BTL Laser 4000 Topline User manual

BTL-4000 Topline

LASER

USER'S GUIDE

APPENDIX | Page1 of 25

100IE20/12/2007

CONTENTS

1 LASER THERAPY.............................................................................................................................................. 3

1.1 Introduction.................................................................................................................................................... 3

1.2 Light -The Principle of Laser Light and its Specifics ...................................................................................... 3

1.3 Types of Lasers ............................................................................................................................................. 5

1.3.1 Source..................................................................................................................................................... 5

1.3.2 Wavelength (primarily semi-conductor lasers)......................................................................................... 5

1.3.3 Beam Operation Mode ............................................................................................................................ 5

1.3.4 Type of Beam.......................................................................................................................................... 6

1.3.5 Laser Class (defined by the output)......................................................................................................... 6

1.3.6 Use.......................................................................................................................................................... 6

1.4 Basic Physical Quantities .............................................................................................................................. 7

1.5 Biological Effects of a Low-power Laser (Non-invasive Laser) ...................................................................... 8

1.6 Acupuncture .................................................................................................................................................. 9

1.6.1 Frequencies for Laser Acupuncture According to Dr. Nogier .................................................................. 9

2 SETUP OF LASER GENERATOR ................................................................................................................... 10

2.1 Access Password ........................................................................................................................................ 10

2.2 Setup and Control of Laser Therapy............................................................................................................ 10

2.2.1 Laser ..................................................................................................................................................... 11

2.2.2 Laser Sequences .................................................................................................................................. 16

2.3 Specific Settings .......................................................................................................................................... 16

2.3.1 Door Activity .......................................................................................................................................... 16

2.3.2 Acupuncture .......................................................................................................................................... 16

2.3.3 Self-calibration of the Laser Probe ........................................................................................................ 17

2.3.4 Sound in running therapy ...................................................................................................................... 17

2.4 Locking of the Equipment If Door Opens ..................................................................................................... 17

2.5 Laser Probes ............................................................................................................................................... 18

2.6 Optical Attachments for Laser Probes ......................................................................................................... 19

2.6.1 Dental Attachment................................................................................................................................. 20

2.6.2 Gynaecological Attachment................................................................................................................... 20

2.6.3 ENT Attachment .................................................................................................................................... 20

2.6.4 How to Connect the Attachment............................................................................................................ 20

2.7 Laser Clusters ............................................................................................................................................. 21

2.8 Use of Safety Eyewear ................................................................................................................................ 22

3 APPENDIX........................................................................................................................................................ 23

3.1 Warning Labels Placed on the Case of the Device and on the Laser Probe ............................................... 23

3.1.1 Label placed on the case of the device, warning about occurrence of visible and invisible radiation

of class 3B............................................................................................................................................. 23

3.1.2 Label placed on the probe, warning about proximity of aperture of laser of the stated wavelength,

power and laser class............................................................................................................................ 24

3.1.3 Label placed on the laser cluster, warning about proximity of aperture of laser of the stated

wavelength, power and laser class........................................................................................................ 24

3.1.4 Label for marking of the laser workplace, warning about proximity of 3B-class laser............................ 25

LASER THERAPY | Page 2 of 25

1 LASER THERAPY

1.1 INTRODUCTION

This User's Guide is intended to make you familiar with the BTL-4000 Topline Laser device, designed to perform

non-invasive, low level laser therapy. At the same time, it will give you general instructions on how to perform low

level laser therapy in clinical practice.

Please note that according to applicable legislation, staff operating therapy lasers must be trained by competent

institutions.

1.2 LIGHT-THE PRINCIPLE OF LASER LIGHT AND ITS

SPECIFICS

The nature and qualities of light can be interpreted in many ways, according to classic, relativistic or quantum

physics. However, the basic nature of light itself as either a particle/corpuscular or an electromagnetic/wave

mechanism remains unreachable for our senses and is incomparable to any other level of reality. Therefore, we

can only accept the conclusions and deductions of numerous experiments.

Laser radiation has specific qualities:

• totally monochromatic: maintaining only one wavelength

LASER 635 nm

Intensity

BULB

Intensity

500 700400

600

LASER THERAPY | Page 3 of 25

800

800 1600400 20001200

• totally polarized – waves are completely spatially oriented onto a defined area

Linear polarization

• totally coherent – it is completely oriented in time - the maxima and minima of all waves are identical in time

and the waveforms are the same

Coherent light Non-coherent light

A laser beam of high output represents the “death ray” of sci-fi authors of old; it can destroy material or matter.

However, a laser beam of low output (not exceeding 500 mW) shows slightly different effects on living organisms

and tissues, especially a significant stimulating effect – see the part concerning clinical effects of low-power laser

beam.

The word LASER stands for Light Amplification by Stimulated Emission of Radiation.

The first theoretical postulates on a laser beam were laid down by Albert Einstein in the early twentieth century,

describing the theoretical possibilities of a stimulated emission of light in 1916-1917. However, the first laser unit

was not constructed until 1960, following other important discoveries in the area of so-called quantum radio

technology (N.G. Basov and A.M. Prochorov of the former USSR and C.H. Townes of the USA received a Nobel

Prize for these discoveries in 1964).

The medical application of laser light followed soon after. At first, only high intensity laser beams were utilized.

Lasers of this type provide a source of energy that can destroy (cut, shear) as well as evaporate and, using its

thermal effect, cauterize tissue.

E. Mester, a Hungarian scientist, was the first to introduce the stimulating effect of a low intensity laser. He

conducted his experiments - which are still of great importance - in the late sixties.

LASER THERAPY | Page 4 of 25

1.3 TYPES OF LASERS

Lasers can be divided according to several criteria:

1.3.1 Source

• solid lasers (ruby laser)

• liquid lasers

• gas lasers - helium-neon, argon

• semi-conductor lasers (GaAs, GaAlAs) – now the most important of the non-invasive therapy lasers

The advantages of semi-conductor lasers include a significant miniaturization of the source, robustness and

immunity to damage and the theoretical possibility to construct a laser unit of any wavelength, according to the

user's requirements. Nevertheless, some lasers still remain at the experimental level (see below).

1.3.2 Wavelength (primarily semi-conductor lasers)

• blue lasers – approx. 400-500 nm

• green lasers – approx.500-550

• red lasers – approx.600-700nm

• infra-red lasers – approx.700-950 nm

Visible spectrum

cosmic radiation; gamma-rays, X-rays, UV radiation

Laser beam penetration through the tissue is largely dependent on the wavelength. In general, green and blue

lasers are still being developed and their clinical use is extremely limited. Most commonly used are the beams in

the wavelength of red light. After 2-3 mm penetration through living tissue, their intensity is reduced to half. This

predetermines red laser beams to be used especially in the therapy of mucous membrane and skin diseases.

Since the output is absorbed by a very small column of tissue, devices of an output of 50 mW or lower are usually

fully sufficient.

The intensity of infra-red lasers is reduced to half after penetration of 2-3 cm through tissue. These lasers are

used especially in treating deeper located structures (joints, muscles, insertions...). Since the output is absorbed

by the column of tissue, and since we want the intensity on the target area deep in the tissue to be sufficient, we

recommend using devices of a minimum output of at least 50 mW.

See the part concerning the emitted power density below.

1.3.3 Beam Operation Mode

• pulse lasers

• continuous lasers

– very short pulses – hundreds of ns, peak output in watts or tens of watts

• lasers with modulated operation – the pulse length depends on the frequency and on the duty factor; the

peak output reaches up to several hundreds of mW.

500nm 700nm

400nm 600nm

infrared radiation, microwaves, radio waves, very long waves

LASER THERAPY | Page 5 of 25

Output

MODULATED PULSE

Mean

value

Time

Output

CONTINUOUS

Mean

value

Time

Manufacturers usually offer various alternatives, including the possibility of combining various modes modulated

according to various parameters.

See the parts concerning clinical effects and use below.

1.3.4 Type of Beam

• convergent (point) beam

• divergent (widening) beam – allows irradiation of a larger area without the need to sweep the probe over the

treated tissue

• laser scanners – devices for irradiation of large areas

• laser clusters – generate several independent laser beams, which may be of various wavelengths. They

enable a large area to be irradiated without the necessity of sweeping over the treated tissue. To some extent

they substitute laser scanners.

1.3.5 Laser Class (defined by the output)

• Class 2: up to an output of 1 mW

• Class 3A (3R, 3M): up to an output of 5 mW and output density of 25 W/m

• Class 3B: up to 500 mW

Note

The stated values are only rough, exact classification of the hygiene class is more complicated and shall be

performed according to applicable standards.

1.3.6 Use

• simple pen lasers ("laser-pen") – usually feature only a very limited range of frequency modes. The

advantage of this type is its perfect portability

• "pocket" lasers – usually designed to fit in a physician's coat pocket; in most cases the probe is connected

to the device's body by a conductor – these devices largely prevail on the market, at present manufacturers

can equip these devices with probes of an output up to hundreds of mW

LASER THERAPY | Page 6 of 25

• desk-top lasers – usually supplied from the mains, the probe is connected to the device by a cable. The

advantages of this type usually include a wide range of frequency modes and the possibility to set many

different parameters. New generation devices (including BTL-4000 Topline Laser) also have the possibility of

replacement of probes of various wavelengths and outputs. These devices are designed especially for

rehabilitation. One of their advantages is the possibility of building "sets" of devices which can provide as

wide a range of treatments as possible on a small area.

1.4 BASIC PHYSICAL QUANTITIES

• Wavelength - one of the basic parameters of a monochromatic laser beam (i.e. of only one wavelength). Its

unit is the nanometer [nm].

• Output – its unit is the mW. The given output is either peak, i.e. pulse amplitude, or mean (average). In case

of the BTL 4000 Topline Laser, the screen displays the peak output value measured on the output aperture of

the probe. Use of an optical attachment or light conductor causes an approximately 10% loss of output which

shall be deducted from the displayed value. For each attachment supplied by the manufacturer of BTL

devices, the decrease in output is stated in the attachment's technical documentation.

It is always necessary to know the output level at the active end of the probe/cluster (output aperture) –

especially when the beam is transmitted by a light conductor, the resulting output can markedly differ from

the output of the source! Every passage between media (source-air, source-lightguide, lightguide-air) lowers

the output.

The mean output also depends on the chosen mode, i.e. continuous or pulse (The computing unit of the BTL-

4000 Topline Laser takes into account the mode in which the device is working when calculating the

treatment time).

• Modulation frequency – its unit is the Hertz [Hz] (= number of oscillations per second), sometimes there is

in addition the percentage value of the active state time ("Duty factor") and the pulse width. The most

commonly used are numerical frequencies (5 Hz stimulation, 10 Hz analgesic effect), very common are also

frequencies according to Dr. Nogier (previously used mainly in acupuncture).

• Power density - its unit is the J/cm

– power emitted per unit of area. This quantity is improperly called the

dose – however, this term has become so common in laser theory that also in this document the terms

"emitted power dose" or "dose" are used, but they always mean "emitted power density".

Below you can see a formula for calculation of an emitted power dose: (Note: this is the dose emitted to the skin

surface, not to more deeply located structures)

mean radiation output (W) x application time (s)

emitted power dose [J/cm

] = -------------------------------------------------------------------

irradiated area (cm2)

Knowledge of basic physical quantities (which is also acquired in obligatory training) significantly facilitates an

understanding of laser therapy.

LASER THERAPY | Page 7 of 25

1.5 BIOLOGICAL EFFECTS OF A LOW-POWER LASER

(NON-INVASIVE LASER)

Specific physical qualities of a laser beam result in specific clinical effects. The most considerable clinical effects

are:

• analgesic effect (A)

• antiphlogistic effect (F)

• antiedematous effect (E)

• biostimulation effect (B)

• vasodilatation effect (V)

All these effects are based on positively established and verified mechanisms:

• acceleration of microcirculation

• increase in intracellular activity of many enzymes, particularly in the Krebs cycle

• increased oxygen circulation, improved glucose utilization

• DNA synthesis stimulation (via phytohemaglutinin stimulation)

• increased fibroblast activity (for keloids these activated fibroblasts are able to perform resorption of fibrin)

• phagocytosis activation

• activation of the Na/K pump on the membrane

• activation of metabolic processes in the cellula: partly through affecting the Na/K pump and Ca transport,

partly through direct activation of the mitochondrial system

• changes in local level of important mediators -- inflammatory (histamine substances, prostaglandins) or

e.g., endorphins

When performing an in vitro experiment, no difference can be seen between laser beams applied in continuous

and pulse modes. However, when performing an in vivo experiment, we observe marked differences between a

continuous beam and a beam adjusted to a certain defined mode. In physical therapy, this phenomenon can be

observed when performing electrotherapy or applying ultrasound. It seems that, for a complex organism with its

numerous information systems and feedbacks, a physical quantity modulated to a certain frequency features one

additional quality -- specific information transmitted by this frequency.

The effect of a laser beam in acupuncture is totally specific. A laser beam affects tissue in a way fully comparable

with the effect of an inserted needle -- but without any pain or complications related to the needle insertion. The

skin above the acupuncture point is a light conductor for the laser beam. We find it interesting that in laser

acupuncture, in contrast to other forms of laser therapy, the wavelength of a laser beam is not of great importance

(however, red lasers are slightly more effective) and the output of the device is of no importance at all (we can

even use a laser-pen). We conclude that in this method of application, it is not the effect of the physical quantity

itself, but the above-mentioned transmission of information that plays the key role.

Many treatments utilize several effects of laser light at one time (e.g. treatment of varicose ulcer combined with

analgesic, stimulating, as well as bactericidal effects).

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