Professional Documents
Culture Documents
Series
SERVICE MANUAL
v100TN01/07/2004EN
BTL-4000
Series
USER’S MANUAL
v100z1TN05/22/2004EN
BTL-4000 SERIES USER'S MANUAL
Dear Customer,
Best regards,
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BTL-4000 SERIES USER'S MANUAL
CONTENTS
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BTL-4000 SERIES USER'S MANUAL
1 GENERAL CHARACTERISTICS
BTL-4000 Series is a series of devices designed for physiotherapy. Depending on the required configuration it has
one or two generators – for electrotherapy, ultrasound therapy and/or laser therapy. The device can be configured for
treating of one or two patients and can run up to four independent therapies. The device can be also further upgraded
– see the configuration tables of individual devices at the end of this User’s Manual.
The BTL-4000 Series devices have extensive databases of preset diagnoses and programs. If the preset diagnoses
and programs do not satisfy your needs you can modify them easily and program and save your own therapies
(programs). You can also program sequences of therapies. The user therapies and sequences can be saved in the
device's memory under the user program number and/or the user diagnosis name. Thanks to this the equipment can
be used not only for common medical practice but also for laboratory work.
The BTL-4000 Series devices detect and check the connected accessories. After each switch-on the device tests its
internal circuits and generators. During therapy it checks the status on the output – for example in case of
electrotherapy it monitors the quality of application of the electrodes to the patient’s body, in case of ultrasound it
monitors the contact between the ultrasound head and the patient’s skin – and according to this status the device
automatically adjusts the output intensity value. If contact is bad, the running therapy is automatically interrupted, data
(intensity and time) on the current channel tab start blinking and an acoustic signal is emitted.
The BTL-4000 Series devices divide into the following type groups: BTL-4000 Puls – electrotherapy devices, BTL-
4000 Sono –ultrasound therapy devices, BTL-4000 Laser – laser therapy devices, and BTL-4000 Combi, made as
combinations of the Puls, Sono and Laser models.
The BTL-4000 Series devices enable to perform combined therapy ultrasound + electrostimulation. Naturally it is
possible to choose the ultrasound head polarity (anode / cathode), in combined therapy it is also possible to utilize
interference currents.
Recommended therapies for the BTL-4000 Series devices, contraindications, additional information about therapies
and references to related literature are in the User’s Guides that are supplied together with each device.
Device BTL-4000 Puls and BTL-4000 Combi can be interconnected with the BTL vac vacuum unit, to apply
electrotherapy using its suction cup electrodes. If the pulse mode is selected on BTL vac, electrotherapy can be
further combined with simple mechanotherapy. The BTL vac device can be controlled by the BTL-4000 Series device
– suction in the vacuum electrodes is adjusted according to the intensity of the output current.
Devices BTL-4000 Puls and BTL-4000 Combi with the electro-generator can apply a wide range of currents – galvanic
current, diadynamic currents, TENS currents, interference currents, a wide range of pulses, microcurrents, even the
high-voltage therapy. For most of the currents the output mode can be selected – constant current or constant voltage
(the constant voltage mode is suitable especially for combined therapy and/or stimulation by a point electrode, or if as
a result of various circumstances the intensity in the CC mode decreases).
Devices BTL-4000 Sono and BTL-4000 Combi with the ultrasound generator work with the ultrasound heads of a size
2 2
of 1 cm or 4 cm ; the frequency of the ultrasound waves can be set to 1 MHz or 3 MHz, which influences the depth of
their penetration into the tissue. You can select either continuous or pulse mode of ultrasound waves, set the pulse
frequency or the “duty factor”.
Devices BTL-4000 Sono and BTL-4000 Combi with the laser generator work with the laser probes, which can
generate many types of laser radiation (red, infrared, divergent or convergent beam, etc.). The probe types include
probes with green supplementary lighting of the laser beam; you can select the continuous or pulse mode of the laser
and set the pulse frequency and the "duty factor".
For the latest information about BTL products and for contact to the BTL companies please refer to our website
http://www.btlnet.com.
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17
10
8
16
11
9
13
14
15
12
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1-6 patient outputs – for exact configuration see table Tab. 2.1
18 mains switch for switching the device on/off – positions 1 / 0.
19 socket for connection of external power supply adapter BTL-228
20 warning label with parameters of power supply and input of the device
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Legend:
E1 connector for connection of electrotherapy accessories (BTL-236-1(2), BTL vac) to the E1 generator
E2 connector for connection of electrotherapy accessories (BTL-236-1(2), BTL vac) to the E2 generator
E1opti connector for connection of electrotherapy cables (BTL-226, BTL vac) to the E1 generator
E2opti connector for connection of electrotherapy cables (BTL-226, BTL vac) to the E2 generator
L1A connector for connection of laser probe BTL-448, e.g. red, to the L1 generator
L1B connector for connection of laser probe BTL-448, e.g. infrared, to the L1 generator
L2A connector for connection of laser probe BTL-448, e.g. red, to the L2 generator
L2B connector for connection of laser probe BTL-448, e.g. infrared, to the L2 generator
2
U1A connector for connection of ultrasound head BTL-237, e.g. 1 cm , to the U1 generator
U1B connector for connection of ultrasound head BTL-237, e.g. 4 cm2, to the U1 generator
E input connector for input of external electrotherapy BTL-46xx, BTL-56xx on the ultrasound device at
combined therapy
E output connector for output of external electrotherapy BTL-46xx, BTL-56xx on the ultrasound device at
combined therapy
door connector for the open door sensor
acup. connector for the acupuncture electrode
To see how many patients and to which outputs you can simultaneously connect, press menu / accessories /
connectors - information.
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12
21 22
23 24
26
25
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Unpack the equipment and place it on a stable horizontal surface proportioned for the equipment's weight, out of
reach of sunlight. During the operation the equipment gets warm, therefore it must not be located close to heat-
producing devices. Cooling of the equipment is provided by forced air circulation. Cooling vents are located on the
rear panel of the equipment and must not be covered. Place the equipment so that the free space behind the rear side
is at least 10 cm. Do not put the equipment on a soft surface so as not to obstruct the airflow. Do not put any heat-
producing devices on the equipment, neither objects containing water or other liquid. Do not place the equipment
close to devices producing strong electromagnetic, electric or magnetic field (diathermy, X-rays, etc.), otherwise the
equipment could be undesirably influenced. In case of any questions please contact an authorized service of BTL
devices.
The same installation conditions apply for the BTL-228 power supply adapter and must be observed.
We recommend keeping the packing of the equipment for further possible transport.
Plug the device in the mains socket by means of the BTL-228 power supply adapter (see Chapter 6 Technical
Parameters.
Plug the power supply adapter directly in the mains socket; do not use any multi-connection extension cable
or adaptor.
Connection of accessories
Connect the supplied accessories successively to the output connectors (1) to (6) on the rear panel of the device
according to Tab. 2.1. The unit automatically detects the accessory, determines its type and displays it in the
corresponding tab on the screen. If you happen to connect unsuitable accessory, e.g. a laser probe to the
electrotherapy generator, the screen displays a warning and information where the accessory shall be connected.
Recharging of accumulator
If the device contains internal accumulator (the Professional variant), it is sold in half-charged status. That is why we
recommend formatting of the accumulator after purchase of the device: connect the device to the mains via the
external adapter for at least 48 hours without interruption, the mains rocker switch (18) in position 1. The device will
be recharged and the accumulator will be properly formatted. The properly formatted accumulator enables longer
operation of the device without . For details see 4.2 Accumulator.
Note:
After the switch-on the equipment tests its internal functions (for approx. 5 – 10 seconds) and in case of any
discrepancy it alerts to it and, if needed, locks itself in the secure state. In such case it is necessary to contact the
authorized service of BTL devices.
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The display contains several graphic elements. Some of them are only for information, some can be activated. The
basic elements are the following:
• buttons (it is possible to activate them by the tab button (15) and to change their values.) The activated
buttons are displayed inversely.
• information texts
• channel tabs (switching between the tabs, selection)
The buttons can be enabled or disabled. The disabled buttons are crossed out.
All the displayed enabled buttons can be successively activated by pressing the tab button (15). By repeated pressing
of this key further buttons on the screen are successively activated.
If the button contains one numeric value, this value can be directly changed by the select/intensity knob (12). If the
button contains more numeric values or an item selected from a list, pressing of the enter button (13) opens the
detailed subscreen of the button. To leave the subcscreen press esc (14) – all data you have changed will remain
changed.
Information texts
The text is displayed directly on the display, in a menu or in a button. If a text is too long and does not fit on the
display in full, after a while it starts scrolling automatically.
Selected channel
Although most of the devices of the BTL-4000 Series can run more therapies at a time, only one channel can be
controlled at the particular moment, That channel is called the "selected channel". The tab of the "selected channel" in
the bottom part of the screen is coloured dark. All information on the screen and all controls relate to this channel. The
most important information about the therapies on the other channels remains visible on their tabs.
tab of the selected channel tab of the channel which is not selected
information
disabled button
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OPENING
SCREEN
diag 1 2 man
SELECTION BY DIAGNÓSIS
prog esc tab enter menu
esc
SELECTION BY
PROGRAM
select
esc
enter enter
MANUAL SETTING
- SETTING OF ALL
THERAPY PARAMETERS
esc esc
start/stop
START OF THERAPY INTERRUPTION
OF THERAPY
start/stop
RUNNING
THERAPY
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Buttons 1(16) and 2(17) located directly under the tabs serve for switching between the tabs.
On the channels where more accessories can be connected to one generator (ultrasound generator and two
ultrasound heads, laser generator and laser probes), repeated pressing of the tab's button serves for switching
between these accessories.
The tab of the channel which is selected (i.e. its information is just on the display) is black.
tab of the E channel which is not selected, with connected accessory BTL-236-2
tab of the selected E2 channel with unsuitable connected accessory, which this generator
cannot work with
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in addition the list can contain e.g. diagnoses for high-voltage and/or combined therapy, depending on the
configuration of the device.
For moving in the list of diagnoses use the select knob (12), the currently selected diagnosis is displayed in bold.
For fast finding of a diagnose select its initial letter by the tab button (15).
After finding of the required diagnosis select it by pressing the enter button (13). If the diagnosis is assigned more
therapies – e.g. the treatment can be done by several various types of current – the list of therapies appears after
selection of the diagnosis. Select the required therapy by the select knob (12) and press enter (13) again.
select select
enter
select
enter
The user therapies which you create yourselves are in the *user diagnoses / programs directory. Their list appears
after pressing the enter button (13).
enter
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After pressing the prog button (9) a screen opens where you can enter the number of the required therapy program.
The program number contains the prefix, i.e. the letter corresponding to the therapy principle: E – electrotherapy; U –
ultrasound; L – laser therapy.
Combined therapies E+U are sorted among the E programs and are on the E1 electrotherapy tab – in the following
pictures on the E1 channel. They are on positions E-35xx to E-39xx.
Your user diagnoses (except sequences) are stored under the program numbers E-80xx to E-89xx for electrotherapy,
U-80xx to U-89xx for ultrasound therapy and L-80xx to L-89xx for laser therapy.
Your user sequences are stored under the program numbers E-95xx to E-99xx for electrotherapy, U-95xx to U-99xx
for ultrasound therapy and L-95xx to L-99xx for laser therapy.
The recommended programs assigned to recommended diagnoses are in the User's Guide.
For faster setting, the program numbers are arranged into pairs. For change of the number use the select knob (12),
for switching between the pairs of digits use the tab key (15).
select
enter
The therapy parameters screen for user (manual) setting appears after pressing the man button (10). All therapy
parameters can be set and saved as a user program or diagnosis.
It Is obvious that the therapy parameters screens of individual currents of electrotherapy, ultrasound therapy and laser
therapy differ in dependence on the options which can be set in the particular moment. For more details see the
respective User's Guide.
To open the required menu or setting dialog select the respective button by the tab key (15) and then press enter
(13). Most dialogs are accompanied with illustration pictures and symbols. See the scheme of possibilities of individual
settings in this mode.
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enter
enter
enter
enter
enter
enter
enter
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enter
select
Select/intensity
By pressing the start / stop1 (23) or start / stop2 (24) knob you can start or interrupt therapy – see 2.5.1 Start,
Interruption and End of Therapy.
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start of
START of therapy interrupted therapy
start / stop1 time / stop
therapy parameters running therapy paused therapy
screen screen screen
time/stop
start / stop1
interruption of therapy
time correction
during interruption
To restart the interrupted – paused – therapy press the start / stop1 (or start / stop2) button, to stop it press the esc
button (14).
During the pause – interrupted therapy – it is possible to modify the time setting by turning of the select / intensity
knob (12) (in laser therapy and all types of sequences it is impossible).
select/intensity
direction of increase
of intensity
Laser therapy can be also started/interrupted by pressing the start / stop button located on the laser probe.
START / STOP
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set intensity
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When you are rotating the dipole, the device automatically switches to the diagnostic – "measuring" mode
(Spectrum = 0 Hz) and after setting after approximately 1 - 2 seconds it gradually returns to the therapy mode – (the
Spectrum value corresponds to the set value).
BTL-236-1: patient cable with two electrodes – blue and yellow pilot light:
• blinks slow – accessories ready for therapy – therapy settings screen displayed
• shines permanently – the device is generating, dangerous voltage may be on the electrodes
BTL-236-2: patient cable with four electrodes – blue and yellow pilot light:
• blinks slow – accessories ready for therapy – therapy settings screen displayed; always the pilot
light at the selected pair of electrodes A or B is blinking
• blinks in the rhythm of the generated currents or shines permanently – the device is
generating, dangerous voltage may be on the pair of electrodes A or B at which the pilot light is
shining
BTL-448: laser probes 635 nm and 830 nm – green pilot light and focusing beam:
• blinks in the rhythm of the generated laser or shines – the device is generating laser radiation,
during generation the device indicates occurrence of laser radiation by acoustic signal
BTL vac: vacuum unit for electrotherapy – see the BTL vac User's Manual
For detailed information please refer to the leaflet which is enclosed to each accessory supplied.
Note:
The tab always displays only a text symbol (description) with no picture.
2.5.5.1 Electrotherapy
Possible occurrence of electric voltage on the output is indicated:
• on the screen – by the value of intensity of the output current
• on the screen – by an animated icon of running current
• on the channel tab – by the value of intensity or running time
• on the electrotherapy accessory BTL-236 – by the blue and yellow
pilot light – for details see Chapter 2.5.4 Accessories –Signalling
of Operation
Disconnection of electric circuit – e.g. in case of bad contact between the electrode and the patient's body – is
indicated by blinking of the information about intensity and time on the respective electro-generator tab. This status
may be also indicated by a sound signal.
The function of monitoring of contact with the patient may be disabled in the menu of the device.
Enabling/disabling of this function is indicated by the figure symbol (crossed-out if disabled).
Note:
Some types of the generated currents do not allow monitoring of the contact with the patient. In such cases the
crossed-out figure is displayed, regardless of the user setting of detection.
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Bad contact between the head and the patient's body is indicated by fast blinking of the blue pilot lights on the head
and blinking of information about intensity and time on the corresponding ultrasound generator tab.
This function is indicated by a figure symbol on the screen.
Parameters in individual therapies vary. For each therapy only those parameters are displayed which describe the
therapy and which can be set in the manual mode after pressing the man button (10). For detailed description of
parameters of individual therapies refer to the respective User's Guide.
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2.7 ENCYCLOPAEDIA
The encyclopaedia provides information about possible therapies. The hard copy (paper or CD) is always supplied
together with the equipment, its electronic version in the device is available from the menu: menu / encyclopaedia.
After opening of the encyclopaedia you get to its contents – the list of diagnoses. For browsing in the list use the
select/intensity knob (12). After selection of the required diagnosis press the enter button (13) to get the specific
information about the diagnosis:
information on diagnosis
select
browsing in diagnoses
loading of parameters
of the selected diagnosis
to the parameters screen
- the device is ready for therapy
After pressing the save button on the screen, the user can save the particular therapy setting under a name of
diagnosis and number of program.
Therapy can be saved always after setting of the therapy parameters – i.e. from the therapy parameters screen. The
following information is saved with each therapy:
electrotherapy:
• all parameters of currents (e.g. pulse length, pause length, modulation, etc.)
• therapy time
• polarity
• output mode (constant current / constant voltage)
ultrasound therapy:
• all therapy parameters (e.g. ultrasound frequency, duty factor, pulse frequency, etc.)
• therapy time
• intensity
combined therapy electro + ultrasound:
• all parameters of electrotherapy (e.g. pulse length, pause length, modulation, etc.)
• all parameters of ultrasound therapy (e.g. ultrasound frequency, duty factor, pulse frequency, etc.)
• therapy time
• electro output polarity
• electro output mode (constant current / constant voltage)
• ultrasound intensity
laser therapy:
• all therapy parameters (frequency, course of signal...)
• irradiated area
• dose
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The number of the saved program falls within the interval from 8000 to 8999. The device suggests the lowest
available number and adds the letter of the corresponding generator. So the resulting number is for example: E-8001
for electrotherapy or combined therapy, U-8526 for ultrasound therapy and L-8002 for laser therapy.
enter
of diagnosis of program
enter
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The saved therapy can be found in the following lists on the corresponding channel:
List of diagnoses
enter
List of programs
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BTL-4000
Puls (Combi)
BTL vac
(the pictures are only an illustration, for real interconnection follow Tab. 2.1 Configuration of Output Connectors)
For interconnection use the interface cables leading from BTL-4000 Puls outputs E1, E2 (or E1opti, E2opti) and
connected to BTL vac inputs IN1 and IN2. For more information see the User's Guide of BTL vac.
Electrotherapy BTL-46xx Puls or BTL-56xx Puls Ultrasound BTL-4710 Sono or BTL-5710 Sono
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ATTENTION
In the case of accesories „1>>2“ is connected to the electrotherapy device the ultrasound head becomes the anode
(+). The catode (-) is connected thru black bannana plug.with minus sing “-„ on it.
In the case of accesories „1>>4“ is connected to the electrotherapy device the ultrasound head becomes the anode
(+). The catode (-) is connected thru red bannana plug.with minus sing “+„ on it, independet of selected output A or
B.
If you want to apply only electrotherapy with such interconnected devices, it makes no problem. Uncheck the option
"with electro" on the BTL-4000 Sono device, and the electrotherapy electrodes are automatically connected to the
electrotherapy output. Connectors E input and E output are interconnected inside the ultrasound device even if the
BTL-4000 Sono device is off.
BTL-4000 BTL-4000
Puls Sono
BTL vac
(the pictures are only an illustration, for real interconnection follow the below-stated table as well as
Tab. 2.1 Configuration of Output Connectors)
Electrotherapy BTL-46xx Puls or BTL-56xx Puls Ultrasound BTL-4710 Sono or BTL-5710 Sono
E2* interface cable to BTL vac (IN2) U1B ultrasound head 4 cm2
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3 "MENU" BUTTON
After pressing the menu button (11) you can browse through the following menus using the select/intensity knob:
• menu
• user settings
3.1 MENU
After selection of menu and pressing enter the following menu appears:
• accessories
• encyclopaedia – see Chapter 2.7 Encyclopaedia
• unit settings
• specific settings
3.1.1 Accessories
In this submenu you can:
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Note:
If you happen to forget the password, you can always use the universal one: "00000000"
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Since the display contrast depends on many factors (e.g. temperature of the display), there is also another fast and
direct way of setting the contrast. Press simultaneously the enter (13) and esc (14) buttons and set the contrast by
the select/intensity knob (12) (when holding the two buttons enter and esc pressed).
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After selection of menu / user settings there appears a menu with items referring to data saved by the user or to
some "extra" features of the selected generator:
• user sequence
• user diagnoses / programs
• recent therapies
• motor point detection*
• accommodation coefficient*
• I/t curve*
*only in the electro-generator and only if the device is equipped with electrodiagnostics – for details see the User's
Guide for Electrotherapy
If the "pause " option is set (meaning "pause between sections"), the unit stops generation after each current and the
intensity of the next current has to be set manually. In this case the currents can be sequenced without a limitation
and the user can select and combine any current in one sequence. We suggest to set this option for electrotherapy
sequences.
If the pause between sections is not set, the device continues generating all currents with the same intensity. Be
careful when setting the sequences. Each current is perceived differently by the patient. Whereas in case of TENS the
patient tolerates intensity of about 100 mA, the maximum tolerated intensity in case of diadynamic currents may be 10
times lower. Combine in one sequence only currents that are perceived by the patient in a similar way – such as
currents with the same pulse length and the maximum difference in frequency 1:10. Monophasic, symmetric and
alternating currents should not be mutually combined.
In the mode without pause between sections we therefore recommend creation of sequences containing only the
following combinations:
• diadynamic currents
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• monophasic pulses of the same length with the DC component (differing in frequency or modulation)
• symmetric pulses of the same length with zero DC component (differing in frequency or modulation)
• alternating pulses of the same length with zero DC component (differing in frequency or modulation)
• mid-frequency bipolar currents (differing in frequency or modulation)
• interference
• TENS (differing in frequency or modulation)
• ultrasound therapies
• laser therapies
In the therapy parameters screen in the manual mode it is possible to select sequence, ultrasound sequence or
laser sequence in the therapy parameter. Creation of a new sequence is displayed in the following picture.
select
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Example: you want to create a sequence of diadynamic DF current (without base, positive polarity, CC mode, time of
stimulation: 1 minute) and CP-ISO current (base 10 %, reversal of polarity in the middle of the set time, CC mode, 10
minutes). Press man to select the manual mode, set diadynamic currents, DF type, without base, positive polarity, CC
mode. Save this setting as a program (for example) E-8001. Then set parameters of the CP-ISO current: base 10 %,
positive, reversal, CC mode, and save it as (for example) program E-8002. Then select therapy: sequence, press
new seq., press new, set the program number 8001, set the time of section 1:00, set positive polarity and press
esc or enter. Then add the second section in the same way – new, program number 8002, time of section 10:00,
positive polarity with reversal, esc or enter. Using the tab button select the save button and press enter to save
the sequence (for example as the number 9501). The cv/cc mode is set globally for the whole sequence before
starting it.
Or from the main manual screen in the same way as the new diagnosis.
User sequences are saved under numbers 9500 - 9999. They can be found under these numbers in the list of
programs, under their names in the list of diagnoses and in the list of sequences.
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4 ACCESSORIES
The equipment is not designed for use in connection with other medical devices than those stated in this Manual.
In the following chapters these lists contain all accessories which can be supplied together with the devices.
For detailed information about individual accessories see the enclosed leaflets and/or the respective User's Guide.
The devices of the BTL-4000 series can be connected to the mains exclusively via the supplied power supply adapter
BTL-228. It is forbidden to connect another adapter than BTL-228 to the device.
ventilation holes
Replacement of fuse
The adapter contains secondary tube fuse. The types of the fuse are specified on the label of the adapter. To replace
the fuses follow the instructions below.
Before replacement of the fuse make sure that the power supply of the adapter is disconnected from the mains.
Unplug the power supply connector from the BTL-4000 device. Turn the segment of the fuse box to the left by a fitting
screwdriver or coin and take the fuse out. Insert new fuse(s) and turn the box to the right. It is forbidden to insert a
fuse with other indication than stated near the fuse box.
This action may only be done by a person acquainted with this procedure!
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4.2 ACCUMULATOR
Devices of the Professional series have a built-in accumulator. Its type is specified in Chapter 6 Technical
Parameters. Replacement of the accumulator is provided by the authorized service of BTL devices.
During operation the accumulator is continuously being recharged from the mains. Its recharging and keeping charged
is running even if the equipment is switched off and connected to mains and the mains switch (18) on the rear panel
is in position I. At switching off, the device checks the status of the accumulators and if it finds them low, it switches to
the charging mode; in the charging mode the display is dark and the main display shows the symbol of recharging
battery. After recharging of the accumulator the device automatically switches off completely. Note that the charging
process runs only if the device is plugged in the mains and the rocker mains switch (18) on the rear panel is in
position I.
Determination of the accumulator status may take some time, therefore the device may respond with a delay after
switching off and then on again.
If the device is supplied from the mains, this status is signalled by the plug picture.
For full charging of the accumulator let it recharge for approximately 6 hours – preferably overnight. The charged
accumulator is signalled by the "full battery" picture.
Recharging of the accumulator is signalled by the picture of recharging battery on the display.
To ensure long lifetime of the accumulator we recommend keeping it permanently charged. When it is possible,
connect the device to the mains via the adapter and switch the mains switch (18) to position I. The indication of
recharging is displayed, after recharging it goes out and the accumulator will be automatically kept charged.
If the device is left unplugged from the mains for a longer time (even in the OFF status), the accumulators gradually
spontaneously discharge. This effect is characteristic of the accumulators and cannot be removed; therefore, if the
device has been off and unplugged for a longer time than approximately 2-3 months, we recommend recharging it,
preferably for 48 hours without interruption.
For the same reason we recommend charging the device continuously for at least 48 hours immediately after
purchase, regardless of the accumulator status indication (you can work with the device normally, only do not unplug it
from the adapter, the accumulator recharges even during standard operation of the device). Thus the accumulator
gets so –called formatted and will keep working longer without recharging.
The device contains a lithium battery for backupping of date and time. The type of the battery is stated in Chapter 6
Technical Parameters. Its possible replacement is provided by the authorized service of BTL devices..
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BTL-4000 SERIES USER'S MANUAL
Keep the device clean, do not store or use it for a long time in enormously dusty environment and do not sink it in any
liquid. Before each use check if the equipment and its accessories (especially cables) are not mechanically or
otherwise damaged. Do not use the equipment if it is damaged!
The measuring system of the laser device does not require (and does not even enable) any user settings or
adjustment. Its inspection is performed at regular recalibration of the device by the authorized service of BTL devices.
Backward measuring of the laser output power does not require (and does not even enable) any user settings or
adjustment. Calibration is performed at regular recalibration of the device by the authorized service of BTL devices.
Cleaning of accessories which come into contact with the patient (e.g. electrodes, ultrasound heads, laser probes and
attachments):
We recommend cleaning of these parts after treating of each patient. For cleaning use agents approved by the
competent health officer, e.g. Sekusept, Bacilol etc., for cables of accessories use e.g. Incidur spray etc.
After each application of the divergent probe wipe the head of the probe by a cotton cloth to keep the lens clean.
Convergent probes: unscrew the head, wipe the lens and blow the head through by compressed air.
Cleaning of accessories which come into contact with the patient – laser optical attachments:
The optical waveguides (attachments) can be sterilized for 10 minutes at the temperature of 120°C.
Replacement of fuse
The protective fuse is located inside the BTL-4000 device. The type of the fuse is specified in Chapter 6 Technical
Parameters The user may not be replace the fuse; for replacement of the fuse always contact the authorized service
of BTL devices.
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BTL-4000 SERIES USER'S MANUAL
5.1 SAFETY
ATTENTION!
The consumed current or voltage at the connectors marked by the above label can exceed the secure values.
The device is equipped with a system of protection against connection of other accessories than supplied from the
manufacturer, so, it cannot work with accessories produced by other manufacturers.
The protection of the equipment is BF-type floating applied part (only if original accessories including power supply
adapter BTL-228 are used).
The equipment does not use any medicaments which would be its integral part or would be applied by means of it.
• Before first switch-on of the equipment read carefully the User's Manual.
• All staff to use the equipment must be instructed of the way of operation, maintenance and checking of the
equipment and of the safety principles.
• The electrical cabling which the equipment will be connected to must be installed and tested according to the
existing valid standards (IEC 364). If you are not sure that the mains are completely OK get them inspected by
an inspection engineer.
• Check if the parameters of the mains correspond to the requirements of the equipment according to Chapter 6
Technical Parameters. It must not be used in the environment which implies the danger of explosion or
penetration of water into the equipment. It must not be used in connection with flammable anaesthetics or
oxidizing gasses (O2, N2O, etc.).
• Do not place the equipment within the reach of direct sunshine and strong electromagnetic fields so as to
prevent undesirable mutual influence. In case that this undesirable influence occurs put the equipment more
distant from the source of interference or contact the authorized service of BTL devices.
• Inspect the equipment thoroughly before each use (loose cables, broken insulation of cables, functions of
displays and controls, etc.); in case of any inconsistency stop using the equipment and contact the authorized
BTL service department. If the equipment's behaviour differs from the function described in this Manual stop
using the equipment and contact the BTL service department.
• If the equipment shows any defect or if you have doubts about its correct function, terminate therapy
immediately. If you do not determine the source of uncertainty after thorough study of the Manual, contact the
BTL service department. If the equipment is used out of accord with this Manual or is used even if it shows
functional differences from this Manual, the user is responsible for the damages caused by the equipment.
• Do not dismantle the equipment in any case, removal of protective covers implies the danger of electrical injury.
Possible replacement of the lithium battery, fuses or accumulators may only be done by the authorized BTL
service department.
• All material and parts which come into direct contact with the patient's body (as well as for example agents for
cleaning of electrodes) must comply with the respective standards related to irritability, allergization, toxicity,
genotoxicity, carcinogeneity (ISO 10993-1, ISO 10993-3, ISO 10993-5). The user is responsible for all these
materials and parts if not supplied by the BTL equipment supplier.
• The connectors for accessories as well as the other connectors must not be used for connection of anything else
than they are designed for, otherwise there is a danger of electrical injury and serious damage to the equipment.
• The equipment does not use or produce any toxic substances during its operation, storage or transport under the
stated conditions.
• After bringing the equipment from cold environment to the warmth do not plug it in the mains until the
temperatures become equal (i.e. for at least 1 hour).
• Before start of therapy check if all set parameters correspond to your intents.
• Do not apply therapy on damaged skin!
• To terminate the application do not switch off the mains switch but press the start / stop knob (18). The time
interval between switching the mains switch on and off must be at least 3 seconds.
• If after many years of operation it is necessary to discard the equipment, it can be done in a way which is usual
for this type of devices after removal of the lithium battery and the leaden accumulator (for the Professional
variant). The removed batteries shall be disposed of in the way designated for hazardous waste - not within the
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BTL-4000 SERIES USER'S MANUAL
municipal waste. The equipment does not contain any toxic materials which could harm the environment in case
of normal way of liquidation.
• The equipment and the accessories must not be used in a way out of accord with this User's Manual.
• During work with this device use the recommended protective equipment.
• Keep the equipment out of reach of children.
• The equipment does not contain any components which could be repaired by the user. Do not remove any
covers from the equipment. All repairs should be done by the authorized BTL service department.
• Don’t connect equipment to patient when equipment is still connected to computer (via service connector)
• When applying DC currents (the polarity button is enabled) it is necessary to pay attention to the set intensity
and time of application of currents. Wrong values can cause burning of the patient's skin.
• The maximum secure effective value of current density on the electrodes is 2 mA/cm2 (according to IEC 601-2-
10) and can be extended only when electrodes smaller than 70 cm2 are used. In such case it is necessary to pay
higher attention to application of currents! Wrong values can cause burning of the patient's skin.
• Application of electrodes near the thorax may increase the risk of cardiac fibrillation.
• For contraindications see Chapter 5.2 Contraindications. Use of electrotherapy in the cases of contraindication
must be approved by a specialist.
• Simultaneous connection of the patient to a high-frequency surgical device may cause burning in the place of the
electrodes and possible damage to the electrotherapy device.
• Simultaneous connection of the patient to an ECG monitor or an ECG alarm system may cause temporary
malfunction of the ECG systems or unreliability of the values measured by the ECG systems.
• Operation of the equipment close to (within 1 m) a short-wave or micro-wave therapeutic device may cause
instability of the equipment's output.
• All supplied electrodes can be used for maximum intensity of currents and voltage that can be set on the device.
• Protect the heads consistently from shocks and frost. Do not uselessly bend the mains cable.
• During therapy hold the head so that you do not touch its metallic parts.
• An impact on the metal part of the head as well as an intense impact on the head's case may negatively change
the parameters of the therapeutic head.
• For contraindications see Chapter 5.2 Contraindications. Use of ultrasound therapy in the cases of
contraindication must be approved by a specialist.
• For therapy use only the BTL ultrasound gel; the head is not tested for other gels or oils and their use could
damage the head. If you still want to use other gels, we recommend them to be only water-based gels. Never
use paraffin-based gels.
• Mark the laser workplace by respective warning notices and connect the door switch.
• Equip the laser workplace with an operating code which must be approved by the competent health officer.
• When using a laser probe with an output of 200 mW or more (300 mW, 400 mW) and if the laser power is set
higher than 150 mW, the duration of therapy must not exceed 15 min.
• Attention – use of any other than the stated control and setting elements and processes may cause dangerous
exposition to radiation.
• The equipment works with laser beam of the 3B class . When working with the beam follow all instructions stated
in this Manual and in the laser therapy User's Guide. Prevent the laser beam from hitting eyes, thyroid and other
endocrine glands, head, etc. (see the User's Guide). Both the therapist and the patient have to wear the supplied
protective goggles during therapy. Incorrect handling of the equipment (out of accord with this Manual) may
cause danger radiation and even damage to eyes! In such a case the user is responsible for all damages.
• During radiation do not disconnect the probe from the equipment and do not switch the equipment off.
• Protect the laser probe consistently from impacts !!!! The probe is not waterproof!
• Protect yourself and your neighbourhood from being directly hit by the laser beam.
• For contraindications see Chapter 5.2 Contraindications. Use of laser therapy in the cases of contraindication
must be approved by a specialist
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BTL-4000 SERIES USER'S MANUAL
5.2 CONTRAINDICATIONS
The list of contraindications gives the cases when the manufacturer does not recommend to apply the selected
therapy. A specialised medical workplace, realizing possible consequences, may decide to apply the therapy in spite
of it. However, in such case they bear all the responsibility for this action.
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BTL-4000 SERIES USER'S MANUAL
• pulse modes (whether red or infrared beams) must not be used for patients with anamnesis of seizure
(epilepsy)
• pregnancy
5.4 WARRANTY
The Manufacturer of this product warrants the product to be free from defects in workmanship and material for a
period of twelve months after the date of shipment from the factory. This warranty excludes any disposable items and
accessories, including, but not limited to cables or leads, power cords and electrodes. The manufacturer agrees to
correct such defects without charge, or at its option to replace the item with a comparable model. To register and be
eligible for warranty service, you must send or fax the fully completed warranty registration form within 30 days of
installation. All costs of shipment are the responsibility of the purchaser. Damage to any part such as by accident or
misuse or improper installation or by use of any accessories or abrasive material not produced by the Manufacturer is
not covered by this warranty. Because of varying climatic conditions, this warranty does not cover any changes in
finish, including rusting, pitting, corrosion, tarnishing or peeling. Servicing performed by unauthorized persons render
this warranty invalid. There is no other express warranty. The Manufacturer hereby disclaims any and all warranties,
including but not limited to, those of merchantability and fitness for a particular purpose to the extent permitted by law.
The duration of any implied warranty which cannot be disclaimed is limited to the time period as specified in the
express warranty. The Manufacturer shall not be liable for incidental, consequential, or special damages arising out of,
or in connection with product use or performance except as may be otherwise accorded by law.
This warranty may differ from the warranty terms and conditions provided by your supplier and by applicable laws in
your country.
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BTL-4000 SERIES USER'S MANUAL
6 TECHNICAL PARAMETERS
Display: graphic
dimensions (mm): 70x38
resolution: 128 x 64
Operating conditions:
temperature: + 10 °C to + 40 °C
relative humidity: 30 % to 75 %
atmospheric pressure 700 hPa to 1060 hPa
position horizontal – on legs
type of operation continuous
Power supply: supply only via the external supply adapter BTL-228
input: 60 W
input voltage ~ 18 V to 25 V, alternating
frequency: 50 Hz to 60 Hz
protection class: II (according to IEC 536, ČSN 33 0600)
T5A / 250V, safety fuse on the printed circuit, acc. to IEC 127-2
internal fuse:
(replacement may only be done by the authorized service)
mains switch: on the rear panel of the device, positions 0 and I
power switch on the front panel of the device, marked on/off
covering: IP20
Classification
applied parts type BF
class according to MDD 93/42/EEC IIb
Therapy duration
for electro and laser therapies 0 to 100 minutes
for ultrasound therapies 0 to 30 minutes
step of setting 1 second
accuracy of therapy time ± 2 % of the set value
Accuracy of time values 5 seconds per day
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BTL-4000 SERIES USER'S MANUAL
Operating conditions:
temperature: + 10 °C to + 40 °C
relative humidity: 30 % to 75 %
atmospheric pressure 700 hPa to 1060 hPa
position horizontal
type of operation continuous, use indoor only
Output parameters
output voltage 18VAC
output current 3.6A
frequency: 50 Hz to 60 Hz
Insulation barriers
mains – output (output connector) 4kV
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BTL-4000 SERIES USER'S MANUAL
Adjustable values
Output current* max. 140 mA (maximum instantaneous value)
Output current - HVT* max. 4 A (maximum instantaneous value)
Output current - microcurrents max. 999 µA (maximum instantaneous value)
Output voltage max. 130 V (maximum instantaneous value)
Output voltage - HVT max. 390 V (maximum instantaneous value)
*maximum value for some currents is limited according to IEC 601-2-10
Tolerance of output amplitude ± 10 % for 5 mA (5 V, 5 µA) and higher; otherwise ± 30 %
± 10 % for 35 V and higher; otherwise ± 30 % (for HVT)
Tolerance of time parameters of current standard ± 5 %; maximum ± 15 %
standard ± 20 % for modulation of HVT from 5 s; otherwise ± 30 %
Nominal load impedance 500 Ω
Internal output resistance in CV mode 96 Ω ± 10 %
Internal output resistance in CC mode 47 kΩ ± 10 %
Output capacity standard 150 pF
Output polarity – can be selected positive / negative / with reversal in the middle of the therapy
Positive polarity red banana plug = + = anode; black banana plug = - = cathode
Negative polarity red banana plug = - = cathode; black banana plug = + = anode
Adjustable values
Effective intensity
Continuous operation 0.1 to 2 W/cm2 ± 20 % for output intensity higher than 0.2W/cm2
Pulse operation 0.1 to 3 W/cm2 ± 20 % for output intensity higher than 0.2W/cm2
Working frequency - Optimal 1 MHz ± 5%
Working frequency - Professional 1 MHz ± 5% and 3.2 MHz ± 5%
Modulation frequency 10 to 150 Hz ± 5%
Duty factor 6 to 100% ± 5% of the set value
Duty factor 6.25% (1:16), 12.5% (1:8), 25% (1:4), 50% (1:2), 100% (1:1) ± 5% of the
set value
Maximum output power 12W
Parameters of pulses
Frequency 10 Hz Frequency 50 Hz Frequency 100Hz Frequency 150 Hz period
Duty period 100 ms period 20 ms period 10 ms 6.67 ms
factor Pulse Pause Pulse Pause Pulse Pause Pulse Pause
length length length length length length length length
50 % 50 ms 50 ms 10 ms 10 ms 5 ms 5 ms 3.33 ms 3.33 ms
25% 25 ms 75 ms 5 ms 15 ms 2.5 ms 7.5 ms 1.67 ms 5 ms
10% 10 ms 90 ms 2 ms 18 ms 1 ms 9 ms 0.67 ms 6 ms
6% 6 ms 94 ms 1.2 ms 18.8 ms 0.6 ms 9.4 ms 0.40 ms 6.27 ms
Indication of emission of laser radiation green pilot light on the probe, supplementary lighting of the probe, sound
Indication of readiness for emission on the screen
Indication of unreadiness for emission on the screen
Additional safety means - warning labels on the device case and on the probe
- warning label for the entrance door of the workplace
- remote control connector
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Adjustable values
Frequency*** 0 – 5000 Hz
accuracy of frequency ± 3 % of the set value
2
Dose* 0.1 – 100.0 J/cm
accuracy of dose ±20% (according to IEC 60601-2-22)
Area* 0.1 – 100.0 cm2
accuracy of area see BNR
Output* 5.0 – 500 mW (depending on the connected laser probe)
accuracy of output ±20% (according to IEC 60601-2-22)
Duty factor** 10 – 90 %
accuracy of duty factor ±1% of the range of DF
*) The stated values are maximum. The actual values depend on the type of the connected laser generator and on the purchased
configuration of the device
**) Can be set only in the pulse mode, in the continuous mode it is always 100%
***) Zero frequency means continuous operation of laser
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BTL-4000 SERIES USER'S MANUAL
Biological evaluation of medical devices - Part 1: Evaluation and testing ISO 10 993-1
The Medical Devices Directive 93/42/EEC MDD 93/42/EEC
Medical electrical equipment
IEC 601-2-5
Part 2: Particular requirements for the safety of ultrasonic therapy equipment
Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and
IEC 601-2-10
muscle stimulators
Medical electrical equipment
IEC 601-2-22
Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
Safety of laser products.
IEC 60 825-1
Part 1: Equipment classification, requirements and user's guide
Amendments to IEC 60 825-1 A1, A2
BTL-4000 Puls can be interconnected with: BTL vac, BTL-4000 Sono, BTL-5000 Sono, BTL-12, BTL-07p
BTL-4000 Combi can be interconnected with: BTL vac, BTL-12
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BTL-4000 SERIES USER'S MANUAL
This product is manufactured in accordance with the EU Medical Devices Directive by:
© All rights reserved. No part of this manual may be reproduced, saved in a research centre or transferred by any means incl.
electronic, mechanic, photographic or other records without previous approval from BTL Industries Limited
BTL Industries Limited operates a policy of continuous development. Therefore, it reserves the right to make changes and
improvements to the Product described in this manual without prior notice.
The contents of this document is provided "as is". Except as required by applicable law, no warranties of any kind, either expressed
or implied, are made in relation to the accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to
revise this document or withdraw it at any time without prior notice.
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7 CONFIGURATIONS OF DEVICES
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micro currents x x x
leduc current x x x
mid-frequency waves x
pulses with exponential rise x x x x x x
preset sequences 20 20 20 20 5 5
electrodiagnostics x
4710 4720
Type:
Professional Optimal
mains supply x x
built-in accumulator x
manual mode x x
number of ultrasound therapies 1 1
user programs 50 5
predefined diagnoses x o
preset programs x x
language versions x x
sound schemes x x
recent therapies 20 20
Ultrasound parameters:
head 1 MHz x
heads 1 and 3 MHz x
detection of contact continuous continuous
continuous mode of operation x x
pulse mode of operation x x
duty factor x x
4110 4110
Type:
Professional Optimal
mains supply x x
built-in accumulator x
manual mode x x
number of laser therapies 1 1
user programs 50 5
predefined diagnoses x o
preset programs x x
language versions x x
sound schemes x x
recent therapies 20 20
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BTL-4000
Electrotherapy
USER‘S GUIDE
v100z1TN21/06/2004EN
ELECTROTHERAPY – USER‘S GUIDE
CONTENTS
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ELECTROTHERAPY – USER‘S GUIDE
Electrotherapy is one of widespread types of physical therapy (PT). When correctly indicated and applied it is very
effective. However, it cannot be lifted out of the context of comprehensive therapy, neither regarded as a cure-all.
Most of the physical procedures have similar effects and, depending on the parameters, some of them may be
dominant. The main effects are:
• analgesic,
• myorelaxation, trophic and antiedematous.
By selection of a procedure and its parameters you can select one of the above stated effects or their combination.
Continuing education is a very important aspect of healthcare delivery. Many excellent resources are today available
to expand a user's knowledge about many aspects of electrical stimulation therapy. BTL recommends a thorough
review of this guide prior to operating the equipment and a search of educational reading material on the internet.
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ELECTROTHERAPY – USER‘S GUIDE
2 CLASSIFICATION OF
ELECTROTHERAPEUTIC CURRENTS
Galvanic current (or “continuous”) is current of constant intensity. It is always DC. It is used mostly for iontophoresis,
or its trophic stimulative (hyperaemic) effect is utilized. A big disadvantage of the galvanic current is the risk of
chemical damage of the tissue under the electrodes. The damage may be caused by the hydrochloric acid which
originates under the anode or by the soda lye which originates under the cathode. Similar danger of the tissue
damage can occur also at any direct current (e.g. diadynamic). Direct currents must not be used for the patients
with metallic implants!
At present this current is often substituted by galvanic intermittent current. This current has the same effects (galvanic
component is 95 %) but thanks to interrupting of the originally continuous intensity by the frequency 8 kHz it is better
tolerated by the patients. It is suitable especially for iontophoresis.
The pulse direct current is current of variable intensity but only one polarity. The basic pulse shape may vary. It
includes e.g. diadynamics (combination of pulse DC – "dosis" and galvanic current – "basis"), rectangular (e.g. Träbert
current), triangular and exponential pulses of one polarity.
Depending on the used frequency and intensity it has the stimulation, trophic and analgesic effects. Generally, direct
current with variable intensity implies the same risks as galvanic current (corrosion of the skin surface) and therefore it
requires careful observance of correct procedure, especially the correlation between the applied intensity and the
length of application.
The main effect is the stimulation which is important especially below the cathode (green negative electrode).
In comparison with DC, alternating current is safer and better subjectively tolerated by the patient. The basic pulse
shape again may be various – rectangular, triangular, harmonic sinusoidal, exponential or combined. It can be
alternating, symmetric or asymmetric. The DC component is always zero, which prevents from chemical damage of
the skin under the electrodes.
Therefore this current enables also long-lasting applications, even for the patients with metal implants. Implanted
electronic stimulators such as pacemakers etc. are indeed absolutely contraindicated. Nowadays the low-power
pulses – TENS (Transcutaneous Electrical Nerve Stimulation) and interference – gain ground among the alternating
currents. Use of alternating currents in the contact electrotherapy implies much lower stress on the tissue under the
electrode.
For these types of current the capacitive component of skin resistance is involved, and also thanks to it these currents
are very well tolerated by the patients.
In general:
• short duration of the pulse improves the subjective perception,
• the zero average value (DC component) prevents from chemical damage of the tissue,
• frequency and amplitude are responsible for the required therapeutic effect.
2.3.1 TENS
TENS = transcutaneous electrical nerve stimulation
Nowadays very prevalent group of currents which substitutes the standard applications of diadynamic currents,
Russian stimulation, etc. TENS pulses are low-power and have zero DC component. Therefore, besides suppression
of chemical damage of the tissue, the risk of electric damage of the tissue is also minimized.
As can be seen from their name, these currents are intended for stimulation of nerve stems or nerve fibres. Their
major utilization is in alleviation of pain, inhibition of itching, etc. The mechanism of their effect is most often explained
by the so-called gate theory of pain. Besides treating of pain, these currents can be also effectively utilized in
electrogymnastics (stimulation of non-denervated muscles).
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ELECTROTHERAPY – USER‘S GUIDE
3 EFFECTS OF ELECTROTHERAPY
Pain is a multi-factor phenomenon and the practice positively shows that various types of pain respond more or less
well to various physiotherapeutic, i.e. also electrotherapeutic procedures. There are several mechanisms of the
analgesic effect of electrotherapy – besides the well-known gate theory of pain there is also proven increase of
production of endogenous opiates. The analgesic effect is also supported by trophic effects of the flowing current.
Timely myorelaxation removes the muscular hypertone and thus also pain of myofascial origin. Since the analgesic
effect of electrotherapy is fundamental and most utilized it shall be described in a little more details.
Pain is usually simply defined as an unpleasant sensuous and emotional experience connected with actual or
potential damage of the tissue. We usually distinguish between acute and chronic pain. Acute pain is short-lasting
(maximum several days or weeks). It is caused by mechanical damage of the tissue or by a disease, comes
immediately after the painful stimulus and subsides after its ending; the intensity of pain depends on the intensity of
stimulation. On the other hand, chronic pain is long-lasting (more than 3 months) or it recurs; its intensity does not
depend on the intensity of stimulation; emotions particularly play a leading role.
The now generally accepted theory of perception of pain is based on the assumption of existence of a specific
sensory system which transfers information from receptors of pain (nociceptors) to the central nervous system by
preformed special nerve paths. However, the process is in fact much more complicated and persons interested can
learn about it from the available specialized literature.
To understand the effects of electrotherapy it is important to understand especially the modulation factors which can
influence the perception and transfer of the painful stimulus:
• First crucial modulation factor is described by the so-called gate theory of pain which is based on the presumption
that the nervous mechanism in posterior medullary horns act as a small gate which lets through only limited flow
of nervous impulses from the peripheral afferent fibres to the central nervous system, depending on how much it
is opened. Stimulation of some particular fibres can modulate the extent of the gate’s opening or closing for pain
and thus also increase or decrease transfer of the nociceptive information. A similar gate system is supposed to
exist also on the level of thalamus.
• The other important modulation factor is described by the neuromodulation theory which is based on the
analgesic effect of some substances belonging to the group of so-called neuromodulators, especially endorphins
and encephalins. These substances are produced in the central nervous system and according to the mentioned
theory they have crucial importance especially for subjective perception of pain.
Anyway, the analgesic effect of electrotherapy is used most often. To make PT a real benefit for the patient, it is
necessary to observe the following principles:
• Do not suppress the signalling and protective function of pain (which is especially important for acute pain!), i.e. at
first decrypt the information being signalled by the pain, properly determine the diagnosis or at least a preliminary
hypothesis and only then intervene against the pain. Pain modified by PT or analgesics can loose its specificity
insomuch that later it cannot be decrypted.
• Together with application of analgesic PT it is necessary to considerably reduce administering of analgesics. This
rule is very important, owing to the possibility of relatively precise aiming of the analgesic effect of PT (in contrast
to the unaimed effect of medicaments) and possible undesired interaction between PT and the medicaments.
• When choosing the type of PT consider the expected effect (gate theory, endorphins).
• For chronic or recurrent complaints do not obstinately apply various types of PT, but examine the locomotive
system (or get it examined by a specialist) – very often the source of these complaints is far from the place of
projection of pain (catenation-generalization).
For stimulation of thick, myelinized nerve fibres of A beta and delta types (gate theory) it is suitable to use low-
frequency currents of the frequency 50 - 150 Hz (optimum 100 Hz) and intensity at or above threshold sensitivity. This
method is effective especially for acute and segmentally localised pains. For chronic painful syndromes it is most
suitable to use low frequencies 2 - 8 Hz and intensity at the highest tolerable level (up to the threshold of pain); thus
thin fibres of C type are stimulated (creation of endorphins). For achievement of combination of both above-stated
mechanisms of easing of pain use the "burst modulation". The carrier frequency should be about 100 Hz, burst
frequency up to 10 Hz (even frequencies lower than 1 Hz are not exceptional). Currents with burst modulation bring
the cumulated analgesic effect. By the depth of the required effect the procedures can be ordered as follows (from the
most superficial to the deepest ones):
• analgesic effect of anelectrotonus (galvanic current)
• diadynamic currents LP and CP-ISO
• Träbert current
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ELECTROTHERAPY – USER‘S GUIDE
• TENS
• 2-pole interference (amplitude-modulated mid-frequency currents),
• 4-pole interference, isoplanar interference and vector fields
Especially after the posturographic examination had proved that overall administering of so-called myorelaxancies has
a negative long-term influence on the body posture, the possibility of exact aiming at the hypertonic muscle has been
regarded as an especially valuable advantage of myorelaxation procedures. At overall application of myorelaxancies
there are first affected the phasic muscles which have been already weakened due to the layer syndrome. Later, or
when stronger dose is applied, there are also affected the tonic muscles and only at the end, at the strongest dosage,
also hypertonic muscles are positively affected. This effect lasts for several weeks and affects the static of the spine
very negatively even after the acute complaints have subsided.
Procedures with myorelaxation effect include therapeutic ultrasound, 2-pole interference with contour frequency 100 –
200 Hz, 4-pole interference currents and high-voltage therapy in the same frequency modulation band. For small
superficial muscles especially on hands also paraffin can be used.
A favourable side effect of myorelaxation is also the analgesic effect.
is caused by hyperaemia which occurs in almost all types of PT (except cryotherapy). Since the mechanism of
hyperaemia in various types of PT is different, it is necessary to take these mechanisms into account so as to be able
to select the particular PT. Generally, galvanization can be recommended, especially longitudinal (capillary
hyperaemia, vessel eutonisation), low-frequency currents of the frequency 30 - 60 Hz and the intensity at or above the
threshold motor activity level (muscle micropump) or ultrasound, laser, polarized specified achromatic light, vacuum-
overpressure therapy, etc.
The trophic effect may be partly caused by the fact that most forms of PT, esp. laser, biolamp and magnetotherapy,
bring energy into the organism, to be used by cells (or other structures) for their activity.
The trophic hyperaemic effect is also usually connected with the analgesic effect.
is practically connected with hyperaemia, vessel eutonisation and higher capillary permeability. Therefore the
therapies referred to as trophic are also antiedematous (see the previous paragraph).
• Owing to the fact that lege artis application of PT requires to take into account especially the patient's individuality
and momentary functional status (including the limbic system status, mood, muscular tonus, season of the year,
weather, motivation, attitude to the troubles, etc.) it is almost impossible to create a group for further statistical
processing. Creation of a control group is practically out of question.
• The effect of PT lies almost only in affecting of the afferent system. The afferent system processes all data,
including the visual, auditory, tactile and other analysers. Since very often a slight stimulus is sufficient to deviate
the organism from the existing functional balance (even the pathological one) and, using its enormous self-
reparation abilities, the organism helps itself, there cannot be carried out e.g. a blind experiment without at least
minimum excitation of an afferent system and/or higher components of CNS.
• Functional defects of the locomotive organs which belong to the main positive effects of PT tend to self-repair, if
they are not prevented from that (e.g. by inappropriate pharmacotherapy). If correctly indicated, PT both initiates
and accelerates this self-reparation, which indeed can be hardly exactly proved.
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ELECTROTHERAPY – USER‘S GUIDE
A "troublesome" patient is often invited for the check examination only after undergoing of usually ten procedures and
"hopefully will be better then". This way of thinking is immoral, unethical and discreditable to a specialist, but
nevertheless most of the existing prescriptions of PT unfortunately belong to this category. In some surgeries the
patients are even told that the effect of the chosen PT will come only after several months (!), which means that the
physician fully relies on the organism's self-reparation abilities.
Indication of PT then should not be based only on the diagnosis, especially if the diagnosis is confusing, e.g.
periarthritis humeroscapularis etc.
The attending physician should know the answers to the following questions:
• What is the cause of the complaints, i.e. usually pain?
• Is the defect functional or organic?
• Where was the defect initiated – where is (are) the key area(s)?
• Which of the above-mentioned effects of PT is the most important for the patient at the moment?
• Is there not a risk of aggravation or organification of the functional defect after the chosen PT?
By these answers the physician should choose the type, location, intensity, frequency and total number of treatments,
and, in relation to them, also the date of the check examination of the patient.
• active TB
• allergy to the solutions used for moistening of the electrode sponge covers
• application in the area of heart or eyes
• pacemaker
• cardiovascular diseases
• cochlear implants
• metal implants and/or malignancies in the current path
• skin defects and inflammations
• bleeding
• menstruation
• tumours
• defects of sensitivity in the point of location of the electrode
• psychopathological syndromes and organic psychosyndromes
• multiple sclerosis
• pregnancy
• inflammations of veins and lymphatic paths
Symbols of effects of therapy used in the equipment have the following meaning:
A - analgesic
E - antiedematous
T - trophic
R - myorelaxation
S - myostimulation
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CV (= constant voltage) mode – in this mode the voltage on the electrodes is constant. Owing to physiological
effects the current in the tissue may slightly rise during therapy and therefore it is usually necessary to adjust the set
intensity according to the patient's feelings, approximately every one or two minutes. Still this mode is suitable
especially in the cases where the CC mode would bring problems – pain and reduction of output intensity – i.e. at the
applications with moving electrodes and at the applications which are accompanied by muscle contraction.
4.1.2 Polarity
• positive polarity: socket marked "+" is anode (use the cable with red banana plugs)
socket marked "-“ is cathode (use the cable with white or black banana plugs)
• negative polarity: the polarity of sockets is reversed ("+" = cathode; "-" = anode)
• positive, reversal: the first half of therapy has positive polarity of signal, in the middle of therapy the
polarity automatically changes to negative
• negative, reversal: the first half of therapy has negative polarity of signal, in the middle of therapy the
polarity automatically changes to positive
• pos., rev. with interrupt.: the first half of therapy has positive polarity of signal, in the middle of therapy the
polarity automatically changes to negative; at the change the equipment interrupts
therapy and waits for re-setting of correct intensity
• neg., rev. with interrupt: the first half of therapy has negative polarity of signal, in the middle of therapy the
polarity automatically changes to positive; at the change the equipment interrupts
therapy and waits for re-setting of correct intensity
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4.2 TENS
4.2.1 Type
symmetric – the positive pulse is immediately followed by the negative one
alternating – the positive pulses regularly alternate with the negative ones
asymmetric – positive rectangular pulses are followed by exponential pulses of negative polarity.
Nowadays the most widespread type of TENS, probably because of its favourable effects which are
similar to those of DC pulses, and electrochemical properties corresponding to AC.
Note: The relations are based on the electric waveform of TENS and the way of their generating.
I [mA]
t [s]
Carrier frequency (high frequency)
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These stimulation pulses are in principle similar to Russian stimulation but have
wider portfolio of possibilities of individual settings.
The limits of setting of the individual parameters are determined by the carrier frequency.
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4.6.1 Type
The basic types of diadynamic currents are as follows:
CP-ISO: the same combination of pulses DF and MF, but the mutual intensity
of currents is equalized by the base-line (owing to the difference in perception
of DF and MF, intensity of the MF current is 11 % lower than that of the DF
current)
RS: diadynamic current combined of the MF current (time 1 or 1.2 second) and
a pause (length 1 or 1.2 second – according to the basic frequency 50 / 60 Hz)
4.6.2 Base
To the pulse component of the diadynamic current there is added the galvanic component – base. It can be defined
proportionally – the base component represents the set percentage of the total intensity.
4.6.3.2 Interruption
This option switches on the "momentary interruption" of the generated
waveform. The length of the interruption is 5 µs and the repeating frequency
of interruption is 8000 Hz. As for power there is no change in the generated
waveform (duty factor is 96 %) but the patient's tolerance is higher.
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4.7.1 Type
monophasic – pulses of only one polarity (ATTENTION! These pulses have galvanic effect!)
alternating – the positive pulses regularly alternate with the negative ones
asymmetric, combined - positive rectangular pulses are followed by exponential pulses of negative
polarity. Their effects are similar to those of DC pulses but the electrochemical properties correspond to
AC.
Note: The relations are based on the electrical waveform of the pulses and the way of their generating.
4.8.1 Type
The two basic types suitable for stimulation are rectangular and triangular.
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Special types of pulse currents, for their parameters see chapter Technical Parameters.
4.10.1 Type
Continuous or interrupted. The length of interruption is 5 µs, repeating frequency is 8000 Hz.
4.11 MICROCURRENTS
4.11.1 Type
The waveforms of the particular current types are best illustrated in the following table :
rectangular monophasic
rectangular symmetric
rectangular alternating
triangular monophasic
triangular symmetric
triangular alternating
exponential monophasic
exponential symmetric
exponential alternating
combined
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4.13.3 Burst
Low-energy group of several pulses following immediately one after
another. It is possible to set the number of pulses in burst and
frequency of bursts [Hz]. For information there is calculated the pause
between bursts [ms] and burst length [ms]. It is also possible to choose from several pre-defined values.
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I [mA]
t [s]
Carrier frequency (high frequency)
Spectrum determines the extent of change of the basic frequency of therapeutic surges – AMF. The resulting
frequency of therapeutic surges then ranges from AMF to AMF + Spectrum and changes according to the set way of
frequency sweep.
The differences among particular ways of sweep are displayed in the following pictures:
The difference between standard and random way of sweep is again best illustrated in the following two pictures. In
the classic way of sweep the change of frequency always involves two values – AMF and AMF + Spectrum. In the
random way of sweep the equipment selects the resulting generated frequencies randomly from the values between
AMF and AMF + Spectrum. This way of sweep reduces the risk that the tissue gets used to the generated
frequencies and thus in some cases it increases the success of therapy:
4.15 ELECTRODIAGNOSTICS
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Anode – positive electrode (red banana plug) connect to the plate electrode as a reference electrode. This electrode
shall be placed proximally or distally to the treated muscle. It is also possible to use suction cup electrode –
continuous vacuum mode.
Cathode – negative electrode (black banana plug) is connected to the stimulation point electrode.
For finding the motor point it is recommended to use pulses of the length approx. 5 ms for the healthy muscle and
approx. 100 ms for the denervated muscle. The pause between pulses should be 2 - 3 seconds. After finding the
motor point reverse the polarity of the output current (positive polarity → negative, or shift the electrodes – red
banana plug to the point electrode and the black one to the reference electrode) and measure the muscle sensitivity
for the reversed polarity of the signal (the stimulation electrode in this case is anode). For further stimulation use that
connection of electrodes (polarity) for which the muscle is more sensitive.
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After pressing the "parameters ultrasound" button you can set all parameters of the ultrasound therapy as required.
For detailed description of ultrasound parameters see the Ultrasound Therapy User's Guide.
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The equipment can work with plate BTL electrodes. For plate electrodes use sponge covers moistened by water (or
by therapeutic solution in case of iontophoresis). Before first use of the covers it is necessary to rinse them in tepid
water. Moistening of covers or sponges prevents the patient from burning. When generating low-energy currents
(TENS) apply side 1 of the electrode in the sponge cover to the patient's body. One ply of the sponge cover will be
between the electrode and the patient's skin. For high-energy currents (recommended for all currents except TENS)
apply side 2 of the electrode in the sponge cover to the patient's body.
1 cover
electrode
2
Before first use rinse the electrode sponge covers thoroughly in tepid water. From the manufacturing they are
impregnated with special substance which prevents them from going mouldy.
After washing and drying the electrode covers harden. It is not a defect – after moistening they will get soft again.
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6.1.1 TENS
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type: asymmetric
pulse: 0.2 to 1 000 ms
pause: 0.5 to 10 000 ms (depending on the pulse length)
frequency: 0.1 to 550 Hz
modulation: see Modulation of Currents below
type:
rectangular, triangular (monophasic, symmetric, alternating)
interruption frequency:8 000 Hz, duty factor 95 %
pulse:
1 to 30 ms
pause:1 to 60 ms (monophasic)
1 to 30 ms (symmetric, alternating)
frequency: 11.1 to 500 Hz (monophasic)
11.1 to 333 Hz (symmetric)
8.3 to 250 Hz (alternating)
modulation: see Modulation of Currents below
type: monophasic
pulse: 2 ms
pause: 5 ms
frequency: 143 Hz
modulation: see Modulation of Currents below
6.1.15 Leduc
type: monophasic
pulse: 1 ms
pause: 9 ms
frequency: 100 Hz
modulation: see Modulation of Currents below
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6.1.17 H-wave
type: symmetric
pulse: 2 x 5.6 ms
pause: 0.22 to 10 000 ms
frequency: 0.1 to 87.7 Hz
modulation: see Modulation of Currents below
6.1.18 Diadynamics
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6.1.20 Microcurrents
type: rectangular, triangular, exponential (monophasic, symmetric,
alternating) and combined
pulse: 0.2 to 1 000 ms (rectangular, combined)
1 to 1 000 ms (other)
pause: 0.1 to 10 000 ms (monophasic, symmetric, combined; then by the
pulse length)
0.1 to 5 000 ms (alternating; then by the pulse length)
frequency: 0.1 to 1 000 Hz (rectangular)
0.1 to 700 Hz (combined)
0.1 to 900 Hz (other, monophasic)
0.1 to 450 Hz (other, symmetric a alternating)
modulation: see Modulation of Currents below
note: CC mode only
pulses: 0.1 to 25 ms
delay between channels: 10 to 3 000 ms
frequency: 0.15 to 50 Hz (depending on the set pulse length and delay)
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TENS:
10 µs to 160 µs 140 mA
161 µs to 400 µs 140 mA (for additional limits see the table)
Diadynamics: DF 70 mA
MF 100 mA
CP 80 mA
LP 80 mA
RS 100 mA
CP-ISO 80 mA
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Stimulation pulses:
0.1 ms to 29 ms 140 mA (for additional limits see the table)*
30 ms to 49 ms 110 mA (for additional limits see the table)*
50 ms to 69 ms 90 mA (for additional limits see the table)*
70 ms to 99 ms 80 mA (for additional limits see the table)*
100 ms to 299 ms 70 mA (for additional limits see the table)*
300 ms to 1000 ms 65 mA (for additional limits see the table)*
Galvanic current: 65 mA
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H – wave:
frequency intensity
0.1 – 35 Hz 140 mA
40 Hz 129 mA
50 Hz 114 mA
60 Hz 103 mA
80 Hz 90 mA
88 Hz 86 mA
Microcurrents: 1000 µA
HVT: 390 V
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BTL-4000
Ultrasound
Therapy
USER'S GUIDE
v100z1TN21/06/2004EN
ULTRASOUND THERAPY – USER'S GUIDE
CONTENTS:
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1 USER'S GUIDE
Continuing education is a very important aspect of healthcare delivery. Many excellent resources are today available
to expand a user's knowledge about many aspects of ultrasound therapy. BTL recommends a thorough review of this
guide prior to operating the equipment and a search of educational reading material on the internet.
Mechanical waves of a frequency higher than 20 000 Hz are called ultrasound. Application of ultrasound does not
generate any electric current in tissues, and thus it is classified as mechanotherapy. The frequency usually used in
physiotherapy is 0.8 – 3 MHz.
When the air gap between the emitter head and the body surface is eliminated, the emitter head vibrations are
transmitted into the tissue and propagate to the depth in the form of longitudinal waves. All cells in the path of
ultrasonic beam begin to oscillate. This causes micro-massage followed by transformation of gel into sol (jelly
structures become liquid), transformation of mechanic energy into thermal, and deep warming of tissues.
The amount of generated heat depends on the amount of absorbed energy. Other effects of ultrasound (degassing of
solutions, formation of cavities in liquids, and local alkalization) are negligible with ultrasound doses and intensities
used in physical therapy.
In order to avoid side effects, it is important to realize that molecular oscillation occurs not only in the path of ultrasonic
beam, but also in places that are distant from the area of application as a result of transmission by body fluids. This
may lead to restoration of former epistaxis or acceleration of menstruation.
The features of ultrasound beam and its distance from the emitter head determine the ultrasound field as being either
close or distant.
Close ultrasound field is characterized by low beam divergence and big intensity variations due to interferential
effects. The length of close field is directly proportional to effective radiation area (ERA – see below) of the emitter
head and inversely proportional to frequency. For example, the length of close field with 4 cm2 ERA emitter head and
1 MHz frequency is approximately 10 cm, and for the emitter head with 1 cm2 ERA and 1 MHz frequency it is
approximately 2 cm.
Distant ultrasonic field is characterized by increasing beam divergence, gradual decrease of intensity, and almost
no interferential effects.
Therapeutic effects take place mainly in the close field. The ultrasonic beam in the close field has significant
interferential effects (interference of applied and reflected waves) - both constructive and destructive. It results in non-
homogenous ultrasonic beam where peak levels of intensity (local increase of intensity caused by constructive
interference) may be many times higher than the pre-set value.
Beam Non-uniformity Ratio (BNR) states how many times the peaks of intensity exceed the pre-set values. This
value characterizes an ultrasound head with a given frequency. The BNR value of a good quality ultrasound head is
lower than 5. It means that if the pre-set intensity of the unit is 1 W/cm2, the intensity in any part of the ultrasonic beam
2
is not higher than 5 W/cm .
The BNR of older ultrasound heads and some newer ones (some manufacturers do not mention the BNR
value) is often 20 or even more!
The Effective Radiating Area (ERA) is always smaller than the actual surface area of the emitter head (the ERA is
determined by the size of the piezoelectric crystal or ceramic table that generates ultrasound by oscillating). The
ultrasound dose (power emitted to a surface area) is, therefore, related to the ERA and not to the actual surface area
of the emitter head.
The phenomena of ultrasound refraction and reflection are caused by ultrasound wave transmission from one
tissue into another and by different transmission speed in these tissues. When applying ultrasound, it is necessary to
eliminate the air gap between the emitter head and the skin. Therefore, modern ultrasound heads have built-in optic
and/or acoustic check of insufficient contact, possibly with automatic termination of application time countdown.
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Due to interference in the close ultrasound field (it reaches the highest level in the place of soft tissue/bone boundary -
up to 35%), ultrasonic beam power increases (constructive interference) or decreases (destructive interference).
In order to avoid tissue lesions at peak levels of intensity, it is necessary to move the emitter head continuously.
As a result of reflection and constructive interference, local increase in intensity and temperature may occur,
particularly in the place of periosteum/bone boundary. This increase can lead to periosteum pain during ultrasound
application. If this occurs, the intensity must be immediately lowered.
Ultrasound is primarily absorbed in deeper tissues. Since these tissues usually do not include thermoreceptors, it is
impossible to perceive local rise in temperature. The patient feels pain only if the local temperature exceeds 45oC and
o
nociceptive receptors are irritated. Most authors agree that a short-term rise in local temperature to 45 C is not
dangerous.
In the area of classic inflammation (edema, erythema, local rise in temperature, pain or dysfunction) additional heat
production is contraindicated, and thus only pulsed ultrasound (athermic) can be applied if necessary.
During peracute phase of post-traumatic conditions (up to 24-36 hours) the pulsed ultrasound application is
contraindicated (vibrations hinder capillary proliferation and may cause delayed bleeding).
Static application - The head is fixed to the treated area by a special holder and it is not moved. Due to the
above-mentioned adverse effects it is the least suitable form of application.
Semistatic application - is used when the application area corresponds to the ERA of the emitter head. The
therapist continuously moves the emitter head, in spiral along the perimeter of an imaginary circle.
Dynamic application - the application area is bigger than the ERA of the emitter head. The therapist moves
the emitter head in spirals in the treatment area. The application time is prolonged proportionally according to
how many times is the application area bigger than the ERA of the head.
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Local application - Ultrasound is applied to the affected area. It is the most common way of application,
particularly suitable for local muscle spasms, chronic post-traumatic edemas, etc.
Segmental application - Ultrasound is applied to the outflows of nerve radices of the affected area (e.g.
Sudeck syndrome, Morbus Reynauld, etc. The application is paravertebral and homolateral; in the area of C5
- Th1 for pathologies of upper limbs and in the L3 - S1 area for lower limbs.
Neural application - is based on the effect of decrease in impulse transmission speed in the peripheral
nerve where ultrasound is applied. As the dividing line between the lowering of conductivity and irreversible
nerve damage (asymptomatic) is very small, this method of application is considered dangerous, and it is
used only exceptionally (e.g., phantom pain).
Radicular application - Ultrasound is applied subsequently to the corresponding spinal root and manifested
Head zone. For application above the spinal root, the same risks and limitations apply as for neural
application.
Direct contact - is provided by a contact medium (ultrasound gel). This is a common way of ultrasound
application, and it is not necessary to mention it in ultrasound therapy prescription. For combined therapy
(ultrasound + electrotherapy) it is recommended to write "conductive gel" in the prescription because some
gels do not conduct electricity. The BTL ultrasound gel is conductive; if this gel is not available you can use
ECG gel or another water-based gel instead. However, never use paraffin oil, because it is non-conductive
and could damage the head.
Subaqual application. This method has a range of advantages: It uses mainly the distant ultrasound field
where interference does not occur. Furthermore, there is no need to press the emitter head against the skin
in order to maintain sufficient contact (this pressure is unpleasant or even painful for post-traumatic
conditions). In addition, this application is not limited by uneven surfaces, and ultrasound can be easily
applied to these surfaces, such as to interphalangeal joints.
Disadvantages of subaqual application include difficult handling of a special porcelain bath, limitation of
ultrasound application to acral body parts, and the risk of the therapist's hand lesions if the hand is put in
water. (It is strictly prohibited due to reflection and interference of ultrasonic waves against walls of the
porcelain bath!) Some emitter heads (even newer) are claimed to be water resistant, but if they do not have a
holder, they do not provide safe subaqual ultrasound application.
Ultrasound can be also applied via a thin-walled rubber bag (surgical gloves, condom) filled with boiled water.
However, when using this method, it is necessary to eliminate the air gap between the bag and skin (use gel)
and between the emitter head and the bag. This method is often perceived as very time-consuming.
Older ultrasound units employ a fixed frequency, usually 0.8 – 1 MHz. Newer ones are multifrequency units, the
selected frequency is determined by the target tissue; 1 MHz frequency is used for deep tissues and 3 MHz frequency
for superficial tissues.
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2 2
The size of the emitter head is determined by the Effective Radiating Area (ERA): 1 cm (small head) and 4 cm
(medium head, or big head according to some manufacturers). The choice of the head depends on the size of the
application area. Ultrasound application to large areas by a small head is too time-consuming, difficult for the
therapist, and the dose is not applied homogeneously.
2
Small heads with ERA about 1 cm are used for trigger points, scars or for small and uneven surfaces where with an
emitter head of standard size the ultrasound would have to be applied subaqually.
Application time varies and largely depends on the stage of disease. For acute conditions, it is 3 minutes at the
beginning; for chronic conditions, it is usually 5 minutes at the beginning, and then it is prolonged using the positive
step method. Application time for most therapies does not exceed 10 minutes. If the application area is x-times larger
than the ERA of the head, application time has to be x-times prolonged and dynamic application is used.
1.7 INTENSITY
For acute conditions start with the intensity of 0.5 W/cm2 (in some cases even lower: e.g., in case of trismus, 0.2
2
W/cm on hypertonic fibres of m. temporalis. The muscle is situated on the bone, just below the surface. Since the
close ultrasound field is used, apply very low intensity.)
For chronic conditions, the intensity of 0.8 - 1.0 W/cm2 is used initially and it is increased according to the patient's
reaction (the positive step method). The ultrasound intensity must not exceed 2.0 W/cm2 in continuous mode and 3.0
2
W/cm in pulse mode.
It is not recommended to increase in steps two parameters at the same time - if you extend application area,
do not increase intensity, and vice versa.
Recommended frequency of treatments for acute conditions is 5 times a week and for chronic conditions 3 times a
week. It is advisable to change frequency during one set of treatments (for example, 3 times a day, then 3 times every
other day).
The total number of treatments varies according to the individual condition. It can range from a single application
before myoskeletal surgery up to 9 applications over a 3-week period for chronic conditions.
Combined therapy is simultaneous application of two or more kinds of energy. (Common diadynamic currents with
simultaneous application of galvanic and pulse low frequency currents can be also considered as combined therapy.)
Typical combinations are:
- ultrasound + low-frequency currents
- ultrasound + amplitude-modulated mid-frequency currents
- ultrasound + TENS
For combined therapy we recommend using of CV mode of electrotherapy.
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covering metallic plate of the emitter head. The other electrode (most usually a plate electrode) is placed
contralaterally, so that both the ultrasound field and low-frequency currents are brought to the treatment area.
A certain disadvantage of this combination is a galvanic (corrosion) effect. It applies especially to diadynamic currents
and to a certain extent also to monophasic pulse currents. This effect is more evident on the emitter head than on the
skin. However, when using higher intensities, it is important to be aware of this effect and ensure the patient’s safety.
1.9.1.2 Intensity
2 2
The intensity of ultrasound set separately - 0.5 - 0.7 W/cm for continuous ultrasound and up to 1.0 W/cm for pulsed
ultrasound with Duty factor 1:2 or more. The intensity of the low-frequency component is set according to the aim.
When locating trigger points, set the intensity at threshold sensitive level outside the area of expected reflex changes
and then approach this area continuously. In the area of hyperalgesic zone, the pre-set intensity is above threshold
sensitive (up to below threshold of pain), and the patient reports subjective intensification of feelings; may even feel
pain. In the area of trigger points in a muscle, the intensity changes to threshold motor level and up to above threshold
motor level. The pre-set intensity causes a motor response. (The patient often does not notice it.) If the threshold of
pain is not reached, use the same intensity for the therapy; otherwise adjust the intensity of the low-frequency
component according to the type of current and the desired effect. (The intensity of the therapy should never be above
threshold of pain!)
The size of the indifferent plate electrode should be at least 2x (but in practice even up to 10x) larger, so that sensitive
feelings are located only on the edge of ultrasound application.
It is obvious that for application to deeper areas lower ultrasound frequency (1 MHz) is chosen. Combination of
modern BTL units enables to select ultrasound parameters or amplitude modulation. Hence, these currents can be
used for treatment of superficial (3 MHz frequency) as well as deep (1 MHz frequency) muscles.
1.9.2.2 Intensity
2
The initial intensity for continuous ultrasound (Duty factor 1:1) is 0.4 - 0.6 W/cm , the initial intensity for pulsed
2
ultrasound with Duty factor 1:2 - 1:4 is 0.5 - 1.0 W/cm , the initial intensity for pulsed ultrasound with Duty factor 1:8 -
1:16 is 1.0 - 1.3 W/cm2.
The AMP intensity is chosen according to the desired effect. Mainly analgesic effect of amplitude modulation about
100 Hz is reached by above threshold sensitive intensity, optimal myorelaxation effect of 150 – 180 Hz modulation is
reached with the intensity at threshold motor level. The patient must not feel pain or burning sensation during
application not even in the place of hyperalgesic zone or trigger point. If pain occurs, lower the ultrasound intensity
immediately (record it to the patient’s card and send the patient to his/her physician for immediate check-up). In order
to eliminate burning sensation in the trigger point area, lower the intensity of mid-frequency component or add the
contact medium. (It is not necessary to inform the patient’s physician.)
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1.9.3.2 Intensity
For the ultrasound intensity please see the previous section. Intensity of TENS is above threshold sensitive outside
the area of reflex changes and above threshold motor level in the area of reflex changes.
1.10.1 Absolute
- epiphyses of growing bones
There is the risk of irreversible damage of the growth zone, deformity and permanent impairment. Since older
types of ultrasound units employed low intensity (displayed data did not correspond with the actual energy
applied), the damage of the growth zones was exceptional and many physicians did not take this
contraindication too seriously. However, modern, effective ultrasounds can cause damage of the growth zone,
especially due to insufficient movement of the emitter head. The responsibility lies with the physician who
prescribed the therapy as well as with the therapist who performed the contraindicated procedure.
- gonads
Small doses cause temporary and high doses permanent spermio / oogenesis impairment.
- pregnancy
- eyes
The use of special ophthalmic ultrasound units is restricted to specialised centres. In physiotherapy, it is
contraindicated.
- post-laminectomy conditions
After laminectomy, the spinal cord is not completely covered by the osseous cover, and ultrasound application
can cause temporary or event permanent paraparesis of lower extremities (if the axons of the spinal cord paths
are disorganised). This is one of the most severe damages in physiotherapy practice and the connection
between the physiotherapy application and the condition is obvious.
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1.10.2 Relative
- brain, parenchymatous organs, heart
There is no reason to apply ultrasound to these organs (The brain is covered by the cranium). In spite of this,
there has been reported a case of a patient who irradiated his sinuses while he applied ultrasound to the knee
and after a few hours died of massive bleeding into his forehead lobe (calcified atheroma plate might have
been disturbed). The patient must not apply ultrasound to himself/herself under any circumstances, not even to
areas easy to reach!
- bony projections located under the skin - spinous projections of spondyles, ankles, condyles, epicondyles
This contraindication is very often ignored. Ultrasound can be used for treatment of epicondylitis, but this is true
only in case of applying ultrasound to a specific muscular group (extensoric in lateral epicondylitis, flexoric in
ulnar epicondylitis). Direct ultrasound application to a painful attachment often causes increased pain, but it
more often leads to the process of chronification (the same effect as in the case of repeated local application of
corticosteroids).
Similarly, direct ultrasound application to spine often results in stubborn periosteum pain around spinal
projections.
- menstruation
Ultrasound application is absolutely contraindicated in lower abdomen area. When applying ultrasound to other
areas, it is advisable to tell the patient that the menstruation might increase (more common is acceleration of
menstruation than metrorrhagia). If the case history shows that the ultrasound application might adversely
affect menstruation, the therapist should refuse to carry out the treatment and suggest that the patient consult
it with her physician. (It is not enough to postpone the ultrasound application after menstruating period when
ultrasound indications may not exist anymore.)
- pacemaker
- cardiovascular diseases
- cochlear implants
- metal implants
- tumours
- acute inflammations
- endocrine glands
- TB
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Treatment is usually asymptomatic, a feeling of moderate warmth can occur. A burning sensation during therapy
indicates insufficient contact medium (it is necessary to add more), pain indicates overdose (it is necessary to interrupt
therapy and consult the prescribed treatment with the physician; treatment with lower intensity usually continues after
one day break) or insufficient movement of the emitter head.
After the first treatment there may occur temporary worsening. Marked subjective and objective improvement should
occur not later than after the third application. If there is no improvement (in acute and subacute states), ultrasound
therapy should not be continued. Telling the patient that improvement will occur after a few months is not professional
and it shows that the physician prescribes the treatment for deferring effect (waits for self-healing processes of the
organism).
If ultrasound is used for treating chronic conditions (which is quite rare) or for change in mechanical features of treated
tissues (e.g., in case of Dupuytren's contracture or plantar aponeurosis related to calcar calcanei), significant
improvement cannot be expected after the third application. (If ultrasound application is not followed immediately by a
manual therapy, improvement cannot be expected even after the tenth application.)
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2.1.1 Ultrasound
2.1.1.3 Intensity
2 2 2
Intensity can be set within the range from 0.1W/cm to 2W/cm for the continuous mode, and from 0.1W/cm to
3W/cm2 for the pulse mode.
2
If the continuous mode is set and then there is set an intensity higher than 2W/cm , the equipment sets duty factor to
2 2
50%. Similarly, if there is set an intensity from 2.1W/cm to 3W/cm and then the duty factor is set to 100%, the
2
equipment limits the intensity to 2W/cm .
2.1.1.4 Time
Time of therapy can be set within the range from 00:01 to 30:00 [min:sec].
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Pulse [ms], period [ms] – information about the length of the pulse and the
period calculated for the set pulse frequency and duty factor.
Duty factor [Hz] – by the select button it is possible to set the value from 6 to
100%. By pressing the duty factor button you can select one of the preset
values. See 2.1.1.2 Duty Factor.
A - analgesic
E - antiedematous
F - antiphlogistic
H - hyperaemic
R - myorelaxation
The heads delivered with the BTL-4000 devices are interchangeable. This means that the head can be connected to
any device of the BTL-4000 series which contains an ultrasound generator and it is not necessary to state the number
of the equipment for which the head is designed.
For optimum detection of the contact between the head and the patient's skin it is necessary to perform calibration of
the ultrasound head, especially for the extra purchased heads – see 2.2.1 Ultrasound Head Calibration.
The ultrasound head supplied with the equipment were calibrated during manufacturing.
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If you decide not to save the measured data (e.g. if the head was not immersed in water after the start of calibration)
press the esc button to refuse saving.
After end of calibration start therapy for 1 MHz and 3 MHz (e.g. with the intensity 1 W/cm2) and put the head in water
and out of it several times, to check the correctness of contact detection.
ATTENTION!
If the prescribed procedure of ultrasound head calibration is not followed, there may occur damage to the
ultrasound generator and the ultrasound head after the start of therapy.
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3 TECHNICAL PARAMETERS
Effective intensity
Continuous operation 0.1 to 2W/cm2 ± 20% for the output intensity higher than 0.2W/cm2
Pulse operation 0.1 to 3W/cm2 ± 20% for the output intensity higher than 0.2W/cm2
Working frequency 1 MHz ± 5% and 3.2 MHz ± 5%
Modulation frequency 10 to 150 Hz ± 5%
Duty factor 6 to 100% ± 5% of the set value
Duty factor – defaults 6.25% (1:16), 12.5% (1:8), 25% (1:4), 50% (1:2), 100% (1:1) ± 5% of the
set value
Time of therapy 0 to 30 minutes ± 2% of the set value
Maximum output power 12W
2
Intensity 0.1 W/cm
Modulation frequency 10 Hz
Duty factor 1%
Time of therapy 1s
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4 ACCESSORIES
User's Manual
User's Guide
Head BTL-237-4-13 (large)
Head BTL-237-1-13 (small)
Holder for ultrasound head
Ultrasound gel 235ml
Ultrasound gel 5l
Ultrasound gel 10l
Touch-pen
Mains cable
Spare fuse
Markers for cables
Interconnection cable for combined therapy (PVAC.056)
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BTL-4000
LASER
USER'S GUIDE
v100z1TN31/05/2004EN
LASER THERAPY – USER’S GUIDE
CONTENTS
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1 USER'S GUIDE
1.1 INTRODUCTION
This User's Guide is intended to make you familiar with the BTL-4000 Laser device designed for performing 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, the staff operating therapy lasers must be trained by competent
institutions.
The nature and qualities of light can be interpreted in more 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 it is incomparable to any other level of reality. Therefore, we can only accept
conclusions and deductions of numerous experiments.
Intensity Intensity
400 500 600 700 800 nm 400 800 1200 1600 2000 nm
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Linear polarization
• totally coherent – it is absolutely oriented in time - maxima and minima of all waves are identical in time and the
waveforms are the same
A laser beam of a 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 significant stimulative 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 the so called quantum radiotechnique
(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 thermic effect,
cauterize tissue.
E. Mester, a Hungarian scientist, was the first to introduce the stimulative effect of a low intensity laser. He conducted
his experiments - which are still of a great importance - in the late sixties.
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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 theoretic possibility to construct a laser unit of any wavelength, according to the user's
requirements. Nevertheless, some lasers still remain at experimental level (see below).
500nm 700nm
400nm 600nm
cosmic radiation; gamma-rays, X-rays, UV radiation infrared radiation, microwaves, radio waves, very long waves
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 therapy of mucous membrane and skin diseases. Since the
output is absorbed by a very small column of the 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 the tissue. These lasers are
used especially in treating of deeper-located structures (joints, muscles, insertions...). Since the output is absorbed by
the column of the 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 at least 50 mW.
See the part concerning the emitted power density below.
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Output Output
PULSE MODULATED
Mean
value
Mean
value
Time Time
Output
CONTINUOUS
Mean
value
Time
Manufacturers usually offer various alternatives, including the possibility of combination of various modes modulated
according to various parameters.
See below the parts concerning clinical effects and use.
Note
The stated values are only rough, exact classification of the hygienic 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
with the device's body by a conductor – these devices largely prevail on the market, at present the
manufacturers can equip these devices by probes of an output up to hundreds of mW
• desk-top lasers – usually supplied from the mains, the probe is connected with 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 Laser) have also 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 of "sets" of the devices which can provide
as wide range of treatments as possible on a small area.
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• Wavelentgh - one of the basic parameters of a monochromatic laser beam (i.e. of only one wavelength). Its
unit is nanometer [nm]
• Output – its unit is mW. The given output is either peak, i.e. pulse amplitude, or mean (average). In case of
the BTL 4000 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 approximately a 10% loss of output which shall be
deducted from the displayed value. For each attachment supplied by the manufacturer of BTL devices, the
decrease of 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 (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 Laser takes into account the mode in which the device is working when calculating the treatment time).
• Modulation frequency – its unit is 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), frequencies according to Dr. Bahr
(nowadays used mainly in acupuncture) or according to Dr. Voll
2
• Power density - its unit is J/cm – power emitted per unit of area. This quantity is improperly called dose –
however, this term has become so common in the 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)
Knowledge of basic physical quantities (which is also acquired in obligatory training) significantly facilitates grasp of
the laser therapy.
Specific physical qualities of a laser beam result in specific clinical effects. The most considerable clinical effects are:
All these effects are based on positively established and verified mechanisms:
• acceleration of microcirculation
• increase of intracellular activity of many enzymes, particularly in 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 the Na/K pump and Ca transport affection,
partly through direct activation of the mitochondrial system
• changes of local level of important mediators -- inflammatory (histamin 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
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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 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 with other forms of laser therapy, the wavelength of a laser beam is not of a big 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 a physical quantity itself, but the above-
mentioned transmission of information, that plays the key role.
Many treatments utilize several effects of laser light at a time (e.g. treatment of the varicose ulcer combine analgesic,
stimulative, as well as bactericidal effects).
1.6 ACUPUNCTURE
As stated above, laser beam has a specific effect on acupuncture points, adequate to use of an acupuncture needle.
The laser acupuncture has several advantages: it is non-invasive, painless (many patients report non-pleasant
sensations when acupuncture needle is being inserted), and saves time (even for sedative techniques the treatment
lasts no more than several tens of seconds).
Modulation by Nogier frequencies or EAV frequencies is very useful and it is commonly used in acupuncture.
Application of these frequencies for the most frequent diagnoses is stated below. For details see specialized literature.
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According to applicable standards, each laser device must be protected against unauthorized handling. In case of the
BTL-4000 series, it is guaranteed by the access password. If the device contains a laser generator, the access
password is always required after the unit is switched on. The password is preset to 0000 by the manufacturer.
After entering the correct password and confirmation by the enter button it is possible to work with the device. If an
incorrect password is entered, the device makes a warning and awaits a new entry.
The password can be changed at any time, but it cannot be disabled. For the process of password change, see
Chapter 3.2.1 Password Setting in the BTL-4000 Series USER’S MANUAL
Note
If you happen to forget your password, you can anytime use the universal one: 00000000.
On the therapy parameters screen it is possible to select individual laser therapies or laser sequences.
All pre-set therapy values are interconnected by the following mathematical relation:
2 2
Dose = Output * (DF/100) * Time / Area [J/cm ; W, %, s, cm ]
All pre-set values except frequency influence each other, and the device always tries to calculate the therapy
parameters in the way that the last pre-set parameter is at the value set by the user. Other parameters can be
changed, if necessary (except dose which is a key therapy parameter). Maximum values of parameters strongly
depend on the maximum power of the connected laser probe; therefore, some values can be set for the probe with the
output of 300mW but they are not allowed for the 30mW probe. When calculating therapy parameters the device tries,
if necessary, to adjust the output of the probe so that the therapy time is 1 minute.
2.2.1 Laser
2.2.1.1 Dose
This value represents the power density to the area [J/cm2]
It is a key therapy parameter – therefore its value is a fixed part of the
program (diagnosis) and the device does not change it at internal
calculations (the user can change it freely). Dose can be changed within the
range stated in the technical parameters of the device. It is the maximum
range, and in practice, with some types of probes it is not possible to reach
the upper limit because they do not have enough power for it and the
necessary time of therapy would exceed the limit of 99:59.
After pressing the dose button it is possible to set dose by steps by the select knob. It is also possible to set the value
directly by the numerical keyboard (see chapter 2.4.2 Numerical keyboard of the BTL-4000 Series USER’S
MANUAL). Under the displayed current value of dose there are "quick jump" buttons – after pressing one of them the
dose value changes to the value written on the button and further setting goes on from this value.
2.2.1.2 Frequency
This parameter states the number of cycles in the time interval of 1 sec, its
unit is Hertz [Hz].
The equipment works either in continuous (i.e. uninterrupted) or in pulse
mode. If the zero value of the laser beam output frequency is set, the
equipment works in the so-called continuous mode (it can be also recognized
visually – the laser beam shines constantly and does not blink). If a non-zero
positive value of frequency is set, the equipment works in the pulse mode
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(the laser beam is blinking). Note: the human eye can recognize blinking of the beam up to the frequency of approx.
25 Hz, higher frequencies are subjectively perceived by the human eye as continuous.
Frequency is a second key parameter of therapy – it is also a fixed component of the program (diagnosis) and the
device does not change it at internal calculations (the user can change it freely). Frequency can be set within the
range stated in the technical parameters of the device. The process of frequency setup is similar to that of other
therapy parameters.
After pressing the frequency button it is possible to set frequency by steps by the select knob. It is also possible to set
the value directly by the numerical keyboard (see Chapter 2.4.2 Numerical keyboard of the BTL-4000 Series
USER’S MANUAL). Under the displayed current value of frequency there are "quick jump" buttons – after pressing
one of them the frequency value changes to the value written on the button and further setting goes on from this
value. Frequency is set by certain preset steps.
Setting frequency to 0 means continuous operation.
Acupuncture therapy requires very precise setting of frequency to the values which cannot be set by steps. In such
case it is necessary to enter the exact value of frequency by the numeric keyboard, or to choose the respective
program or diagnosis (Nogier, EAV) in which the frequency is set to the required value.
2.2.1.4 Area
This therapy parameter is often changed by the user because each treated
part has a different size. This parameter is also available in the ergonomic
mode. When using a divergent probe the screen displays the distance
between the probe and the surface so that the irradiated area equals to the
pre-set one. The maximum displayed distance is 25 cm, and when irradiating
from larger distance the diverged laser beam is too dispersed and
therapeutic effects are lower. If the injured area is larger, it is necessary to
treat it similarly as with convergent probes and continuously "sweep" over the
affected area. With convergent probes, it is necessary to continuously sweep
the beam over the whole injured area. When calculating therapy parameters
the device assumes that the whole area is irradiated evenly, which is
achieved by the above-mentioned continuous sweeping.
The maximum accessible area also depends on the connected laser probe –
for low-power probes the maximum area that can be set can be reduced by
the device if the maximum therapy time 99:59 could be exceeded.
After pressing the area button it is possible to set the area by steps by the
select knob. It is also possible to set the value directly by the numerical keyboard (see chapter 2.4.2 Numerical
keyboard of the BTL-4000 Series USER’S MANUAL). Under the displayed current value of area there are "quick
jump" buttons – after pressing one of them the area value changes to the value written on the button and further
setting goes on from this value.
Area can be also changed directly by turning the intensity knob.
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Adiditional information:
pulse [ms], period [ms] – information about length of the pulse and of the period calculated from the pre-set
frequency and duty factor
Duty factor (DF) stated in [%] expresses the ratio of the pulse length ti to the period tp (see picture); it can be set only
in the pulse mode.
Change of value of the duty factor considerably influences the value of the average laser output. The following picture
shows comparison of two different duty factor settings, all other conditions being equal. From the picture it is apparent
that for higher DF the laser emits higher average output which implies shorter time of irradiation.
a) f = 10 Hz, P = 20 mW, DF = 50 %
Average output 10 mW
Output [mW]
20
Time [s]
ti=0.05 tm=0.05
tp=0.1
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b) f = 10 Hz, P = 20 mW, DF = 90 %
Average output 18 mW
Output [mW]
20
tm=0.01 Time [s]
ti=0.09
tp=0.1
A analgesic
F antiphlogistic
E antiedematous
B biostimulation
V vasodilatation
For the factory-preset programs and diagnoses, the effects are filled in. If you are not satisfied with them, you can edit
them and save the program as a user one.¨
Since a sequence is a series of individual existing therapies one after another, it is necessary that all programs to be
included in the sequence are created before creation of the sequence.
Unlike ultrasound and electro sequences, the laser sequences do not include the time parameter for individual
sections. Time for individual sections is displayed only for information and cannot be changed. The reason is that time
of individual sections is directly influenced by the dose, which is set in each individual section, and the currently
connected probe. Therefore where the probe is replaced, time of individual sections and thus also time of the whole
sequence changes. Time changes so that the needed dose is achieved in each section in the sequence. The total
time of the sequence is limited to 99:59.
The area is set globally for the whole sequence before the start of therapy.
Besides common settings, each generator has some specific setting items. These items are included in the specific
settings menu item which can differ äccording to which tab (generator) is active. The following part describes specific
settings for the laser generator.
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In case of any questions, contact the authorized BTL service department. It is also possible to buy the complete door
switch set from the BTL supplier.
2.3.2 Acupuncture
Using a special attachment, the laser generator can measure acupuncture.
Since this attachment is not standardly supplied with the device, the
acupuncture measuring function is off. This item serves for switching the
function on.
To find an acupuncture point, slowly sweep the probe with the acupuncture attachment above the place of an
expected location of the acupuncture point. After finding the acupuncture point it is possible to start therapy by
pressing the button on the probe. During irradiation the device suspends the search mode and returns to it after
stopping the therapy or after activating the pause.
Owing to the fact that the acupuncture attachment significantly attenuates the passing laser beam, the equipment
corrects the maximum adjustable output when irradiating in the acupuncture mode. If you irradiate using the
acupuncture attachment and the acupuncture mode is off, it is necessary to "manually" recalculate the dose or output
for the 85% attachment attenuation.
CAUTION
The self-calibration does not in any case replace the required regular calibration and check of the device by
the manufacturer or authorized service of BTL-4000 series devices.
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According to applicable standards, each laser generator must be equipped with the safety door switch which prevents
generation of the laser beam if the door is open and there is a real danger of hitting an unprotected person by the
laser beam. This door contact is brought to the rear panel of the device. Its position depends on the current
configuration of the device – see table Tab. 2.1 Configuration of output connectors in the BTL-4000 Series
USER’S MANUAL.
If the level on the connector's input is active (e.g. in case of open door) the equipment for safety reasons does not
allow to run a therapy. If a therapy is already running, it is interrupted (PAUSE status) and the screen displays a
warning, optionally together with a sound signal. The therapy can continue only after the signal on the connector's
input subsides (i.e. after closing the door), and it can be cancelled by the esc button. Any security equipment with
voltage output can be connected to this connector. Polarity of voltage does not matter, the equipment detects it and
adapts to it. The minimum voltage is 5V, maximum 35V. The current in the connector is max. 10mA. It is possible to
pre-set if the switch is considered active in the connected or disconnected status (with or without voltage supply).
Defaultly, the switch is set active in the connected status. For details on setting the activity of the door switch see
Chapter 2.3.1 Door Activity. Voltage is brought between the contacts of the connectors 3 and 4.
In case of any questions, contact the authorized BTL service department. It is also possible to buy the complete door
switch set from the BTL supplier.
Power source
AC/DC 5-35V / 10mA
Connector
Door contact
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Laser probes are used for laser beam therapy. There are many types manufactured, of various power, and the
customers can choose according to their needs.
power cable
direction of laser beam radiation
laser aperture
Note:
The probes are constructed in the way that the active area of the button does not protrude the outline of the probe.
This prevents from accidental pressing e.g. in case of laying the probe on a flat surface (such as a desk, etc.).
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Special lightguide attachments serve for leading the laser beam to hardly accessible places. The range includes
attachments for dentistry, gynaecology and otorhinolaryngology (ENT). The lightguide attachments reduce the
maximum achievable output of the probe which they are connected to – therefore, when they are used, it is necessary
to make adjustment of the dose or output according to the values given below in the parts concerning individual
attachments.
Note: The attachments are not included as standard accessories of the BTL-4000 series devices.
When using the dental optical attachment it is necessary to increase the dose by 15 % (when using probes with
wavelength of 685 nm or 830 nm).
When using the gynaecological optical attachment it is necessary to increase the dose by 25 % (when using probes
with wavelength of 685 nm or 830 nm).
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According to applicable standards, both the therapist and patient must use safety eyewear which prevents from
damage to eyes in case of undesirable hitting by the laser beam. The protective eyewear supplied by BTL was
approved by the Czech Occupational Safety Research Institute and certified under the number 235/T-010/1999.
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3 APPENDIX
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LASER RADIATION
CLASS III. B
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028-94supload_service100en
process of upload
Switch the device off by the mains switch (rocker switch on the rear panel). Connect the power adaptor to the device and
switch on the mains switch.
Then switch the device on by longer holding of the ON/OFF button on the front panel. After a while the button should light up
and after releasing it the device should remain in the ON status (shining). After some 15 seconds there should appear the
opening screen of the application. If the device contains the proper version of the application, do not continue. The version of
the application is stated in the initial title on the start-up screen (ver XX.XX.XXXX).
If the device contains only the program loader the display does not show anything, but the device remains in the ON status.
If the device contains different type or version of the application, use the same process.
connection to PC
Switch the device off, press simultaneously the two lower buttons (START/STOP1, START/STOP2) and the ENTER button
and, when holding them pressed, switch the device on. The display should remain dark and after a while (approx. 10
seconds) the device should play a short tune. If so, the device is in the mode for upload of firmware by external serial line.
Remove cover from service connector on bottom panel. Conect the loading cable to the service connector on the bottom
panel. The other end of the cable connect to the serial port of the PC – it is also possible to use the USB-COM adapter.
Start the "FirmwareLoader.exe" program on the PC.
We recommend setting the communication speed to 115200 bit/s.
The version of the loader can be found out after loading of HW Info (see below). If you are not sure you can leave this item
checked off, the loading will work even with the new devices, but it will be slower.
Set the proper communication port ("Settings" tab) and communication rate. It is possible to use the "Auto find" function
which will try to find the device in all available serial ports (only the ports really connected to the computer are displayed).
To check the connection with the device at any time press the "Check connection" button in the program. If everything works
OK, the dialog box with the message "Unit present" must appear then.
If there appears the message "Unit not found", the computer cannot connect to the device for a reason – it is necessary to
find out why, try to repeat the previous steps with other communication rate, check the cable, etc.
unit HW Info
Switch over to the "Unit info" tab and press the "Reload" button in the upper left corner of the window. The percentage status
of communication should appear at the bottom of the window.
After a while a table in the program should list the hardware configuration of the tested device.
On the "Unit info" tab you can see the hardware configuration of the device. The key data are especially the version of the
loader and the versions of particular printed circuits in the equipment. Unit info can be updated (reloaded from the device) at
any time by pressing the "Reload" button.
- 1 - TN02/07/04
028-94supload_service100en
loading of firmware
If the information in the Unit info is correct it is possible to start loading of firmware. Switch to the "Programming" tab.
Press the button with a directory tree symbol to select the file with the application to be loaded to the device
(028-56autoXXX.bin). The selected file is displayed in the upper field. The program remembers the last setting.
Press the "Program file auto" button to start the procedure which compares the selected file with data from the device – if the
device is compatible, this procedure modifies the loaded file according to parameters read from the device and starts loading
of the program to the device. If any problem occurs, there appears an error message with possible description of the error.
During loading the program informs about the current percentage status of completion.
If programming passed OK, there appears the dialog box "Complete OK". Now you can reset and disconnect the device.
To abort programming press the "Abort action" button. However, after starting a device with incompletely loaded firmware
there is a risk of its failure.
If this work with the device is complete, disconnect it by pressing the "Restart unit" button. The device first restarts itself and
then the PC disconnects from it.
- 2 - TN02/07/04
028-94supload_service100en
Appendix
Loading is completely automatic, i.e. it is not necessary to check the versions in the device and the loaded file. The program
automatically modifies itself according to the parameters read from the device – i.e., if the program finds out that the device
contains another type of hardware than is set in the loaded file, the loaded file is internally modified before loading so that it
corresponds to the configuration of the device. This automatic control is fully functional if there have not been any major
hardware changes in the device. If there have been such changes, it is necessary to load the correct new configuration (i.e.
file with the correct new hardware configuration) at least once to the device. A typical example is replacement of the supply
part in physiotherapy devices by a more powerful one: in such case it is not possible to load the universal file to the device
as usually, but at the first loading after the replacement it is necessary to load to the device a specific file containing this
change. Next loading works standardly with the automatic configuration.
It is possible to upload to several devices at the same time – their number is limited only by the number of COM ports on the
PC. Each of these devices has its own FirmwareLoader session running.
During loading do not move the window with the running application in the Windows environment, otherwise there is a risk of
a programming error – in such case restart programming.
- 3 - TN02/07/04
028-94supload_user100en
controls of FirmwareLoader
1 … path and name of the file with new firmware 7 … setting of communication speed
2 … button for starting of upload of new firmware 8 … cancelled
3 … button for searching for a file with new firmware 9 … cancelled
4 … process of upload of new firmware 10 … button for check of correct connection of the device to PC
5 … button for automatic searching 11 … button for restart of the device
6 … selection of communication port 12 … button for termination of the program FirmwareLoader
process of upload
Switch the device off by the mains switch (rocker switch on the rear panel). Connect the adaptor to the device and switch on
the mains switch. Then switch the device on by longer holding of the ON/OFF button on the front panel. After a while the
button should light up and after releasing it the device should remain in the ON status (shining). After some 15 seconds
there should appear the opening screen of the application. If the device contains the proper version of the application, do not
- 1 - TN02/07/2004
028-94supload_user100en
continue. The version of the application is stated in the initial title on the start-up screen (ver XX.XX.XXXX) or in the menu
item "unit settings" – "unit information".
connection to PC
Remove cover from service connector on bottom panel. Conect the loading cable to the service connector on the bottom
panel. The other end of the cable connect to the serial port of the PC – it is also possible to use the USB-COM adapter.
Switch the device off, press simultaneously the two lower buttons (START/STOP1, START/STOP2) and the ENTER button
and, when holding them pressed, switch the device on. The display should remain dark and after a while (approx. 10
seconds) the device should play a short tune. If so, the device is in the mode for upload of firmware by external serial line.
Set the correct communication port (6) and communication speed (7). It is possible to use the "Auto find" function (5) which
will try to find the device in all available serial ports. (Note: In some types of computer this function may not work reliably.)
Check the connection with the device by the "Check connection" button (10). If everything works OK, the dialog box with the
message "Unit present" must appear after pressing this button. If there appears the message "Unit not found", the computer
cannot connect to the device for a reason – it is necessary to find out why, try to repeat the previous steps with other
communication speed, check the cable, etc.
Note:
If the program does not find the device on the first try, it is suitable to press the "Check connection" button (10) for several
more times, the device could respond later.
loading of firmware
Do not switch the device and/or the PC during loading – incorrectly loaded firmware could cause locking of the
device (this status could require even a servicing intervention of the manufacturer).
During loading do not move the window with the running application in the Windows environment, otherwise there
is a risk of a programming error – in such case restart programming.
Press the "Browse file" button (3) with a directory tree symbol to select the file with the application to be loaded to the device.
The selected file is displayed in the upper field (1). The program remembers the last setting.
Press the "Program file auto" button (2) to start loading of the program to the device. First there is detected configuration of
the device and consistency of the loaded file. This part is indicated by the message "Reading unit information…" (4). If any
incompatibilities or other problems are found, there appears an error message with the description of the error. These errors
are usually caused by incorrect or corrupted input file – in such case it is necessary to get a new file.
After this testing the process of loading is started – it is indicated by the message "Programming…" (4). If any problem
appears during programming, an error message is displayed. During loading the program informs about the current
percentage status of completion. If an error occurs during programming, do not switch the device off and restart
programming. If the error repeats, contact the service department.
If programming passed OK, there appears the dialog box "Complete OK". Now you can reset and disconnect the device.
If this work with the device is complete, disconnect it by pressing the "Restart unit" button (11). The device first restarts and
then the PC disconnects from it. After restart of the device there should appear the standard opening screen of the
- 2 - TN02/07/2004
028-94supload_user100en
application and it is possible to standardly work with the device. To check that the new version of firmware is loaded in the
device, see the "unit information" menu item.
Disconnect serial cable from unit and put cover back to serial connector.
- 3 - TN02/07/2004
036-65gener108z1
EL+JCB09151XX0 L7 Bottom
EL+JCB09151XX0 L8 Top
EL+JCB09152XX0 L9 Top
EL+JCB09152XX0 L10 Top
EL+JCB09152XX0 L11 Top
EL+JCB09152XX0 L12 Top
EL+JCB09152XX0 L13 Top
EL+JCB09152XX0 L14 Bottom
EL+68U1.52AXX0 L15 Top
EL+JCB09152XX0 L16 Top
EL+JCB09151XX0 L17 Top
EL+JCB09151XX0 L18 Top
EL+JCB09151XX0 L19 Bottom
EL+JCB09151XX0 L20 Bottom
EL+JCB09151XX0 L21 Bottom
EL+JCB09151XX0 L22 Bottom
EL+JCB09151XX0 L23 Bottom
EL+JCB09151XX0 L24 Bottom
EL+JCB09151XX0 L25 Top
EL+JCB09151XX0 L26 Top
EL+JCB09151XX0 L27 Bottom
MTHOLE3.2_NONPLATED MH1 Top
MTHOLE3.2_NONPLATED MH2 Top
MTHOLE3.2_NONPLATED MH3 Top
MTHOLE3.2_NONPLATED MH4 Top
MTHOLE3.2_NONPLATED MH5 Top
MTHOLE3.2 MH6 Top
MTHOLE3.2_NONPLATED MH7 Top
MTHOLE3.2_NONPLATED MH8 Top
MTHOLE3.2_NONPLATED MH9 Top
NAVADECI_ZNACKA_BUTTERFLY NZ1 Top
NAVADECI_ZNACKA_BUTTERFLY NZ2 Bottom
NAVADECI_ZNACKA_BUTTERFLY NZ3 Top
NAVADECI_ZNACKA_BUTTERFLY NZ4 Bottom
NAVADECI_ZNACKA_BUTTERFLY NZ5 Top
NAVADECI_ZNACKA_BUTTERFLY NZ6 Bottom
NAVADECI_ZNACKA_BUTTERFLY NZ7 Top
NAVADECI_ZNACKA_BUTTERFLY NZ8 Bottom
ER+10R0.1WXXF R1 Top
ER+47R0.1WXXF R2 Top
ER+10K0.1WXXF R3 Bottom
ER+47K0.1WXXF R4 Bottom
ER+47K0.1WXXF R5 Bottom
ER+4K70.1WXXF R6 Top
ER+0RXX1 R7 Bottom
ER+470R0.1WXXF R8 Top
ER+47K0.1WXXF R9 Top
ER+4K70.1WXXF R10 Top
ER+470R0.1WXXF R11 Bottom
ER+470R0.1WXXF R12 Bottom
ER+470R0.1WXXF R13 Bottom
ER+470R0.1WXXF R14 Top
ER+470R0.1WXXF R15 Top
ER+4K70.1WXXF R16 Top
ER+4K70.1WXXF R17 Bottom
ER+4K70.1WXXF R18 Bottom
028-65shcpu103z2
ED+US1G400VXX0 D1 Top
ED+US1G400VXX0 D2 Top
ED+US1G400VXX0 D3 Top
EDD+BAV99XX0 DD1 Top
EDD+BAV99XX0 DD2 Top
EDD+BAV99XX0 DD3 Top
EDD+BAV99XX0 DD4 Top
EDD+BAV99XX0 DD5 Top
EDD+BAV99XX0 DD6 Top
EDD+BAV99XX0 DD7 Top
EDD+BAV99XX0 DD8 Top
EDD+BAV99XX0 DD9 Top
EDD+BAV99XX0 DD10 Top
EDD+BAV99XX0 DD11 Top
EDD+BAV99XX0 DD12 Top
EDD+BAV99XX0 DD13 Top
EDD+BAV99XX0 DD14 Top
EDD+BAV99XX0 DD15 Top
EDD+BAV99XX0 DD16 Top
EDD+BAV99XX0 DD17 Top
EDD+BAV99XX0 DD18 Top
EDD+BAV99XX0 DD19 Top
EDD+BAV99XX0 DD20 Top
EDD+BAV99XX0 DD21 Top
EDD+BAV99XX0 DD22 Top
EDD+BAV99XX0 DD23 Top
EDD+BAV99XX0 DD24 Top
EDD+BAV99XX0 DD25 Top
EDL+SMDYELOWXX0 DL1 Top
EJ-MLW10GXX0 J6 Top
EL-3UXXM L1 Top
EL-6UXXM L2 Top
EL+JCB09152XX0 L3 Top
EL+JCB09152XX0 L4 Top
EL+JCB09151XX0 L5 Top
EL-0.2UXX0 L6 Top
EL-0.2UXX0 L7 Top
EL-0.2UXX0 L8 Top
EL+JCB09151XX0 L9 Top
EL+JCB09151XX0 L10 Top
EL+JCB09151XX0 L11 Top
EL+JCB09151XX0 L12 Top
EL+330U0.68AXX0 L13 Top
EL-3UXXM L14 Top
EL+JCB09151XX0 L15 Top
EL+JCB09151XX0 L16 Top
EL+220U0.66AXX0 L17 Top
EL+JCB09151XX0 L18 Top
EL-6UXXM L19 Top
MTHOLE3.2_NONPLATED MH2 Top
MTHOLE3.2_NONPLATED MH3 Top
MTHOLE3.2_NONPLATED MH4 Top
NAVADECI_ZNACKA_BUTTERFLY N1 Top
NAVADECI_ZNACKA_CIRCLE N2 Top
NAVADECI_ZNACKA_BUTTERFLY N3 Top
NAVADECI_ZNACKA_DIAMOND N4 Top
037-65gener151
NAVADECI_ZNACKA_CIRCLE N5 Top
NAVADECI_ZNACKA_DIAMOND N6 Top
NAVADECI_ZNACKA_BUTTERFLY N7 Top
NAVADECI_ZNACKA_CIRCLE N8 Top
NAVADECI_ZNACKA_DIAMOND N9 Top
EO+PC817XX0 O1 Top
EO+H11L1VXX0 O2 Top
EO+PC817XX0 O3 Top
EO+H11L1VXX0 O4 Top
ER+47K0.1WXXF R1 Top
ER+4K70.1WXXF R2 Top
ER+22K0.1WXXF R3 Top
ER+47K0.1WXXF R4 Top
ER+47K0.1WXXF R5 Top
ER+47K0.1WXXF R6 Top
ER+220R0.1WXXF R7 Top
ER+220R0.1WXXF R8 Top
ER+100K0.1WXXF R9 Top
ER+47K0.1WXXF R10 Top
ER+10R0.1WXXF R11 Top
ER+47K0.1WXXF R12 Top
ER+10R0.1WXXF R13 Top
ER+47K0.1WXXF R14 Top
ER+10R0.1WXXF R15 Top
ER+10R0.1WXXF R16 Top
ER+220R0.1WXXF R17 Top
ER+220R0.1WXXF R18 Top
ER+10R0.1WXXF R19 Top
ER+47K0.1WXXF R20 Top
ER-0.16R0.6WXX0 R21 Top
ER-0.16R0.6WXX0 R22 Top
ER-0.16R0.6WXX0 R23 Top
ER+10R0.1WXXF R24 Top
ER+47K0.1WXXF R25 Top
ER+1K0.1WXXF R26 Top
ER+1K0.1WXXF R27 Top
ER+220R0.1WXXF R28 Top
ER+220R0.1WXXF R29 Top
ER+10R0.1WXXF R30 Top
ER+10R0.1WXXF R31 Top
ER+47R0.1WXXF R32 Top
ER+10R0.1WXXF R33 Top
ER+10R0.1WXXF R34 Top
ER+10R0.1WXXF R35 Top
ER+10R0.1WXXF R36 Top
ER+10R0.1WXXF R37 Top
ER+10R0.1WXXF R38 Top
ER+10R0.1WXXF R39 Top
ER+10R0.1WXXF R40 Top
ER+47K0.1WXXF R41 Top
ER+10R0.1WXXF R42 Top
ER+10R0.1WXXF R43 Top
ER+47R1WXXJ R44 Top
ER+47R1WXXJ R45 Top
ER+47R1WXXJ R46 Top
ER+10K0.1WXXF R47 Top
037-65gener151
output 6 output 5
MEC 106 MEC 105
J16 at M028-52POWERxxx J20 at M028-52POWERxxx
Position 2 MEC2
Position 1 MEC1
M031-52GENERxxx L
channel A J1
channel B J2
acupuncture J3
door J4
M036-52GENERxxx E
pat. output J2
sync IN J5
sync OUT J4
M037-52GENERxxx S
M037-52GEN2Mxxx T
channel A J2
channel B J3
electro IN J4
electro OUT J5
Page 1 of 4 AM23/04/2004
028-gener100z1
Page 2 of 4 AM23/04/2004
028-gener100z1
2810T, 2815T, 2821T OPTI M028-S2810T100
Page 3 of 4 AM23/04/2004
028-gener100z1
4120 PROFI M021-S4120100
Page 4 of 4 AM23/04/2004
Test protocol 028-96prien100z2
Type of unit: Configuration: Colour of frame:
BTL-4110 [L1] Blue
BTL-4120 [L1, L2] Yellow
BTL-2210 [T1]
BTL-2710 [U1]
DIAG
Measuring conditions: ambient temperature: ..………........……°C mains voltage (215 to 240V): ............…....……...………….……………….V
Used equipment:
test device TK01 №:...TK01-E.................................................................... HV supply V199-VNZDROJ10x №: ...V199-E..............................................
multimeter TM03 №:...TM03-E................................................................... test electro load №: ...V236-E.......................................................................
ultrasound heads BTL-237 №: ... M237-HEAD1110..... M237-HEAD4110..... M237-HEAD12110..... M237-HEAD42110..................................
ultrasound scales №: ................................................................................................................................................................................................................
test laser probe BTL-448 685 nm №:.....V448-E........................................ test laser probe BTL-448 830 nm №:.....V448-E..........................................
burn-in ultrasound heads, burn-in simulator of laser probe, PC
Other: ........................................................................................................................................................................................................................................
..................................................................................................................................................................................................................................................
1. Basic setting of device (contrast, language, touch panel, RTC …)................................................................................................... YES NO
2. Burn-in of device. Time of burning:..............................................................................................................................................................................hr
3. Check of leakage currents according to OTP-126
a) Leakage current between patient part A and patient part B: less than 90 µA: ..................................................................................................... µA
b) Leakage current between connector door and patient parts: less than 90 µA (applicable only for units with laser generator): ........................... µA
4. Check of insulation:
a) between L1A and L1B: more than 3 MΩ, standardly more that 19.99 MΩ ............................................................................................................ MΩ
b) between L2A and L2B: more than 3 MΩ, standardly more that 19.99 MΩ ............................................................................................................ MΩ
c) between U1A and U1B: more than 3 MΩ, standardly more that 19.99 MΩ............................................................................................................ MΩ
e) between T1A and T1B: more than 3 MΩ, standardly more that 19.99 MΩ ............................................................................................................ MΩ
5. Check of insulation barriers according to OTP-124
a) Insulation barrier patient part A to patient part B: 3 600 V; less than 5 µA: ......................................................................................................... µA
b) Insulation barrier connector door to patient parts: 4 800 V; less than 5 µA (applicable only for units with laser generator):................................ µA
6. Run ultrasound heads calibration (only for unit configuration containing U1, U2, T1, T2) ............................................ N/A YES NO
7. Run internal final check in unit
a) Check of appearance, LCD and buttons assembly (step 1, 4) .................................................................................................... YES NO
b) Check of mechanical and electrical function of all buttons and encoders (step 2, 3) .................................................................. YES NO
c) The device does not clatter when shaken (step 5) ...................................................................................................................... YES NO
d) Type, serial and safety labels are properly stuck-on (step 6) ...................................................................................................... YES NO
e) Check hard reset function (step 8) ............................................................................................................................................... YES NO
Page 1 of 2 JD24/05/2004
Test protocol 028-96prien100z2
d) Check E2 output current +15mA (only for unit configuration containing E2): from 13.5 mA to 16.5 mA .............................................................mA
e) Check E2 output voltage reduction (only for unit configuration containing E2): from 75 mA to 99 mA................................................................mA
f) Check E2 output voltage -15V (only for unit configuration containing E2): from -16.5 V to -13.5 V .......................................................................V
g) Check U1A output power 6.4W / 1MHz (only for unit configuration containing U1): from 5.44 W to 7.36 W.........................................................W
h) Check U1A output power 6.4W / 3MHz (only for unit configuration containing U1): from 5.44 W to 7.36 W.........................................................W
i) Check U1B output power 6.4W / 1MHz (only for unit configuration containing U1): from 5.44 W to 7.36 W.........................................................W
j) Check U1B output power 6.4W / 3MHz (only for unit configuration containing U1): from 5.44 W to 7.36 W.........................................................W
k) Check T1A output power 6.4W / 2MHz (only for unit configuration containing T1): from 5.44 W to 7.36 W .........................................................W
l) Check T1B output power 6.4W / 2MHz (only for unit configuration containing T1): from 5.44 W to 7.36 W .........................................................W
m) Check L1A laser emitting (only for unit configuration containing L1) ......................................................................... N/A YES NO
n) Check L1B laser emitting (only for unit configuration containing L1) ......................................................................... N/A YES NO
o) Check L2A laser emitting (only for unit configuration containing L2) ......................................................................... N/A YES NO
p) Check L2B laser emitting (only for unit configuration containing L2) ......................................................................... N/A YES NO
11. Check again of cleaning of touch-panel, LCD display and unit body........................................................................................... YES NO
12. Mains switch on adaptor BTL-228 is in position by order (115 or 230) ......................................................................................... 115 230
13. Packaging, completing of accessories:
Page 2 of 2 JD24/05/2004
Test protocol - appendix 028-96prien100z2
Type of MAINS for each unit type (use proper mdf file during first upload of firmware “028-PCBV_xxx_MAINSV_POWx.mdf”):
2610, 2615, 2621 - MAINSV_POWB 4610, 4615, 4621 - MAINSV_ POWB
2620, 2625, 2640 - MAINSV_POWA 4620, 4625, 4640 - MAINSV_POWA
2110 - MAINSV_ POWB 4110 - MAINSV_ POWB
2120 - MAINSV_POWA 4120 - MAINSV_POWA
2710, 2210 - MAINSV_POWA 4710, 4210 - MAINSV_POWA
2810S, 2815S, 2821S - MAINSV_POWA 4810S, 4815S, 4821S - MAINSV_POWA
2810T, 2815T, 2821T - MAINSV_POWA 4810T, 4815T, 4821T - MAINSV_POWA
2810L, 2815L, 2821L - MAINSV_POWA 4810L, 4815L, 4821L - MAINSV_POWA
2800SL, 2800TL - MAINSV_POWA 4800SL, 4800TL - MAINSV_POWA
After uploading enter the correct serial number using the "FirmwareLoader" – tab “Serial Number”
By order enter the correct HW_KEY mode using the "FirmwareLoader" – tab “HW key”
For OPTI model (yellow case) unit there are 6 possibilities - select one by order
“KEY_MODE_OPTI_BASIC” – 2800xx, 2x10, 2810x, 2x20
“KEY_MODE_OPTI_PLUS” – 2615, 2625, 2815x, 2825x
“KEY_MODE_OPTI_FULL” – 2621, 2640, 2821x
For PROFI model (blue case) unit there are 3 possibilities - select one by order
“KEY_MODE_PROFI_BASIC” – 4800xx, 4x10, 4810x, 4x20
“KEY_MODE_PROFI_PLUS” – 4615, 4625, 4815x, 4825x
“KEY_MODE_PROFI_FULL” – 4621, 4640, 4821x
Step B
Only for factory:
Enter "menu-menu-service functions special-factory settings". Run the "format all disks" function (after formatting the device will be restarted).
Step C – point 1
Only for factory:
• Calibrate battery – only for PROFI units (blue case).
("menu-menu-service functions special-factory settings-callibration of battery") – Measure real battery voltage by TM03 (battery voltage is
accessible on test points behind connector for firmware uploading.
• Set/check the RTC time and date.
("menu-service functions special-factory settings-setting of system time and date")
• Set/check the display contrast to be optimum.
("menu-service functions special-factory settings-syst. contrast setting")
• Set/check the system language to "English".
("menu-service functions special-factory settings-system language")
Step D
Switch the device over to the service mode (hold the ENTER button pressed when switching the device on by the ON/OFF button. The main switch is in
the "1" position and the device is plugged thru adaptor BTL-228 to the mains). Enter the password for the service mode. If the laser generator is
mounted in the device, enter first the password "0000".
Step E – point 2
After the restart enter the service mode again. Connect the proper accessories to the generator outputs: burn in laser probe for laser generator, burn-in
ultrasound head for ultrasound generator and test electro load for electro generator. Run the "burn-in" function in "menu-menu-service functions special-
factory settings-burn in" or "menu-menu-service functions special-service functions-burn in". It is recommended to let the device burn in for at least 10
hours.
For service except factory
Function is available to run from "menu-menu-service functions special-service functions-burn in"
Step F – point 3, 4
Using the TK01 device check the leakage currents and insulation.
Step G – point 5
Using the high-voltage equipment check the insulation barriers.
Step H – point 6
Switch the device over to the service mode.
ATTENTION
During calibration in water the metal part of the head must not touch the wall or the bottom of the vessel. The calibration vessel containing water must be
adapted against standing wave. During calibration in air the metal part of the head must not touch anything (it must not lay on the table, etc.).
Step I - point 7
Switch the device over to the service mode.
Enter "menu-menu-service functions special-factory settings". Run function "final check" and select "start".
Go successively through all points of the final inspection. Al tests must end up with the "pass" result. Fill the partial results in the report.
For service except factory
Function is available to run from "menu-menu-service functions special-service functions-final check"
to 7o) Only for PROFI unit. Unplug connector of adapter from unit. Unit must still work. Plug again connector of mains adapter, symbol of battery on the
LCD must start to display “charging”.
Step J - point 8
Switch the device to the service mode for measuring of output values (password "123456789")
to 8.a) (only for unit configuration containing E1)
Connect alternative load (1000 Ω ± 1 % / 10 W) to output E1. Switch over to tab E1. Select the MAN mode and set therapy to "galvanic current" or
program 0001. Type: continuous, mode: cc, polarity: positive. Run therapy and measure and write down the current flowing through the alternative
load.
to 8.b) (only for unit configuration containing E1)
Connect alternative load (1000 Ω ± 1 % / 10 W) to output E1. Switch over to tab E1. Select the MAN mode and set therapy to "2-pole interference" or
program 0810. Carrier frequency: 4000Hz, polarity: positive, mode cc, polarity: positive. Run therapy and set current to 100mA. Wait until (if) the
device reduces intensity and then measure and write down the current flowing through the alternative load.
to 8.c) (only for unit configuration containing E1)
Do not connect anything to output E1 (disconnect the alternative load). Switch over to tab E1. Select the MAN mode and set therapy to "galvanic
current" or program 0001. Type: continuous, mode: cv, polarity: negative. Measure and write down the voltage on the output.
to 8.d) (only for unit configuration containing E2)
Connect alternative load (1000 Ω ± 1 % / 10 W) to output E2. Switch over to tab E2. Select the MAN mode and set therapy to "galvanic current" or
program 0001. Type: continuous, mode: cc, polarity: positive. Run therapy and measure and write down the current flowing through the alternative
load.
to 8.e) (only for unit configuration containing E2)
Connect alternative load (1000 Ω ± 1 % / 10 W) to output E2. Switch over to tab E2. Select the MAN mode and set therapy to "2-pole interference" or
program 0810. Carrier frequency: 4000Hz, polarity: positive, mode cc, polarity: positive. Run therapy and set current to 100mA. Wait until (if) the
device reduces intensity and then measure and write down the current flowing through the alternative load.
to 8.f) (only for unit configuration containing E2)
Do not connect anything to output E2 (disconnect the alternative load). Switch over to tab E2. Select the MAN mode and set therapy to "galvanic
current" or program 0001. Type: continuous, mode: cv, polarity: negative. Measure and write down the voltage on the output.
Step K – point 10
Switch the device on in the standard regime and enter "menu-menu-unit settings-service functions". Run function "file system formatting". After
completion the device restarts (and thus sets to the default state). DO NOT ENTRY IN THE SERVICE MODE!
Step L – point 11
Check again that the touch panel as well as the whole device is clean.
Step M – point 12
Set adapter on the proper mains according order. Apply the step only if it is possible.
Step N
Perform all the still uncompleted points of the Test Report.
A B 10,91
A A
1,36
5
°
92
°
B 92 B
51,44
57,54
C C
C C
1,11
2°
116,62 - 0,10
112,22
8,90
1,60
2°
1
1,11
D D
51,44
57,54
E E
1,36
F A B 1,80 F
0 A-A B-B
31,63 - 0,10
0,80 2°
91
22,60 8,91
,50
°
20,01 0,80
1,80
0,50
3,50
5,94°
G G
3,30
2
13,32°
5
1,80
91,
1,30
8,90 - 0,10
50°
1,30
,50
0
91
2,10 1 2,10
A A
B B
C C
D D
E E
F F
Název výrobku:
H Product name: SKLÍCKO CÍSLICOVEK H
Kreslil: Materiál:
Drawn by:
JM17/06/03 MAKROLON 2805 FARBE 750 359 svetlý
Konstr: Povrch. úprava : Merítko:
Designed by: JM17/06/03 Surface finish: Scale: 2:1
Medical Technologies Schválil: List: z Císlo výkresu:
Approved by: TN18/06/03 Sheet: 2 of 2 Sheet number: 028-3201100
1 2 3 4 5 6 7 8 9 10 11 12
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
A A
53
5,30
3,20
2,50
1
B B
°
95
65
°
,50
88
5,30
3,20
2,50
C C
1
91
,50
°
2
B-B
D
B B D
E E
A A
116,92
68,24
138
24,93
156
138
F F
G G
17,96 205
H H
R5
60
°
J J
R1
55,50
43
D C 48,94
D
K 46,60 K
R4
46,60 3
3,60 R572
97,82
R2
10
3
25°
5
20
2,50
5,30
3,20
23,15
23,45 PASOVAT S OSTATNÍMI DÍLY SESTAVY
4,75
L L
2°
1 23,15
110 23,45 VŠECHNY VNEJŠÍ VIDITELNÉ PLOCHY DEZÉN VDI3400 REF.32
47,28
42
23,15
7,90
48,87
2,50
6
30°
11,50
D-D A-A
Název výrobku:
Product name: RÁMECEK
M M
32,50 Kreslil: Materiál:
234,05 Drawn by: JM19/06/03 ABS RAL 2506015
Konstr: Povrch. úprava : Merítko:
Designed by: JM19/06/03 Surface finish: Scale: 1:1
Medical Technologies Schválil: List: z Císlo výkresu:
Approved by: TN20/06/03 Sheet: 1 of 1 Sheet number: 028-3101100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
1 2 3 4
A A
40x45 10 40x45
32
32
22,63
- 0,20
38,50
45°
45°
0
44
B B
1,50
R0
,4
M
17,37
3-
3x
7
38
28
C TYTO HRANY SRAZIT C
(PRUCHOD KABELU)
4,5
0
D -2 D
22
90
E E
160
A A
157,40
116,52
3
5
35
37
°
,50
B B
88
C C
88 2,50
,50
°
1,50
2
D D
2,50
° D-D
128,67 134,60 ,50
88
123,54
A 4,17 7 4,17
15 52
52 50,18 4,17 7 2,30 35
0
R600 12
3,2
2,50
0,80
E E
1
5,5 R8
0
24,43
2,5
0 2,50 13,87
3,2
0
105,65
5,50
D D
8
35 17,50
6
F 35 F
82
24,55
35 1,40
95
25,31
1,40
0
R4
2,5
3,20
R2
R6 ,30
11,50
0,2
R0
5
95°
G 6 G
17
8,50
6
0
80
3,2 118
B
R0,
,80
30°
R0
C C
293
H H
177,40
5°
10
333,23
2
126,87
120°
20,19
3 2
15° 2,50 3
J J
205
88,70
5,30 5
9,20
13
2,50
1
K K
13 R3
5
5
89,27 80
55,50
°
0
32°
3,2 69
29,46
R2
5
0
6,2
2,50
1
L 11 L
18
R3 3,20
3,20 8 5
2,5
0 51 R4
A
1
3
53
21,20
7,03
46,24
A-A
62,43
1
138
68
1
5,15
M M
35
31,69
3,60 2
8,15
23,30
2,50
1,30
46,60
130
8,15
R2
5,15
34
1
,80
R0
N N
1,20
65
R8
°
91
,50 1,50
9
° R0,
30 1,20
79,50
68,50
P P
50,33
26
46,85
R5
2,20
49,85 5
6,7
116,7
70,84
8
0
5
119,7 12
Q 126 39,50 PASOVAT S OSTATNÍMI DÍLY SESTAVY Q
79
VŠECHNY VNEJŠÍ VIDITELNÉ PLOCHY (SPECIFIKOVÁNO NA ZVL. VÝKRESU) DEZÉN VDI3400 REF.32
OSTATNÍ PLOCHY TECHNICKÝ LESK
5,50
5
134,21
B Zmena: Popis zmeny: Kreslil: Konstruoval: Schválil: Pred. verze:
1,30
15°
1
Approved by:
1,80
Change No.: Change description: Drawn by: Designed by: Prev. ver.:
160 92
,50 3
°
C-C
Název výrobku:
R Product name: HORNÍ DÍL R
2,50
14 Kreslil:
JM27/06/03
Materiál:
Drawn by: ABS RAL7035
51 Konstr:
JM27/06/03
Povrch. úprava :
Surface finish:
Merítko:
1:1
Designed by: Scale:
Medical Technologies Schválil: List: z Císlo výkresu:
Approved by:
TN30/06/03 Sheet: 1 of 1 Sheet number: 028-1401100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
138,07
30 15
A A
157
18
2
5
13,20
2
80
1
12,
40
19,50
11,80
2
B B
2
12
0,97
9
°
135
16 152,89
138,28
C 142,90 C
D-D
134,60
39,50
23,30
C
2,40
D 3 B D
2,50
2,50 2
2,10
2
0
13,50
9,49
6
1,20 7,31
35,81
40 4 2,40
1,20
56,84
2
18
61,63
3,20
10°
9
E 1,50 33,84 E
72
88,14
3,20
29,72
2,50
45,50
122,80 82,50
0,70
2
18
24
1,50
F F
35 35 B 20
5
80
40
ZÁVITOVÁ VLOŽKA M4 23 1
0,30
B-B
126
88,70
G G
10
30 30 30 30
R0,5
D D
0
205
335,34
80
H H
6 1,50 6,20
1,50
40
217,50
88,70
3,20
226,50
2,50
J J
122,80
8
2,50
20 22 115
80
1,50
10,48
7,83
6
100,20
270,55
3,30
4,20
K K
1,50
16
7,20
4 1,50
2,50
2,50
0
3,2
40
20
2
9
L L
326,84 PASOVAT S OSTATNÍMI DÍLY SESTAVY
7,30
10,33
OSTATNÍ PLOCHY TECHNICKÝ LESK (VCETNE PLOCH PRO ŠTÍTKY A NOŽICKY)
5
4,52
55,30 55
45° Zmena: Popis zmeny: Kreslil: Konstruoval: Schválil: Pred. verze:
0,80 1,50 Change No.: Change description: Drawn by: Designed by: Approved by: Prev. ver.:
134,60
M
2 57
C Název výrobku:
Product name: SPODNÍ DÍL M
C-C Kreslil:
JM19/06/03
Materiál:
Drawn by: ABS RAL 7045
Konstr: Povrch. úprava : Merítko:
Designed by: JM19/06/03 Surface finish: Scale: 1:1
Medical Technologies Schválil: List: z Císlo výkresu:
Approved by: TN20/06/03 Sheet: 1 of 2 Sheet number: 028-1301100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
A A
B B
C C
ZÁVITOVÁ VLOŽKA M4
D D
E E
F F
G G
H H
J J
K K
L L
PASOVAT S OSTATNÍMI DÍLY SESTAVY
VŠECHNY VNEJŠÍ VIDITELNÉ PLOCHY DEZÉN VDI3400 REF.32
OSTATNÍ PLOCHY TECHNICKÝ LESK
Název výrobku:
M Product name: SPODNÍ DÍL M
Kreslil: Materiál:
Drawn by: JM19/06/03 ABS RAL7045
Konstr: Povrch. úprava : Merítko:
Designed by: JM19/06/03 Surface finish: Scale: 1:1
Medical Technologies Schválil: List: z Císlo výkresu:
Approved by: TN20/06/03 Sheet: 2 of 2 Sheet number: 028-1301100
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Medical Technologies