1. TattooStar R and Y
USER MANUAL

3. TattooStar
TattooStar R (1640, 1641) TattooStar Y (1644, 1645)
USER MANUAL

4. Copyright
Important information for the user:
Knowledge of this manual is required for the operation of the instrument. Therefore,
please make yourself familiar with the contents of this manual and pay special attention to
hints concerning the safe operation of the instrument.
In this manual, the following symbols are used to draw your attention to dangers or to
give notes on operating the device:
Risk of accidents or physical injury.
Risk of technical damage.
The specifications are subject to change; the manual is not covered by an update service.
© Unless expressly authorized, forwarding and duplication of this document, and the
utilization and communication of its contents are not permitted.
Violations will entail an obligation to pay compensation.
All rights reserved in the event of granting of patents or registration of a utility
model.
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5. Contents
1 INTENDED USE ...................................................................................................... 1
2 TECHNICAL DATA ................................................................................................. 3
2.1 General technical data ................................................................................................. 3
2.2 Technical data of the lasers .......................................................................................... 4
2.2.1 Ruby laser TattooStar R (1640,1641) ....................................................................................... 4
2.2.2 Nd:YAG laser TattooStar Y (1644, 1645) ................................................................................. 5
2.2.3 Aiming laser ............................................................................................................................. 5
2.3 Technical description ................................................................................................... 6
2.4 Laser safety units......................................................................................................... 7
3 SAFETY INFORMATION ....................................................................................... 10
3.1 Safety regulations .......................................................................................................10
3.2 Optical hazards caused by laser emission .....................................................................10
3.3 Laser-induced fire hazard ............................................................................................12
3.4 Electrical hazards ........................................................................................................13
3.5 Biological hazards .......................................................................................................13
3.6 Radio interference ......................................................................................................13
4 START-UP ............................................................................................................ 14
4.1 Scope of supply ..........................................................................................................14
4.2 Storage and transport conditions.................................................................................14
4.3 Ambient conditions for operation ................................................................................15
4.4 Installation .................................................................................................................16
4.4.1 Installation note ..................................................................................................................... 18
4.4.2 Connector for door interlock and external warning lamp ....................................................... 18
4.4.3 Connectors for handpiece spot-size detection and purge gas................................................. 19
4.4.4 Footswitch ............................................................................................................................. 19
4.4.5 Handpiece ............................................................................................................................. 20
4.4.6 Connection to power outlet ................................................................................................... 20
4.5 Preparations for use....................................................................................................21
5 OPERATION OF THE DEVICE ............................................................................... 22
5.1 Switching-on ..............................................................................................................22
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6. Contents
5.2 Setting the treatment parameters ................................................................................23
5.3 Treatment database ....................................................................................................24
5.3.1 Storing treatment parameters ................................................................................................ 24
5.3.2 Editing the program name ..................................................................................................... 25
5.3.3 Activating a stored treatment ................................................................................................ 26
5.3.4 Deleting a stored treatment ................................................................................................... 27
5.3.5 Special functions (TOOLS) ..................................................................................................... 28
5.4 Activating the READY mode .......................................................................................30
5.5 Checking the beam delivery system.............................................................................31
5.6 Releasing the treatment beam ....................................................................................31
5.7 Logging of treatment parameters and finishing laser operation ....................................32
5.8 MicroSpot mode for TattooStar R (optional) ................................................................32
6 APPLICATION ...................................................................................................... 33
6.1 Important considerations before the first treatment .....................................................33
6.2 Laser-tissue interaction in the removal of natural (melanin) and artificially introduced
pigments. ...................................................................................................................34
6.3 Skin types of patients .................................................................................................35
6.4 Removal of pigmented lesions.....................................................................................36
6.4.1 Effective mechanism of pigment removal .............................................................................. 36
6.4.2 Treatment notes .................................................................................................................... 36
6.4.3 Test treatment ....................................................................................................................... 36
6.4.4 Laser treatment ..................................................................................................................... 37
6.4.5 Follow-up treatments and possible side effects ...................................................................... 38
6.4.6 Follow-up treatment procedures ............................................................................................ 38
6.5 Removal of tattoos and other kinds of dyschromia ......................................................39
6.5.1 Effective mechanism in tattoo removal .................................................................................. 39
6.5.2 Treatment notes .................................................................................................................... 39
6.5.3 Test treatment ....................................................................................................................... 40
6.5.4 Follow-up treatment procedures ............................................................................................ 40
6.6 Fractional treatment with the MicroSpot handpiece .....................................................41
7 ACCESSORIES ...................................................................................................... 41
8 MAINTENANCE .................................................................................................... 42
9 CLEANING, DISINFECTION AND STERILIZATION ................................................. 43
9.1 Instructions for cleaning, disinfection and sterilization of accessories ............................43
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7. Contents
9.2 General advice for cleaning, disinfection and sterilization .............................................43
9.3 Special instructions for handling, cleaning, disinfection and sterilization ........................45
10 FAULT MANAGEMENT ........................................................................................ 47
11 REGULAR SAFETY TESTS AND CALIBRATION ...................................................... 49
12 SERVICE ............................................................................................................... 51
13 LABELS ................................................................................................................. 52
14 DISPOSAL ............................................................................................................ 56
14.1 Lifetime of the system ................................................................................................56
14.2 Disposal .....................................................................................................................56
ANNEX: MANUFACTURER’S DECLARATION – EMV TOPICS ........................................ 57
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8. List of Figures
FIG. 1: LASER WARNING SIGN AT THE ENTRANCE ............................................................................... 12
FIG. 2: FRONT VIEW AND CONNECTORS ON REAR PANEL OF DEVICE................................................ 17
FIG. 3: CONNECTORS FOR DOOR INTERLOCK AND LASER WARNING LAMP ............................................ 18
FIG. 4: HANDPIECE ....................................................................................................................... 20
FIG. 5A: BASIC MENU OF TATTOOSTAR R ........................................................................................ 22
FIG. 6B: BASIC MENU OF TATTOOSTAR Y ........................................................................................ 23
FIG. 7: STORE MENU ................................................................................................................... 25
FIG. 8: NAME MENU ................................................................................................................... 26
FIG. 9: RECALL MENU ................................................................................................................. 26
FIG. 10: TOOLS MENU ................................................................................................................ 28
FIG. 11: ABSORPTION CURVE ........................................................................................................ 34
FIG. 12: INTERACTION BETWEEN VERY SHORT PULSES AND SKIN PIGMENTS ............................................ 35
FIG. 13: SYSTEM FAULT MENU ....................................................................................................... 47
FIG. 14: LABELING ON TATTOOSTAR .............................................................................................. 52
FIG. 15: LASER EXIT APERTURE DIN EN 60 825-1 ............................................................................ 53
FIG. 16: BEAM EXIT APERTURE........................................................................................................ 53
FIG. 17: LASER STOP BUTTON....................................................................................................... 53
FIG. 18: INTERFACE CONNECTORS .................................................................................................. 53
FIG. 19: FUSES ............................................................................................................................ 53
FIG. 20: CAUTION: OBSERVE ACCOMPANYING DOCUMENTATION. ...................................................... 53
FIG. 21: EQUIPOTENTIAL TERMINAL ................................................................................................ 53
FIG. 22: TYPE LABEL TATTOOSTAR Y .............................................................................................. 53
FIG. 23: TATTOOSTAR R (1640, 1641) LASER WARNING SIGN DIN EN 60 825-1 ............................ 54
FIG. 24: TATTOOSTAR (1644, 1645) LASER WARNING SIGN DIN EN 60 825-1 ............................. 54
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9. Intended Use
1 Intended use
The TattooStar laser device is a Q-switched solid-state laser. With durations in the
nanosecond range, Q-switched laser pulses are extremely short. Optionally, the TattooStar
can also emit pulses in the microsecond range ('Free Running').
Therefore, the TattooStar is very well suitable for the vaporization and ablation of soft
tissue, particularly for a selective damage of pigments in the epidermis and dermis and
thus the gentle treatment of benign pigmented lesions and artificial lesions by means of
selective photothermolysis.
For the different wavelengths of the TattooStar the indications are as follows:
694nm (TattooStar R): removal of pigmented lesions
removal of black, dark blue and green tattoo inks
532nm (TattooStar Y): removal of pigmented lesions
removal of red tattoo inks
1064nm (TattooStar Y): removal of black and dark blue tattoo inks
In providing this new powerful medical device, Asclepion Laser Technologies GmbH made
use of its long-standing experience in the development and manufacture of medical lasers.
The TattooStar is a reliable laser device that is easy to operate. It has a compact design, is
largely maintenance-free and features a long lifetime. The device can be used in both
clinics and private practices.
Restriction of use:
The TattooStar may only be used for treatment by a physician or under the supervision
of a physician or of expert medical personnel.
It is the responsibility of the attending physician to decide about the suitability of the
individual patient for a laser treatment. Moreover, the physician is obliged to inform the
patient about all risks that may be caused by the laser treatment itself and by the pre-
and post-operative treatments. Other relevant information is to be given too.
The manufacturer does not accept any liability for direct results or side effects that are
due to the therapeutic use of the system. The physician bears the full responsibility for
them.
It must be pointed out expressly here that only those persons are allowed to use the
device who attended an introductory course on the use of the device as confirmed by
their signature in the medical device logbook. In addition, the user must have read this
User's Manual.
Active medical devices may only be used by persons who can ensure proper handling
because of their qualification and practical experience. Specialist training courses are
offered, for instance, also by Asclepion Laser Technologies GmbH.
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10. Intended Use
The initial introduction into the operation of the device will be given by persons
employed with or trained by Asclepion Laser Technologies GmbH.
Non-observance of the hints and instructions given in this User’s Manual may cause risks
to the health of patients and operators as well as damages to the device!
The manufacturer will not assume any liability for such damage.
Specifically contraindications have to be learned from chapters 'Treatment notes'.
The TattooStar satisfies the generally accepted rules of technology and
complies with the relevant safety standards.
The TattooStar complies with the EC Medical Device Directive 93/42/EEC.
(and its national regulations according to the German MPG).
Device type acc. to 93/42/EEC: II b
UMDNS no. TattooStar R: 17-815
UMDNS no. TattooStar Y: 17-775
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11. Technical Data
2 Technical data
Device models:
Designation Model no. Built-in laser source
TattooStar R 1640 Ruby laser (power requirements: 230V)
TattooStar R 1641 Ruby laser (power requirements: 120V)
Nd:YAG-Laser (power requirements: 230V)
TattooStar Y 1644
with KTP frequency duplication
Nd:YAG laser (power requirements: 120 V)
TattooStar Y 1645
with KTP frequency duplication
The basic unit is identical for all device models; the models only differ in the type of the built-in
laser source.
The models can be identified by the model number specified on the type label on the rear panel of
the device (see Labels).
2.1 General technical data
Beam guidance: articulated arm with handpiece
Display: LCD display
Operator guidance: Touch screen with rotary controls
Power requirements: versions 1640, 1644: 230 V
versions 1641, 1645: 230 V,
50/60 Hz, single-phase
Rated power: max. 2500 VA
Cooling: integrated water-air cooling
Dimensions: 36 x 78 x 97 cm³ ( W x D x H without articulated arm)
Weight: ca. 95 kg
Door interlock connector: potential-free contact: max. 24 VDC / 0.5A (TTL)
Laser warning lamp: relay with +24 V / max. 1 A
Operating conditions: temperature: 15°C ... +30 °C
rel. humidity: 20% …80%
Atmospheric pressure: 700 ... 1060 hPa
Transport and storage conditions: temperature: 0°C … +50°C
rel. humidity: 10 % … 80 % (no condensation)
Periods of operation: continuous operation
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12. Technical Data
Classification acc. to II b
!!!EC Medical Device Directive
Protection Class: I
Device type: B
Accessories: see Section 6
2.2 Technical data of the lasers
2.2.1 Ruby laser TattooStar R (1640,1641)
Laser type: Ruby (Cr : Al2O3) solid-state laser
Laser class: 4
Required laser-protective eyewear: R 694 nm L7 (acc. to EN 207: 2002)
Wavelength: 694 nm
Pulse duration: ca. 40 ns
Pulse energy: max. 1,2 J
Energy density: Standard handpiece:max. 20 J/cm²
MicroSpot handpiece: max. 8 J/cm²
Spot size: Standard handpiece: 2.5; 4; 5 and 6 mm
MicroSpot handp.: 7.1 x 7.1 mm² (total, 14 x 14 spots)
300 µm (single spot)
Pulse rate: 0.5 – 2 Hz or single pulse
Tolerance of output power: max. ± 20 %
Laser beam mode: multimode
Laser beam size: maximal: 9 mm (1/e²)
Divergence of handpiece (full angle): min. 1.2°
Nominal ocular hazard distance 1600 m
(NOHD) with handpiece:
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13. Technical Data
2.2.2 Nd:YAG laser TattooStar Y (1644, 1645)
Laser type: Nd:YAG laser (power requirements: 120 V)
with KTP frequency duplication
Laser class: 4
Required laser-protective eyewear: R 532 nm L6 and IR 1064 nm L7 (acc. EN 207: 2002)
Wavelength: 532 nm and 1064 nm
Pulse duration: Q-switch: ca. 8 ns, free running: ca. 300 µs
Pulse energy: Q-switch: max. 0.8 J @ 1064nm; max. 0.4 J@ 532 nm
free running: max. 1.5J@ 1064 nm
Energy density: max. 20 J/cm²
Spot sizes: 2 / 2.5 / 4 / 5.5 and 7 mm
Pulse rate: 1; 2; 5; 10 Hz or single pulse
Tolerance of output power: max. ± 20 %
Laser beam mode: multimode
Laser beam size: max.: 10 mm (1/e²)
Divergence of handpiece (full angle): min. 2.9°
Nominal ocular hazard distance Q-switch 1064nm: 232m, free running 1064nm: 19m
(NOHD) with handpiece: Q-switch 532nm: 585m
2.2.3 Aiming laser
Laser type: laser diode
Wavelength: 635 – 670 nm
Laser output power: < 1 mW, adjustable in steps
Laser class: 1
Laser beam size: < 1 mm
Divergence: < 4 mrad
Operating mode: cw
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14. Technical Data
2.3 Technical description
Although laser operators do not get into contact with the interior of the laser unit, it
should be helpful for them to have an understanding of how the system works.
Laser
The laser unit consists of the laser head, the optical resonator and the laser bench. In the
laser head, the multispectral light of a pulsed flash lamp is imaged into the laser rod by
means of an optical reflector. Through optical excitation of the laser rod, light is generated
that is bundled in the optical resonator. In addition, the resonator suppresses all
wavelengths that do not correspond to the laser wavelength. The optical resonator consists
of mirrors that are arranged in parallel to each other with each being positioned at the end
of the laser head. One mirror reflects 100% of the incident light, while the other one only
reflects a portion of the beam and allows the remainder of the laser energy to pass as
useable laser light. The laser bench is the mechanical support for the laser head and
resonator and accommodates further functional elements, such as the electrooptical q-
switch for the reduction of the pulse length, in the TattooStar Y the KTP crystal for the
duplication of the emitted wavelength, the energy meter, the system for coupling in the
aiming laser, and the mechanical beam shutter. The treatment laser beam is coaxial with
the aiming laser beam and directed into the articulated arm that delivers both beams to the
handpiece.
Cooling
The cooling system cools the pump chamber to prevent it from being overheated. The
generated heat is dissipated to the ambience via a water-air heat exchanger. A pump
circulates the coolant through the laser head and the heat exchanger. In addition to this,
integrated temperature and flow sensors provide safe operation. An external cooling-water
connection is not necessary.
Power supply
The integrated power supply transforms the line voltage into rectified low voltage for the
electrical supply of the device. At the same time, it generates the high-power pulses
needed for the excitation of the flas hlamp.
Microcontroller
The device is equipped with a microcontroller that controls and monitors all functions of
the system.
Operating modes
The device operates in pulsed mode only. It is designed for discontinuous operation
(60 min operation, 20 min pause).
User interface
The device is operated via a touch screen in combination with a combined rotary/push
button; display is in plain text on an LCD panel.
The following parameters can be adjusted: fluence, pulse repetition rate and aiming beam
brightness.
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15. Technical Data
In addition to the selected operating parameters, the following parameters and states are
displayed: Spot size, pulse energy, laser mode (STANDBY or READY) and error messages in
plain text, if necessary.
The device contains a database to which the user can store treatment protocols with the
parameters typically used for various types of treatment.
Laser beam delivery system
The beam delivery system is an opto-mechanical assembly that consists of the articulated
mirror arm and the handpiece (see Fig. 2). It transmits the laser radiation to the treatment
location.
The articulated mirror arm is permanently mounted to the device. It consists of seven
mirrors that are installed at swiveling joints. The range of motion of the articulated mirror
comprises a radius of about 100 cm. The transmission loss is compensated by an
appropriate calibration of the internal energy meter.
The handpiece is permanently mounted to the distal end of the articulated arm. It has a
purge gas connector to keep the optical system of the handpiece clean and an electrical
connection to detect the spot size of the treatment beam. To adjust the spot size of the
treatment spot the distance holder of the handpiece can be changed (Fig. 4).
Additional information
Upon request, the manufacturer will provide circuit diagrams, component parts lists,
descriptions, calibration instructions, or other information not yet contained in this User
Manual to assist appropriately qualified technical staff to repair those parts of the device
that have been designated by the manufacturer as repairable. In this context,
“appropriately qualified technical staff” means staff that attended a manufacturer’s a
service training course on this device and that was authorized to repair it.
2.4 Laser safety units
The TattooStar is equipped with several safety units that shall prevent misuse or
unintentional activation of the system. All the persons who operate the laser or assist
during the treatment should make themselves familiar with these units.
Power switch
The power switch separates the device from the line voltage. If the device is not in use, the
switch should be in the OUT (O) position.
Key switch
The key switch is used to activate the system. Only authorized persons having access to
the switch can start the system. The key switch can turn on the system only if the Laser
STOP button has been unlocked.
Remove the key always after having switched off the system and ensure that it is kept
by authorized persons only.
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16. Technical Data
Laser STOP button
The Laser STOP button is used to switch off the laser system instantly in cases of
emergency. It should only be activated in emergencies, e.g. if it is necessary to interrupt
the laser emission immediately.
This is done by pushing in the button as far as it goes. To unlock this button after the
elimination of the emergency, turn it anticlockwise until it jumps out again.
Do not use the Laser STOP button to turn the device on or off in normal condition.
Footswitch
The footswitch is an electrical switch that releases laser emission when the device is in
READY mode. It is equipped with two redundant switching elements. Position the
footswitch always close to the treatment area.
STANDBY mode
In STANDBY mode, unintentional or accidental activation of the laser is prevented. If the
device is in the STANDBY mode, the laser emission will not be possible. The operator can
activate the treatment laser beam only after the READY key was pressed.
The system changes to the STANDBY mode in the following situations:
- after the first start of the device,
- if the operator presses any of the parameter selection keys,
- if the operator pressest he STANDBY key when the system is in READY mode
- if the laser has not been activated although the system has been in the READY mode
during a longer period
Automatic switching-off
The TattooStar is equipped with an automatic shutdown system. If a specific problem
arises, the system will automatically change into the safe mode.
The beam shutter is closed, the laser discharge is switched off and the footswitch is
deactivated. The screen shows an error message identifying the specific fault (see Section
“Fault Management”).
Remote door locking contact
The system contains a remote interlock contact that may be connected to the entrances to
the laser room. If the remote locking contact is open (e.g. if the door is opened), the laser
emission will be interrupted automatically and the device will change to the STANDBY
mode.
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17. Technical Data
Acoustic signal
A pulsed acoustic signal is generated while laser radiation is being emitted. In addition to
this, all key operations are signalized acoustically.
Laser warning labels
The device carries several safety labels. These labels must always be clearly readable and
replaced instantly when damaged.
The manufacturer shall only be liable for the effects on safety, reliability and
performance of the device caused by servicing the system, if the following requirements
have been met:
- the device has been used in accordance with the instructions (on the safety measures
and the use of the system) given in this manual,
- the installation, assembly, extensions, changes, repair and maintenance works have
been performed by persons being authorized and qualified for them, and
- the electric system at the place of installation complies with the requirements placed by
the EN/IEC and the local regulations.
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18. Safety Information
3 Safety information
3.1 Safety regulations
As with any equipment, the operation of the TattooStar involves potential hazards which
the user should be aware of before using it. They include optical, electrical, biological and
fire hazards.
Observe the relevant national legislation and regulations regarding the operation of laser
devices. The german MPG and the Medical Devices Operator Ordinance (MPBetreibV)
bind the owner/operator, the authorized persons and users of Class IIb devices to take
several safety precautions. In particular, such devices should be operated only in
accordance with the generally accepted rules of technology and the relevant regulations on
labor safety and on the prevention of accidents.
In handling medical laser devices, observe the relevant national regulations on the
prevention of accidents by laser radiation, as amended. Furthermore, you are bound to
keep a medical device logbook. A copy of this book is provided together with the device
documentation. Our service technician will assist you in filling it in as part of the startup
procedure.
Please note that the manufacturer recommends subjecting this device to regular safety
tests and calibration at annual intervals. The results of these tests must be recorded in
the medical device logbook.
Do not install the TattooStar in explosion-risk rooms.
Only persons employed with or authorized by Asclepion Laser Technologies GmbH are
allowed to service, repair or modify the device.
3.2 Optical hazards caused by laser emission
The Regulations for the Prevention of Accidents by Laser Radiation of the German
Professional Associations (or any equivalent national regulations) lay down general rules
for the protection against hazardous laser exposure. The precautions stipulated there aim
to protect operating personnel and patients in medical applications. The laser devices are
classified in different classes depending on the potential risks involved. The TattooStar is
classified in Class 4.
This classification means that the improper use of the device constitutes a hazard to the
eyes by direct and scattered laser radiation. Moreover, the laser emission may cause fire
and explosion hazards.
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19. Safety Information
To avoid these hazards, the owner/operator of the device is bound to meet e.g. the
following requirements:
- Before initial start-up, the competent professional association and the labor-safety
authority are to be informed about the intended use of the laser.
- A laser safety officer must be appointed in writing. The duties of said laser safety
officer should include at least the following tasks:
- supervision of the operation of the laser device
- assistance to the owner/operator with regard to safe operation and the
implementation of the necessary safety precautions
- co-operation with labor-safety specialists in fulfilling their tasks, including the
information about important issues of laser radiation protection
- While the laser is in operation, the area in which the maximum permissible radiation
level may be exceeded, the sol-called „laser zone“, must be delimited and marked by a
laser warning sign.
- Warning lamps at the entrances must indicate the operation of the laser.
- The TattooStar emits a high-intensity visible laser beam that may cause eye and skin
injuries by direct or indirect exposure. Please observe the following precautions to
minimize optical damage to the patient, the operator of the laser and the assisting
personnel:
- All persons present in the laser room during treatment must wear laser protective
eyewear. The laser protective eyewear must meet the requirements of the European
Standard EN 207, ”Personal eye protection; filter and eye-protective devices against
laser radiation”, as amended, and have the properties specified in the technical data in
Section 2.2.
- Never look directly into the exit aperture of the handpiece or the articulated mirror arm
even if wearing laser protective eyewear.
- Mark the treatment room clearly to prevent other persons from entering the room
unexpectedly during the laser operation.
- Restrict the access to the treatment room to the persons who assist during the
treatment and are trained to operate the device.
- Cover the windows and other openings in the treatment room to avoid the
unintentional emergence of laser radiation.
- Direct the activated laser only onto the area to be treated.
- Remove all metallic objects such as watches, rings, necklaces and similar things from
the working range and, if possible, do not use any reflecting instruments or other
materials.
- Reflecting objects could interrupt the laser beam and guide it to another area than the
intended treatment one. Many surfaces, even the ones that seem to be mat, can
strongly reflect the emission wavelength of the laser.
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20. Safety Information
- If you do not use the laser, switch it to the STANDBY mode (in the STANDBY mode
the laser cannot be activated unintentionally).
- Ensure that the trained personal assisting during the treatment knows how to switch
off the laser in case of emergency.
- Remove the key always from the key switch after having switched off the system and
ensure that it is kept at a safe location.
The NOHD (Nominal Ocular Hazard Distance) of the laser device is so high that the entire
room where the laser is operated is to be considered as laser area.
With each laser system, the manufacturer delivers an additional laser warning sign. We
recommend you to fix this sign (Fig. 1) at the entrance door to the laser treatment room to
warn persons entering the room of the existence of the laser device.
Fig.. 1: Laser warning sign at the entrance
3.3 Laser-induced fire hazard
Do not install this device in explosion-risk areas. Make sure that solvents and
combustible liquids being used for cleaning and disinfecting purposes can evaporate
before the laser device is put into operation.
If the laser beam impinges onto a surface, this surface will absorb the laser energy and its
temperature will increase; no matter whether these surfaces are skin, hair, clothing or
other combustible substances. The operator should take the following safety measures in
order to prevent fires caused by laser radiation:
- Use non-flammable substances for anesthesia, for the preparation of soft tissue for
treatment, and for the cleaning and disinfection of instruments.
- Avoid the use of oxidizing gases, e.g. nitrogen oxide (N2O) and oxygen. Be especially
careful when using oxygen. Oxygen increases both the intensity and the extent of the
fire.
- Keep only a minimum quantity of combustible materials in the treatment room. If
treatment requires the use of combustible materials, such as gauze, soak it in water
first.
- Keep clothing as far as possible away from the treatment zone.
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21. Safety Information
- If you treat an area with hair avoid singeing or burning it by wetting the area with
water or salt solution before starting the treatment.
- Have always a small fire extinguisher and water ready in the treatment room.
- Some materials, such as cotton, penetrated by oxygen can be ignited by the high
temperatures that develop during the normal laser operation.
- Make sure that the solvents of adhesives and combustible liquids being used for
cleaning and disinfecting purposes can evaporate before the laser device is activated.
Observe the risk of ignition of endogen gases, too.
3.4 Electrical hazards
The TattooStar uses line voltage and high voltage. Do not open any protection covers, if
you neither are trained nor authorized to do so.
Never place any liquids on the device as liquids entering the device might reduce the
protection against dangerous electric voltages. If liquids entered into the device, switch
off the device instantly by pressing the Laser STOP button and disconnect the power
cable. Contact the Technical Service immediately.
3.5 Biological hazards
Laser smoke is a potential biological danger, because it contains particles of the radiated
tissue.
Laser smoke might contain viable material. You are advised to use a smoke evacuation
system with filters.
3.6 Radio interference
The TattooStar complies with the requirements of the DIN EN 60601-1-2 standard. The
system is not affected by electromagnetic noise generated by other devices that conform
to the same standard. Moreover, the system does not generate electromagnetic radiation
beyond the liming values indicated in DIN EN 60601-1-2. The manufacturer’s declaration
about the electromagnetic compatibility according to DIN EN 60601-1-2 is enclosed to this
manual.
Medical devices are subject to specific precaution measures concerning the
electromagnetic compatibility (EMC). During the installation and operation of the laser
device, please pay attention to the special notes given in the accompanying
documentation under "EMC Manufacturer’s Declaration".
Portable and mobile HF communication devices can influence medical electric systems.
Therefore, switch off cellular phones and similar equipment before putting the laser
device into operation,
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22. Start-Up
4 Start-up
The TattooStar may only be commissioned by an authorized representative of Asclepion
Laser Technologies GmbH. Based on the instructions given in this manual this expert will
explain the responsible operator of the laser device how to operate it.
4.1 Scope of supply
Check if all components required for the safe operation of the laser device are included in
the delivery:
Basic unit
- basic laser device with articulated arm for beam delivery
- footswitch
- door interlock plug
- keys (two)
- power cable
- purge plastic tube
Accessories
- handpiece
- set of documents
- 2 pcs. laser protective eyewear
4.2 Storage and transport conditions
To maintain the laser system in proper condition during storage and transport, make sure
to meet the following requirements:
- ambient temperature: 0 … 70°C.
- relative humidity: 10% … 85% (no condensation)
- Minimize shocks and vibrations.
- Do not drop the device.
- Store the laser system in an atmosphere that is free of corrosive substances, such as
salts or acids.
- Store the system in an atmosphere with a minimum of dust particles.
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23. Start-Up
4.3 Ambient conditions for operation
To maintain the laser in proper condition, the following ambient requirements should be
met:
- Keep the room atmosphere free of corrosive substances, such as salts and acids. These
may damage optical wiring and optical surfaces.
- Keep the dust content in the room as low as possible. Dust particles may cause
permanent damage to optical components.
- Keep humidity in the laser room in the range between 20% and 80% (no
condensation).
- Keep temperature in the laser room in the range between 15°C and 30°C. Do not
install the laser device close to heating system openings or other sources of
temperature changes.
- Protect the laser from direct exposure to sunlight.
- For efficient cooling of the device a minimum distance of 10 cm of the side and back
planes of the TattooStar to the wall has to be observed.
The operation beyond the ambient conditions mentioned above can lead to impairment
of the device or to wrong output numbers and so affect the treatment result adversely.
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24. Start-Up
4.4 Installation
Handpiece Articulated mirror
Laser aperture
Purge gas inlet connector
Connector for handpiece
Jog Dial
Laser emission indicator
Display with
touch screen
Laser STOP button Key switch
Openings for ventilation
Fig. 2: Front view
1640 99 004_5 – 21th of June 2010 16

25. Start-Up
Laser aperture
Holder for footswitch
Footswitch connector
Fußtaster Remote locking contact connector
I²C connector
Services interface
Line power input
Equipotential terminal
Power switch
Fig. 2: Connectors on rear panel of device
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26. Start-Up
4.4.1 Installation note
To ensure efficient cooling of the device, keep a minimum distance of 10 cm between side
and rear panels of the TattooStar and the wall.
4.4.2 Connector for door interlock and external warning lamp
In addition to the prescribed warning signs, warning lamps that are lighting (or flashing)
as long as the laser emits radiation must be installed at every entrance to the laser area
(usually the laser treatment room).
On the rear panel of the device, a connector is provided for the connection of a door
interlock (see Fig. 3: laser warning lamp
).
Door contact 5 VDC / 20 mA
Relay contact of laser emission ( max. 24 V / 0,5 A )
Fig. 3: Connectors for door interlock and laser warning lamp
By connecting the two "remote door interlock contact” terminals to an external contact,
such as a door interlock, you can prevent laser radiation from being emitted when the door
of the laser room is opened.
The laser can only be operated with this contact being closed. This safety system serves to
shut off the surgical beam automatically when the door is being opened thus precluding
any risk to the person entering.
The door interlock connector delivered is factory-fitted with a shorting bridge. To connect
a door interlock circuit, remove this bridge and connect your door interlock contact to the
same terminals. The external contact must be potential-free and provided for at least
24 VDC and 0.5 A. If a door-interlock circuit is not used, make sure to keep the plug with
the factory-fitted jumper connected.
If you have connected the door interlock contact with the entrance, please check every
day before starting a treatment that the laser cannot be switched to the READY mode
with this door being open. In case of malfunction (relay suspends), please inform the
Service Department.
An external voltage source for a low-voltage warning lamp can be switched via two
further contacts of this connector. The internally installed switching relay is designed for a
maximum voltage of 24 VAC and a maximum current of 1 A. Absolutely observe the
following safety requirements for the connection of an external warning lamp:
1640 99 004_5 – 21th of June 2010 18

27. Start-Up
By connecting the warning lamp and the external transformer the user creates a system
according to IEC60601-1-1 and possibly influences the permissible insulation system of
the device. Therefore, it is only allowed to use safety transformers with
double/reinforced insulation with a minimum test voltage of 4 kV according to
IEC/EN61558-2-6. It must also be ensured that after the connection of the transformer
the leakage current of the device is within the limits stipulated in IEC60601-1.
The internal relay of the device is closed, if the device is in the READY mode.
The prescribed laser warning lamp may, of course, also be turned on and off via a normal
light switch.
If you intend to install a door interlock or the external laser warning lamp later, make
sure to switch off the device before and disconnect the power cable from the mains.
The contactors for the remote door interlock and the footswitch must never be
connected to the line voltage, because this would cause great damages to the system.
Establish the connections only in the way described in this section.
4.4.3 Connectors for handpiece spot-size detection and purge gas
The device is provided with an automatic detection system for the handpiece and thus for
the spot size of the treatment beam. The information about the handpiece type connected
is sent through an electrical cable to the control module of the device. This cable must
always be connected. Otherwise, the system cannot detect the handpiece and will
generate an error message.
In addition, the device is equipped with an internal pump, which produces a continuous
airflow to prevent dust and particles from depositing on the optics during laser operations.
A plastic tube, the purge tube, provides connection between the device and the
handpiece.
Both connectors are mounted to the top of the device right next to the articulated arm
(see Fig. 2) and to the handpiece (see Fig. 4).
Always make sure that both ends of the purge tube are properly connected to the device
or the handpiece. Never use the device without the purge tube between device and
handpiece, otherwise damages of the optics of the handpiece are possible.
4.4.4 Footswitch
Connect the footswitch plug to the footswitch connector on the rear panel of the device
(see Fig. 2). Make sure to insert the plug as far as it will go. Then, lock it by turning the
cap nut clockwise.
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28. Start-Up
4.4.5 Handpiece
The basic body of the handpiece with its connectors for spot-size detection and the purge
tube always remains firmly connected to the articulated arm. To change the spot size of
the treatment beam, only the spacer must be replaced. For doing this, insert the spacer
into the handpiece body by pushing it down until it clicks into place and fix it by putting on
the cap nut. To remove the spacer again, push down the both locking buttons
simultaneously and withdraw the spacer from the handpiece body. The metal part of the
spacer can be removed for cleaning and sterilization purposes.
Always make sure the spacer has firmly clicked into place and the handpiece body has
been fixedly screwed to the articulated arm.
Purge gas connector
Spacer and
spot-size detection
Locking buttons connector
a) Handpiece mounted
b) Spacer removed
Fig. 4: Handpiece
4.4.6 Connection to power outlet
The TattooStar must be directly connected to a wall outlet. The system should be
connected neither to an uninterruptible power supply (UPS) nor to an electronic phase
advancer or isolation transformer.
Absolutely make sure that the power cable is disconnected from the power outlet when
installing the device!
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29. Start-Up
When selecting the power outlet, consider all technical data of the local mains and the
device (see Section 2.1). First, verify that the available line power agrees with the
specified power requirements. Please observe the requirements of DIN VDE 0100 or any
national equivalent in the currently valid form.
The TattooStar system should not share a power line with other heavy power-load
equipment such as air conditioners or elevators. Ideally, the laser unit should be powered
by a separate power line with a separate circuit breaker.
The device is provided with a power cable. First, plug the power cable into the power input
connector on the rear panel of the device before connecting the other end of the cable to
the power outlet.
If required, an earth wire can be connected between the equipotential terminal on the rear
panel of the device (see Fig. 2) and the earth-potential terminal of the electrical supply
system.
The operation of the laser requires that the device is connected to a single-phase power
outlet protected by a fuse rated for at least 2500 VA (slow-blow fuses).
4.5 Preparations for use
After the installation and any relocation of the device from a cold to a warm
environment with a temperature difference of more than 5°C, allow the device to adjust
to the room temperature in unpacked condition before being used (laser operation):
At least 2 hours for temperature differences of up to 10°C,
At least 4 hours for temperature differences of up to 15°C,
At least 8 hours for temperature differences exceeding 15°C.
Afterwards, switch the device on and let it warm up for at least 30 minutes. Take care
that the installation and operating environment of the device meets the following
conditions:
temperature: 15 to 30°C
relative humidity: max. 80%.
Non-observance may result in the destruction of the device.
Besides, verify that the following requirements have been met:
- The line voltage available agrees with the line voltage marked on the type label.
- The power plug as been plugged into a suitable power outlet.
- The equipotential cable has been connected (if required).
- The power switch on the rear panel has been switched to ON.
- The footswitch has been connected properly.
- The door interlock plug has been connected properly.
- The handpiece has been mounted correctly; purge tube and spot-size detection cable
have been connected to the laser device.
- The warning lamp has been connected to the entrance (if requested).
- The safety door-interlock circuit has been connected (if requested).
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30. Operation of the Device
5 Operation of the device
The use of controls or adjustments or performance of procedures other than those
specified in this manual may result in hazardous laser radiation exposure.
5.1 Switching-on
Make sure you have taken all safety precautions.
Then, proceed as follows:
- Verify that the Laser STOP button is deactivated (not pressed).
- Afterwards, insert the safety key in the key switch and turn it clockwise as far as it will
go.
After switching on, the system will perform a self-test of the essential and safety-relevant
components of the device. After some seconds, the basic menu will appear (see Fig. 5a:
Basic menu of TattooStar R) on the screen. The system will automatically activate the
following settings:
- STANDBY mode
- footswitch is locked
- aiming laser is active
- spot size according to the spacer used
- laser parameters stored last
TattooStar R:
Display of program name Display of spot size Pulse energy display (optional)
Fluence selector key
Key for activation of
TOOLS menu
Pulse rate selector key
Laser warning sign
READY state display
Key for propgram storage Program selector key STANDBY/READY key
Fig. 5a: Basic menu of TattooStar R
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31. Operation of the Device
TattooStar Y:
Display of program name Display of spot size Pulse energy display
(optional)
Q-switch blocked during
Fluence selector key
change to Ready
(only for upgrade)
Wavelength
Key for activation of
Pulse rate selector key TOOLS menu
Display of
STANDBY/READY
Key for program storage Program selector key
Fig. 6b: Basic menu of TattooStar Y
5.2 Setting the treatment parameters
The operation of the device with touch screen and combined rotary/push button is very
simple and self-explanatory.
Successful key pressures are confirmed by the system by a short acoustic signal. Dieser
Signalton kann unterdrückt werden
Laser parameters can be activated by touching the corresponding field on the touch
screen. The values of the activated parameter can be varied by turning the combined
rotary/push button and accepted by either pushing the rotary/push button or pressing the
parameter field on the touch screen.
The spot size of the connected spacer, which is to be selected according to the structure to
be treated, is automatically detected and displayed in millimeters in the screen header on
the right.
The adjustable energy density, which is the crucial parameter for the treatment, is
displayed in J/cm² in the Fluence field.
If the energy range is not sufficient to achieve the desired fluence level for the selected
spot size, use a spacer with a smaller spot size. The detection of the changed spot size and
the new calculation of the fluence value are performed automatically.
If within the Fluence field a small triangle appears, the energy has slightly increased
(arrowhead pointing up) or decreased (arrowhead pointing down) within the tolerance
limits.
The variable pulse repetition, which determines the operating speed, is adjustable via the
SPEED field: 0.5 Hz, 1 Hz, 1.5 Hz and 2 Hz (depending on the adjusted FLUENCE).
By pressing the READY key at the bottom right, the laser can be switched from Standby
(footswitch not activated) to the READY mode (footswitch is activated, yellow laser
warning appears).
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32. Operation of the Device
TattooStar Y only :
Depending on the indication, it is possible to switch the wavelength of the laser between
1064nm (near infrared) and 532nm (green) via the COLOR field. (A note that says that
the laser-protective eye-wear is to be changed appears!)
for upgrade only: Also depending on the indication, you can switch from the 'Q-Switch'
mode (VHF pulses in the nanosecond range) to the 'Free Running' mode (longer pulses in
the microsecond range) by pressing the top right button. The active mode is always
marked green.
5.3 Treatment database
The TattooStar lets you store 80 treatment records.
At the first start up of the system (after the installation), the database is completely empty. The
manufacturer does not provide any predefined treatment protocols, as the treatment parameters
must always be specifically selected to fit the treatment to be performed.
If you have found the correct parameters for the treatment, you can store them in the database as
a treatment protocol. Thus, you can call them anew, if you have to treat either the same illness or
kind of illness.
5.3.1 Storing treatment parameters
Frequently used combinations of fluence values and pulse rates can be stored to the
database under a definable program name. In addition, the following values are stored
automatically:
- program number,
- wavelength and
- spot size (used for the respective fluence).
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33. Operation of the Device
By pressing the STORE key, the database menu appears with the first free memory
location being highlighted (see figure below).
Program name Wavelength Fluence Repeat pulse
Program number Usable range fort he spot
size
Key for loading the selected Cancel key
program
Key for activating program name
entry
Fig. 7: STORE menu
You can execute the following functions by pressing the corresponding keys:
Key Function Remarks
Rotary/push selecting another memory location scrolling function
button
YES: storing parameters to the selected automatically activates the
memory location of the database and NAME menu if a name has
returning to the basic menu not yet been assigned
NAME: activating the submenu for the entry of enters a new or edits an
a program name existing program name
CANCEL: canceling returns to the basic menu
without saving any data
5.3.2 Editing the program name
To edit the program name, select the program name to be edited and press the NAME key
in the STORE menu. This will bring up the keyboard display shown in the figure below:
1640 99 004_5 – 21th of June 2010 25

34. Operation of the Device
Program name
Selection field
Key for loading the selected Cancel key
program
Fig. 8: NAME menu
By turning and pushing the rotary/push button control, you can select and accept the
desired characters. Names may have a length of maximally 12 characters.
An unintentionally entered character can be deleted by activating «.
If the YES key is pressed, the name will be accepted and entered into the database. The
name entry can be cancelled by activating the CANCEL key.
5.3.3 Activating a stored treatment
Stored parameters can be recalled by pressing the RECALL key (see figure below). In this
list, the first program (Program No. 01) will be highlighted (see figure below). You can
choose any other program by turning the rotary/push button.
Program name Wavelength Fluence Repeated pulse
Program number Usable range for the spot
size
Key for loading the selected Cancel key
program
Fig. 9: RECALL menu
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35. Operation of the Device
You can execute the following functions by pressing the corresponding keys:
Key Function Remarks
YES: loading the selected program loads the selected program
and returning to the basic
menu
CANCEL: cancel returns to the basic menu
without loading new
parameters
If, after a RECALL action, the selected FLUENCE cannot be adjusted with the currently
used spot size, the system will prompt you to change the spacer.
5.3.4 Deleting a stored treatment
Stored treatments cannot be deleted but overwritten.
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36. Operation of the Device
5.3.5 Special functions (TOOLS)
The TOOLS menu (see figure below) is activated by pressing the TOOLS key in the Basic
menu.
Key for activating the pulse
energy display
Reset of current pulse count
current pulse count RETURN key
Key for switching on and off
total pulse count
the audible confirmation of
Display brightness keys
Software version display Key for adjusting the pilot
intensity
Software version controller
Display of pilot intensity
Language selection key
Display of next scheduled
service
Fig. 10: TOOLS menu
You can execute the following functions by pressing the corresponding keys:
Key Function Remarks
ENERGY: activating/deactivating the display of display in Basic menu
energy in the Basic menu
RETURN: returning to Basic menu stores the changes made
BEEP ON/OFF switches the acoustic confirmation of recommendation:
key pressures on and off activate the energy indication
reset current manual resetting of the current pulse current pulse count will
count (pres the key at least for 3 automatically be reset to zero
seconds) when the device is switched
off
current displaying the current pulse count can be reset to zero
(pulse counter)
total displaying the total pulse count cannot be reset to zero
(pulse counter)
brightness adjusting the brightness of the display activation by pressing the key,
(display) adjustment by means of
rotary/push button
Pilot (special) adjusting the aiming beam brightness activation by pressing the key,
adjustment with rotary
controls
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37. Operation of the Device
Language selecting the user interface language in selection by scrolling with the
(special) the LANGUAGE menu rotary/push button; activation
by pressing the YES key.
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38. Operation of the Device
5.4 Activating the READY mode
Once again, verify that:
- all laser safety precautions have been taken,
- all laser parameters are adjusted properly,
- the intended distance holder is used (spot size),
- the handpiece has been placed onto the desired treatment area.
All persons being present in the room have to put on the laser protective eyewear with
the suitable protection level (see section Technical Data). Before pushing the READY
key, the attending physician must check this.
The device is equipped with a Laser STOP button that is easy to operate. It is located at
the top front side of the device (See Fig. 2). In cases of emergency, the laser will be
instantly deactivated when this button is pushed down hard thus ruling out any hazard to
the operator and the patient.
After remedying the emergency, restore the function of the Laser STOP button by turning
the button counterclockwise until it comes out.
After the READY key was pressed:
- the current values of laser wavelength and spot size appear briefly on the display,
- various hardware components are activated (only after longer period of inactivity),
Please check carefully that the displayed spot size corresponds to the used distance
holder (labeling spot size). Otherwise the fluence is wrongly calculated, which leads to
mistreatment (missing treatment result, unwanted side effects).
- the display shows the laser warning sign above the READY key (see Fig. 5a: Basic
menu of TattooStar R),
- the pilot beam is activated, and
- the laser is switched to READY mode and is thus operational.
From this moment on, laser radiation of the selected parameters will be emitted at the
end of the handpiece when the footswitch is pressed.
Note that in READY mode a laser pulse will be fired when you inadvertently depress the
footswitch!
(After a few minutes without any action the device switches into STANDBY mode
automatically.)
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39. Operation of the Device
5.5 Checking the beam delivery system
The beam delivery system consists of the articulated arm and the handpiece. As the
treatment beam and the aiming beam are coaxially transmitted through the beam delivery
system, the aiming beam can be used to check the state of the beam delivery system. If
the aiming beam does not appear at the distal end of the beam delivery system, or if its
intensity is low or the spot looks diffuse, this may indicate that the beam delivery system is
either damaged or misaligned. In these cases, you should stop using the device and
instantly contact the Technical Service.
If the spot of the aiming beam shows any imperfections at the distal end of the beam
delivery system, you must not activate the treatment beam to avoid damage to the
device.
Assess the spot of the aiming beam only by directing the handpiece to a white sheet of
paper (spacer in contact). Never look directly into the beam (into the handpiece).
The therapy beam may only be activated after the successful check of the beam delivery
system. Make sure that you do not press the footswitch unintentionally.
5.6 Releasing the treatment beam
Depress the footswitch to release the treatment beam with the parameters selected. While
laser radiation is being emitted, the laser emission indicator beside the screen is lighting. In
addition, the system generates an acoustic signal.
When you change any parameter in READY mode, the device will be automatically
switched to STANDBY. This means, that you have to press the READY key again to be able
to release the next laser pulse.
When depressing the footswitch, Class 4 laser radiation will be emitted from the end of
the handpiece. Make sure to comply with all relevant regulations for the protection
against unintentional laser radiation effects.
In particular, the attending physician is not allowed to release the laser unless the aiming
beam spot was found to be perfect and the handpiece was placed directly onto the skin
area to be treated.
The adjusted fluence must be regularly checked for correctness.
Instantly press the Laser STOP button in the event of dangerous malfunction.
If you intend to interrupt the treatment for some time or when you have finished the
treatment, switch the laser into the safe STANDBY mode by pressing the STANDBY key.
After a longer period of inactivity in READY mode, the device will automatically switch to
STANDBY.
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40. Operation of the Device
5.7 Logging of treatment parameters and finishing laser operation
The total number of pulses emitted and the number of pulses emitted after the last RESET
action are displayed in the TOOLS menu.
Before you start the treatment of the next patient, you can reset the current pulse count to
zero by pressing the RESET key (for 3 sec).
To switch the device off, follow this procedure:
- Turn the key switch counterclockwise as far as it will go. By doing so, the RESET of the
current pulse count is performed automatically.
- Switch the power switch on the rear panel of the device to OFF.
- Put down the handpiece safely and check its spacer for any contamination. Clean it
immediately, if necessary.
Never leave the device unattended while it is switched on. Switch the power switch to
"0" for an all-pole disconnection from line power supply.
After having switched off the device, make sure to remove the key from the key switch.
Keep it in a safe place to prevent unauthorized use of the laser device.
5.8 MicroSpot mode for TattooStar R (optional)
The MicroSpot mode can be activated only if the MicroSpot handpiece was adapted and if
the software for the MicroSpot has been implemented. Handpiece and software are parts
of the optional MicroSpot Set.
After connection of the MicroSpot handpiece to the articulated mirror arm the electrical
plug of the handpiece has to be connected with the socket at the laser device (like
standard handpiece). The device automatically recognizes the MicroSpot handpiece and
the MicroSpot mode is shown at the display.
In this mode it is not possible to store and recall own parameters.
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41. Application
6 Application
6.1 Important considerations before the first treatment
This chapter Application contains detailed information on the operation and application of
the laser device. Of course, the instructions given can never replace the careful study of
relevant literature, the personal experience gained under supervision and the critical
assessment of the current situation.
But they shall be a useful support to the novice and those not working regularly with the
laser.
Therefore, we recommend you to study current medical literature and to contact
physicians in private practices using such type of equipment in order to familiarize with the
methods of laser treatment before you begin treating patients yourself.
We will readily assist you in getting into contact with other laser users. The responsible
partner of Asclepion Laser Technologies GmbH will readily inform you accordingly in detail.
Make sure you have understood the principles of laser/tissue interaction, the correlation
between the individual application parameters, the application techniques as well as the
basics of laser safety.
If you have the slightest doubt, consult experienced colleagues and/or the application
specialists of Asclepion Laser Technologies GmbH before you begin a laser treatment.
If the laser is applied, the use of an ear protection is highly recommended for all persons
in the treatment room.
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42. Application
The following notes on treatments by courtesy of
Mrs Dr. med. Tanja Fischer, Potsdam/Germany.
6.2 Laser-tissue interaction in the removal of natural (melanin) and artificially
introduced pigments.
The goal especially for dermatological and aesthetic treatments is to remove the unwanted
lesions or the lesions to be treated without any side effects. The selective phototermolysis
method introduced by Anderson as a treatment concept in 1983 ensures an effective
damage of the target and the simultaneous protection of the skin surrounding it.
Therefore, the following aspects are to be observed for a successful treatment:
- The absorption of the laser beam must be higher in the target (pigment) than in the
surrounding skin area which mainly contains water (see Fig.).
- However, with dark skin types and tanned skin the epidermis also contains melanin which,
of course, likewise will absorb the energy of the laser beam. Therefore, tanned persons
must not be treated (undesired side effect: hypopigmentation). Dark skin should be
treated with care and pigment changes are to be expected, of which the patient should be
informed.
Absorptionskoeffizient KTP Rubin Nd:YAG
532nm 694nm 1064nm
102
Wasser
Melanin
Melanin
101
HbO
HbO2 2
100
1 0 -1
1 0 -2 500 700 1000
Wellenlänge (nm)
Fig. 11: Absorption curve
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43. Application
- The pulse duration (exposure time) of the laser should not be significantly longer than the
thermal relaxation time of the target to avoid unnecessary heating of the surrounding
area.
As the relaxation time of natural and artificially introduced pigments is very short
(pigments are very small), the gentle removal of the pigments through fragmentation of
melanin or of the introduced particles requires the use of a laser, which – like the
TattooStar – operates with Q-switched pulses in the nanosecond range.
Fig. 12: Interaction between very short pulses and skin pigments
6.3 Skin types of patients
Skin type
I
extremely fair skin, freckles always sunburn
blond or red hair, blue or green eyes no tanning
II
fair skin, freckles mostly sunburn
blond hair, blue or green eyes slight tanning
III
light brown or brown hair, sometimes sunburn
brown eyes good tanning
IV
light brown skin, dark or seldom sunburn
black hair, brown eyes fast tanning
V
dark skin, seldom sunburn
black hair, brown eyes very fast tanning
VI
very brown or black skin, mostly sunburn
black hair, brown eyes very fast tanning
Table 1: Skin type classification according to Fitzpatrick
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44. Application
6.4 Removal of pigmented lesions
In recent years, the interest in the gentle removal of disturbing pigmented lesions has
strongly grown among population.
Q-switched lasers (Q-switched laser TattooStar) are very well suitable for the removal of
natural pigments (melanin). Basically, however, only benign skin lesions can be treated
with a laser!
6.4.1 Effective mechanism of pigment removal
The green light of the frequency-doubled Nd:YAG laser (532 nm) and the dark red light of
the ruby laser (694 nm) are very strongly absorbed by the natural skin pigment melanin.
This leads to the fragmentation of melanin because of the extremely short pulses emitted
by Q-switched lasers. Afterwards, the skin reacts with an inflammation. Part of the
fragmented particles will then be taken away by the lymphatic system, while the other part
will be cast off by the following incrustation.
On the other hand, this wavelength is only absorbed to a very low degree by tissue water
and blood. Therefore, this wavelength is well suitable for the removal of benign pigmented
lesions.
6.4.2 Treatment notes
Before beginning the laser treatment of pigmented skin lesions, strictly verify that the
lesion is benign. In particular, the patient must not have a malignant melanoma or a
melanoma in one of its premalignant stages.
Patients with Fitzpatrick skin types I to III may well be treated with 694 nm or 532 nm.
The darker the skin, the higher will be the risk of pigment changes. As a rule, these will
persist during a few weeks or some months. With very dark skin, however, in exceptional
cases they may persist permanently! Make sure to inform your patients accordingly.
6.4.3 Test treatment
The treatment success achieved for the various indications is individually different. Therefore, it
is advisable to perform a test treatment within the scope of patient information. It allows to
assess the skin reaction of the patient; besides it gives the patient a better idea of the treatment
procedure.
The test treatment including the required pre-operative and post-operative treatments should
be performed by using the same procedure as for the actual laser treatment. However, in test
treatments a few pulses are to be fired only.
The treatment area must be clean. Hair, cosmetics, deodorants, etc. have to be removed
completely beforehand!
All persons present in the laser room must put on laser protective eyewear before starting
the laser treatment!
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45. Application
The test treatment is started with a low fluence, which is then increased until the stratum
corneum becomes distinctly white under laser treatment. This is caused by the generation of
very fine intraepidermal gas bubbles that disappear again after approximately 10 to
20 minutes. The lowest fluence value with which this effect is achieved is the fluence value to
be used for the treatment.
The less pigments the skin contains, the higher will be the fluence level needed to achieve
the white tissue reaction. If for the larger spot sizes the maximally adjustable fluence is not
sufficient to obtain the effect, a smaller spot size must be set by replacing the used spacer. The
new spot size will be automatically detected by the device. This spot size will then allow you to
adjust a higher fluence level.
6.4.4 Laser treatment
For the laser treatment, adjust the fluence found in the test treatment. Fire laser pulses to the
area to be treated without any overlaps and gaps. The handpiece of the TattooStar is equipped
with a microlens array that ensures an ideally homogeneous spot of hexagon shape. This
provides very homogeneous treatments without any ‘hot spots’ (increased power) and without
leaving any gaps between the spots.
For darker skin types (type III and darker) you should not treat much area beyond the edge of
the pigmentation. The spot size used is to be adjusted accordingly to avoid pigment changes in
the area surrounding the treatment zone. With small lesions, of course, possibly a single spot
will do.
Laser treatment involves little pain. Therefore, anesthesia is normally not necessary. With
extensive areas to be treated, a topical anesthetic may be used, if necessary. In addition,
effective skin cooling before and after the treatment decreases pain sensitivity (e.g. Cool Packs
or cold air), which is also achieved by a reduction of the pulse rate (SPEED) or by treatment
breaks.
The formation of erythemas and edemas after the treatment is normal. Partly, point bleeding
may occur. Afterwards, usually blisters and crusts will form; they will heal within about two
weeks.
The intensity of all concomitant reactions will be the higher the more pigments are embedded
in the skin, the larger the treatment area and the higher the fluence used.
Therefore, if large areas with strong pigmentation are to be treated, it is advisable either to
treat only a part of this area in one session or to apply the so-called ‘polka-dot technique’ (i.e.
always skipping one spot in lasing, which will then be lased the next time):
Fig. 14: “Polka-dot“ technique
Likewise, when sensitive skin is to be treated, a careful procedure is advisable. So, for instance,
you should not remove all lentigines from the back of the hand in the same session, if their
number is great. This would be found very unpleasant by patients because of the following
incrustation.
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46. Application
6.4.5 Follow-up treatments and possible side effects
With the exception of individual small lesions, the treated area should be continuously cooled
after treatment, e.g. with Cool Packs.
Possible epidermal irritations are to be covered with antibiotic ointments; they will heal within
two weeks without leaving any scars.
Post-operatively, the skin must be protected from intensive sunlight or exposure in a
solarium for at least six weeks (light-protection factor 20, minimally) in order to avoid
hypopigmentation or hyperpigmentation.
Patients must not manipulate on forming crusts.
Reversible pigment shifts and atrophies are possible side effects. Permanent pigment shifts and
cicatrization are rare. Inform the patients accordingly!
6.4.6 Follow-up treatment procedures
The number of treatment sessions needed for a good result depends on the depth of pigments
in the skin and ranges from a single treatment only with most of the lentigines to numerous
sessions to achieve complete brightening of dark nevi ota.
The interval between the treatment sessions should be at least six weeks. If after several
treatments stagnation is to be observed in the brightening, a longer break of at least 3 months
should be taken.
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47. Application
6.5 Removal of tattoos and other kinds of dyschromia
In recent years, many millions of people – especially young ones – had themselves
tattooed. Later, tattoos often become annoying. Then, the wish to have the tattoo
removed is the logical consequence. Only Q-switched lasers can do this without leaving
any scars.
But not only tattoos, also dirt tattoos caused by accidents and colored changes of the skin,
e.g. by the embedding of iron or amalgam, can be removed very gently with the Q-
switched TattooStar.
Imperfect permanent make-up can be corrected with this laser as well.
For the first time, the laser treatment of tattoos was performed with the Q-switched ruby
laser more than 20 years ago. Since then, numerous studies have been published proving
the good effectiveness of laser treatment.
6.5.1 Effective mechanism in tattoo removal
Like the natural pigment melanin, color and dirt particles, which absorb the laser light
much stronger than the surrounding skin, are destroyed by the high power density of the
very short Q-switched pulses and subsequently phagocyted.
The darker the tattoo, the higher is the absorption and thus the effect.
6.5.2 Treatment notes
Dark tattoos (black, dark blue) and dirt particles can be removed very well by using the
ruby laser or the basic wavelength of the Nd:YAG laser (1064 nm). Green tattoos can be
treated with the red ruby laser (694 nm). To remove red tattoos, the green wavelength
(532 nm) is best suitable.
Because of their low absorption, bright tattoos (yellow, white, ‘skin colored’) can be
removed only with difficulties or not at all.
In patients with dark skin, melanin absorbs too, of course, so that pigment changes are to be
expected of which the patients should be informed! A relatively careful treating of dark skin is
reached by using Nd:YAG laser of 1064 nm.
Tanned patients should postpone laser treatment!
The area to be treated must not contain any malignant or premalignant lesions!
The success of treatment, however, depends on various factors. Tattoos made by
nonprofessionals require fewer treatments than professional tattoos, where usually many more
color pigments were introduced into the skin. The composition of the colors is also very
different. Colored tattoos and permanent make-ups must be treated with particular care, as
partly color changes may occur (e.g. from red to green on lips), which can then be removed
only with difficulties or not at all.
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