1640 99 004 6 18.04.2011 tattoo-star usermanual

C M Y CM MY CY CMY K

TattooStar R and Y

U S E R M A N U A L

TattooStar TattooStar R (1640, 1641) TattooStar Y (1644, 1645)

USER MANUAL

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Copyright

1640 99 004_5 � 21th of June 2010

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.

Contents

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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

Contents

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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

Contents

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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

List of Figures

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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

Intended Use

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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.

Intended Use

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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

Technical Data

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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)

TattooStar Y 1644 Nd:YAG-Laser (power requirements: 230V) with KTP frequency duplication

TattooStar Y 1645 Nd:YAG laser (power requirements: 120 V) 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

Technical Data

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Classification acc. to !!!EC Medical Device Directive

II b

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 (NOHD) with handpiece:

1600 m

Technical Data

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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 (NOHD) with handpiece:

Q-switch 1064nm: 232m, free running 1064nm: 19m 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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Technical Data

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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.

Technical Data

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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.

Technical Data

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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.

Technical Data

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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.

Safety Information

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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.

Safety Information

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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.

Safety Information

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- 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.

Safety Information

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- 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,

Start-Up

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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.

Start-Up

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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.

Start-Up

1640 99 004_5 � 21th of June 2010 16

4.4 Installation

Fig. 2: Front view

Laser emission indicator

Laser STOP button Key switch

Articulated mirror

Display with touch screen

Handpiece

Laser aperture

Purge gas inlet connector

Jog Dial

Connector for handpiece

Openings for ventilation

Start-Up

1640 99 004_5 � 21th of June 2010 17

Fig. 2: Connectors on rear panel of device

Footswitch connector Fußtaster Remote locking contact connector

Equipotential terminal

Line power input

Power switch

Services interface I²C connector

Holder for footswitch

Laser aperture

Start-Up

1640 99 004_5 � 21th of June 2010 18

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:

Start-Up

1640 99 004_5 � 21th of June 2010 19

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.

Start-Up

1640 99 004_5 � 21th of June 2010 20

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.

Spacer

Locking buttons

Purge gas connector and spot-size detection 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!

Start-Up

1640 99 004_5 � 21th of June 2010 21

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).

Operation of the Device

1640 99 004_5 � 21th of June 2010 22

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

Pulse rate selector key

Key for activation of TOOLS menu 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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TattooStar Y:

Display of program name Display of spot size Pulse energy display (optional)

Fluence selector key

Wavelength

Pulse rate selector key

Q-switch blocked during change to Ready (only for upgrade) Key for activation of 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).


1640 99 004_5 � 21th of June 2010 24

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).


1640 99 004_5 � 21th of June 2010 25

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

Key for loading the selected program

Usable range fort he spot size

Cancel key

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 button

selecting another memory location scrolling function

YES: storing parameters to the selected memory location of the database and returning to the basic menu

automatically activates the NAME menu if a name has not yet been assigned

NAME: activating the submenu for the entry of a program name

enters a new or edits an 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 26

Selection field


Program name

Cancel key

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

Cancel key

Fig. 9: RECALL menu


1640 99 004_5 � 21th of June 2010 27



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.


1640 99 004_5 � 21th of June 2010 28

5.3.5 Special functions (TOOLS)

The TOOLS menu (see figure below) is activated by pressing the TOOLS key in the Basic menu.

Reset of current pulse count

current pulse count total pulse count

Display brightness

Software version display

Software version controller

Key for activating the pulse energy display RETURN key Key for switching on and off the audible confirmation of keys

Key for adjusting the pilot intensity

Display of pilot intensity Language selection key

Display of next scheduled service

Fig. 10: TOOLS menu



ENERGY: activating/deactivating the display of energy in the Basic menu

display in Basic menu

RETURN: returning to Basic menu stores the changes made

BEEP ON/OFF switches the acoustic confirmation of key pressures on and off

recommendation: activate the energy indication

reset current manual resetting of the current pulse count (pres the key at least for 3 seconds)

current pulse count will automatically be reset to zero when the device is switched off

current (pulse counter)

displaying the current pulse count can be reset to zero

total (pulse counter)

displaying the total pulse count cannot be reset to zero

brightness (display)

adjusting the brightness of the display activation by pressing the key, 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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Language (special)

selecting the user interface language in the LANGUAGE menu

selection by scrolling with the rotary/push button; activation by pressing the YES key.


1640 99 004_5 � 21th of June 2010 30

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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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.


1640 99 004_5 � 21th of June 2010 32

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.

Application

1640 99 004_5 � 21th of June 2010 33

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.

Application

1640 99 004_5 � 21th of June 2010 34

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.

Fig. 11: Absorption curve

WWeelllleennlläännggee ((nnmm))

AAbbssoorrppttiioonnsskkooeeffffiizziieenntt

110022

110011

110000

1100--11

1100--22 550000 11000000 770000

Rubin 694nm

Wasser

HbO2

Melanin

Nd:YAG 1064nm

KTP 532nm

HbO2

Melanin

Application

1640 99 004_5 � 21th of June 2010 35

- 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

blond or red hair, blue or green eyes

always sunburn

no tanning

II fair skin, freckles

blond hair, blue or green eyes

mostly sunburn

slight tanning

III light brown or brown hair,

brown eyes

sometimes sunburn

good tanning

IV light brown skin, dark or

black hair, brown eyes

seldom sunburn

fast tanning

V dark skin,


seldom sunburn

very fast tanning

VI very brown or black skin,


mostly sunburn

very fast tanning

Table 1: Skin type classification according to Fitzpatrick

Application

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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!

Application

1640 99 004_5 � 21th of June 2010 37

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.

Application

1640 99 004_5 � 21th of June 2010 38

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.

Application

1640 99 004_5 � 21th of June 2010 39

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.

Application

1640 99 004_5 � 21th of June 2010 40

Tattoos near the trunk show a faster reaction compared to the removal of very distal tattoos on the fingers, which takes longer.

Inform the patients accordingly (written Declaration of Consent!).

6.5.3 Test treatment

In general, always perform a test treatment on an area that is as inconspicuous as possible to be able to assess the skin reaction and rule out any unwanted side effects! Be particularly careful in the following cases: � dirt tattoos after injuries by explosives (danger of explosion, brush out the area as good as possible before treatment while rinsing it with physiological solution!) � dirt tattoos after a graze (dirt particles can blow up, too!) ) � colored tattoos, so-called bio tattoos, permanent make-up (change in color) - allergic reaction in pricking the tattoo (allergic reaction)

The success achieved in treating the various kinds of dyschromia varies. 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.

In the case of colored tattoos and permanent make-ups, a change in color is to be expected. Therefore, first you should fire one pulse only to an inconspicuous area. Even better it would be, if the patients could get a dye sample from the tattooist. Then, it would be possible to fire with the laser directly onto the color pigments affixed to a white sheet of paper with a colorless adhesive tape to assess the reaction.

The test treatment procedure is analogous to those of pigmented lesions:

The performance of the treatment and the follow-up treatment are also analogous to the treatment of pigmented lesions, possible side effects included.

6.5.4 Follow-up treatment procedures

In follow-up treatments, particularly in treating very black tattoos, a higher fluence must be adjusted than in the first treatments, as the color in the skin continuously decreases.

The number of treatment sessions needed to achieve a satisfactory result varies greatly ranging from about three sessions for non-professional tattoos to 20 sessions and more for the removal of professional black tattoos.

As mentioned above, also the location of the tattoo is of importance.

The interval between the treatment sessions should be at least 6 weeks. After several treatments, it is advisable to keep a treatment break of about three months, particularly in those cases where you get the impression that there is no real progress. Then, it is likely that the lymph system needs time to take the particles away.

It should be considered that the complete removal of dyschromias is not successful in every case.

Accessories

1640 99 004_5 � 21th of June 2010 41

6.6 Fractional treatment with the MicroSpot handpiece

Instead of a treatment spot by spot (without gaps), it is possible to apply a series of very small micrometer spots which are arranged at certain gaps.

The transient white skin reaction which can be seen immediately after each pulse (as described above) is limited to the tiny spots as well as the subsequent formation of crusts.

As these spots are surrounded by untreated skin, this method is gentle and the healing process runs faster (perfection of the �Polka-Dot technique above).

But dependent on indication more treatments have to be done.

7 Accessories

Please note that the EC Medical Device Directive (93/42/EEC) binds you to use only such accessories that have been tested and approved for the use in combination with this laser and are intended for this purpose by Asclepion Laser Technologies GmbH. On request, Asclepion Laser Technologies GmbH will send you an updated list of usable accessories.

We strongly advise against the use of accessories made by other manufacturers. Even if an official testing authority should have certified that a specific accessory unit could be used safely, Asclepion Laser Technologies GmbH cannot assume any liability for these products.

The following accessories can be additionally supplied with the TattooStar.

Designation

TattooStar R :

MicroSpot FRx handpiece

Spacer for 6 mm spot size

TattooStar Y :

Spacer for 7 mm spot size for Free Running mode

On request, the manufacturer will send you an updated, detailed list of accessories.

Maintenance

1640 99 004_5 � 21th of June 2010 42

8 Maintenance

The routine maintenance procedures described below may be performed by the staff of the registered doctor in private practice or of the clinic/hospital:

VISUAL INSPECTION OF THE DEVICE

Check all cables for their intact and firm connection.

Frequency: weekly

To be checked by: staff of private practice / clinic / hospital

CHECK OF COOLING SYSTEM

Check whether all ventilation grids of the cooling system are uncovered.

Frequency: weekly

To be checked by: staff of private practice / clinic / hospital

CHECK OF ACCESSORY UNITS

Check whether all accessory units are in perfect condition.

Frequency: before every use

To be checked by: operator of the device

PREPARATIONS FOR RELOCATION / TRANSPORT OF THE DEVICE

Before relocating the device:

- disconnect the power plug from the power outlet.

- fix the footswitch to its holder on the back panel of the device.

- disconnect the door interlock plug from its terminals.

If it is necessary to transport the device over longer distances by car or any other vehicle, please pack it in its original case.

For information on the regular safety tests and calibration, refer to Section "Regular safety tests and calibration

".

Cleaning, Disinfection and Sterilization

1640 99 004_5 � 21th of June 2010 43

9 Cleaning, disinfection and sterilization

9.1 Instructions for cleaning, disinfection and sterilization of accessories

Multiple use accessories

The parts of the spacers that are made of special steel can be sterilized and are designed for multiple uses.

Parts that do not get into touch with patients, if used as intended, can be disinfected by wiping them with a disinfectant.

For this, follow the general instructions given in Sections 0 and 9.3 of this user manual.

9.2 General advice for cleaning, disinfection and sterilization

NOTE: Aluminum alloys can be made out by a colored layer on the respective metal component.

Instruments containing aluminum are damaged by alkaline cleaning agents (pH > 7) and solutions. The cleaning of elongated and narrow cannulas and blind holes requires particular attention. The temperature should not exceed 150°C.

Limitation of reconditioning:

The accessory is designed for 100 reconditioning cycles. A higher number of reconditioning cycles will affect the accessory.

INSTRUCTIONS:

Workplace: Remove dirt from surfaces by using a disposable / paper towel.

Storage and transport:

No special requirements.

It is advisable to recondition accessory items as soon as possible after their use.

Preparations for cleaning:


Disassemble accessory units by following the instructions for use/cleaning provided.

Manual cleaning: Equipment: neutral cleaning agent (e.g. Edisonite Super), brush, running water

Procedure: Rinse the accessory part to remove dirt from its surface (temperature <30°C); apply cleaning agent to all surfaces by using a brush.


1640 99 004_5 � 21th of June 2010 44

Manual cleaning: NOTE: For cleaning cannulas and blind holes, use a suitable brush to access all parts. Use an ultrasonic cleaning device, if necessary. Hold the accessory under running water for three minutes. When doing this make sure that the water rinses through the cannulas. Blind holes must be filled with water and emptied repeatedly.

Automatic cleaning: Equipment: Cleaning/disinfecting equipment, cleaning agent (e.g. Edisonite Super) Load accessory parts in the equipment so that water can drain from cannulas and blind holes. Set the standard cycle: wash at least five minutes and rinse three minutes. When taking the accessory parts out, inspect them visually for dirt. Particularly take care that blind holes and cannulas are clean. Repeat the cleaning cycle or clean the accessory manually, if necessary.

Disinfection: In manual cleaning, spray disinfectant (e.g. Softasept N or Meliseptol) onto the accessory parts. Let the disinfectant take effect and wipe it off following the instructions of the manufacturer. In automatic cleaning procedures, generally use thermal disinfection (e.g. disinfection temperature: 93°C, time 10 min.)

Maintenance, control and test:


Package: A standard polyethylene / Tyvek bag can be used. The bag must be large enough for the accessory to allow to close the bag without the seal being strained.

Sterilization: Vacuum autoclave, at least 5 minutes at 134°C

150°C must not be exceeded.

Storage: No special requirements.

The manufacturer has validated that the instructions given above are SUITABLE for the preparation of the accessory parts for their reuse. The reconditioner is responsible that the actually performed reconditioning procedure yields the desired results with the equipment and material used and the personnel working in the reconditioning facility. For this purpose, normally validation and routine supervision of the reconditioning procedures are necessary. Likewise, any departure from the provided instructions should be assessed carefully by the reconditioner for efficacy and negative consequences.


1640 99 004_5 � 21th of June 2010 45

9.3 Special instructions for handling, cleaning, disinfection and sterilization

As a rule, accessories should be cleaned and sterilized immediately after their use with the device switched off.

If immediate cleaning should be necessary, make sure to switch the device into STANDBY mode before starting to clean the handpiece! Because of the risk of fire, do not use alcohol or isopropyl alcohol near the treatment area.

Dirt on optical surfaces burns in by exposure to laser radiation and results in malfunction and overtreatment.

To remove oil, grease, dirt, chemical compounds or other contaminating substances, use neither water nor soap.

The used spacers, which are detachable from the handpiece, are to be sterilized before every use on the patient. If used without sterilization, there is the risk of contamination by viable particles.

Handpiece and spacers

The spacers (see Fig. 5a) can be cleaned and the metal part (special steel) can be sterilized. The metal part can easily be removed from the rest of the spacer. For the reconditioning of spacers, observe the general advice given in Section 9.

If the device is not used for a longer period, the beam exit aperture of the spacer must be protected against dust by the delivered protection sleeve.

Complete device

Before cleaning the device, disconnect the device from line power by unplugging the power cable from the power outlet.

Remove any solid residues (dust, particles, etc.) with a vacuum cleaner. Avoid the contact of the device with water or other liquids. Dry with soft, clean cloths or chamois.

Users are only allowed to clean the external surfaces of the device. Do not use chemical solvents and/or abrasive detergents. Take care that detergents do not get into cavities or apertures of the device.

Do not use alcohol to clean the surface of the display.


1640 99 004_5 � 21th of June 2010 46

You may clean all accessible surfaces of the device as well as of the articulated arm and handpieces with a soft, slightly moistened cloth. Take care that the cloth is neither wet nor even dripping wet.

To remove sticking dirt, you can use a mild detergent or disinfectant.

Do not use aggressive disinfectants or abrasive cleaning agents.

Fault Management

1640 99 004_5 � 21th of June 2010 47

10 Fault management

If the device does not respond when the key switch is turned to ON, check whether the following requirements have been met:

- The Laser STOP button has been unlocked (by turning the red button counterclockwise until the lock is released and the knob comes out; see also Fig. 2: Front View).

- The thermal input circuit breaker on the back panel of the device has blown. To reactivate the circuit breaker, switch off the power switch on the back panel of the device (see Fig. 2: ) and after approximately five minutes switch it on again.

- The power cable on the back panel of the device has been connected to the power outlet.

- The line fuses of the laser room have not blown.

The TattooStar has an integrated fault management system that permanently monitors fault conditions that may be hazardous to the patient, the operator or the device. Every detected fault will be displayed in a system fault menu (see figure below).

As soon as a fault condition is detected, the system will automatically switch to the safe mode: The shutter is closed, the laser is switched off and the footswitch is disabled. The device will remain in this condition until you switch it off. If after having restarted the device the fault persists, take down the displayed error message (error text and/or 4-digit error code) and contact the Technical Service.

Fig. 13: System fault menu

In the case of safety-relevant faults, the device will shut down within milliseconds. In this case, the display of error messages is impossible. If this happens or any other fault appears that has not been described in this manual, disconnect the device from line power by unplugging the power plug from the power outlet.

You are strongly advised against any attempt to repair the device yourself! When you remove device covers, components become accessible which carry extremely hazardous high voltage that may still be applied even after the power cable was disconnected from the power outlet.

Fault Management

1640 99 004_5 � 21th of June 2010 48

Improper use or maintenance of the laser system may void the warranty granted by Asclepion Laser Technologies GmbH. Before starting any repair or if you have questions that have not been answered by this manual, contact your service partner (see Section 12).

Regular Safety Tests and Calibration

1640 99 004_5 � 21th of June 2010 49

11 Regular safety tests and calibration

Routine maintenance is described in Section 7 "Maintenance".

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.

In case that the required safety tests have not done in time and at regular intervals the device may not be used any longer.

The device may only be serviced, repaired or modified by persons employed with or authorized by Asclepion Laser Technologies GmbH.

The power delivered by the surgical laser must be checked at least once a year by a service technician employed with or trained and authorized by Asclepion Laser Technologies GmbH.

The use of controls or adjustments of the equipment for operation, maintenance, testing and calibration or the performance of procedures other than those specified in this manual may result in hazardous laser radiation exposure.

Scope of annual safety tests

Only service technicians who are appropriately qualified and authorized by the manufacturer are allowed to carry out the annual safety tests and the calibration of the laser power.

The safety tests should be performed in compliance with national law and standard EN 60 825-1 (or IEC 60 825), as amended, and include at least the tests mentioned below.

The tests should be performed in the specified order:

- visual inspection of laser source, device and accessories

- check of coolant level and check for leaks in the cooling system

The coolant used for the TattooStar is distilled water (deionized and chemically pure according to VDE 0510). Do not use any liquids other than those supplied and recommended by the manufacturer. The use of unsuitable liquids may permanently damage the laser.

- measurement of protective-conductor resistance

- measurement of earth leakage current under normal conditions

- measurement of the actual output power of the laser at the handpiece; calibration of laser and internal power meter, if necessary

- functional test

Regular Safety Tests and Calibration

1640 99 004_5 � 21th of June 2010 50

Wear parts to be replaced annually:

- filter insert F100 µm

- deionized water

Accessible fuses (fine-wire fuse 5 x 20 mm; 250 V):

- F1 T 2.0 A water pump

- F2 T 1.0 A air pump

- F3 T 0,.063 A HV driver

On written request, the manufacturer will provide wiring diagrams, parts lists, descriptions, adjusting instructions or other information not contained in this user manual and needed my maintenance staff to service those system components described by the manufacturer as repairable.

Service

1640 99 004_5 � 21th of June 2010 51

12 Service

Never open the device and attempt to repair the device yourself if the laser should not work properly. The laser does not contain any components that are to be maintained by the users themselves. Only service technicians employed with or trained by Asclepion Laser Technologies GmbH are authorized to service the device. This also applies to the prescribed annual safety tests.

If you need assistance by customer service, please get in touch with us via the address or phone number given below. When contacting your service representative of Asclepion Laser Technologies GmbH, always keep the model and the serial number of the device at hand. These numbers are specified on the type label located at the rear panel of the laser device (see Section Labels).

Asclepion Laser Technologies GmbH

Service

Brüsseler Str. 10

D - 07747 JENA

Tel.: 0800-ALTGmbH (2584624)

+49 (0) 3641 / 7700 - 401

Fax.: +49 (0) 3641 / 7700 - 402

E-Mail: [email protected]

Please note that the manufacturer, installer or importer will not consider themselves responsible for the effects of servicing on safety, reliability and performance of the device unless the following requirements are met:

- installation, extensions, readjustments, modifications or repairs have been performed by authorized persons,

- the electric installation conditions of the laser room meet the requirements of IEC 64 in the currently valid form,

- the device has been used in accordance with the instructions given in this manual.

mailto:[email protected]

Labels

1640 99 004_5 � 21th of June 2010 52

13 Labels

The TattooStar has warning labels affixed to appropriate places on the device. All personnel should be familiar with these labels and their meaning.

Fig. 14: Labeling on TattooStar

Laser warning sign DIN EN 60 825-1 (Fig. 27 or. 28)

Reference to accompanying documentation

Laser STOP

Interface connections

Type labe Fig. 26

Laser exit aperture

Beam exit aperture

Equipotential terminal

Fuses

Labels

1640 99 004_5 � 21th of June 2010 53

Fig. 15: Laser exit aperture DIN EN 60 825-1 This label marks the aperture of the device at which the laser radiation enters the articulated arm.

Fig. 16: Beam exit aperture This label marks the place where laser beam exits the beam delivery system.

STOP

Fig. 17: Laser STOP button This label marks the Laser STOP button for the quick shutdown of the laser.

Fig. 18: Interface connectors Warning: Do not connect any devices to these connectors other than those approved by Asclepion Laser Technologies.

Fig. 19: Fuses

Fig. 20: Caution: Observe accompanying documentation. Warning: Operators are advised to read the user manual carefully before using the system.

Fig. 21: Equipotential terminal The contact is used for the additional connection of the device to a building potential equalization line.

Fig. 22: Type label TattooStar

Type label with type-specific data of the device, among them serial number and date of

manufacture

T1 T2,0A

T2 T1,0A

T3 T0,063A

Application part type B

Date of manufacture (YYMMDD)

Serial number

Model

Labels

1640 99 004_5 � 21th of June 2010 54

Fig. 23: TattooStar R (1640, 1641) Laser warning sign DIN EN 60 825-1

This label informs about hazards, maximum values of

energy emission and the classification of the laser

source.

Fig. 24: TattooStar Y (1644, 1645) Laser warning signDIN EN 60 825-1

For 694nm Ruby laser For 1064nm and 532nm Nd:YAG Laser Figure 25: Laser warning label (US)

This label informs about the dangers, the maximum values of energy emitted by, and the classification of, the laser source.

Labels

1640 99 004_5 � 21th of June 2010 55

All labels must be kept affixed to their places and in good condition. Replace damaged labels immediately.

Disposal

1640 99 004_5 � 21th of June 2010 56

14 Disposal

14.1 Lifetime of the system

The lifetime has been established based on considerations related to the ageing time of the type or class of the product, rather than to technical considerations on the deterioration of critical parts or components.

The lifetime of the device is seven years.

14.2 Disposal

At the end of its lifetime, the device and/or the accessory parts can be disposed of as not hazardous standard material.

At the end of the lifetime of the equipment and/or accessories, the material must be disposed of in compliance with the European Directive 2000/532/EC, the regulations on electronic waste, and in consideration of relevant local regulations.

Annex: Manufacturer�s Declaration � EMV Topics

1640 99 004_5 � 21th of June 2010 57

Annex: Manufacturer�s declaration � EMV topics

Caution

The usage of others than the following accessories, transducers and cables may result in an increased interference emission and/or decreased immunity of the device.

Accessory/ Designation Model number Length / Dimensions

Cable of the laser handpiece 1640 01 041 < 3.0 m

Footswitch with cable 5501 99 021 < 3.0 m

Line cord (3 - pole) 5507 04 013 < 3.0 m

1. Electromagnetic emissions This device is suitable for use in the specified electromagnetic environment. The customer and/or the user of the TattooStar should assure that it is used in an electromagnetic environment as described below:

Emissions test Compliance Electromagnetic Environment Guidance

HF emissions acc. to CISPR 11 Group 1 The TattooStar uses HF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

HF emissions acc. to CISPR 11 Class B The TattooStar is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

Harmonic emissions acc. IEC 61000-3-2 Class A

Voltage fluctuations / flicker emissions acc. to IEC 61000-3-3

complies


1640 99 004_5 � 21th of June 2010 58

2. Electromagnetic immunity This device is suitable for use in the specified electromagnetic environment. The customer and/or the user of the TattooStar should assure that it is used in an electromagnetic environment as described below.

Immunity test Test level acc. EN60601-1-2

Compliance level Electromagnetic environment guidelines

Electrostatic discharge (ESD) acc. IEC 61000-4-2

± 6 kV contact charge ± 8 kV air discharge (Luftentladung)

+/- 6kV +/- 8kV

Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient interferences/burst acc. IEC 61000-4-4

2 kV for power lines 1 kV for input/output lines

+/- 2kV +/- 1kV

Mains power quality should be that of a typical commercial and/or hospital environment.

Surges acc. IEC 61000-4-5

+/- 1 kV differential mode +/- 2 kV common mode

+/- 1kV +/- 2kV

Mains power quality should be that of a typical commercial and/or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines acc. IEC 61000-4-11

< 5 % UT for 0.5 cycle (> 95 % dip)

40 % UT for 5 cycles (60 % dip)

70 % UT for 25 cycles (30 % dip)

< 5 % UT for 5 sec (> 95 % dip)

< 5 %

40 %

70 %

< 5 %

Mains power quality should be that of a typical commercial and/or hospital environment. If the user of the TattooStar requires continued operation during power mains interruptions, it is recommended to power the TattooStar from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field acc. IEC 61000-4-8

3 A/m 3 A/m The magnetic field strength should be at levels characteristic of a typical commercial and/or hospital environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.


1640 99 004_5 � 21th of June 2010 59

This device is suitable for use in the specified electromagnetic environment. The customer and/or the user of the TattooStar should assure that it is used in an electromagnetic environment as described below.

Immunity test Test level acc. DIN EN 60601-1-2

Compliance level Electromagnetic environment guidelines

Conducted HF emissions acc. DIN EN 61000-4-3 Radiated HF interferences acc. to DIN EN 61000-4-3

3 Veff 150 kHz bis 80 MHz 3 V/m 80 MHz bis 2,5 GHz

3 V 3 V/m

Portable and mobile RF communications equipment, including cables, should be used no closer to any part of the TattooStar than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter. Recommended separation distance:

d = [ 3,5

] P 3V

d = [ 3.5

] P for 80 MHz to 800 MHz 3

d = [ 7

] P

for 800 MHz to 2,5 GHz 3

Where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).a Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: ((( )))


1640 99 004_5 � 21th of June 2010 60

a Field strengths of fixed transmitters, such as base stations for radio telephones (cellular/cordless) and land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the TattooStar is used exceeds the applicable RF compliance levels given above, the TattooStar should be observed to ensure its normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the TattooStar. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

3. Recommended separation distances Recommended separation distances between portable and mobile HF communications equipment and the TattooStar according to EN 60 601-1-2 (DIN EN 60 601-1-2)

Frequency of transmitter Equation

150 kHz to 80 MHz

d = [ 3,5

] P 3

150 kHz bis 800 MHz

d = [ 3,5

] P 3

800 MHz to 2,5 GHz

d = [ 7

] P 3

Rated output power of

transmitter (Watt)

Separation distance (meter)



0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33

10 3.70 3.70 7.37 100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the separation distance can be estimated by using the equation in the corresponding column, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

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1640 99 004 6 18.04.2011 tattoo-star usermanual

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external warning lamp

laser warning lamp

generally accepted rules

laser warning sign

articulated mirror arm

smaller spot size

laser stop button

current pulse count