the instructions manual may result in radiation hazards.
Ensure that the treatment room is clearly identified and that only persons wearing the appropriate
laser protective eyewear may enter the room during treatment. If this is not possible, you must
install a door switch as per section 4.1.2 that switches off the laser output when the door is
opened. Note that switching off the laser during treatment may result in unintended
complications.

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4.1.1 Footswitch

Figure 5: Foldable footswitch

The footswitch is included in the delivery and is to be attached to the footswitch connector on the
rear of the device.
Warning: Do not touch the pins of the footswitch connector. Turn the device OFF before
connecting or disconnecting the footswitch.

4.1.2 Door interlock connection scheme

Connect the door interlock as shown in figure 6. A door interlock cable can be requested free of
charge from the manufacturer.
For additional connections, see also section 4.1 (Preparing the laser unit).

+5V
electrically signal lamp with separate
R electric circuit
5V separated
5mA
IC
S1

2 PIN
Interlock
S2
LASER for example:
S1: door
S2: window
S3 S3: …

Figure 6: Door interlock connection scheme

Warning: Do not touch the pins of the door interlock connector. Turn the device OFF before
connecting or disconnecting the door interlock connector.
Recommendation: It is recomm mended that all staff receive an explanation and training in ESD
procedures. The ESD precautions procedure training shall include at least the safe connection
and disconnection of the footswitch and door interlock connectors.

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4.2 Switching on the device
To switch on the device, use the switch
switc on the rear of the device. The laser activates and enters
standby mode. Now you can switch the device on and off by pressing the touch surface (biolitec®
logo). During power-up up the boot image and the first instructions appear on the start screen. After
initialization,
nitialization, the login screen for entering the user code pops up. This user code must be entered
everytime the device is switched on.

Figure 7: Start screen 1

Figure 8: Start screen 2 (Selecting

Selecting the language the first time the device is switched on)
on

The language used by the user interface needs to be entered the first time the device is switched
on. This setting is requested just once, and only if the device does not have a saved preset
language.

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 Figure 9: Login screen. The device activates after entering the number code

The access code is entered using the numeric keypad. By pressing OK the code is being
submitted and the device switches to standby mode. The code will be provided upon delivery of
the laser and the related introduction by a service assistant or by personnel
personne authorized by
CeramOptec.

Figure 10: An example of the monitor display when CW mode was the last active mode (for dual-
dual
wavelength devices)

The monitor will display the following for single-wavelength

single devices:

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 Figure 11:: An example of the monitor display when CW mode was the last active mode (for
single-wavelength devices)

4.3 Settings and parameters for all treatments

4.3.1 Setting language
The language the user would like can be selected by pressing
pressing the respective language button.
This setting can be saved by tapping the save button on the control panel.

Figure 12: Menu item: language setting

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4.3.2 Configuring the aiming beam
The aiming beam follows the same path as the therapeutic beam, so it also shows which area is
receiving therapeutic radiation.

The device starts with the aiming beam switched off. You have to press the PILOT button to
switch on the aiming beam. The screen will then display whether the aiming beam is switched on
and what color it is.
The color of the aiming beam can be selected using the PILOT box in the top bar.

Figure 13: Menu item: setting the aiming beam

You can configure a number of different settings for the aiming beam (see illustration 14). There
are options for a continuously active aiming beam and a flashing aiming beam, or it can be
deactivated. Moreover, it is possible to interrupt the aiming beam as soon as the therapeutic
beam is active. To change the intensity of the aiming beam, move the green bar or press the -/+
button. A numeric display also indicates the intensity selected. The operation panel can be used
to set the aiming beam to green or red.

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 Figure 14: Setting the aiming beam in any application mode by using the PILOT box

4.3.3 Help system

Help is available for every treatment mode in the form of brief instruction guides. This information
can be accessed by clicking the question mark icon on the screen.

Figure 15: Controls for Help

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 Figure 16: Help for Pulse mode

The help windows are marked by the violet frame and are intended to deliver quick information to
the user that can be helpful while using the application.

Figure 17: Help for 2D Power Control™ (not available in single-wavelength devices)

In case the brief instruction guide is not sufficient, by clicking the question mark you can find the
respective section in the user manual that is saved in the device. It can be found via the info
screen as well. A hard copy user manual is included in the delivery and should therefore also be
available.

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4.4 Extras
4.4.1 Info screen
The instructions for use and further information about the treatment modes and laser therapies
can be viewed by pressing the corresponding button.

Figure 18: Information screen

Figure 19: Navigating document display

By clicking the -/+ button you can scroll to the previous/next pages.
By pressing << you can directly jump to the first page of the document, by >> to the last one.

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4.4.2 User administration
This device has functionality for administrating more than one user. This allows each individual
user to work with his or her laser settings after logging in. User administration can be accessed
by entering and confirming the ADMIN password (53121) via the login screen.

Figure 20: Login screen

It is possible to add, edit and remove users. These options appear in the pop-up
pop window that
appears after the ADMIN password has been confirmed.

Pressing the and buttons in the lower right of the screen closes user administration.

Figure 21: User administration option menu

To create a new user, press the “Add” button. This opens the fields for defining the new user:

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 24 of 70

- User name
- Comment
- Setting number: Laser settings can be defined here. Different users can have the same
setting number – this allows them to use the same saved laser settings. If one user changes
these laser settings, the change will then affect all users who have the
the same setting number.
- If one user would like to keep his or her laser settings independent of all other users, that user
needs to be given a unique setting number that is not shared with any other users.
- Password
- Repeat password

When entering the parameters “Setting number”, “Password” and “Repeat password”, no letters
may be used, so the letter keys on the touchscreen keyboard will appear in gray to show that
they have been deactivated.

To save a new user, press the “disk” button in the upper right of the screen. The button
in the upper right can be used to close the “Add” option without saving. After it is pressed,
pressed the
option menu opens.

Figure 22: Add user

Choosing “Edit” from the option menu opens fields for making changes to existing user accounts.
The user account you want to edit must be selected from the drop-down
drop down list in the upper left of
the screen. Then the parameters “Comment” and “Password” (together with password
confirmation) can be
e changed for the user you have selected.
When entering the parameters “Password” and “Repeat password”, no letters may be used, so
the letter keys on the touchscreen keyboard will appear in gray to show that they have been
deactivated.

To save changes to the user account, press the “disk” button in the upper right of the
screen. The button in the upper right can be used to close the “Edit” option without saving.
After it is pressed, the option menu opens.

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 Figure 23: Edit user

To delete a user account, select “Remove” from the option menu. The user account you want to
delete must be selected from the drop-down
drop down list in the upper left of the screen.

To remove the selected user account, press the “disk” button in the upper right of the
screen. The button in the upper right can be used to close the “Remove” option without
saving. After it is pressed, the option menu opens.

Figure 24: Remove user

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4.4.3 4.4.3 Video display
Video display is still in the process of being prepared and will be installed on the device once it is
ready.

4.4.4 Online shop

The online shop is still in the process of being prepared and will be installed on the device once it
is ready.

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4.5 Treatment
4.5.1 Configuring the laser output
You can configure the laser output in all treatment modes individually. The setting of the laser
output for devices that emit a single wavelength can be configured by tapping the white operation
panel during application (method 1). The laser output of devices that emit two wavelengths can
be configured by method 1 (constant ratio between power of wavelength 1 and wavelength 2) or
method 2 (laser powers for both wavelengths can be changed independently of each other).

Method 1

Method 2

Figure 25: Setting the laser output for a dual-wavelength

dual wavelength device

Figure 26:: Setting the laser output for a single-wavelength

single wavelength device

Method 1: The setting of the laser output can be configured by tapping the white operation panel
for laser power.
wer. To increase the power level currently set, move the bar to the right.
ri To decrease
the power level,, move the bar to the left.

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Alternatively, the and buttons can be used.

In devices that emit two wavelengths, laser output can be adjusted simultaneously for both
wavelengths with a constant mixing ratio between the laser power output of the two wavelengths
(figure 27).

Figure 27: Setting the laser output for devices that emit one or two wavelengths

Method 2: In devices that emit two wavelengths, laser power output can be set separately for
each wavelength by using the pencil field. If 2D Power Control™ is NOT enabled, a window with
4 scroll bars will pop up (figure 29). In this window, the total output, the combined factor or the
output for each wavelength can be set separately, either by moving the scroll bars or by pressing

the or buttons.

Figure 28: Laser power setting for dual wavelength without 2D Power Control™

If 2D Power Control™ is enabled, two different therapy lasers can be set by using this function.
The therapy laser at a wavelength of 1470 nm is controlled on the horizontal axis and the therapy
laser at a wavelength of 980 nm is controlled on the vertical axis.

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 Figure 29: Method 2: Setting the laser power using 2D Power Control™

Figure 30: Setting output with constant total laser power output

By pressing the FIX field next to the guide surface, a green guide line pops up that helps you to
adjust the mixing ratio between the two wavelengths while the total output is held constant.

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 Figure 31: Setting the output with constant relation between two wavelengths

By pressing the FIX field at the bottom left of the window, a green guideline pops up that helps
you to adjust the total output of the laser.

You can also fix the output of the laser for one wavelength on the respective axis while the output
for the other wavelength remains adjustable.

Figure 32: Fixing the power for the wavelength 1470 nm on the horizontal

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 Figure 33: Fixing the power for the wavelength 980 nm on the vertical axis

2D Power ControlTM also makes it possible for you to save four different power settings.
settings

Figure 34: Saving four power settings

For power settings that have been saved, just press one of the four buttons in the lower part of
the screen to retrieve the setting (e.g.
(e.g ).

To save a power setting, first make the selection using the control panel.
panel Keeping one of the four
save buttons for longer than 1 second stores the setting.
setting
This opens another pop-up window for naming the button.
button The button needs to be pushed briefly
so that a blank (_____) appears. Then you can use the screen keypad to enter and confirm any
name you wish to give the setting.
setting
Note: The previously selected power setting
set will appear below the button (the
the power for the 1470
nm wavelength on the left and the power for the 980 nm wavelength on the right).
right

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 Figure 35:
35 Pop-up window for saving the power setting

Figure 36: New name for the button

Tapping the button in the lower right of the screen saves the settings.
settings Use the button to
close the menu without saving any changes.
changes

4.5.2 Selecting a treatment mode

Press the treatment mode field to select a treatment mode. All available modes will appear on the
screen so that one can be selected.
selected

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 Figure 37: Selecting a treatment mode on the touchscreen

4.6 Description of the treatment modes

All LEONARDO® lasers can be operated in two basic modes, Continuous (Continuous Wave CW)
or Pulse mode as well as in the conducted treatment modes ELVeS signal, ELVeS segment and
Derma mode.

In CW mode, the laser continuously emits radiation at the selected power level as long as the
footswitch is pressed.

In Pulse mode, the laser emits radiation at the selected power level with the specified number of
pulses and pulse format (pulse duration/pulse pause) as long as the footswitch is pressed.
• Defined number of pulses → between 1 and max. 99 pulses (depending on configuration)
• A continuous series of pulses as long as the footswitch is pressed
This pulse procedure is repeated as long as the footswitch is pressed or until the defined number
of pulses is reached. If the footswitch interrupts a pulse or a pulse pause, the entire pulse
procedure is repeated when the footswitch is pressed again.

The ELVeS signal mode is derived from the continuous mode. The device indicates the pulling
speed of the fiber from the vein via auditory signals. This speed is calculated from a combination
of output and energy per signal that have been selected by the user.

The ELVeS segment mode is derived from the continuous mode and has an additional visual
support for the user during vein treatment.

The Derma mode for dermatology is derived from the pulse mode. Here, the laser sets the
required laser output for the selected power density in relation to the selected handpiece.

4.6.1 Continuous mode CW

The laser starts in the last saved mode. The mode can be changed when the laser is in standby
by pressing the treatment mode button on the screen. The laser shows CW mode here. In
standby mode, you can change the settings of the laser. No radiation can be emitted in standby
mode, even by pressing the footswitch.

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 Figure 38: Screen display of Continuous mode CW in standby

Figure 39:: Screen display of Continuous mode CW (for devices that emit one wavelength)

Laser power can be set in continuous mode as shown in figures 26 - 27. As soon as you have
changed all settings (operating mode, power, aiming beam), you can enable the laser unit for
laser emission by tapping the "Standby" button in the upper right corner of the screen and putting
it into "Ready" mode.
When the "Standby" button is activated, the laser is put into the preparation phase for about 3
seconds. After that, the laser is ready for emission.
The laser is now active and the laser hazard area must be secured. The yellow LED next n to the
display flashes and the message "Press Footswitch to Fire Laser" appears in the screen footer.

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When the unit is in "Ready" mode, pressing the footswitch causes the application fiber to
emit laser light. The laser emits a continuous beep and the LED next to the screen remains
lit during the entire laser emission.
When the unit is enabled in continuous mode, laser light is emitted using the connected
application fiber as long as the footswitch is pressed. You can discontinue laser emission
by simply releasing the footswitch. As long as the laser unit is in "Ready" mode, the laser
can be activated repeatedly.

Figure 40: Display of laser ready for emission

During laser emission, the message "LASER FIRING" appears on the screen. The treatment time
and the emitted treatment energy are simultaneously added up and displayed. The treatment
time and treatment energy can be reset when the laser is enabled or when it is in standby mode.

You can use the "Ready" button in the upper right of the screen to switch to secure standby at
any time. You should always switch to standby after a treatment is completed or when
temporarily putting down the application fiber.
You can end laser emission at any time by
• releasing the footswitch
• pressing the "STOP LASER" button
• pressing the "Standby" button
Laser emission can also be interrupted (usually unintentionally) by safety circuits. During normal
use, these circuits should not be triggered intentionally to switch off laser emission:
• by opening the door in the case of a connected door interlock
• by disconnecting the application fibers
In these cases, laser emission stops immediately, the audible signal stops and the laser emission
symbol is turned off. The laser unit switches to secure standby. Messages indicating the reason
for shutdown appear on the screen.

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 Figure 41: Examples for continuous mode

4.6.2 Pulse Mode

The laser starts in the last saved mode. The mode can be changed when the laser is in standby
by pressing the treatment mode button on the screen. Now you can select the pulse mode.

Figure 42: Screen display of Pulse mode

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 Figure 43:: Screen display of Pulse mode (for devices that emit one wavelength)

Figure 44:: Screen display of Pulse mode, parameter settings

The settings for Pulse mode can be set on the display (as described on the following page). The
intervals are displayed graphically on the left.
left

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 Figure 45: Pulse duration zoom settings

For fine adjustments of the pulse duration and the pulse pause, there is a zoom function for
precisely adjusting single segments.

In pulse mode, you can set the following parameters by touching the appropriate bar on the
screen:
Pulse repetition Pulse duration Pulse pause
(Number of pulses) (Pulse length (Interval between pulses
max value configurable by max value configurable by
service assistant) service assistant)
1 – 99 pulses (depending on 0.01 – 60.0 s 0.01 – 60.0 s
configuration)
Continuous series of pulses as long as 0.01 – 60.0 s 0.01 – 60.0 s
the footswitch is pressed

To change the currently selected settings, touch the relevant field and move the green bar or

press the and buttons.

To increase the set values (power, pulse duration, pulse pause, number of pulses), move the bar

to the right or press the button. If the values are to be decreased, move the bar to the left or

press the button.

Once you have set the desired pulse format, the setting can be saved via the OK field.
In PULSE MODE, the laser emits radiation at the selected power level with the specified number
of pulses and pulse format (pulse duration, pulse pause) as long as the footswitch is pressed.
• Defined number of pulses → between 1 and max. 60 pulses can be selected
• A continuous series of pulses as long as the footswitch is pressed
This pulse procedure is repeated as long as the footswitch is pressed or until the defined number
of pulses is reached. If the footswitch interrupts a pulse or a pulse pause, the entire pulse
procedure is repeated when the footswitch is pressed again.

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 Figure 46: Single-pulse mode

Figure 47: Multi Pulse mode

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4.6.3 ELVeS® segment mod
ode
ELVeS® segment mode is a continuous mode with additional acoustical and visual support for the
user. To enable targeted treatment of individual vein sections, you configure the power settings
for a specific vein length on the laser device. During treatment, a progress bar on the display
indicates how much energy in joule per cm has been emitted by the laser in accordance with the
settings for the selected vein segment.
segment

Figure 48:: Start screen of ELVeS® segment mode for setting

Figure 49:: Start screen of ELVeS® segment mode for setting parameters (for devices that emit
one wavelength)

In the upper screen section of the ELVeS® segment mode, the laser output can be defined. In the
bottom section, pressing the white field opens a new window where the following parameters
must be configured:

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 Vein length: Select the length (in cm) of the vein segment that is to be treated (0 cm –
100 cm)
Energy/length: Select how much energy (in joules) is to be emitted per cm

Figure 50: Setting the parameters in ELVeS® segment mode

To change the parameters, tap the or buttons or move the green bar. LEONARDO®
then automatically calculates the length of the vein segment in proportion to the selected quantity
of energy and displays it as a progress bar.
Once you have checked all parameters again, you can enable the laser unit for laser emission by
tapping the "Ready" button in the upper right of the screen. When the "Ready" button is activated,
the laser switches to the preparation stage. This is indicated by PREPARATION lighting up in the
top right next to SYSTEM STATUS. The laser emits a continuous beep.
The laser is now active and the laser hazard area must be secured. The yellow LED next to the
display flashes and the message "Press Footswitch to Fire Laser" appears in the screen header.
When the unit is enabled, pressing the footswitch causes the application fiber to emit
laser light. The laser emits a continuous beep and the LED next to the screen remains lit
during the entire laser emission.
When the unit is in "Ready" mode in the ELVeS® segment mode, laser light is emitted
using the connected application fiber as long as the footswitch is pressed. You can
discontinue laser emission by simply releasing the footswitch. As long as the laser unit is
enabled, the laser can be activated repeatedly.
During laser emission, the message "LASER FIRING" appears on the screen. The treatment time
and the emitted treatment energy are simultaneously added up and displayed on the progress
bar.

Example: You want to emit treatment energy of 80 J per 1 cm of vein when treating a vein that is
50 cm long. You configure the vein length and the quantity of energy on the ELVeS® segment
setting screen. Based on the selected energy per unit of length and the actually emitted treatment
energy, the LEONARDO® automatically calculates the relevant vein segment length and indicates
it on the progress bar.

Caution: Note that the actual energy per vein length emitted in this mode is still determined by
the user. The laser unit only displays the target values as a guide to optimal and homogeneous

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 42 of 70

energy emission. This can be considered a theoretical (target) value and can be used for the
purpose of comparing target and actual values.
The progress bar only provides a theoretical value indicating how much distance the user should
have covered to maximize the homogeneity of the energy emitted within the vein. It never
measures whether the fiber is moved or how far it is moved.
The user is personally responsible for comparing and reconciling the actual traction speed and
distance covered by the laser within the vein with the parameters calculated by the device and
indicated on the progress bar!

4.6.4 ELVeS® signal mode

ELVeS® signal mode is a continuous mode with additional visual and auditory support for the
user.
In ELVeS® signal mode, you can configure an energy interval (of between 20 J and 200 J) in
addition to the laser power. During treatment, a beep is sounded to indicate that the configured
energy interval has been reached. This provides an auditory signal to the user indicating how
much energy has already been emitted in the vein.

Figure 51: Setting the parameters in ELVeS® signal mode

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 Figure 52:: Setting the parameters in ELVeS® signal mode (for devices that emit one wavelength)
wavelength

The laser output can be configured in the top section of the screen by tapping the white operation
panel.
Tapping the white field next to the energy interval opens another window where you can define

the energy interval by moving the green bar or pressing the or button. When the OK
button is pressed, the settings are accepted.
accepted

Figure 53: Setting laser power

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 Figure 54: Defining the energy interval

Example: You want to emit 140 J for each 1 cm of vein to be treated. You configure an energy
interval of 140 J and also define the required laser power. During treatment, a beep sounds each
time 140 J of treatment energy has been emitted. For example, you will hear a beep after 140 J,
280 J, 420 J, 560 J etc. If you have set power at, say, 10 W, the beep sounds every 14 seconds
and you would have to have moved the laser 1 cm along the vein by the time each beep occurs
in order to achieve the target energy density of 140 J/cm.
The total treatment energy emitted is calculated independently and displayed on the screen.

Once you have checked all parameters again, you can enable the laser unit for laser emission by
tapping the "Ready" button in the upper right of the screen.
When the "Ready" button is activated, the laser switches to the preparation stage. This is
indicated by PREPARATION lighting up in the top right next to SYSTEM STATUS. The laser
emits a continuous beep.
The laser is now active and the laser hazard area must be secured. The yellow LED next to the
display flashes and the message "Press Footswitch to Fire Laser" appears in the screen footer.
When the unit is enabled, pressing the footswitch causes the application fiber to emit
laser light. The laser emits a continuous beep and the LED next to the screen remains lit
during the entire laser emission.
When the unit is in "Ready" mode in the ELVeS® signal mode, laser light is emitted using
the connected application fiber as long as the footswitch is pressed. You can discontinue
laser emission by simply releasing the footswitch. As long as the laser unit is enabled, the
laser can be activated repeatedly.
During laser emission, the message "LASER FIRING" appears on the screen. The treatment time
and the emitted treatment energy are simultaneously added up and displayed on the progress
bar.

Warning: Please note that the actual energy per vein length emitted in this mode is still
determined by the user. The laser unit only displays the target values as a guide to optimal and
homogeneous energy emission.
The user is responsible for comparing these values with the actual emitted energy and distance
covered by the fiber within the vein!

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Attention: In this mode, NO beep is heard during laser emission (in contrast to the other modes).
An auditory signal is heard only when the energy interval is reached.

4.6.5 Derma mode (for LEONARDO® Dual 45 only)

Derma mode is used in combination with handpieces for dermatological applications. Depending
on the handpiece used (laser beam diameters on the skin may be 0.6 mm, 1 mm or 1.5 mm), the
laser device automatically calculates part of the parameter configuration based on the energy
density set (see Figure 56: Setting parameters for Derma mode).

Caution: Note that laser produced skin vaporisation / smoke could contain viable particles.

Caution: Note that the safe distance, i.e. the NOHD (Nominal Ocular Hazard Distance), depends
on the handpiece selected. This distance is specified in the table below:
Handpiece for a beam LEONARDO® Dual 45
diameter of 980nm/30W
0.6mm 4.1m
1.0mm 6.8m
1.5mm 11m

Select the energy density and the applied handpiece by tapping the respective pencil fields

(gearwheel). All values can be selected by moving the green bar or pressing the or
buttons.
If you then change the pulse duration or pulse pause, the laser automatically sets all additional
parameters – in relation to the setted enery density and choosed handpiece (within the available
range of values).

Figure 55: Screen display of Derma mode, dual laser setting

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 Figure 56: Setting parameters for Derma mode

4.7 Switching off the laser system

You can switch off the laser via the touch switch with the biolitec® logo in the front left. The last
used mode is saved and is used the next time the system is started. Via the touch switch you can
switch the laser on again and open the entry field for the user code.
With the switch on the rear of the device, you can cut off the power supply entirely.

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4.8 Messages and possible causes
In case the message "door interlock error” appears on the screen, the respective plug on
the rear of the device is not in use. Please read the section on installation of the door
interlock (see also section 4.1.2).
In the case that no application fiber is connected to the laser output of the device, the
message "No fiber connected” is displayed. In this case, connect an appropriate fiber.
In the case that the message "Not a valid biolitec® fiber” appears on the screen, the intern,
automatic fiber identification system has identified the connected application fiber as
inappropriate (see section 0). Unconnect the fiber and then try reconnecting it. If the
message appears again, even though it is an appropriate CeramOptec fiber, please
contact our service department and use another application fiber in the meantime. In case
the message appears for every application fiber, please also contact our service
department.
For the increased patient safety, our single-use products are shipped with a limited
service life, which starts the first time the laser is switched to enable mode. After use, the
device will automatically enter standby mode and a message will appear with information
on the remaining service life. To continue the treatment, switch into enable mode. The
device will inform you again about the exact remaining life of the fiber at a later time.

Message / Possible causes Suggested action

Display
Black display Power supply Check the power connection.
interrupted Check the fuse.
Plug not connected to
the main power
Black display Laser is not switched Touch switch with the biolitec® logo.
on
Black display Other reasons Servicing required
Emergency off Laser stop button was Confirm by pressing OK.
switch pressed pressed
Door interlock error Door interlock not Connect door interlock again, paying attention to
connected the red markings.
Door interlock error Error in door interlock
Check and repair door interlock system, see
system section 4.1.2.
Door interlock error Loose blanking plug Connect blanking plug again, paying attention to
the red markings.
Door interlock error Faulty blanking plug Replace blanking plug (obtain from service
department).
Temperature out of Temporary overheating Check for blocked ventilation slots.
tolerance Laser unit switches automatically to standby until
the optimal operating temperature is restored.
No fiber connected Fiber connection not Reconnect and secure the application fiber.
complete
No fiber connected Fiber coupling faulty Replace the application fiber.

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Not a valid biolitec® The fiber was not recognized as approved. Use an application fiber
fiber approved for this device
(see also section 5).
Contact the fiber supplier if
necessary.
Can be used for less The remaining time for this use is indicated. To proceed with treatment,
than xx min There will be at least one more use after the switch back to Ready
present use. mode.
Fiber valid for less The remaining time for using this fiber is To proceed with treatment,
than xx min indicated. It cannot be used again after this. switch back to Ready
mode.
xx uses remaining Indicates the number of uses remaining,
excluding the current use.
One use remaining You have one use remaining, excluding the
current use.
Last use Indicates that the current use is the last use
remaining.
Fiber expired The fiber has expired. Use a new application fiber.
Fiber: Software The current version of the laser software is The laser requires a
update unable to interpret all of the data on the fiber. software update. Contact
recommended However, you can still continue using the our service department.
fiber.
Fiber: Software The laser requires a
The current version of the laser software is
update required software update. Contact
unable to interpret the data on the fiber and
or you must therefore stop using this fiber. our service department.
Invalid fiber. Error If possible, use an
Code 55. application fiber from an
earlier delivery.
Footswitch not No footswitch is attached to the device. Please connect a suitable
connected footswitch to the device.
Shunt Voltage Error Relation between Laserdiode and Photodiode Call service
out of tolerance
Energy out of Laserpower out of tolerance (+/- 20%) Continue to monitor laser
tolerance power and consult service
Device error Internal Device Error Call service

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5 Accessories
5.1 Sales package for the laser includes
• Laser device
• Footswitch
• Power cable
• Door interlock
• Manual
• Laser warning triangle
• Carrying case
• 3 Laser safety goggles
If required, you can request an interlock cable for your door interlock free of charge from
CeramOptec.

Order numbers for available replacement parts.

Footswitch SA 2271
Power cable LA 0027 Europe
LA 1271 India
LA 1509 China
LA 4264 Great Britain
LA 4265 Japan
LA 4266 Italy
LA 4425 Australia
LA 4426 North America
LA 4498 Canada
Door interlock SA 2292

Note: Check that you have received all standard accessories listed here. Check the device and
accessories for any obvious signs of damage, and do not use them should any be found.

5.2 Laser safety eyewear

Figure 57: Laser safety eyewear

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Caution: Protective eyewear must always be worn when using the laser.
Goggles must have sufficient optical density for a laser beam wavelength of 980 +/- 30 nm or
1470 +/- 30nm. CeramOptec recommends goggles with the following lenses, which fulfill the
requirements of the ANSI Z136.1 and CE / EN 207 standards. These goggles are manufactured
by the company Sperian Eye (GPT-Glendale).

Lens
Alternative lens
Model number EN207:2002 EN207: 2010
number (Honeywell)
(Honeywell)
LEONARDO® DUAL
45 950-1010 DL4 950-1010 DLB 6
#xx-21096 -
980nm /30W 1430-1510 DL2 1430-510 DLB 4
1470nm /15W
LEONARDO® 1470
#xx-2219 #xx-21096 1430-1510 DL2 1430-510 DLB 4
1470nm/15W

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 51 of 70

6 Application systems, fibers and medical probes

Attention: Only application systems, fibers and medical probes approved by CeramOptec may
be used. Use of systems that have not been approved may damage the device and will invalidate
the warranty.

6.1 Application fibers and medical probes

Only application fibers and medical probes with a minimal fiber core diameter, as indicated in the
technical specifications (see section 9.1), may be used with your LEONARDO® model.

6.2 Handling and use of application systems and medical probes

Caution: It is essential that you adhere to the clinical stipulations for handling sterile application
systems, medical probes and handpieces. The valid regulations for the handling of sterile
products must be observed. CeramOptec is not liable for accidents or damage to the device
resulting from violations of these regulations.
To ensure the proper and safe use of medical laser systems, only qualified doctors who have
received the appropriate training or instruction should use the application systems and medical
probes.

Attention: Follow the instructions enclosed with the application fiber to ensure safe handling.
Noncompliance with the manufacturer’s handling recommendations may result in damage to the
application fiber or medical probe and/or injury to the patient or user.
The application fiber or probe must only be cleaned and/or disinfected in accordance with the
manufacturer’s recommendations. Inappropriate use of cleaning or disinfectant products may
result in (sometimes unnoticeable) damage to the fiber, which could cause injury to the patient or
doctor.

Attention: Particular caution is required when handling application systems or medical probes. If
these are knocked against a hard surface or bent excessively, they may be damaged and their
functioning impaired. Fiber tips may be damaged by incorrect handling. Fibers suspected of being
damaged may not be used.

• Check that the sterile packaging is undamaged.

Laser probes delivered in opened or damaged packaging are not sterile and therefore should
not be used.
• Remove the system from the packaging.
• Perform a visual inspection.
• Insert the probe into the laser device’s aperture port and secure it fully. Otherwise, the safety
contact of the fiber socket is not closed.
• Remove the protective covering at the distal end of the fiber. Visually inspect the laser tip for
damage.
• Since the aiming beam follows the same path as the therapeutic beam through the application
fiber, it can be used to check that the application fiber is undamaged. If the aiming beam does
not appear at the distal end of the application fiber, if its intensity is weak or if it unexpectedly
appears to be diffuse, this may indicate a damaged or defective application fiber. Bright points
glowing along the length of the laser are another possible indication of the same.

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 52 of 70

7 Safety
7.1 Safety elements

Figure 58: Safety elements

Attention: Safety elements S1 to S9 are part of the laser system. These must always be used to
improve safety when using LEONARDO®. Therefore, check as thoroughly as possible that these
are functioning correctly.

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 53 of 70

8 Maintenance and care
LEONARDO® is designed to be particularly low-maintenance and reliable.

Attention: LEONARDO® contains no parts that are serviceable by the user. Any attempt to
repair, adjust, or modify the system (outside of the procedures outlined in this manual) by
any person not authorized by CeramOptec is strictly FORBIDDEN and will invalidate the
warranty.
The final decision will rest with CeramOptec in all cases.
To avoid risk of electric shock, do not open the housing. During the warranty period, servicing
and maintenance may only be carried out by CeramOptec or by qualified personnel authorized by
CeramOptec.

8.1 Routine maintenance

The following checks should be performed regularly:
• Check laser protective eyewear (correct type, intact).
• Check that all labels and markings can be read and are positioned correctly (see section 0).
• Check that the emergency off switch is working.
• Check that an interlock interruption puts the laser into standby mode.
• Check that the auditory signal is activated when the footswitch is pressed and that laser
radiation is emitted.
• At the lowest possible power setting, check that the laser switches to standby when the
connector of the application fiber is loosened.

8.2 Cleaning
Attention: Unplug the device before cleaning.

Clean the housing with a damp cloth and a mild alcohol-based antiseptic detergent or mild
cleaning agent. Chemical cleaning agents, abrasive cleaning agents, and rough cleaning cloths
may damage the surface of the housing and therefore should not be used. Do not spray with
water as it may penetrate the equipment.

Attention: Please follow national regulations for clinical hygiene.

8.3 Changing fuses

Attention: Unplug the device before changing the fuses. The fuses are located on the rear of
the device above the power plug.

Fuses that have blown must only be replaced with fuses of the same type (see the model-specific
specifications in section 9.1.
Should a replacement fuse also blow, stop using the device and contact our service department.

8.4 Technical safety check

A technical safety check of the LEONARDO® laser system must be performed on a two year
intervals in accordance with statutory requirements, and the results documented in the relevant
maintenance log. To perform the technical safety check, proceed as described in section 13.3.
During the warranty period, the technical safety check must be performed by CeramOptec or by
persons authorized by CeramOptec. Otherwise, any warranty or liability claims will be invalidated.

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 54 of 70

9 Technical specifications and labeling
9.1 Model-specific specifications

9.1.1 LEONARDO® DUAL 45

Model 1470 nm / 15 W + 980 nm / 30 W
Power 15W ± 20% + 30W ± 20%
Wavelength 1470 nm ± 30 nm + 980 nm ± 30 nm
Power supply / Power consumption 100 – 240 VAC; 50-60 Hz / 450VA
Fuses T4AL, 250V AC, 5x20 mm
Minimal fiber diameter 360µm

9.1.2 LEONARDO® 1470

Model 1470 nm / 15 W
Power 15 W ± 20%
Wavelength 1470 nm ± 30 nm
Power supply / Power consumption 100 – 240VAC; 50-60 Hz / 450VA
Fuses T4AL, 250V AC, 5x20 mm
Minimal fiber diameter 360µm
9.1.3

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 55 of 70

9.2 General specifications for all LEONARDO® models

Numerical aperture NA = 0.25 (or higher)

Fiber connector Modified SC
Treatment mode Continuous (CW) / Pulse
Pulse duration Variable: 0.01 to 60.0 seconds
Power control Integrated power control
Aiming beam; power 635 ± 10 nm; 4 mW (max) 532 ± 10 nm; 1 mW (max)
Laser class according to 60825-1 4
Class of device according to 60601-1 I
Cooling Cooling fan
Storage and transport conditions Temperature: -10 to +40°C
Rel. humidity: <80% RH non condensing
Atmospheric pressure: 700 to 1100 hPa
Operating conditions Temperature: +10 to +25°C
Rel. humidity: < 50% RH non condensing
Atmospheric pressure: 760 to 1100 hPa
Dimensions (housing) 275 mm x 370 mm x 85 mm (HxWxD)
Weight Approx. 8.5 kg
Applied part Applied part: Type B
Mains isolation Disconnection from mains is done by mains switch

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9.3 Labeling

9.3.1 Certification and power rating label

Model: Model name as in section 9.1
Input: Electrical connection as specified for each model in section 9.1

INVISIBLE LASER RADIATION

AVOID EYE OR SKIN EXPOSURE TO DIRECT OR INDIRECT RADIATION

Class 4 laser product

Diode-Laser 980 +/-
+/ 30 nm CW 30 W (MAX) | Diode-Laser 1470 +/- 30 nm CW 15 W (MAX)

EN 60825-1:2008 EN 60601-2--22:2007

VISIBLE LASER RADIATION

AVOID EYE EXPOSURE TO DIRECT RADIATION
Class 3R laser product
Diode-Laser 635 +/- 10 nm CW 4 mW (MAX) (Aiming)
Diode
Diode
Diode-Laser 532 +/- 10 nm CW 1 mW (MAX) (Aiming)
EN 60825-1:2008 EN 60601-2--22:2007

MADE IN GERMANY
CeramOptec GmbH
Siemensstr. 44 * 53121 Bonn
Operation
www.ceramoptec.com/support

Storage
2013
®
Type LEONARDO
Model DUAL 45 SN xxxxx
Input 100-240
240 VAC, 50-60
50 Hz, 450VA Fuse 2 x T4AL / 250V
Figure 59:: Label for devices that emit laser power of two wavelengths

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 57 of 70

 INVISIBLE LASER RADIATION
AVOID EYE OR SKIN EXPOSURE TO DIRECT OR INDIRECT RADIATION

Class 4 laser product

Diode-Laser 1470 +/- 30 nm CW 15 W (MAX)

EN 60825-1:2008 EN 60601-2
2-22:2007

VISIBLE LASER RADIATION

AVOID EYE EXPOSURE TO DIRECT RADIATION
Class 3R laser product
Diode-Laser 635 +/- 10 nm CW 4 mW (MAX) (Aiming)
Diode-Laser 532 +/- 10 nm CW 1 mW (MAX) (Aiming)
EN 60825-1:2008 EN 60601-2
2-22:2007

MADE IN GERMANY
Operation:
CeramOptec GmbH
Siemensstr. 44 * 53121 Bonn
www.ceramoptec.com/support
Storage:

2013
®
Type LEONARDO
Model 1470 SN xxxxx
Input 100-240
240 VAC, 50-60
50 Hz, 450VA Fuse 2 x T4AL / 250V
Figure 60:: Label for devices that emit laser power of 15W at wavelength of 1470 nm

Danger and laser warning

Diode laser xxx +/- 30 nm CW yy W (MAX)
Diode laser 635 +/- 10 nm CW 4 mW (MAX)
xxx, yy are the wavelength and power of the LEONARDO® model.

Warning: To avoid risk of electrical shock, this device must be connected to a power supply with
protective conductor only.

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 58 of 70

 Figure 62:: Laser emergency stop button

Figure 61:: Laser warning sign

Figure 63:: Laser aperture at distal end of

fiber. Figure 64:: ESD warning symbol

9.3.2 Symbol key

Figure 66:: Fuse

Figure 65: Year of manufacture

Figure 67: Manufacturer

Figure 68:
68 Up

Figure 69: See user manual

Figure 70: Fragile goods

Figure 71: Admissible temperature

range
Figure 72: Keep away from water and
dampness

Figure 74: CE mark

Figure 73: Maximum admissible air
humidity

Figure 75: Atmospheric pressure

limitation
Figure 76: WEEE sign (see chapter 11)

Figure 77: Applied part type B

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 59 of 70

9.4 Manufacturer’s Declaration Regarding Electromagnetic Compatibility

Table 201 as per EN 60601-1-2:2007, IEC 60601-1-2:2007

1 Guidance and Manufacturer's Declaration - Electromagnetic Emissions

2 The LEONARDO® laser device is intended for use in an electromagnetic environment as described
below. The user of the device should ensure that the device is operated in such an environment.
3 Norms, measurements Compliance Electromagnetic Environment - Guidance
4 RF emissions acc. to Group 1 The device uses RF energy exclusively for its
CISPR 11 internal function. Thus the RF emission is very
low and it is unlikely that nearby electronic
devices would be disturbed.
5 RF emissions acc. to Class B The device is suitable for use in all
CISPR 11 establishments, including domestic environments,
directly connected to the public low-voltage power
6 Emission of overtones Class A supply network that supplies residential buildings.
acc. to IEC 61000-3-2

7 Emission of voltage Complies

fluctuation/flicker acc. to
IEC 61000-3-3

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Table 202 as per EN 60601-1-2:2007, IEC 60601-1-2:2007
Guidance and Manufacturer's Declaration - Electromagnetic Compatibility
Norms, Measurements IEC 60601 Compliance Electromagnetic Environment -
Test level level Guidance
EN 61000-4-2:2009 ± 6 kV ± 6 kV Floors should be of wood, concrete or
Electrostatic discharge Contact ceramic tiles. If the floor is tiled with
(ESD) discharge ± 8 kV synthetic material, the relative air
± 8 kV humidity should be 30 % at least.
Air discharge
EN 61000-4-4: 2004 + ± 2 kV for ± 2 kV The quality of the supply voltage
A1: 2010 power lines should conform to a typical business
Fast transient electric ± 1 kV for ± 1 kV or clinic environment.
disturbances / bursts input and
output lines
EN 61000-4-5:2006 ± 1 kV ± 1 kV The quality of the supply voltage
High energy pulses normal mode should conform to a typical business
(surge) voltage or clinic environment.
± 2 kV ± 2 kV
common
mode voltage
Voltage drops, short <5% UT <5% UT The quality of the supply voltage
interruptions and (>95% break (0 V) should conform to a typical business
variations in supply of UT for 0.5 or clinic environment.
voltage acc. to period
IEC 61000-4-11:2004 If the user of the device requires
40% UT 40% UT continued operation during power
(60% break (40V, 96 V) mains interruptions, it is
of UT for 5 recommended that the device be
periods powered from an uninterruptible
power supply or battery.
70% UT 70% UT
(30% break (70V, 168 V)
of UT for 25
periods

<5% UT <5% UT
(>95% break (0 V)
of UT for 5
seconds
EN 61000-4-8: 2010 3 A/m 3 A/m Magnetic fields at the supply
Magnetic fields at the 10 A/m 10 A/m frequency should conform to the
supply frequency typical values as they occur in the
business or clinic environment.

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Table 204 as per DIN EN60601-1-2:2001+A1:2006, 6.8.3.201
Norms, IEC Compliance Electromagnetic Environment - Guidance
Measurements 60601- level
Test
level

EN 61000-4-6:2009 3 Veff 3V Portable and mobile RF communications

Conducted RF 150 KHz equipment should be used in a no less
disturbances – 80 distances to the device including the cables
Mhz than it is recommended by the equation for
EN 61000-4-3: 2006 + 3 V/m the frequency.
A1:2008+A2:2010 3 V/m
80 MHz Recommended safety distance:
Electromagnetic fields
– d=1.2 √P for 150 kHz to 80 MHz
2.5 GHz d=1.2 √P for 80 MHz to 800 MHz
d=2.3 √P for 800 MHz to 2.5 GHz
whereby P is the nominal power of the
transmitter in watt (W) according to the
specifications of the transmitter
manufacturer; d is the recommended safety
distance in meters (m).
The field strength of stationary transmitters
should be lower than the accordance level
for all frequencies according to testing on
location.
Disturbances are possible near devices with
the following symbol:

NOTE 1: For 80 MHz and 800 MHz, the higher frequency range is valid.
NOTE 2: These guidelines may not be applicable for all cases. The propagation
of electromagnetic values is influenced by absorptions and reflections of
buildings, objects and people.

a. The field strength of stationary transmitters such as fixed parts of cellular phones and
mobile radio sets, amateur radio stations, AM and FM radio and television cannot be
determined exactly in theory. A study of the location may be considered to detect the
electromagnetic environment in regard to stationary transmitters. If the measured field
strength at the location where the device is being used exceeds the accordance level
above, the device should be watched to verify proper functioning. If abnormal
performance is observed, additional actions might be necessary such as a modified
orientation or another location of the device.
b. For the frequency range of 150 kHz to 80 MHz, the field strength should be lower than 3
V/m.

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 62 of 70

Table 206 as per DIN EN60601-1-2:2001+A1:2006,
EN60601 6.8.3.201
RECOMMENDED SAFETY DISTANCESDISTANCES BETWEEN PORTABLE AND MOBILE RF R
®
TELECOMMUNICATION DEVICES AND THE LEONARDO LASER AS PER DIN EN
60601
60601-1-2, 6.8.3.201, Table 206
The device is intended for use in an electromagnetic
electromagnetic environment with controlled RF
R
disturbances. The user of the device can help to avoid electromagnetic disturbances by
keeping the minimum distance between portable and mobile telecommunication devices
(transmitters) and the device - depending on the output power of the telecommunication
devices as described below.
Nominal power of the 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter P (W) d=1.2√P d=1.2√P d=2.3√P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

For transmitters with a maximum nominal power not mentioned above: To detect the
recommended safety distance, use the equation in the corresponding column. P is the maximum
nominal power of the transmitter in watt (W) according to the specifications of the transmitter
manufacturer.

NOTE 1: For 80 MHz and 800 MHz,

MHz the higher frequency range is valid.

NOTE 2: These guidelines may not be applicable for all cases. The propagation of
electromagnetic values is influenced by absorptions and reflections of buildings, objects and
people.

10 Service policy
The manufacturer will provide, on request, schematic connection diagrams,
diagrams, lists of replacement
parts, descriptions, configuration instructions and other information to be used by qualified
line maintenance and repair of components of the LEONARDO®
technical personnel for first-line
system that the manufacturer has deemed repairable.
repairabl
When parts are deemed to be irreparable by the manufacturer or when special training and/or
equipment are required to perform the repair or adjustments, the manufacturer reserves the right
to withhold information on the grounds of safety.
If you wish to return the LEONARDO® laser to the manufacturer for servicing, it must be returned
in its original packaging. You must also provide a statement guaranteeing that the device has
been disinfected accordingly.

11 Environmental protection
The LEONARDO® laser must be disposed of in compliance with the applicable regulations.
regulations

The bin symbol on the product or in the manual indicates that this product must not
be disposed of with other waste. CeramOptec has built up a waste management
electroni waste. This also includes free return of your LEONARDO®
system for electronic
laser.

Arrangements for the return of all unusable equipment to CeramOptec for correct
removal and environmentally friendly disposal should be discussed with the local
distributor or dealer of the country in which the equipment was purchased.

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12 Warranty policy
CeramOptec provides a warranty of six months from the date of purchase on all LEONARDO®
models, provided that no other warranty terms have been agreed in the contract of sale. Material
defects detected during this period will be repaired by CeramOptec.

Attention: The warranty is invalidated in the cases listed below. The final decision will rest with
CeramOptec in all cases:
• Improper handling or misuse of the laser
• Use of components that do not belong to the laser
• Use of application systems that have not been approved
• Any of the following actions performed by persons not authorized by CeramOptec:
o Installation
o Servicing
o Configuration or adjustment of the laser

Notwithstanding any alternative terms of warranty that may have been specified in the contract of
sale, the conditions of warranty specified here exclude and replace all other verbal warranties or
warranties in writing that were explicitly agreed or tacitly implied.
The conditions of warranty specified here apply exclusively to defective devices. In no case will
CeramOptec accept liability for accidental or indirect losses (including loss of profit), bodily injury,
damages or costs directly or indirectly resulting from use of the LEONARDO® laser system.

12.1 Important conditions

The following conditions of warranty apply to your purchase of a LEONARDO® laser system
(referred to below as “the laser”):
1. The only fiber optics that may be used in conjunction with the laser are fiber optics
manufactured and sold by CeramOptec (“CeramOptec fiber optics”). The laser is
specifically designed to work only with CeramOptec fiber optics. Attempts to use any other
fiber product with the laser may result in suboptimal functioning of or damage to the laser.
CeramOptec expressly excludes liability or responsibility for any loss or damage caused
or suffered by you (“the purchaser”) arising from any attempt to use fiber optics other than
original CeramOptec fiber optics in conjunction with the laser. The use of CeramOptec
fiber optics with the laser should ensure effective functioning of the laser in accordance
with the CeramOptec specifications. Any loss or damage arising from the use of fiber
optics other than CeramOptec original fiber optics will be borne solely by the purchaser.
2. The laser incorporates proprietary CeramOptec software (“the software”). The software is
essential for proper and effective functioning of the laser in accordance with the
CeramOptec specifications. CeramOptec expressly reserves the right to replace, change,
improve, modify and enhance the software (collectively referred to as “software
upgrades”) at any time while the laser is in the possession of the purchaser or while the
laser is in use by a person other than the purchaser. The purchaser and any other user of
the laser undertake to grant CeramOptec continuous and unlimited access to the laser
and the software for the purposes of monitoring the laser and its functional efficiency and
for the purposes of installing software upgrades and monitoring the functioning and
efficiency of the software. All software upgrades will be installed by CeramOptec free of
charge to the purchaser, provided that the purchaser covers the cost of transporting the
laser to CeramOptec for each software upgrade. The cost of returning the laser to the
customer will be covered by CeramOptec. CeramOptec expressly excludes any liability or
responsibility for failure of the laser to function properly and effectively in accordance with
the CeramOptec specifications in cases where the purchaser or another user of the laser
fails to send the laser to CeramOptec for all software updates of which CeramOptec
provides notification.
3. If the laser does not function in accordance with the CeramOptec specifications, this is
due to problems either with the laser hardware or with the software. The purchaser is

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 64 of 70

 requested to notify CeramOptec without delay should the laser fail to function in
accordance with the CeramOptec specifications in order to allow CeramOptec to eliminate
the problem, to issue the purchaser with permission to return the material to CeramOptec
for the purpose of running an appropriate diagnostic analysis and taking corrective action
as needed. The scope of liability and responsibility that will be accepted by CeramOptec
in cases where corrective action is required is specified in CeramOptec’s general terms
and conditions of sale.

For more information, contact our service department or the manufacturer.

Manufactured by CeramOptec GmbH

Siemensstraße 44, D-53121 Bonn, Germany, Tel: +49 228 97 967 0, Fax: +49 228 97 967 99
[email protected] + http://www.ceramoptec.com + http://www.biolitec.de
Copyright 2014, CeramOptec GmbH
Document: CO_IFU_Leonardo-E_F.docx
Last updated: 26.02.2014

Rev.: F / 26.02.2014 User Manual: LEONARDO® Page 65 of 70

13 Appendix
13.1 Device master data
DEVICE MASTER DATA LEONARDO®

Model: nm / W/ µm Operator:

S/N: Location:

Inventory
no.:

13.2 Training record

Person responsible

Name / Signature:

Date:

Checked:

Name of trained
personnel / Signature:

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13.3 Technical safety check

Person Device
Log entry
responsible / Comments status (Pass Signature
no.:
Date / Fail)

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1. Visual inspection Passed Failed Assessment
Labeling/warning labels (laser class, max. power,
1.1
wavelength) (refer to the section on labeling)
Information signs/warning signs correct and
1.2
complete (refer to section 0 “Labeling”)
1.3 User manual

1.4 Equipment complete

1.5 Connections

1.6 External surfaces of device

2. Functional capability check

2.1 Footswitch
Beam guidance system: Coupling/decoupling/aiming
2.2
beam
2.3 Interlocks

2.4 Display and operation

3. Check of monitoring, safety, display and reporting systems

3.1 Laser safety eyewear

3.2 Indicator lights

3.3 Emergency stop button

4. Electrical safety EN60601-1

4.1 Insulation resistance Ω

4.2 Earth leakage current

mA
4.3 Protective ground wire resistance Ω

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5. Measurements for safety-critical output parameters

Attention: Always wear protective eyewear during this check.

Laser calibration test:

®
Connect a new LEONARDO Bare Fiber

- Bare Fiber 400 µm, Flat Tip (BFF 403 DL)

to the output port of the laser. Place the distal end of the application system in the power meter
adapter of your power measurement device. Enable and fire the laser, and record the value.

A1. Test 1470 nm, Laser

Put the laser into continuous mode.
Fire the laser and use the power meter to check whether the output is within the tolerance
limits:
Power selected Power selected Actual value Passed Failed Comment
up to max. output Value [W] +/- 20%
only [W] Min / Nominal / Max

2 1.6 - 2 - 2.4
5 4- 5 -6
10 8- 10 - 12
15 12 - 15 - 18

A2. Test 980 nm, Laser

Put the laser into continuous mode.
Fire the laser and use the power meter to check whether the output is within the tolerance
limits:
Power selected Power selected Actual value Passed Failed Comment
up to max. output Value [W] +/- 20%
only [W] Min / Nominal / Max

5 4- 5 -6
10 8- 10 - 12
15 12 - 15 - 18
20 16 - 20 - 24
30 24 - 30 - 36

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B3. LEONARDO® 400 µm fiber
Put the laser into pulse mode.
Laser setting: 1/3 1470 nm + 2/3 980 nm, e.g. 45 W = 15 W 1470 nm + 30 W 980 nm
- Pulse duration: 1 sec. / Pulse pause: 0.3 sec.
- No. of pulses: 3
Observe the pulse count and treatment energy [J] displayed.
Power selected Treatment energy Actual value Passed Failed Comment
up to max. output Value [J] +/- 20%
only [W] Min / Nominal / Max

5 12 - 15 - 18
10 24 - 30 - 36
15 36 - 45 - 54
®
20 48 - 60 - 72 Only LEONARDO
DUAL 45
®
30 72 - 90 - 108 Only LEONARDO
DUAL 45
®
45 108 - 135 - 162 Only LEONARDO
DUAL 45

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