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041-80 - BTL-6000 Láser de Alta Intensidad

The BTL-6000 High Intensity Laser is a therapeutic device designed for non-invasive treatment using infrared energy to stimulate biological tissue, promoting healing and pain relief. It is intended for use by medically educated professionals in clinical settings, with specific indications and contraindications outlined for patient safety. The user manual includes detailed operational instructions, device characteristics, and safety precautions to ensure effective and safe usage.

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Luis Hathaway
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0% found this document useful (0 votes)
58 views40 pages

041-80 - BTL-6000 Láser de Alta Intensidad

The BTL-6000 High Intensity Laser is a therapeutic device designed for non-invasive treatment using infrared energy to stimulate biological tissue, promoting healing and pain relief. It is intended for use by medically educated professionals in clinical settings, with specific indications and contraindications outlined for patient safety. The user manual includes detailed operational instructions, device characteristics, and safety precautions to ensure effective and safe usage.

Uploaded by

Luis Hathaway
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 40

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BTL-6000
HIGH INTENSITY LASER
USER'S MANUAL
Machine Translated by Google
Machine Translated by Google

BEFORE YOU START

Dear Customer,

Thank you for purchasing BTL technology. All of us at BTL


wish you every success with your system. We pride ourselves
on being as responsive as possible to our customers' needs.
Your suggestions and comments are always welcome since
we believe an ongoing relationship with our customers is
critically important to our future product line.

While we would like you to start using your new equipment


right away, we encourage a thorough reading of this manual in
order to fully understand the operational features of the system.

Please visit our corporate website at http://www.btlnet.com


for the latest information on BTL products and services.

Again, thank you for being a BTL customer.

BTL Industries, Ltd.


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CONTENTS
1 GENERAL CHARACTERISTICS OF THE DEVICE ....................................................................................... 6
1.1 Intended use ........................................................................................................................................... 6
1.2 Indications................................................................................................................................................ 6
1.3 User Profile ........................................................................................................................................... 6
1.4 Patient Profile................................................................................................................................................ 6
1.5 Operating Environment.............................................................................................................................. 6
1.6 Device description ................................................................................................................................... 6
1.6.1 BTL-6000 High Intensity Laser ........................................................................................................... 7
1.6.2 Laser Light and Its Characteristics................................................................................................................ 7
1.6.3 Sources of the Laser Light................................................................................................................... 8
1.7 Biological Effects of High Intensity Laser.............................................................................................................. 8
1.8 Advantages of High Intensity Laser Treatment................................................................................................ 9
1.9 Contraindications and Possible Side Effects ........................................................................................... 9
1.9.1 Contraindications for High Intensity Laser Treatment................................................................................ 9
1.9.2 Possible Side Effects of High Intensity Laser Treatment ................................................................................... 9
1.10 General Warnings and Precautions................................................................................................................ 10
1.10.1 Skin Test Evaluation According to Fitzpatrick ................................................................................... 11

2 INSTRUCTIONS FOR OPERATION ........................................................................................................... 12

2.1 The Front Panel of the BTL-6000 High Intensity Laser ........................................................................... 12
2.2 Handpiece of the BTL-6000 High Intensity Laser ................................................................................... 12
2.3 The Rear Panel of the BTL-6000 High Intensity Laser................................................................................ 13
2.4 Footswitch.............................................................................................................................................. 13
2.5 Assembly and Set-Up................................................................................................................................ 14
2.5.1 Installing the Handpiece Holder................................................................................................................ 14
2.6 Basic Displays and Operating of the Device.............................................................................................. 16
2.6.1 Initial Screen and Types of Tabs ....................................................................................................... 16
2.6.2 Touch Screen ................................................................................................................................... 16
2.6.3 Numeric Keypad ................................................................................................................................... 17
2.7 Setting of Therapy ................................................................................................................................ 17
2.7.1 General Guidelines for Therapy Setting................................................................................................... 17
2.7.2 Setting Therapy Parameters Via the 'diag' Button................................................................................... 17
2.7.3 Setting Therapy Parameters Via the 'prog' Button................................................................................... 17
2.7.4 Setting Therapy Parameters Manually (User Setup) Via the 'man' Button ........................................... 18
2.7.4.1 Setting the Therapy mode................................................................................................................ 19
2.7.4.2 Setting the Output power ........................................................................................................... 19
2.7.4.3 Setting of the Dosage ................................................................................................................... 19
2.7.4.4 Setting of the Treatment Area ................................................................................................... 19
2.7.4.5 Setting of the Frequency................................................................................................................ 19
2.7.4.6 Setting of the Pulse Width.............................................................................................................. 19
2.8 Course of Therapy................................................................................................................................ 20
2.8.1 Start, Interruption and End of Therapy.............................................................................................................. 20
2.8.2 Screen During Therapy ....................................................................................................................... 21
2.8.3 End of Therapy ........................................................................................................................... 21
2.9 Application of Laser Light.............................................................................................................................. 22
2.10 Unit Settings: The 'menu' Button.............................................................................................................................. 22
2.10.1 Accessories ................................................................................................................................... 22
2.10.2 Encyclopedia ................................................................................................................................ 22
2.10.3 Unit Settings ....................................................................................................................................... 23
2.10.3.1 Password Setting.............................................................................................................................. 23

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2.10.3.2 Sound Setting................................................................................................................................ 23


2.10.3.3 Screen Saver and Auto Switch-Off................................................................................................... 23
2.10.3.4 Color Setting.............................................................................................................................. 23
2.10.3.5 Setting of Display Contrast................................................................................................................ 24
2.10.3.6 Date and Time Setting ................................................................................................................ 24
2.10.3.7 Language Setting ....................................................................................................................... 24
2.10.3.8 Touch Panel Calibration................................................................................................................ 24
2.10.3.9 User Options ................................................................................................................................ 24
2.10.3.10 Setting of HW Key ....................................................................................................................... 24
2.10.3.11 Unit Information.............................................................................................................................. 24
2.10.3.12 Unlock Code................................................................................................................................ 24
2.10.3.13 User Accounts ........................................................................................................................... 24
2.10.3.14 Firmware Upgrade.............................................................................................................................. 24
2.10.3.15 Service Functions ....................................................................................................................... 25
2.10.4 Specific Settings ................................................................................................................................... 25
2.10.4.1 Sound During Therapy................................................................................................................ 25
2.10.4.2 Calibration................................................................................................................................... 25

3 LIST OF STANDARD AND OPTIONAL ACCESSORIES.............................................................................. 26

4 MAINTENANCE AND SAFETY INSTRUCTIONS ....................................................................................... 27


4.1 General Safety Precautions ................................................................................................................... 28
4.2 Troubleshooting................................................................................................................................... 31
4.3 Used Symbols ....................................................................................................................................... 32
5 TECHNICAL PARAMETERS.............................................................................................................................. 33
5.1 Safety Eyewear ................................................................................................................................... 34
5.2 Electromagnetic Compatibility (EMC).................................................................................................................... 35
5.3 Manufacturer.......................................................................................................................................... 38

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 5 OF 40


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1 GENERAL CHARACTERISTICS OF THE DEVICE

1.1 INTENDED USE


BTL-6000 High Intensity Laser is a non-invasive therapeutic device intended to emit energy in the infrared spectrum
to provide topical stimulation of the biological tissue. This tissue stimulation results in local acceleration of healing,
increase of metabolism, and analgesic reaction.

1.2 INDICATIONS
Indications for use of BTL-6000 High Intensity Laser are the following:

• Presence of pain (eg low back pain syndrome; cervicobrachia pain syndrome; shoulder pain)

• Tendonitis; Rotator cuff injury; Arthrosis (eg Gonarthrosis), Arthritis (periarthritis humeroscapularis), Epicondylitis;
Muscle and tendon ruptures; Deep muscle trigger points

• Calcification of subacromia bursa; Calcar calcanei

• Paresis; Carpal tunnel

• Scars; Herpes; Hematomas

• Distortions and sports injuries

1.3 USER PROFILE


The device shall be used by medically educated healthcare professionals. The user shall be familiar with all safety
precautions, operating procedures and maintenance instructions given in this User's Manual.

1.4 PATIENT PROFILE


The device is intended for adult patients only. The patient must not show any symptoms listed in the Chapter
Contraindications. The user should take into account a detailed patient's medical history and examine the patient
thoroughly to determine whether or not the application of therapy is suitable for the patient.

1.5 OPERATING ENVIRONMENT


The device is intended solely for professional use in medical facilities, for indoor use only, not for use in wet or humid
environment, and not to be exposed to direct sunshine. The device is not intended for home-use.

1.6 DEVICE DESCRIPTION


The device is equipped with a color touch screen on the main unit which considerably simplifies its use. The touch
screen is equipped with a stylus (touch-pen) for easy operation of the device. Horizontal orientation of the device
allows the information on the screen to be seen clearly from different servicing positions. Additionally, the brightness
of the screen can be set to match the lighting in the room of the office or the health-care center. The on-screen
information will guide the user step-by-step through the entire therapy process. The therapeutic parameters are easily
set using the touch screen buttons and knobs/buttons on the device.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 6 OF 40


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Therapy is simply started by selecting a diagnosis from an alphabetized list of treatment protocols or by selecting
a therapy program. The treatment parameters can be manually set using the touch screen buttons. Throughout the
therapy the user is informed about the remaining time of the therapy and remaining dose to be applied. These values
are automatically calculated from the parameters that can be set by the user: operation mode (continuous or pulsed),
frequency, treatment area, dose and power output.

A time-saving feature of the BTL-6000 High Intensity Laser is the list of predefined programs stored in the memory of
the main unit. Based on detailed research and practical use of the device, the well-organized predefined programs
will provide recommendations for the treatment of various conditions.

For the latest information on BTL products and services, please visit our corporate website at http://www.btlnet.com.

1.6.1 BTL-6000 HIGH INTENSITY LASER

The device consists of three parts: main unit, handpiece and footswitch control.

• Main unit: BTL-6000 High Intensity Laser contains the main microcomputer and software for controlling the entire
system. It also includes the user encyclopaedia and the therapy guide. The unit is password secured and
safety interlock is obligated to be connected.

• Handpiece: ergonomic and extremely light-carrying handpiece with three removable ending spacers for precise
adjustment of the treatment area. The laser light is delivered to the handpiece from the main unit using a
permanently attached optical fiber.

• Footswitch control: for safety reasons the unit's laser source can only be activated via foot switch control.

1.6.2 LASER LIGHT AND ITS CHARACTERISTICS

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 the so-called quantum radio technique
(NG Basov and AM Prokhorov of the former USSR and CH Townes of the USA received a Nobel Prize for these
discoveries in 1964).

The medical application of laser light followed soon after. E. Mester, a Hungarian scientist, was the first to introduce
the stimulative effect of laser. He conducted his experiments - which are still of a great importance - in
the late 1960s.

Laser radiation has specific qualities:

• Total monochromacy: maintaining only one wavelength


• Directionality and polarization: the light is emitted in a specific direction and is usually polarized
• Coherency: it is absolutely oriented in time - maxima and minima of all waves are identical in time and the
waveforms are the same

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Laser light source classification:

Laser sources are classified according to their wavelength and maximum output power into classes marked 1, 1M,
2, 2M, 3R, 3B and 4. The higher class number the more powerful the laser is. The classes 1, 1M, 2, 2M and 3R are
mostly used in industrial applications. In medicine, lasers class 3B and 4 are used.

Since E. Mester in the late sixties explored the biostimulative effect of laser therapy, this type of treatment underwent
great technical development. In previous decades so called Low Intensity Laser Therapy (LLLT, class 3B) became
extremely popular for its biostimulative effects. But the latest research and clinical experiences show that with
increasing the power and dosage using the class 4 lasers the therapeutic effect can be multiplied. Apart from this
class 4 lasers compared to LLLT have the ability to penetrate into almost unlimited depth of the body.

1.6.3 SOURCES OF THE LASER LIGHT

There are several types of laser light generators used in the therapy of musculoskeletal apparatus. These laser light
sources differ mainly in the various technical characteristics. BTL-6000 High Intensity Laser unit uses diode laser
light source which emits light in the near infrared light spectrum.

1.7 BIOLOGICAL EFFECTS OF HIGH INTENSITY LASER


High Intensity Laser therapy has strong influence on the human tissues. The most considerable clinical effects
are:

• Analgesic effect

• Biostimulation effect

• Antiphlogistic effect

• Antioedematous effect

Vasodilation effect

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

• Acceleration of microcirculation

• Activation of Melzack gate control mechanism – pain perception inhibition

• Increase of intracellular activity of many enzymes, particularly in Krebs cycle

• Increased oxygen circulation, improved glucose utilization

• DNA synthesis stimulation (via phytohemagglutinin stimulation)

• Increased fibroblast activity (for keloid scars 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 cell: partly through the Na/K pump and Ca transport affection,
partly through direct activation of the mitochondrial system

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


e.g., endorphins

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 8 OF 40


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1.8 ADVANTAGES OF HIGH INTENSITY LASER TREATMENT


• Extremely well targeted application into defined therapeutic area and depth of the tissue

• Strong analgesic effect without pharmacotherapy needed

• Possibility to prevent surgical intervention and its related risks

• Highly positive clinical outcomes, with long lasting effects

1.9 CONTRAINDICATIONS AND POSSIBLE SIDE EFFECTS

1.9.1 CONTRAINDICATIONS FOR HIGH INTENSITY LASER TREATMENT

• Psychological illness

• Major systemic diseases – eg uncontrolled Diabetes mellitus

• Uncontrolled hypertension

• Current pregnancy

• Photosensitivity, tattoos and pigment around the treated areas which could result in different levels of
absorption of the administered light

• Medications affecting sensitivity to light

• Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use

• Active heart disease

• Pacemaker

• Anticoagulant therapy, bleeding disorders

• Haemorrhage in the treated area

• Endocrine gland disease

• History of cancer or any type of malignancy

• Febrile conditions and serious illness, chronic infection

• Metallic implants in the treated area

• Cochlear implants

• Epilepsy

1.9.2 POSSIBLE SIDE EFFECTS OF HIGH INTENSITY LASER TREATMENT

• Unpleasant sensation of heating

• Erythema

Temporary hyposensitivity

• Temporary hypersensitivity

• Petechiae

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 9 OF 40


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1.10 GENERAL WARNINGS AND PRECAUTIONS


Use clinical assessment to determine all aspects of the treatment including, but not limited to, the laser treatment
protocol, technique, power settings, pulse duration and interval settings and other procedural requirements. Some of
the situations where the special precautions are required:

• All the patients should receive skin type assessment according to Fitzpatrick (see the Chapter
1.10.1). The therapy parameters have to be adjusted accordingly to this assessment.

• It is necessary to move the handpiece during the whole therapy. Avoid static applications (see
Chapter 2.7.1).

• The therapy must not be performed without the spacer. Always attach the removable spacer to the
handpiece.

• Scar tissue is associated with poor circulation and reduced cooling through heat transport by blood. Power
settings may have to be reduced to avoid heating.

• Tender or Sensitive Skin: Patient may be hypersensitive to heat. Reduce power as necessary to
ensure comfort during treatment.

• Swelling/inflammation: Patient may be sensitive to heat. Reduce power as necessary to ensure comfort
during use.

• Redness: can be associated with increased temperature and an increase in absorption properties of the
skin. Reduce power as low as necessary to maintain comfort during use.

• Excessive fat tissue is known to transmit heat without much attenuation. Reduce power as necessary.

• Implants: Different materials will respond differently to the laser energy and heat. Be aware of anyone
implants and location. Avoid direct exposure of the implant site to laser or heat.

• No ointments, creams, lotions or heating lotion patches should be used at the site or in close proximity.

• No therapies that could change body temperature (ultrasound, thermotherapy and electrotherapy) should be used
prior to laser treatment.

• No treatment over the articles of clothing. Only direct application to the uncovered skin surface is
acceptable.

• All persons present in the operation must wear protective laser eyewear.

• Do not look directly into the beam or at accidental reflections.

• All reflective materials and windows in the treatment room must be covered in order to prevent
reflection of the laser beam or unwanted irradiation outside.

• Do not aim the laser at metallic or reflective surfaces. If aimed directly at these surfaces, the laser
beam will reflect and create a potential hazard.

• Patients must be monitored for pain or discomfort throughout the entire procedure. In case the patient
does not tolerate the therapy, discontinue the treatment immediately.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 10 OF 40


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1.10.1 SKIN TEST EVALUATION ACCORDING TO FITZPATRICK

The Fitzpatrick Scale (Fitzpatrick skin typing test or Fitzpatrick phototyping scale) is a numerical classification scheme
for the color of skin. It was developed in 1975 by Thomas B. Fitzpatrick, a Harvard dermatologist, as a way to classify
the response of different types of skin to UV light.

All patients should receive orientation skin test assessment according to Fitzpatrick prior to the treatment. The
Fitzpatrick Scale:

• Type I Skin white; very fair; freckles; typical albino skin. - Always burns, never tans.

• Type II Skin white; fair. - Usually burns, tans with difficulty.

• Type III Skin beige; very common. - Sometimes mildly burns, gradually tans to light brown.

• Type IV Skin beige with a brown tint; typical Mediterranean Caucasian skin. - Rarely burns, tans with ease
to moderate brown.

• Type V Skin dark brown - Very rarely burns, tans very easily.

• Type VI Skin black - Never burns, tans very easily, deeply pigmented.

Patients evaluated as skin type V. and VI. must be treated with special precautions. Monitoring of discomfort
and unpleasant sensations of warming must be performed during the whole treatment procedure with special care!

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 11 OF 40


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2 INSTRUCTIONS FOR OPERATION

2.1 THE FRONT PANEL OF THE BTL-6000 HIGH INTENSITY LASER

1 10

1 70

1 30

1 40

1 20
1 60 1 50

1. touch screen
2. select knob (to select individual parameters) 3. enter button

4. esc button
5. laser stop: emergency laser stop button 6. on/off switch
(back lit, in blue, when the control unit is ''on'' )
7. USB port in the space of the device's grip for use only in compliance with IEC 60950-1.
The USB port serves only for service purposes such as upload of firmware; it is not designed for therapeutic use!

2.2 HANDPIECE OF THE BTL-6000 HIGH INTENSITY LASER

1 80 9 110 0

8. safety ending spacer – 30 mm 9. main body


of the handpiece 10. optical fiber

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 12 OF 40


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2.3 THE REAR PANEL OF THE BTL-6000 HIGH INTENSITY LASER

1110

1120
110 4

1130
110 8

110 5

110 6

110 7

11. connector for power cable 12. power


on/off switch 13. footswitch
connector
14. calibration window 15.
safety interlock/door lock sensor connector 16. connector for
handpiece – handpiece is permanently attached 17. type and safety labeling 18.
communication link connector

2.4 FOOTSWITCH

1190 210 0 210 1

19. connection cable


20. footswitch safety metallic cover 21. footswitch
bellows

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 13 OF 40


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2.5 ASSEMBLY AND SET-UP


Inspect the box for damage and report any damage to the transport carrier and the distributor. Do not proceed with
assembly and set-up if the box is damaged. Keep the original box and packaging to ensure safe future transportation
of the device.

When bringing the device from a cold environment into a warm one, do not plug it into the power source until the
device has had to equilibrate to room temperature (minimum 2 hours).

Unpack the device and place it on a stable horizontal surface which is suitable for its weight. Always position the
device out of direct sunlight. During operation, the control unit gets warm, so it must not be positioned near direct heat
sources. The device is self-cooled by forced air circulation. The cooling vents are located on the rear panel and on
the bottom. Do not cover or block these vents. Allow a minimum of 4 inches (10 cm) clearance behind the rear panel.
Do not place the device on a soft surface (such as a towel) which may obstruct air flow to the bottom cooling vents.
Do not put any heat-producing devices or any objects containing water or other liquids on the device. Do not place
the device close to appliances producing strong electromagnetic, electric or magnetic field (diathermy, X-rays, etc.),
otherwise it could be undesirably influenced.

In the event of any questions, please contact an authorized service of BTL devices.

Procedure:

1. Install the handpiece holder using the procedure described in the Chapter Installing the Handpiece Holder.

2. First connect the device to the mains supply using power cord cable, which you will connect to the connector on
the rear panel (11) of the device and to 100 V – 240 V mains socket. Plug the device directly into the mains
socket. Do not use any multi-connection extension cables or two-socket adapters.

3. Connect the footswitch control cable (19) to the connector in the rear panel (13).

4. Connect the safety interlock to the connector in the rear panel (15).

5. Then switch on the power switch (12) in the rear panel of the device.

6. Press the on/off switch located on the front panel of the device.

Note:

After switching the device on, the device will run a self-diagnosis of its internal circuits and its functions for about 10
to 15 seconds. If any fault is detected, the screen will display a warning message. If necessary; The control unit will
lock itself into a “secure” mode. If this situation occurs, please contact your authorized BTL distributor.

2.5.1 INSTALLING THE HANDPIECE HOLDER

To install the handpiece holder you will need the following components that were supplied with the device:
• 1x handpiece holder
• 1x handpiece holder cup
• 2x torx screws M5x16 for
• 1x torx screwdriver TX25

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 14 OF 40


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The procedure is depicted in the following figure.

Procedure:

1. Install the handpiece holder using the 2 torx screws M5x16 and the supplied torx screwdriver. The
handpiece holder can be attached to either the left or the right side of the device.

2. Insert the handpiece holder cup into the holder.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 15 OF 40


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2.6 BASIC DISPLAYS AND OPERATING OF THE DEVICE

2.6.1 INITIAL SCREEN AND TYPES OF TABS

The initial screen after the device is switched on contains the tab displaying information about the instrument model:

Tab of the instrument with the Tab of the instrument with the
1064 nm laser 810 nm + 980 nm laser

During therapy, this tab displays information about the therapy in progress:

Tab during therapy in analgesic Tab during therapy in single


and biostimulation therapy pulse therapy mode. The number
modes. The time remaining and of administered pulses and the
the current power setting are current power setting are
displayed. displayed.

2.6.2 TOUCH SCREEN

The touch screen can display several graphic elements. Some are only for informative purposes but others can be
pressed and activated. These basic elements include:

• 3D buttons which can be pressed to change the indicated values


• Informative text

The items on the touch screen can be pressed by a finger or by a touch-pen, which is included in the accessories of the
device. The touch screen must not come in contact with any sharp objects, ball pens etc.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 16 OF 40


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2.6.3 NUMERIC KEYPAD

In addition to the setting of the numerical values with the select knob on all the screens, the ”numeric keypad" can
be used for the faster setting of values.

This is the icon for the opening the numeric keyboard window:

Press the numeric keypad button to display the window with the numeric keypad for the parameter with the “pressed”
light button. Set the required values and return to the previous screen by pressing the enter button. If you do not want
to enter any values or change the selected parameter, leave the window with the numeric keypad by pressing the esc
button.

If you enter a value out of the allowed range of values (stated above the entering box) or the device cannot set it,
then the value is rounded to the nearest lower allowed value.

2.7 SETTING OF THERAPY

2.7.1 GENERAL GUIDELINES FOR THERAPY SETTING

1. Set the therapy parameters according to the patient's conditions and skin type.

2. Select appropriate spacer. Do not perform the therapy without the spacer.

3. During the therapy keep the spacer perpendicular to the patient's skin.

4. Always move the handpiece to avoid tissue overheating. Avoid static applications.

2.7.2 SETTING THERAPY PARAMETERS VIA THE 'DIAG' BUTTON

A list of diagnoses will display after pressing the diag button.

To find a diagnosis quickly, press the button for the first letter of the therapy required. For example, after pressing the
MNOP button once, there are listed diagnoses starting with the first letter, in this case "M". Other letters are searched
depending on how many times the button is pressed. Thus pressing MNOP twice will equal N, pressing the button
three times will equal "O" and pressing the button four times will equal "P". The currently selected letter will be
displayed in the box to the right of the buttons:

After finding the required diagnosis, press the enter button to select it.

2.7.3 SETTING THERAPY PARAMETERS VIA THE 'PROG' BUTTON

After pressing the prog button, a screen will appear, where the number of the required therapy program can be
entered. The numbers of the particular programs will be prefixed with the letter “L”. For faster entry of the program
number, use the numeric keypad. For more details see the Chapter Numeric keypad.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 17 OF 40


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2.7.4 SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE 'MAN' BUTTON

The therapy parameters screen for the manual setting will be displayed by pressing the man button. All specifications
of the therapy can be set and possibly saved as a user program or a user diagnosis.

The following parameters can be set:

Therapy
Mode of the laser light emission. The available therapy modes are:
• analgesic mode (pulsed mode); •
biostimulation mode (continuous mode); •
single press mode.

Power
Output power of the emitted laser light in watts (W). This parameter is available in all three therapy modes.

Dosage
Therapeutic dosage in joules per cm2 (J/cm2 ). This parameter is available only in the analgesic and biostimulation
therapy modes.

Area
Therapeutic area in square centimeters (cm2 ). This parameter is available only in the analgesic and biostimulation
therapy modes.

Frequency
Frequency of the pulsed laser light in hertz (Hz). This parameter is available only in the analgesic therapy mode.

Pulse width
Width of the single pulse emitted in milliseconds (ms). This parameter is available only in the single pulse therapy mode.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 18 OF 40


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The following parameters are indicated:

Total energy
Automatic calculation of the total energy in joules (J) to be delivered during the therapy. The total energy is calculated
using the Dosage and Area. This parameter is indicated only in the analgesic and biostimulation therapy modes.

Therapy time
Automatic calculation of the therapy time in minutes and seconds (m:s). The therapy time is calculated using the Total
energy and Power. This parameter is indicated only in the analgesic and biostimulation therapy modes.

NOTE: The maximum Therapy time is limited to 99 minutes 59 seconds.

Energy per pulse


Automatic calculation of the energy in joules (J) delivered by a single emitted pulse. This parameter is indicated only
in the single pulse therapy mode.

2.7.4.1 Setting the Therapy mode


The following therapy modes can be set:
• analgesic mode: repetitive pulsed laser emission with duty cycle of 25 % and adjustable frequency;
• biostimulation mode: continuous laser emission;

• single pulse mode: single pulse laser emission with adjustable pulse width.

2.7.4.2 Setting the Output power


The output power can be set on the therapy parameters screen, even during the course of therapy. After pressing the
“power” button it is possible to set the intensity either by means of the numeric keypad, preset values written on the
buttons or by the select knob. During therapy, the intensity value can only be changed by means of the
select knob.

2.7.4.3 Setting the Dosage


Crucial therapeutic parameter of the High Intensity Laser therapy is the dosage in joules per one centimeter square of
the treatment area. Dosage (J/cm2 ) is set on the therapy parameters screen. Setting is enabled when either the
analgesic or the biostimulation therapy modes are active.

2.7.4.4 Setting of the Treatment Area


Appropriate treatment area can be set on the therapy parameters screen. Set the value accordingly to the expected size of the area to be treated.
Setting is enabled when either the analgesic or the biostimulation therapy modes are active.

2.7.4.5 Setting of the Frequency


Optimum frequency of the pulsed laser light emitted can be set on the therapy parameters screen. Frequency of the laser pulses can be set in the
range from 1 Hz up to 100 Hz. Setting is enabled when analgesic therapy mode is active.

2.7.4.6 Setting the Pulse Width


Pulse width can be set in the range from 2 ms up to 1000 ms. Setting is enabled when single press mode is
active.

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2.8 COURSE OF THERAPY

2.8.1 START, INTERRUPTION AND END OF THERAPY

For safety reasons the therapy can be only started by performing two consequent steps.

First, press the start button on the screen and the “therapy” window will open. The device will start emitting the red
aiming beam from the handpiece. The aiming beam marks approximately the treatment area and indicates to the
user that the device is ready to start the therapy. Note that the footswitch must be released and the safety interlock
must be connected while pressing the start button.

In the second step, the emission of the laser light is activated by pressing down the footswitch control. When the
footswitch control is pressed down, the therapy laser light is emitted:

1. In analgesic and biostimulation mode the laser light will be emitted until the footswitch control is released.
The therapy in progress is indicated by the device by yellow backlight around the laser stop
button and by beeping sound.

2. In single pulse mode by pressing the footswitch control, the device will emit one laser light pulse.
During the pulse generation, the backlight around the laser stop button is yellow and the device makes a
beeping sound. Hold the footswitch until the pulse generation is complete. For another emission the
footswitch control must be pressed again.

During the therapy the device continues to emit the red aiming beam.

The laser therapy is invisible to human eye.

To stop the laser emission before the therapy is over, release the footswitch control. To interrupt/pause the therapy
press pause button on the therapy screen. To resume the interrupted – paused – therapy press the continue button
on the screen. To stop the therapy, press esc.

The laser power can also be changed during therapy by turning the select knob to the right to increase the intensity
or to the left to decrease the intensity.

For immediate discontinuation of the laser unit activity in case of emergency press the red laser stop emergency
button on the front panel of the unit.

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2.8.2 SCREEN DURING THERAPY

Screen during therapy when either analgesic or biostimulation therapy mode is selected:

Name of the
selected therapy /
program and the set
parameters

Output power
setting

Indication of the Indication of the


remaining energy remaining
to be delivered therapy time

Screen during therapy when the single pulse therapy mode is selected:

Name of the
selected therapy /
program and the set
parameters

Output power
setting

Number of
Indication of the applied pulses
delivered energy

2.8.3 END OF THERAPY

In analgesic and biostimulation modes, the therapy will end automatically when the calculated therapy time/total
energy decreases to zero.

To stop emitting of the laser release the footswitch control. To interrupt/pause the therapy, press the pause
button on the therapy screen. To resume the interrupted – paused – therapy press the continue button on the screen.
To stop the therapy, press esc.

In single pulse mode by pressing the footswitch control, the device will emit one laser light pulse. During the pulse
generation, the backlight around the laser stop button is yellow and the device makes a beeping sound.
Hold the footswitch until the pulse generation is complete. For another emission the footswitch control must be
pressed again.

For immediate discontinuation of the laser unit activity in case of emergency press the laser stop emergency button
on the front panel of the unit.

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2.9 APPLICATION OF LASER LIGHT


Application of laser light is provided via ergonomic handpiece which is connected to the source of the laser light in the
main unit. Handpiece is supplied with three removable ending spacers in order to define the treatment area.
Following types of the spacers can be used:

• 10 mm length for applications in proximity of the skin of the patient. Spot diameter 12 mm.

• 30 mm length – standard spacer, defining therapeutic area suitable for most common applications. spot
diameter 20 mm.

• 60 mm length – optimum size when large areas are to be treated. Spot diameter 35 mm.

2.10 UNIT SETTINGS: THE 'MENU' BUTTON


After pressing menu it is possible to browse the following menus using the select knob:

• Accessories

• Encyclopaedia
• Unit settings
• Specific settings

2.10.1 ACCESSORIES

Displays information about the laser handpiece such as its operating wavelength.

2.10.2 ENCYCLOPAEDIA

The encyclopaedia provides information about the preset clinical protocols, therapeutic possibilities and examples of
how to use the device. An electronic version in the device is accessible from most screens and from the device menu.

Icon to open the encyclopaedia:

After opening the encyclopaedia following the selection of a specific diagnosis, the information on the selected diagnosis
will be displayed. Otherwise you will enter the encyclopaedia's table of contents which lists the individual clinical
protocols. Here it is possible to scroll using the select knob. After selecting the required diagnosis, press the enter to
get the specific information on the clinical protocols.

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2.10.3 UNIT SETTINGS

This submenu offers the setting and displaying these parameters:

• Password setting

• Sound setting

• Screen saver and auto switch-off

• Color setting

• Setting of display contrast

• LED brightness settings

• Date and time setting

• Language setting

• Touch panel calibration

• User options

• Setting of HW key

• Unit information

• Unlock code

• User accounts

• Firmware upgrade

• Service functions

• Dialog history

2.10.3.1 Password Setting


Allows change of the device's password which is required by the device after it is switched on. Without entering the password, further work with the
device is impossible.

2.10.3.2 Sound Setting


Allows the setting of the acoustic signaling for when buttons or the touch screen are pressed as well as for certain operations such as therapy
start, therapy interruption, end of therapy etc. The device includes a set of standard sounds from the manufacturer, for example signaling the
therapy operations. All audio tones can be muted (no sound) or modified as required.

Allows editing of the individual audio schemes, the creation of new ones and the modification of the audio tones for each operation separately. The
user's own settings will always be displayed at the end of the list of sound schemes.

The sound volume can be set under the User options menu.

2.10.3.3 Screen Saver and Auto Switch-Off

Includes the setup of the screen-saver type, the activation time of the screen-saver, the period of time before which the screen will switch off and
idle time for the whole device.

To cancel the screen-saver mode, press the esc button on the device. Do not forget to save the settings by pressing the enter button.

2.10.3.4 Color Setting


Allows setting the colors of the controls displayed on the screen. There are 5 preset color schemes available to choose from.

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2.10.3.5 Setting of Display Contrast


Allows the setting of the optimum contrast of the display by turning the select knob.

Since the contrast of the screen depends on various factors, such as the temperature of the room, there is a faster and
direct way of setting the screen contrast. To quickly change the contrast, turn the “select” knob while simultaneously
holding the enter and esc buttons.

2.10.3.6 Date and Time Setting


Allows the setting of the date and time for the device.

2.10.3.7 Language Setting


Allows the setting of the preferred language of the texts displayed on the device's screen. The factory default is English.

2.10.3.8 Touch Panel Calibration


If the buttons on the touch screen do not react when pressed, the touch screen needs calibration. The process of the
calibration is shown on the screen. During the calibration, use the touch-pen (stylus) and follow the on-screen
instructions. Calibration, if not successful, can be interrupted at any time by pressing the esc button.

To verify the touch screen adjustments, use the "touch panel function test" function.

2.10.3.9 User Options


This submenu allows the setting and displaying of the following parameters:
• direction of movement of menu (standard / reverse)
• sorting of diagnoses (in ascending order / in descending order)
• tabs position (top/bottom)
• sound volume

2.10.3.10 Setting of HW Key


The device can be remotely reconfigured. If it is later decided to purchase the upgrade, the manufacturer (distributor)
will send the 64-digit code (the so-called “HW key”) that entered when it will reconfigure its hardware according to that
key. For the current HW configuration see the next entry, Unit information.

2.10.3.11 Unit Information


Shows specific information about the device such as serial number, device type, firmware version etc. It also contains
the information of when the device will operate – so called "device validity". If the operation of the device is time
limited, this item indicates until which date the device remains fully functional.

2.10.3.12 Unlock Code


If the operation of the device is time limited, then in this item you can enter the so-called "unlocking code" for
cancellation of the operational time limitation of the device.

2.10.3.13 User Accounts


The function allows creating personal account for every person who operates the device. Everyone has their own
password to log in.

2.10.3.14 Firmware Upgrade


Enables to upgrade the firmware version in the device.

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2.10.3.15 Service Functions


• repair of files
Checks the file storage system of the device, the system of saved information. It will repair possible errors,
delete empty files, etc. We recommend using this feature in the event of a lack of memory space, if the device
rejects saving any data, or if you are in doubt that some data may have been lost.

• file system formatting


Should be used only if the repair of damaged files feature did not help. Unfortunately, when this feature is
used the entire memory is re-formatted and all the user-data and the user setup of the device will be lost.

• default setting without loss of user data


Restores all functions of the device to the factory default settings. However, all user–data related to clients,
programmed therapies, etc. will stay saved.

• unit log data export

2.10.4 SPECIFIC SETTINGS

2.10.4.1 Sound During Therapy


Sound setting of the unit allows choosing between two sound modes indicating running laser therapy and two
levels of the volume intensity.

2.10.4.2 Calibration
It is recommended to calibrate the laser source every 3 months. The calibration process is automatic and takes about 10. Calibration has to be
done without any spacer attached to the handpiece. The procedure is as follows.

Procedure for the calibration of the handpiece:

1. Place the ending part of the handpiece without the spacer into the calibration window on the back of the unit.

2. Choose “calibrate” in the “specific settings” menu.

3. Choose “start calibration”.

4. Press and hold the footswitch until the device indicates on the screen that the calibration is finished.

5. Release the footswitch and remove the handpiece from the calibration window.

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3 LIST OF STANDARD AND OPTIONAL ACCESSORIES

The device is not designed for use with other accessories or other medical equipment other than those stated in this manual.

Standard accessories:

• 1x laser handpiece
• 1x safety handpiece spacer 30 mm
• 1x footswitch control

• 1x safety interlock
• 2x safety eyewear
• 1x handpiece holder
• 1x handpiece holder cup
• 2x torx screws M5x16 for attaching the handpiece holder
• 1x torx screwdriver TX25 for mounting the handpiece holder
• 1x power cord
• 1x user's manual

• 1x touch pen
• 1x dust cover for BTL-6000 devices

• 1x laser warning label


• 2x T2AL fuse, 250 V

Optional accessories:

• 1x safety handpiece spacer 60 mm


• 1x safety handpiece spacer 10 mm
• transport case for the BTL-6000 High Intensity Laser
• door lock sensor

• trolley for BTL-6000 series

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4 MAINTENANCE AND SAFETY INSTRUCTIONS

The recommended intervals for inspection of the device are 24 months after installation, subsequently each
12 months. The intervals may differ according to the local regulations. The inspection shall be performed according to
procedure authorized by BTL.

To keep the device clean, do not store or use it in extremely dusty environment for a long time. Do not immerse it in
any liquid. Before each use, check that the device and its accessories (especially cables) are not mechanically or
otherwise damaged. Do not use the device if it is damaged!

Maintenance and cleaning of the protective window on the handpiece:


Check the window that protects the optical fiber outputs in the handpiece. In case the
window is damaged, contact an authorized BTL service department.

Keep the protective window clean. Avoid touching the window with bare hands.
Clean the protective window regularly. Use a cotton swab with isopropyl alcohol.

Damaged and/or dirty protective window will result in lower laser power
efficiency, excessive heat-up of the handpiece above 41 °C, and it may damage the
device permanently.

Exterior cleaning of the device:


Use a soft cloth slightly moistened with water or with a 2% detergent solution to clean the exterior of the device and its
parts. Never use cleaning agents containing alcohol, ammonia, benzine, thinners, etc. Never use abrasive cleaning
materials which will scratch the device's surfaces. No parts of the device require sterilization. Care should be given to
prevent water or other liquids from getting inside the device.

Cleaning and maintenance of accessories which come into contact with the patient:
Clean and disinfect after each client using approved cleaning agents. For example, Sekusept, Bacilol, and Incidur
Spray can be used. For the cables of accessories, use Incidur Spray and the like. DO NOT USE SOLVENTS!!!

Fuse replacement:
The fuses are placed in the box between the power switch and the power socket in the rear panel. During replacement,
check the correctness of the fuses being inserted. This action should only be done by a person familiar with this
procedure!

Before replacement, make sure that the main power switch of the device is in the “0” position and the power cord
is unplugged from the unit. Use a flathead screwdriver to release the fuse box. Insert new fuses and plug the fuse box
back in the rear panel.

Do not use fuses other than those stated next to the fuse box!

Plugging the device into an electrical outlet:


The device is equipped with automatic voltage detection, so it can be used for voltages within the 100–240 V
range.

Transport and Storage:


Keep the shipping container and all packaging materials. Transport the unit in original box to ensure maximum
protection. Unplug the main power cable and all accessories including the handpiece holder. Note that the optical fiber
with the handpiece are permanently attached to the device and cannot be unplugged. Make sure the optical fiber is
not twisted during transportation. The optical fiber must not be coiled up to diameters smaller than 15 cm.
Take care to avoid shocks or jarring movements to the device during transportation. This device should only be
transported and stored under the conditions defined in the Chapter Technical Parameters.

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4.1 GENERAL SAFETY PRECAUTIONS

Before turning on the device for the first time, read this manual carefully.

• All operating entrances must be marked with an appropriate laser warning sign included with shipment.
• All personnel must be properly trained before using the device. This training should include the operating technique, maintenance, verification
of proper functioning and safety precautions associated with using the device.

• Protect the device against unauthorized use. The device can be protected by switching the device off (a password is required to switch on
the device) or by removing the supplied safety interlock from the connector on the back of the unit.

• Do not operate in the presence of explosive or flammable materials. Flammable anesthetics or oxidizing gases such
as nitrous oxide (N2O) and oxygen should be avoided. Solvents of adhesives and flammable solutions used for
cleaning and disinfecting should be allowed to evaporate before laser is used. Attention should also be drawn to
the danger of ignition of endogenous gases.

• All persons present in the operation must wear protective laser eyewear. Use only protective eyewear
designed for the BTL-6000 High Intensity Laser. Periodically inspect the protective eyewear for any damage.
Do not use damaged protective eyewear!
• For replacement or additional protective laser eyewear, please use only eyewear from your authorized
dealer.

• Do not look directly into the beam or at specular reflections.

• All reflective materials and windows in the treatment room must be covered in order to prevent
reflections of the laser beam or unwanted radiation outside the room.

• Do not aim the laser at metallic or reflective surfaces, such as surgical instruments. If aimed directly at
these surfaces, the laser beam will reflect and create a potential hazard.

• The device does not use any drugs, creams, gels or other substances which are an integral part or which
are applied by its use.

• Use only accessories supplied by the manufacturer. Accessories from other manufacturers will not work with the
device and might damage it. Use of unauthorized accessories may result in increased electromagnetic emission
and/or decreased electromagnetic immunity of the device.

• The product complies with Class A emissions according to CISPR11, IEC 60601-1-2.
• Portable and mobile high-frequency communication devices (such as mobile phones) may affect the function of the device.

• The electrical cables which are to be connected to the device must be installed and tested according to the existing
valid standards (IEC 364). If it is not known whether cables are safe and/or correct, then they should be checked
and/or upgraded by an inspection engineer.

• Check whether the parameters of the mains power supply correspond to the requirements of the device
according to the Chapter Technical Parameters.

• The device requires the environmental conditions that are stated in the Chapter Technical Parameters. It must not
be used in an environment where there is a danger of explosion or of water penetrating the device.
The device cannot be in connection with flammable anaesthetics or oxidizing gases (O2, N2O, etc.).

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• Do not place the device in direct sunlight or near strong electromagnetic fields to prevent mutual functionality
influence. If this happens, move the device further away from the source of interference or contact an authorized
BTL service department.

• Do not twist or bend sharply the optical fiber leading to the handpiece. It might damage the optical fiber.
• Inspect the device thoroughly before each use. Look for loose cables, cracked cable and/or fiber cable
insulation, cracks in the laser handpiece's housing and functional behavioral differences in the display or the
operating elements. If any anomalies or inconsistencies are found, stop using the device and contact an
authorized BTL service department. If the behavior of the device shows any divergences from the functionality
procedures described in this user's manual, stop using the device and contact an authorized BTL service
department.
• If the device shows any defects or if there are any doubts concerning its correct and safe functioning, terminate
the therapy immediately. If the source of the concern can be determined after a thorough study of the user's
manual, then contact an authorized BTL service department immediately. If the device is not used
in accordance with this manual or if it is used when the device exhibits functional differences from those
stated in this manual, then BTL is not responsible for any damage to or caused by the device.

• As the aiming beam passes down the same delivery system as the therapy laser light, it provides a good means of
checking the integrity of the optical fiber. If the aiming beam is not present at the output of the handpiece or its
intensity is reduced, this is a possible indication of a damaged or malfunctioning of the optical fiber.

• No user modification of this device is allowed. Do not try to open the device, remove protective covers, or
dismantle the device for any reason. There is a danger of electrical shock and/or serious injury.
Replacement of any part, even of the lithium battery, must be done an authorized BTL service department only!

• All material and parts which come into direct contact with the client's body (such as cleaning agents, and the
handpiece) must respectively comply with the standards related to irritants, allergens, toxins, geotaxis and
carcinogens (ISO 10993-1, ISO 10993-3, ISO 10993 5). The user is responsible for all these materials and parts
if they were not supplied by an authorized BTL equipment supplier.

• The connectors for accessories, as well as the other connectors, must not be used for connecting anything else other than what they are designed
for. There is a danger of electrical shock and/or serious damage to the device.

• The device does not use or emit any toxic substances during its operation, storage or transport under the
stated conditions.
• Before the start of therapy make sure that all set parameters comply with your requirements.

• To terminate operation, do not use the main power switch! Instead, press the "on/off" button. In case of
emergency, use the “laser stop” button for immediate stop of laser emission and device shutdown.

• The time interval between turning off the main power switch and turning it back on must be at least
3 seconds.
• If it is necessary to discard the device, the lithium battery must be removed. The removed battery must be
disposed according to local hazardous waste disposal requirements. Do not place the device in municipal waste
containers. The device itself does not contain any toxic materials which could harm the environment when
disposed of ecologically.

• The device and its accessories must be used in compliance with this manual.

• The device must be placed out of the reach of children.

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• The device does not contain any components, except for the fuse, which can be repaired or replaced by
the user. Do not remove the cover from the control unit. All repairs must be done by an authorized BTL service
department.

• Use of controls or adjustments or performance of procedures other than those specified in this manual
may result in hazardous radiation exposure.

• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
• During the therapy the operator must not touch other electrical equipment.

• Dissipate static electricity before manipulating with the safety interlock and/or door lock sensor by
touching a grounded metal object, such as the device's unpainted metal chassis.

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4.2 TROUBLESHOOTING
The table below shows the list of error messages which can be fixed by the user in most cases.

Fault Possible cause Corrective actions

System does not work Power failure Check the power supply.

Defective mains fuse Replace the fuses.

Defective mains plug Replace the mains cable.


Display and/or button backlights not lit
Switch the device off using the mains
switch and contact an
Device malfunction
authorized service of BTL
devices.

Plug in and tighten the safety interlock


into the corresponding socket in the back
Safety interlock not connected
panel of the instrument.

Door open Safety interlock not plugged in properly Unplug and re-plug again the safety
interlock and tighten it.

Contact an authorized service of


Safety interlock damaged
BTL devices.

Connect the footswitch to the


Footswitch not connected corresponding connector on the
Pressing footswitch does not start therapy instruments back panel.

Contact an authorized service of


Footswitch damaged
BTL devices.

Switch the instrument off

Temperature alarm Instrument too hot completely and let it cool down for 20
min.

Check the placement of the


handpiece in the calibration window
Handpiece not inserted properly in the
in the back of the
calibration window
instrument and repeat the
calibration.

Repeat the calibration procedure.


Footswitch released before the Release the footswitch only after
Calibration failed
finished calibration the device indicates the
calibration is finished.

Switch the instrument off and on

again. Repeat the calibration. If the


Calibration procedure not
calibration fails again, contact an authorized
completed successfully
service of BTL
devices.

Error message System exception Follow the displayed instructions.

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4.3 USED SYMBOLS

Warning: the values of laser light energy used during therapy can be potentially hazardous.

Warning

Caution

Type BF applied part

Read the manual before operating the device.

Electric and electronic equipment. Do not use municipal waste to dispose of the
unit. Its disposal is subject to the 2002/95/EC Directive.

Optical fiber handpiece

Foot-operated switch

Symbol marking a connector sensitive to electrostatic discharge (ESD)

Name and address of the manufacturer

Date of manufacture

Serial number

Batch code

Catalogue number

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5 TECHNICAL PARAMETERS

Yam BTL-6000 High Intensity Laser


Laser specifications
Laser classification Class 4
ÿ = 600 nm ÷ 2000 nm (±20%)
Wavelength
(actual wavelength is specified on the explanatory label)
Maximum output power up to 15 W (actual maximum power is specified on the explanatory label)
Power accuracy ±20%
Beam divergence 35° (±20%)
Nominal Optical Hazard Distance
2.42 m (at 15 W)
(NOHD)
Spot size
10 mm spacer Ø 12 mm (1.13 cm2 )
30 mm spacer Ø 20 mm (3.14 cm2 )
60 mm spacer Ø 35 mm (9.62 cm2 )
Maximum power density
10 mm spacer Up to 13.3 W/cm2
30 mm spacer Up to 4.8 W/cm2
60 mm spacer Up to 1.6 W/cm2

Aiming beam specifications


Aiming beam laser classification Class 3R
Wavelength 650 nm (±20%)
Maximum output power 5 mW (±20%)

Operation modes
Biostimulation (continuous mode)
Power from 0.5 W up to the maximum power (see the explanatory label)
Dosage 1 J/cm2 – 200 J/cm2
Treatment area 1 cm2 – 500 cm2
Analgesic
Power from 0.5 W up to the maximum power (see the explanatory label)
Frequency 1 Hz – 100 Hz (±20%)
Duty cycle 25% (±20%)
Dosage 1 J/cm2 – 20 J/cm2
Treatment area 1 cm2 – 500 cm2
Single pulse
Power from 0.5 W up to the maximum power (see the explanatory label)
Pulse duration 2 ms – 1000 ms (±20%)

Classification
Applied part type BF1
Class according to IIb
MDD 93/42/EEC

Power supply
Maximum input 160 VA
Mains voltage 100–240 V AC
Mains frequency 50–60 Hz
Equipment protection class Class I
External interchangeable fuses 2x T2AL, 250 V, tube safety fuse 5 × 20 mm, IEC 60127-2
Power switch according to On the back of device, positions 0 (off) and I (on). To disconnect from the
IEC 60601-1 mains, unplug main power cable from the mains socket outlet

1
The classification of the applied part applies to the handpiece including the safety spacer (see Chapter 2.2).

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Display elements
Graphic color touch screen diag. 5.7" / 14.5 cm, resolution 640x480 pixels
Indicators 1x orange, 4x blue, 1x yellow

Operating conditions
Ambient temperature +10 °C to +34 °C
Relative humidity 30% to 75%
Atmospheric pressure 800 hPa to 1060 hPa
Position horizontal on legs
Type of operation permanent

Transport and storage conditions


Ambient temperature -10 °C to +55 °C
Relative humidity 10% to 85%
Atmospheric pressure 500 hPa to 1100 hPa
Position of the main unit horizontal
Storage time transport only in the original container

Design
Weight of the main unit including
max. 8 kg
the handpiece
Main unit dimensions (w × h × d) 320 × 190 × 280 mm
IP code according to EN 60529 IP 20

5.1 SAFETY EYEWEAR


Use only eyewear with suitable protection level (according to EN 207:2009):
• protection level at least L5 for wavelength ÿ = 810 nm
• protection level at least L5 for wavelength ÿ = 980 nm
• protection level at least L5 for wavelength ÿ = 1064 nm
• transparent for ÿ = 650 nm

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5.2 ELECTROMAGNETIC COMPATIBILITY (EMC)

The BTL-6000 High Intensity Laser needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this document. Portable and mobile RF communications
equipment can affect the BTL-6000 High Intensity Laser.

Guidance and manufacturer's declaration – electromagnetic emissions


The BTL-6000 High Intensity Laser is intended for use in the electromagnetic environment specified below. The
customer or the user of the BTL-6000 High Intensity Laser should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance

RF emissions The BTL-6000 High Intensity Laser uses RF energy only for its
CISPR 11 Group 1 internal function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic equipment.
RF emissions
Class A
CISPR 11
Harmonic emissions The BTL-6000 High Intensity Laser is suitable for use in all
Class A establishments other than domestic and those directly connected to
IEC 61000-3-2
the public low-voltage power supply network that supplies buildings
Voltage fluctuations / used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

The BTL-6000 High Intensity Laser should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the BTL-6000 High Intensity Laser should be observed to verify normal operation in such
configuration.

Recommended separation distances between portable and mobile RF communications equipment


and the BTL-6000 High Intensity Laser
The BTL-6000 High Intensity Laser is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the BTL-6000 High Intensity Laser can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the BTL-6000 High Intensity Laser as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output
150 kHz to 80 MHz 80 MHz to 800 MHz 150 kHz to 80 MHz
power of transmitter W
d = 1.17ÿP d = 1.17ÿP d = 2.34ÿP
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 23
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 35 OF 40


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Guidance and manufacturer's declaration – electromagnetic immunity


The BTL-6000 High Intensity Laser is intended for use in the electromagnetic environment specified below. The customer or the user of
the BTL-6000 High Intensity Laser should assure that it is used in such an environment.
IEC 60601 Electromagnetic environment –
Immunity test Compliance level
test level guidance
Floors should be wood, concrete or
Electrostatic ceramic tile. If floors are
±6 kV contact ±6 kV contact
discharge (ESD) covered with synthetic material, the
±8 kV air ±8 kV air
IEC 61000-4-2 relative humidity should be at least
30 %.

±2 kV for power
Electrical fast ±2 kV for power supply lines Mains power quality should be that
supply lines
transient/burst
of a typical commercial or hospital
±1 kV for input/output
IEC 61000-4-4 ±1 kV for input/output lines environment.
lines

Surge ±1 kV line(s) to line(s) ±1 kV line to line Mains power quality should be that
of a typical commercial or hospital
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV line to earth
environment.

<5% UT <5% UT Mains power quality should be that


(>95% dip in UT) (>95% dip in UT) of a typical commercial or hospital
for 0.5 cycle for 0.5 cycle environment. If the user of the BTL-6000

40% UT 40% UT High Intensity Laser requires continued


Voltage dips, short
operation during power mains
interruptions and (60% dip in UT) (60% dip in UT)
voltage variations on for 5 cycles for 0.5 cycles interruptions or voltage dips below

power supply input 80 V and lasting more than 0.5


70% UT 70% UT
cycle, it is
lines
(30% dip in UT) (30% dip in UT)
IEC 61000-4-11 for 25 cycles for 0.5 cycles recommended that the

<5% UT <5% UT BTL-6000 High Intensity Laser be

(>95% dip in UT) (>95% dip in UT) powered from an


for 5 s for 5 s uninterruptible power supply.

Power frequency magnetic fields


Power frequency
should be at levels characteristic
(50/60 Hz) magnetic
3 A/m 3 A/m of a typical location in a typical
field
commercial or hospital
IEC 61000-4-8 environment.

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

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 36 OF 40


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Guidance and manufacturer's declaration – electromagnetic immunity


The BTL-6000 High Intensity Laser is intended for use in the electromagnetic environment specified below. The
customer or the user of the BTL-6000 High Intensity Laser should assure that it is used in such an environment.
IEC 60601 Compliance
Immunity test Electromagnetic environment – guidance
test level level

Portable and mobile RF communications equipment should be used


no closer to any part of the BTL-6000 High Intensity
Laser, including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.

Recommended separation distance d =


1.17ÿP d =
1.17ÿP 80 MHz to 800 MHz
Conducted RF 3 Vrms 3 Vrms
d = 2.34ÿP 800 MHz to 2.5 GHz
IEC 61000-4-6 150 kHz to 80 MHz

where P is the maximum output power rating of the transmitter


in watts (W) according to the transmitter manufacturer and d
Radiated RF 3 V/m 3 V/m
is the recommended separation distance in meters (m).
IEC 61000-4-3 80 MHz to 2.5 GHz

Field strengths from fixed RF transmitters, as determined by


an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked


with the following symbol

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the BTL-6000 High Intensity Laser is used exceeds the applicable RF compliance level above, the BTL-6000 High
Intensity Laser should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the BTL-6000 High Intensity Laser.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 37 OF 40


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5.3 MANUFACTURER

BTL Industries Ltd.

161 Cleveland Way

Stevenage

Hertfordshire

SG1 6BU

United Kingdom

Email: [email protected]
http://www.btlnet.com

For service, please contact our service department at [email protected].

Date of last revision: 22nd June 2017

ID: 041-80MANEN02223

© All rights reserved. No part of this manual may be reproduced, saved or transferred by any means including
electronic, mechanical, and photographic without the prior written approval from BTL Industries Limited.

BTL Industries Limited operates on a policy of continuous development. Therefore, we reserve the right to make
changes and/ or improvements to the product described in this manual without any prior notice.

Except as required by applicable law, no warranties of any kind, either expressed or implied, are made for the
accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to review or withdraw this
document at any time without prior notice.

BTL-6000 HIGH INTENSITY LASER – USER'S MANUAL | PAGE 38 OF 40


Machine Translated by Google
Machine Translated by Google

041-80MANEN02223

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