058 80manen02102
058 80manen02102
BTL-4000 PREMIUM
USER’S MANUAL
101IE30/07/2008EN
CONTENT
1 BASIC CHARACTERISTICS OF THE DEVICE.................................................................................................................5
1.1 Intended Use ...................................................................................................................................................... 5
1.1.1 Electrotherapy ............................................................................................................................................... 5
1.1.2 Ultrasound Therapy ...................................................................................................................................... 5
1.1.3 Laser Therapy ............................................................................................................................................... 5
1.1.4 Magnetotherapy ............................................................................................................................................ 5
1.2 User Profile ......................................................................................................................................................... 6
1.3 Operating Environment ....................................................................................................................................... 6
1.4 Patient Profile ..................................................................................................................................................... 6
2 SAFETY PRECAUTIONS ..................................................................................................................................................7
2.1 General Safety Precautions for Device Operation .............................................................................................. 7
2.2 Specific Safety Precautions for Electrotherapy ................................................................................................... 9
2.3 Specific Safety Precautions for Ultrasound Therapy ........................................................................................ 11
2.4 Specific Safety Precautions for Laser Therapy ................................................................................................. 11
2.5 Specific Safety Precautions for Magnetotherapy .............................................................................................. 12
2.6 Specific Safety Precautions for Combined Therapies ....................................................................................... 13
2.7 Possible Side Effects ........................................................................................................................................ 13
2.7.1 Possible Side Effects for Electrotherapy ..................................................................................................... 13
2.7.2 Possible Side Effects for Ultrasound Therapy ............................................................................................. 13
2.7.3 Possible Side Effects for Laser Therapy ..................................................................................................... 13
2.7.4 Possible Side Effects for Magnetotherapy .................................................................................................. 13
3 CONTRAINDICATIONS ..................................................................................................................................................14
3.1 General Contraindications for Physiotherapy ................................................................................................... 14
3.2 Special Contraindications for Physiotherapy .................................................................................................... 14
3.2.1 Contraindications for Electrotherapy ........................................................................................................... 14
3.2.2 Contraindications for Ultrasound Therapy ................................................................................................... 15
3.2.3 Contraindications for Laser Therapy ........................................................................................................... 15
3.2.4 Contraindications for Magnetotherapy ........................................................................................................ 15
4 SYMBOLS AND MARKING OF THE DEVICE ................................................................................................................16
5 INSTRUCTIONS FOR OPERATION ...............................................................................................................................17
5.1 Front Panel of the BTL-4000 Smart .................................................................................................................. 17
5.2 Front Panel of the BTL-4000 Premium ............................................................................................................. 18
5.3 Rear Panel of the Device – Model without Magnetotherapy ............................................................................. 19
5.4 Rear Panel of the Device – Model with 2 Channel Magnetotherapy ................................................................. 20
5.5 Rear Panel of the Device – Model with 4 Channel Magnetotherapy ................................................................. 21
5.6 Putting the device into operation ...................................................................................................................... 22
5.6.1 Connecting the Accessories ....................................................................................................................... 23
5.6.2 Accessories Holders ................................................................................................................................... 24
5.7 Description of the Device Control ..................................................................................................................... 25
5.7.1 Touch Screen.............................................................................................................................................. 25
5.7.2 Initial HOME Screen – Screen for the Selection of Therapy Type .............................................................. 26
5.8 Principles of Therapy Setting ............................................................................................................................ 27
5.8.1 Setting a Therapy by Selecting from the List of Therapeutic Protocols – LIST Screen ............................... 27
5.8.2 Quick Therapeutic Protocol Selection – QUICK Screen ............................................................................. 28
5.8.3 User Settings of Therapy Parameters – MANUAL Screen.......................................................................... 29
5.8.4 Setting of the Therapy Time ........................................................................................................................ 31
5.8.5 Setting of the Therapy Intensity / Dose ....................................................................................................... 31
5.8.6 Selection of Accessories ............................................................................................................................. 32
5.8.7 Combination Therapies ............................................................................................................................... 34
5.9 Process of Treatment ....................................................................................................................................... 34
5.9.1 Start – Interruption – End of Therapy .......................................................................................................... 34
Both variants of the device – BTL-4000 Smart and BTL-4000 Premium – are equipped with a colour touch screen
which considerably simplifies its operation. The therapy is simply started by a quick selection from a list of most
frequently used therapeutic protocols or by selecting from a list of all therapeutic protocols. A sophisticated function of
the device is the possibility to select the optimum therapy based on the required therapeutic effect or place of
application.
You can easily adjust any therapy parameter using the buttons on the touch screen and/or on the front panel of the
device. Throughout the therapy the device keeps you informed on the screen about the applied therapy type,
accessories used, remaining therapy time and main therapy parameters.
1.1.1 Electrotherapy
Electrotherapy is a non-invasive therapeutic method based on electrical current flow through human tissues. The
electric current is applied with the use of electrodes directly through patient’s skin. The use of electrotherapy is
accepted in the field of rehabilitation for acute and chronic pain management, treatment of nerve and muscle tissue
dysfunctions, treatment of post-traumatic joint mobility impairments, acute and chronic oedema reduction and
peripheral blood flow increase.
Ultrasound therapy is a non-invasive therapeutic method which uses mechanical energy of longitudinal waves
penetrating deep through human soft-tissues resulting in local increase of blood flow and metabolism. The ultrasound
therapy is mainly intended for treatment of muscle and connective tissue disorders, reduction of post-traumatic
conditions as oedema and healing process acceleration.
Low-level laser therapy is a non-invasive therapeutic method based on application of coherent, polarized,
monochromatic light in a form of laser beam. The laser beam is absorbed in human tissues and its energy is
transmitted to the tissue cells to help restore their normal function. The effect is above all bio-stimulating,
regenerating, anti-inflammatory and analgesic, based on the induced photochemical reactions. Low-level laser is
useful in the therapy of painful disorders of the musculoskeletal system, in the therapy of inflammatory conditions of
skin, mucosa and soft-tissue and in accelerated healing of wounds (e.g. burns, scars) and soft-tissue injuries.
1.1.4 Magnetotherapy
Read the User’s Manual carefully and become familiar with all its safety requirements, operating
procedures and maintenance instructions before using the device. It is prohibited to use the device and its
accessories in any manner that is not in accordance with the User’s Manual.
If the device is used in compliance with the User’s Manual and all operating and maintenance conditions, safety
precautions and contraindications are observed, no adverse side effects of electrotherapy, ultrasound therapy,
laser therapy and magnetotherapy are known.
The device can consist of up to three generators. Four types of generators are available – generators for
electrotherapy, ultrasound therapy, laser therapy and magnetotherapy. It is allowed to start up to three therapies
at a time. The device is certified to perform the therapy on one patient.
Before the first plug-in of the device, check whether the parameters of the mains meet the device requirements
stated in the Chapter Technical Parameters of this User’s Manual. The mains to which the device will be
connected must be installed and revised according to the current standards for electrical installations in medical
locations.
The device must be powered exclusively by the power adaptor supplied together with the device (for the type of
the power adaptor see Technical Parameters). The use of any other power adaptor than stated may cause
serious damage to the device and be a risk to the patient’s and operator’s health. Do not use extension cords
with multiple sockets or multi-socket adaptors. To disconnect the device from the mains, detach the power
adaptor from the device, unplug the supply cable from the socket or disconnect the supply cable from the power
adaptor.
The device must be transported, stored and operated in the environment defined in the Chapter Technical
Parameters of this User’s Manual. The device is designed for indoor use only. It is prohibited to use the device
in a location where explosion or water intrusion risks are present or in dusty or humid environments. It is
prohibited to use the device in spaces where flammable anaesthetic oxidizing gases (O 2, N2O) and other
flammable gases or vapours are present.
The device does not include any medicaments or substances to be applied by it. During the storage and
operation under the specified conditions the device does not use or emit any dangerous substances, radioactive
substances or materials with induced radioactivity.
Place the device out of direct sunlight and strong electromagnetic fields of nearby devices (diathermy, X-rays,
mobile phones and other radio-frequency equipment) to prevent unwanted interference. If unwanted interference
occurs, place the device farther from the source of interference or contact the BTL authorized service.
The device heats up during operation and therefore must not be located near devices that heat up or produce
heat. The device is cooled by forced air circulation. The cooling vents are located on the rear and side panels of
the device and must not be covered. When placing the device, leave at least 10 cm of space behind the rear
panel.
It is prohibited to place any objects that produce heat or objects that contain water or other liquid on the device.
No modification of this equipment is allowed! Do not try to open or remove the protective covers or
disassemble the device for any reason. There is a danger of electric shock and serious injury. All service actions
must be done by an authorized BTL service only, otherwise BTL bear no responsibility for further operation of
the device.
Never use the accessories connector or other connectors to plug in anything else than they are designed for
(see Connection of Accessories). There is a serious risk of electric shock and serious damage to the device!
The device is equipped with a protective system against connecting other accessories than those supplied by
the manufacturer, so it does not function with accessories of other manufacturers.
The device has applied parts of the BF (Body Floating) type – i.e. parts which come into direct physical
contact with the patient during normal device use. This includes the electrodes for electrotherapy, applicators
for ultrasound therapy and applicators for magnetotherapy. Applicators for laser therapy are not intended to be
in touch with a patient and they are therefore not considered as applied parts.
The output current or voltage may exceed safe values in connectors marked with this symbol.
Before starting the therapy make sure that all set parameters match your requirements. Follow the therapy
contraindications detailed in the Chapter Contraindications.
When terminating the therapy, do not press the on/off button (2), but the start/stop button (5). The time interval
between switching the device off and switching it on again using the on/off button must be at least 3 seconds.
If the device does not respond and cannot be operated, it is possible to reset it by pressing the on/off button (2)
for at least 10 seconds. If the device does not respond to pressing the on/off button (2) during switching off,
unplug the power adaptor from the mains and contact an authorized BTL service.
The device accessories (ultrasound applicators, laser probes/clusters, electric cables with electrodes) should
always be placed properly in the holders when not in use (see Holders for Accessories). Improper storage and
handling can cause wear of the accessories and/or change of their properties. If more accessories are
connected to the device at a time (for example two various ultrasound applicators), do not touch the accessory
which is not currently in use during the therapy.
Before each therapy check carefully the device and its accessories (cables, connectors, electrodes, ultrasound
heads, laser probes/clusters, magnetotherapy applicators, controls, touch screen) for any mechanical, functional
or other damage. If any faults or anomalies in the device function are found, stop using the device immediately
and contact an authorized BTL service. In case that the device or the accessories are used despite the
deviations, the user will be solely responsible for the damages caused by the device.
The device displays system and error messages to inform the user of problems or potential problems with the
unit or accessories. These are designed to be self-explanatory. In case of any uncertainties stop using the
device and contact an authorized BTL service.
When disconnecting the connected accessories from the device, pull them out by the connector, never by the
cable itself. Never disconnect the accessories during therapy! Never touch the connectors on the rear panel of
the device with your hand. Never touch the connectors on the rear panel of the device and the patient
simultaneously.
The liability of continuous (at least acoustic) contact with the patient applies to all physical therapy procedures.
All electrodes supplied with the BTL device for electrotherapy can be used for current intensities and voltages in
a manner that is stated in Technical Parameters of Electrotherapy. Never use the electric cables without the
electrodes connected. We recommend that you check the quality of electrodes periodically. During direct current
electrotherapy, electrolysis products accumulate near to the electrodes, so it is necessary to rinse the electrodes
in clean water after each therapy. Nevertheless, wear of the electrodes may be faster and their earlier
replacement is then necessary.
When applying electrotherapy, an electrode pad is always used for correct electric current flow, which must be
thoroughly moistened with tepid water before each therapy. Water must not drip spontaneously from the
moistened electrode pad.
The electrode pads must be thoroughly washed in tepid water before first use! They are impregnated during
production with a special substance to prevent mildew. After the electrode pads have been washed and dried,
they harden which is not a defect – they will soften again after they have been moistened. After each therapy the
electrode pads must be washed in a manner described in Maintenance of the Device. We recommend that the
quality of the pads is checked before each use – in case of any signs of wear they have to be replaced.
When applying direct currents and currents with a direct component, always soak the electrode pads with
suitable cathode / anode protective solutions which protect skin against burning! When using anode and cathode
protective solutions, always make sure not to confuse them and not to change polarity during therapy! In this
case, electrolysis products accumulate in the electrode pads which may result in faster wear. It is necessary to
check the electrode pads regularly and replace them earlier if necessary. After each therapy, the electrode pads
must be washed thoroughly in tepid water and cleaned in a manner described in Maintenance of the Device.
When applying diadynamic currents without using protective solutions, the therapy time must not exceed 6
minutes. You can change polarity once per therapy and the total therapy time in such case must not exceed 12
minutes. When applying direct (monophasic) pulsed currents (Träbert, Farad, Leduc etc.) the application time
without protective solutions should not exceed 15 minutes.
2 2
The maximum safe current density on an electrode is 0.1 mA/cm for direct currents, 1 mA/cm for low-frequency
2
currents and 10 mA/cm for TENS and mid-frequency currents. It thus depends on the electrode surface size
(size of the electrode pad) and the type of current! If these values are exceeded, there is a risk of patients’
burns!
2
The current density values over 2 mA/cm always require special user attention!
Connecting the patient to a high-frequency surgical device may result in burns in the locations of electrodes of
the electrotherapy device and possible damage to the electrotherapy device.
Simultaneous connection of the patient to an ECG system may result in temporary outage of the ECG system or
may distort the data measured by the ECG system.
Operating the device near (e.g. 1 m) a short-wave or microwave therapeutic device may cause instability of the
device output.
Electrodes with the prescribed pads must not overlap during application; the optimum placement of electrodes is
described in the encyclopaedia of the device for individual therapy protocols. Electrodes must be reliably
connected in the prescribed manner (elastic straps, vacuum electrodes); they should not be loaded down by the
body segment weight and the patient must not be lying on them.
During the therapy the patient and the operator must not touch the electrodes. If you want to adjust the
attachment of the electrodes, always interrupt or stop the therapy first.
Patients are not allowed to manipulate the device or regulate current intensity.
If the device automatically reduces intensity (during therapy or when the intensity is set) check the condition of
the electrodes. This phenomenon is caused by high contact resistance.
Vacuum electrodes cannot be used for the application of direct currents and currents with a direct component,
where the sponges must be soaked in protective solutions and could be damaged by the electrolysis products.
Direct currents are not intended for a combination therapy either.
The use of electrotherapy for the sole purpose of symptomatic analgesic treatment may suppress pain
perception which has a protective and informative purpose in human body.
Electrotherapy contraindications are listed in the Chapter Contraindications. The physicians prescribing the
therapy despite the contraindications bear full responsibility for such an action.
The type and size of electrodes should be selected according to the treated area.
For ultrasound treatment, use an ultrasound head or operator independent HandsFree Sono applicator.
HandsFree Sono is an operator independent applicator for ultrasound therapy. Before the start of therapy, apply
ultrasound gel on the plate of the HandsFree Sono and attach the applicator to the treated area using the
fixation straps. After the start of therapy do not manipulate the applicator; the applicator simulates the therapist’s
movements by means of automatic switching of the ultrasound crystals.
Always protect the ultrasound heads and HandsFree Sono applicators from hitting their metal parts and housing;
any shock can adversely affect their parameters. When not used in therapy, ultrasound heads should be placed
in the holders. Do not bend the power cord. Check the applicators for damage (especially cracks) before each
therapy. If you find damage, do not continue using the applicator and contact an authorized service.
During the therapy, hold the ultrasound head in such a way to avoid the contact with its metal part. It is
necessary to move the head continuously during the application according to the prescribed therapy type to
prevent tissue damage at the maximum intensity. During subaqual application, hold the head so that your hand
is not immersed in the water and the ultrasound head is placed about 10–12 cm from the target tissue. When
using the HandsFree Sono, ensure sufficient contact between the applicator and the patient’s body by fastening
the applicator with fixation straps. To let the patient apply ultrasound to himself/herself is a serious infringement
of the lege artis rules!
When applying ultrasound by means of any applicator, ultrasound gel shall be used for correct passage of the
ultrasound waves. It is recommended to use the BTL ultrasound gel. The applicators have not been tested for
use with other gels or oils and can be damaged.
Use of ultrasound applicators leads to their heating. In sporadic cases the temperature can rise significantly. In
such situation the device temporarily decreases the ultrasound intensity for the patient’s safety. You will be
informed about this situation by the following changes on the display: Change of duty factor to 10% on the
screen of running therapy. Change of graphical representation and a message “output power limited” in the text
window of MANUAL screen. The parameters are automatically reset to the original values after the temperature
decreases again. In case the temperature still increases, the therapy is immediately stopped. The heating of
applicators can be limited by using enough gel.. The better the contact, the lower is the heating.
Ultrasound therapy contraindications are listed in the Chapter Contraindications. The physicians prescribing
the therapy despite the contraindications bear the full responsibility for such an action.
The device must be located in a special (flank) room with minimum reflective surfaces with beam reflection risk.
The room shall be fitted with warning signs. The device must be protected from unqualified use. The laser
workplace must be equipped with service regulations approved by a health officer.
The safety door switch must ensure that the device is automatically switched off once the door is opened. The
door switch (not supplied with the device) can be connected in the connector on the rear side of the device;
a standard connector of the power jack type is used for the interconnection.
During the therapy, the laser probe/cluster is just above the treated area, for hygienic reasons it does not touch
the body surface. The laser radiation comes out through the aperture at the end of the probe (which is covered
by protective glass in case of the laser cluster). Never disconnect the probe/clusters from the device during
radiation and never intentionally switch off the device in this situation.
Protect the laser probe / cluster consistently from shocks! When not used in therapy, they must be placed in the
holders. The probe and the cluster are not waterproof.
Laser therapy contraindications are listed in the Chapter Contraindications. The physicians prescribing the
therapy despite the contraindications bear full responsibility for such an action.
Never use damaged applicators. Electric shock to personnel or patient may occur.
Attending personnel should keep away from the patient side of the applicator during the therapy. The relevant
channel should be switched off during necessary manipulation.
Watches, electronic devices and magnetic recording carriers can be damaged when closely exposed to
applicators and cables.
Do not connect anything else to the connectors – there is a danger of injury by electric shock and / or serious
damage to the device.
Magnetotherapy contraindications are listed in the Chapter Contraindications. The physicians prescribing the
therapy despite the contraindications bear the full responsibility for such an action.
Use of the magnetotherapy applicators leads to their heating. In sporadic cases the temperature can rise
significantly. In this situation the device temporarily decreases the intensity of magnetic field to the half for the
patient’s safety. You will be informed about this situation by the following changes on the display: Decreased
value of the intensity on the touch screen. In the text window of MANUAL screen, the message “applicator power
limited” will display. In case the temperature still increases, the device decreases the intensity of the magnetic
field to a quarter of the original value. The parameters are automatically reset to the original values after the
temperature decreases again.
Combination of individual therapies to be simultaneously used on one patient is allowed only for combination
of electrotherapy and ultrasound therapy. Other combinations are not recommended by the manufacturer.
Specific safety precautions for combination therapy are the same as for electrotherapy and ultrasound therapy
modalities.
Galvanic currents or currents containing a significant direct (galvanic) component should not be applied
during combination therapy because of the need to use protective solutions.
The application of electrodes near the chest area may increase the risk of arrhythmia.
Electrotherapy use for the sole purpose of symptomatic analgesic treatment may suppress pain perception, which has
a protective and informative purpose in human body.
If the maximum safe current density values are exceeded, there is a risk of burns.
There is risk of burns when high-intensity, continuous ultrasound is used in a stationary application.
There is risk of infection as a consequence of patient cross-contamination when violating the instructions of the
transducer head cleaning.
There are no known possible side-effects for the clinical application of magnetotherapy.
Before the application it is necessary to take the patient’s medical history and make a thorough examination to
determine whether or not the application of physiotherapy is suitable for the patient.
If contraindications are not respected, the physicians prescribing therapy and the centre or clinic where the
procedure is performed are fully responsible for the treatment and the patient's safety.
Warning
Caution
Laser equipment warning label. Warning: the values of laser light energy used
during therapy may exceed safe values.
Class II equipment
Before the use of the device read the manual and follow its instructions
Date of manufacture
Serial number
Batch code
Catalogue number
CE mark
1 accessories holder (the type of the holder depends on the specific device configuration – see Chapter
Accessories Holders)
2 on/off button (to switch the device on/off)
3 4.3" touch screen
4 enter button (to confirm the selection)
5 start/stop button (to start/stop the therapy)
6 select buttons with the indicated up and down arrows (to move in the device menu and to set the therapy
parameters)
7 home button (to return to the initial screen)
8 esc button (to reject the selection and return to the previous state)
9 list button (to set the therapy by selecting the therapeutic protocol)
10 manual button (for the user settings of therapy parameters)
11 menu button (to set the functions of the device)
1 accessories holder (the type of the holder depends on the specific device configuration – see Chapter
Accessories Holders)
2 on/off button (to switch the device on/off)
3 7" touch screen
4 enter button (to confirm the selection)
5 start/stop button (to start/stop the therapy)
6 select knob (to move in the device menu and set the therapy parameters)
7 home button (to return to the initial screen)
8 esc button (to reject the selection and return to the previous state)
1 accessories holder (the type of the holder depends on the specific device configuration – see Chapter
Accessories Holders)
12 E1 output connector for the connection of electrotherapy accessories on channel 1
13 manufacturing label of the device containing the serial number
14 device type label
15 E2 output connector for the connection of electrotherapy accessories on channel 2
16 UB output connector for the connection of ultrasound therapy accessories
17 power supply label
18 LB output connector for the connection of laser therapy accessories
19 power supply connector (exclusively for the use of the power adaptor mentioned in Chapter Technical
Parameters)
20 connector of the laser therapy door switch
21 LA output connector for the connection of laser therapy accessories
22 UA output connector for the connection of ultrasound therapy accessories
1 accessories holder (the type of the holder depends on the specific device configuration – see Chapter
Accessories Holders)
12 E1 output connector for the connection of electrotherapy accessories on channel 1
13 manufacturing label of the device containing the serial number
14 device type label
15 E2 output connector for the connection of electrotherapy accessories on channel 2
16 LB output connector for the connection of laser therapy accessories
17 power supply label
18 M2 output connector for the connection of magnetotherapy accessories on channel 2
19 power supply connector (exclusively for the use of the power adaptor mentioned in the Chapter Technical
Parameters)
20 connector of the laser therapy door switch
21 M1 output connector for the connection of magnetotherapy accessories on channel 1
22 LA output connector for the connection of laser therapy accessories
1 accessories holder (the type of the holder depends on the specific device configuration – see Chapter
Accessories Holders)
12 E1 output connector for the connection of electrotherapy accessories on channel 1
13 manufacturing label of the device containing the serial number
14 device type label
15 E2 output connector for the connection of electrotherapy accessories on channel 2
16 M4 output connector for the connection of magnetotherapy accessories on channel 4
17 power supply label
18 M2 output connector for the connection of magnetotherapy accessories on channel 2
19 power supply connector (exclusively for the use of the power adaptor mentioned in the Chapter Technical
Parameters)
20 connector of the laser therapy door switch
21 M1 output connector for the connection of magnetotherapy accessories on channel 1
22 M3 output connector for the connection of magnetotherapy accessories on channel 3
Unpack the device and place it on a firm and stable horizontal surface, which is suitable for its weight, or place it on
an original BTL trolley. Place the device in accordance with the instructions listed in the Chapters Technical
Parameters and Safety Precautions (operating conditions, undesirable interference with other devices etc.)
Prior to switching the device on, carefully read the information related to the connection to the mains in the
Chapters Technical Parameters and Safety Precautions. Connect the device to the mains only by means of the
power adaptor supplied together with the device! In case of any doubts, please contact an authorized BTL service.
After plugging the power adaptor in the mains, the device is put into the standby mode which is indicated by the
orange backlighting of the on/off button (2) on the front panel of the device. If the on/off button (2) does not shine, re-
check the connection of the power adaptor and, if necessary, contact an authorized BTL service.
To put the device into operation press the on/off button (2). Switching on the device is indicated by blue backlighting
of this button and – for the BTL-4000 Premium – also by blue backlighting of all buttons on the front panel of the
device.
If the test of internal functions is passed OK, the display shows the initial screen and the device is ready for operation.
If the device finds any discrepancy during the test of internal functions, it warns of it and, if necessary, locks itself in
the secure mode. In such case it is necessary to contact an authorized BTL service.
In case of units with laser generators it is necessary (according to the standards) to enter a password, which is pre-set
to 0000, before opening the initial screen. Press enter to confirm the password. It is recommended to change the
password at the first use of the device, so as to protect the device from unauthorized use. The password can be
changed in the device menu (menu – unit settings – password).
With units without laser generators the use of a password is not required but is recommended. The password use can
be activated in the device menu (menu – unit settings – password).
To switch off the device, press the on/off button (2). Switching off the device is indicated by orange backlighting of
this button. At the end of every working day, and especially in case of a longer planned pause in the use of the device,
it should be disconnected from the mains socket.
The supplied accessories have to be connected in the output connectors on the rear panel of the device (for the
description of the connectors see Rear Panel of the Device). The device does not allow the use of other
manufacturers’ accessories.
The output connectors are marked with the letter of the generator and the number of the channel, or if need be, with
the letter of the output.
st nd
Connectors E1 and E2 (12, 15) are the outputs of the 1 and 2 channel of electrotherapy, designed for the
connection of electric cables with electrodes. The electric cable of channel 1 is light grey with a press-on marked “1”.
The electric cable of channel 2 is dark grey with a press-on marked “2”.
The connectors of the electric cables intended for the connection into the device are marked with an arrow indicating
the direction of connecting.
Connectors UA and UB (16, 22 on the model without magnetotherapy) are the outputs of the ultrasound therapy
channel, intended for the connection of the ultrasound therapy applicators (ultrasound heads and HandsFree Sono).
Connectors LA and LB (18, 21 on the model without magnetotherapy; 16, 22 on the model with 2-channel
magnetotherapy) are the outputs of the laser therapy channel, intended for the connection of the laser therapy
applicators (laser probes and laser clusters).
The connectors of ultrasound and laser accessories are equipped with a locking tongue which sets the correct
connector position when connecting it.
a) guiding groove of the output connector on the rear panel of the device
b) locking tongue on the accessories connector
The device detects the accessory, determines its type and displays it on the therapy parameter screen - see
Selection of Accessories.
When disconnecting the accessories from the device, pull them out by the connector, never by the cable itself!
The device is equipped with holders for various accessories – ultrasound heads, laser probes or clusters and
electrotherapy cables (1). When not in use, the accessories have to be stored in these holders, to prevent their wear
and change of properties. The type of holders depends on the specific device configuration.
The ultrasound head / laser cluster holder and the electrotherapy cables holder are located in the upper corners of the
device front panel:
ultrasound head /
laser cluster holder
The touch screen displays graphical elements which can be pressed and activated, and other graphical elements
which are only informational. The buttons on the screen can be pressed with a finger or any stylus without a sharp
point (do not use pencils or pens, for example).
The touch screen is basically layered to the channel tabs at the bottom edge of the screen which contain the letters
indicating what generators the device includes. The tabs are marked with the letter “E” for electrotherapy (E1 for the
first electrotherapy channel and E2 for the second one), “U” for ultrasound therapy, “L” for laser therapy, “M” for
magnetotherapy (M1 for the first magnetotherapy channel and M2 for the second one on the model with 2 channels
for magnetotherapy, M1+M3 for the first and third magnetotherapy channels and M2+M4 for the second and fourth
magnetotherapy channels on the model with 4 channels for magnetotherapy). The number and type of these tabs
(channels) depends on the specific device configuration.
Although the BTL-4000 Smart/Premium devices with more generators allow running up to three therapies
simultaneously, only one therapy can be controlled at any given moment; this therapy is selected on the initial HOME
screen or by touching the respective tab. The tab of the selected channel is highlighted and all information on the
screen and all controls refer to that channel. The most important information about the therapies performed on the
other channels remains visible in their tabs.
The BTL-4000 Premium device has a bar with device control buttons at the upper edge of the touch screen:
The initial HOME screen, which is displayed after switching on the device by the on/off button (2), offers the basic
selection of the therapy type. Depending on the specific configuration of the device, the buttons on this screen may
offer to select the first and second channels of electrotherapy, ultrasound therapy, combination therapy, laser therapy
and up to four channels of magnetotherapy.
In case of devices containing only one generator of ultrasound or laser therapy, the initial HOME screen is not
displayed and after switching on the device the screens for starting the therapy – LIST, QUICK or MANUAL – are
displayed; see below. In such case the home button (7) takes you back to one of these screens.
After selecting the therapy type on the initial screen, the BTL-4000 Premium displays the therapeutic protocols quick-
selection screen and the BTL-4000 Smart displays the MANUAL therapy parameters screen. At the same time the
selected channel is highlighted on the tabs. The type of screen to be displayed in this step can be modified in the
device menu (menu – unit settings – advanced settings – HOME screen mode).
5.8.1 Setting a Therapy by Selecting from the List of Therapeutic Protocols – LIST Screen
The list of all therapeutic protocols is displayed after pressing the list button (on the touch screen for the BTL-4000
Premium, on the device for the BTL-4000 Smart). For each therapy type there is a list of all available therapeutic
protocols. The saved user protocols are marked in the list of therapeutic protocols by a card icon.
To move in the list of therapeutic protocols, use the arrows on the right side of the touch screen; for the BTL-4000
Smart by pressing the select buttons with the indicated up and down arrows (6) and for the BTL-4000 Premium by
turning the select knob (6). A protocol can be also quickly found by pressing the required alphabet letter on the
bottom bar. After finding the required protocol, select it by touching its name on the screen or pressing the enter
button on the touch screen or the enter button (4) on the device front panel. If the therapeutic protocol offers more
therapy options – i.e. the treatment can be performed by several different types of current – their list is displayed after
the selection of the therapeutic protocol. Select the current type you require and press enter (4) again. For
magnetotherapy you can choose from three types of magnetic field.
After the selection of the required therapeutic protocol the device displays the therapy parameters screen (see
below – MANUAL screen), from which the therapy can be started directly by pressing the start button on the touch
screen or start/stop on the front panel of the device (5).
5.8.1.1 BODY PARTS – Filtering the Therapeutic Protocols by the Body Region
For the BTL-4000 Premium, the LIST screen offers the function of filtering the therapeutic protocols by the body
region. Pressing the button with the figure symbol will open the BODY PARTS screen indicating ten human body
regions. Pressing the button with the required region displays the list of therapeutic protocols relevant for the
respective region. This function is not available for BTL-4000 Smart.
After the selection of the required therapeutic protocol it is possible to find detailed information for the
selected protocol by pressing the button with the encyclopaedia symbol on the therapy parameters screen.
The encyclopaedia also includes a graphical part – pressing the respective button on the touch screen will
display the recommended placement of electrodes or the place of application of ultrasound or laser therapy for every
therapeutic protocol.
Note: the therapeutic protocols (including the suggested times, intensities, doses and other parameters) serve only as
a guide or a therapy proposal and by no means can they replace the professional consideration and experience from
the clinical practice.
After pressing the quick button on the touch screen of the BTL-4000 Premium the device displays the therapeutic
protocol quick-selection screen – QUICK (in the BTL-4000 Smart this screen is not available).
The QUICK screen serves as a quick starting point of a therapy without the need to browse the entire list of all
protocols. To select a protocol just press the respective button. If you use other protocols than those pre-set in the
factory more frequently, you can modify the protocol list in the device menu (menu – specific settings – QUICK screen
protocols).
Instead of the QUICK screen and the pre-set therapeutic protocols it is possible to display the screen for the selection
of therapy by the program number; this option can be set in the device menu (menu – unit settings – advanced
settings - QUICK screen mode). The program screen allows starting a therapy by selecting the program number
which is assigned to every therapeutic protocol. The program numbers can be found in the protocol description in the
encyclopaedia. To set the program value, press the required element on the touch screen and then use the select
buttons/knob (6) or the numerical keyboard. The screen for the selection of therapy by the program number can be
also displayed by pressing the list button twice.
After the selection of one of the pre-set therapeutic protocols on the QUICK screen it is possible to find the
detailed information for the selected protocol by pressing the button with the encyclopaedia symbol on the therapy
parameter screen.
Pressing the manual button on the touch screen or on the device (10) displays the MANUAL therapy parameters
screen in which it is possible to set the therapy parameters completely according to the user’s requirements and from
which the therapy can also be started immediately.
This screen is also displayed every time before the start of a therapy by selecting one of the pre-set therapeutic
protocols of the LIST or QUICK screens.
In case of electrotherapy and combination therapy, the current selection screen is always displayed first before the
therapy parameters screen after pressing the manual button on the touch screen or on the device (10). In case of
magnetotherapy, the selection of continuous or pulsed magnetic field is always displayed first. Select the required
current or the type of the magnetic field and press enter (4) on the front panel of the device or on the touch screen. If
you want to select another current or another type of magnetic field for the therapy later, it will be necessary to open
the current selection screen again by pressing the manual button.
The therapy parameters screen allows setting the most important parameters of the required therapy (time, intensity
etc.) To change the parameters, press the specific button (the selected button is backlit according to the current
colour scheme) and then use the select knob/buttons (6).
Repeated pressing of the buttons will open a dialog window allowing a more detailed setting of the parameter. Enter
the required value using the select knob/buttons (6) and confirm it by pressing enter (4) or cancel it by pressing esc
(8) on the front panel of the device or on the touch screen.
The figure and bell symbols inform about the behaviour of the device during the therapy (this signalization is not
available for magnetotherapy):
Set up these functions by pressing menu-specific settings – contact loss signalization/check contact during therapy.
In case of electrotherapy the device measures the right contact of the electrodes; if the contact is lost it
interrupts the therapy and warns the user. In case of a bad contact of the applicator during ultrasound therapy the
device interrupts the therapy time countdown. For combination therapy the figure is always crossed when the contact
is lost the therapy time countdown is never interrupted.
In case of electrotherapy the device does not interrupt the therapy at the loss of the electrode contact (e.g.
withdrawing of the electrode during dynamic application or combination therapy). In case of a bad contact of the
applicator during ultrasound therapy the device does not interrupt the therapy time countdown.
In case of electrotherapy, ultrasound and combination therapy the device indicates the loss of contact by
a sound signal. In case of laser therapy the device warns by a sound signal that the therapy is in progress (in
compliance with the applicable standards, this function cannot be switched off in the device menu).
In case of electrotherapy, ultrasound and combination therapy the device does not indicate the loss of contact
by a sound signal.
To start the therapy according to the selected parameters from the therapy parameter screen, press the start button
on the touch screen or start/stop on the front panel of the device (5).
If you want to set the therapy parameters in more detail than offered by the MANUAL therapy parameter screen,
press the edit button on this screen. This will display the screen of advanced therapy parameters (e.g. it allows setting
the amplitude modulation of the currents, frequency sweep of the currents, synchronization of the electrotherapy
channels, ultrasound therapy, laser therapy and magnetotherapy signal waveforms etc.).
By pressing the save button on this screen you can save therapy parameters as a user-defined therapeutic protocol,
which may be assigned to a specific client (available only in BTL-4000 Premium).
This screen does not allow starting the therapy directly; it is necessary to confirm the set parameters by pressing the
enter button (4) and return to the MANUAL therapy parameter screen with the start button.
For higher patient comfort during ultrasound or combination therapy use the applicator preheating function. The
ultrasound applicator is heated to a comfortable level and a contact of cold applicator head with the patient´s body is
avoided.
2 2
This option is available for ultrasound heads (1 cm , 5 cm ), not for operator independent applicators HandsFree
Sono.
For setting press the “flame symbol” on screen, than press “applicator preheating” and choose on/off. To confirm
press enter.
When the preheating is in progress, do not touch the applicator head – ultrasound is generated.
The preheating can run only if contact is not detected. Always remove the gel from the ultrasound head after finishing
the therapy.
You can also set preheating in device MENU (menu-specific settings-applicator preheating).
The therapy time is pre-set for every therapy and therapeutic protocol so that after entering the therapy parameters
screen it is possible to start the therapy directly by pressing the start button on the touch screen or start/stop on the
front panel of the device (5). If you want to set a different therapy time, you can modify it directly using the select
knob/buttons (6). Repeated pressing of the time button on the touch screen will open the dialog window for the setting
of time. Enter the required time using the select knob/buttons (6) or the numerical keyboard and press enter (4) to
confirm.
You cannot modify the therapy time when the therapy is in progress. For electrotherapy, ultrasound therapy and
magnetotherapy the time can be modified after pressing pause or start/stop. For laser therapy this option is not
available.
For electrotherapy it is possible to set the intensity by means of the intensity button on the touch screen after starting
the therapy by turning the select knob (6) in case of the BTL-4000 Premium or by repeated pressing of the select
buttons with the up and down arrows (6) in case of the BTL-4000 Smart.
For ultrasound therapy it is possible to set the intensity on the therapy parameter screen, when the therapy is not in
progress, on the screen during therapy and in the pause. For setting the value use the intensity button on the touch
screen. To change the value, turn the select knob (6) in case of the BTL-4000 Premium or repeatedly press the
select buttons with the up and down arrows (6) in case of the BTL-4000 Smart.
For laser therapy, the laser radiation dose can be set only on the therapy parameter screen when the therapy is not in
progress. To change the value, turn the select knob (6) in case of the BTL-4000 Premium or repeatedly press the
select buttons with the up and down arrows (6) in case of the BTL-4000 Smart. The laser dose modification button is
not available on the screen either during the therapy or during the pause.
The accessories button on the therapy parameters screen displays the symbol of the accessory which is ready for
use (for more information about individual applicators see Accessories and Technical Parameters):
5.8.6.1 Electrotherapy
plate electrodes
vacuum electrodes
2
ultrasound head 5 cm
2
ultrasound head 1 cm
5.8.6.4 Magnetotherapy
disc applicator
solenoid 30 cm
solenoid 60 cm
linear applicator
ring applicator
the question mark indicates that no accessories are connected to the chosen channel
If two ultrasound therapy applicators (outputs UA and UB) and/or two laser therapy applicators (outputs LA and LB)
and/or up to four magnetotherapy applicators (outputs M1 and M2 on the device with 2-channel magnetotehrapy,
outputs M1, M2, M3 a M4 on the device with 4-channel magnetotherapy) are connected to the device simultaneously, it
is possible to switch between the applicators to be used for the therapy by pressing the accessories button. The
button always displays the currently selected accessory. For electrotherapy, the accessories button is only
informational – switching between the plate and vacuum electrodes can only be done by switching on/off the vacuum
on the front panel of the vacuum unit (see the User’s Manual of the BTL-Vac II).
If the device is equipped with electrotherapy and ultrasound therapy generators, you can select the combination
therapy option by pressing the respective button on the initial HOME screen. Thus the first channel of electrotherapy
E1 and the channel of ultrasound therapy are selected and their tabs are highlighted.
After the interconnection with electrotherapy, the ultrasound applicator becomes the cathode. The other pole is always
the anode – the electrode with a red end connected to the patient. If ultrasound applicators are connected to both
outputs UA and UB, you can use the accessories button on the therapy parameters screen to select which one will be
used for the combination therapy.
To start the therapy according to the required parameters after the selection of the required protocol from the therapy
parameters screen, press the start button on the touch screen or start/stop on the front panel of the device (5).
To start the therapy on the selected channel after selecting one of the pre-set therapeutic protocols or after setting the
therapy parameters on the MANUAL screen, press the start button on the touch screen or start/stop on the front
panel of the device (5). The therapy can only be started if the therapy parameters screen is displayed on the selected
channel.
The therapy can be interrupted at any time by pressing the pause button on the touch screen or start/stop on the
front panel of the device (5) and the interrupted therapy can be resumed by pressing the start button on the touch
screen or start/stop on the front panel of the device (5) or terminated by pressing the esc button (8).
In case of laser therapy, the therapy can also be started/interrupted by pressing the button on the
probe/cluster.
During the therapy the screen contains buttons with the main therapy parameters, similarly to the MANUAL therapy
parameters screen. The running time value is highlighted to provide the instant overview of the course of therapy.
The accessories button displays the symbol of the accessory on which the therapy is performed. During the therapy
this button is only of informative nature, the accessories cannot be changed when therapy is in progress.
The presence of voltage, ultrasound waves, laser radiation or magnetic field on the output of the device is indicated as
follows:
by the running time value, showing the time remaining until the end of therapy, on the screen during therapy
by the running time and intensity values on the channel tab
in the BTL-4000 Premium, by the change of the blue backlighting of the start/stop button (5) on the device
to yellow; the backlighting of the other buttons remains blue
in ultrasound therapy, by the blue backlighting of the ultrasound heads and the operator independent
HandsFree Sono applicator (the blue light is shining permanently as long as the device is generating
therapy)
in laser therapy, by the green indicator on the probe, aiming beam and acoustic signal (which, in compliance
with the applicable standards, cannot be switched off)
in magnetotherapy (not valid for linear applicator and applicator ring) by the blue backlighting of the controls
on the applicators (the blue light is shining permanently as long as the device is generating therapy)
You can also save the protocol and assign it to a client. The saved protocol will be then displayed also in the list of
therapies assigned to the specific client (menu - user settings / database – clients).
In case of the BTL-4000 Premium, user therapeutic protocols may be also displayed on the QUICK screen for the
quick selection of therapeutic protocols. The list of the protocols displayed on the QUICK screen may be modified in
the device menu (menu – specific settings – QUICK screen protocols).
Selecting the user settings / database item displays a menu with items referring to the data saved by the user:
clients (only for BTL-4000 Premium)
user therapeutic protocols
user sequences (only if the device contains the electrotherapy generator)
recent therapies
5.11.1.1 Clients
This item enables users to establish, edit and delete information about clients. It is possible to assign therapies from
the list of user therapeutic protocols to any client and run these therapies after pressing the load button. This function
is available only for BTL-4000 Premium.
Limitation of the range of currents in the sequence when the mode without pause between sections is
selected:
If the option “pause between sections” is set in the sequence, the device stops the generation at the passage to the
next section and it is necessary to set the intensity manually again. This allows adding the currents into sequences
without limitation and utilizing the full range. We recommend setting this option.
If the option “pause between sections” is not set, the device continues generating the current in the next section with
the same intensity.
ATTENTION! In this case you shall be very careful when setting the sequences. Each current type has different
requirements for the subjective current intensity and therefore it is necessary to include only those currents that the
patients perceive similarly. This may include currents with similar pulse length, frequency etc. Never should you
mutually combine monophasic and biphasic currents.
5.11.2.1 Language
Selection of the language for the texts on the display. English is set as default.
5.11.2.6 Password
This menu makes it possible to change the password which the device requires after being switched on. Without
entering this password, no further work with the device is possible. By default the devices are supplied as “unlocked”
– with the password off. However, in the units containing a laser generator the password cannot be switched off
(according to the requirement of the standard) and by default it is pre-set to 0000.
This option allows setting the protocols of the QUICK (only for BTL-4000 Premium) screens and additional functions
referring only to the selected generator.
5.11.3.1 Electrotherapy
This option allows starting the electrode quality test and setting a sound signalization of contact loss between the
patient and the electrode during the therapy.
5.11.3.4 Magnetotherapy
This option allows starting a test of the connected magnetotherapy applicator and changing the default program time.
The change of the default program time will show on the manual therapy parameter screen and will change the time
of all programs.
5.11.4 Electrodiagnostics
This option is displayed in the menu only if the device is equipped with the electrodiagnostics functions. It allows
performing the muscle motor point detection, measuring the value of the accommodation coefficient and measuring
the I/t curve.
To find the motor point, it is recommended to use pulses of a length of approx. 5 ms for healthy muscles and approx.
100 ms for denervated muscles. The pause between pulses should be 1–2 seconds. Having found the motor point,
reverse the polarity of the output current (positive polarity negative) and measure the muscle sensitivity to the
reversed polarity of the signal. For further stimulation use that connection of electrodes (polarity) to which the muscle
was more sensitive.
It is possible to set more options when the HandsFree Sono 6 is connected. Press EDIT button - application
parameters and set:
application mode – circular or random switching between crystals
switching period – switching between crystals in 0.3 s / 0.5 s / 0.7 s
application area – activation/deactivation of crystal pairs (at least one pair)
For safety reasons the switching period is fixed to 0.3 s when you choose one pair of crystals.
It is possible to set more options when the HandsFree Sono 4 is connected. Press EDIT button - application
parameters and set:
application mode – circular or random switching between crystals
The devices of the BTL-4000 Smart/Premium series can be connected to the mains exclusively via the supplied
power adaptor.
It is forbidden to connect any other power adaptor than the above mentioned one to the device.
The devices of the BTL-4000 Smart/Premium can be extended with a battery pack. The battery pack is not supported
in devices containing a magnetotherapy generator. To insert the battery into the device disconnect the device from the
mains and proceed according to the manual placed in the package. The tab next to the channels tab shows the
battery state.
The device is connected to the battery pack and at the same time to the mains with the power adaptor.
In the standby mode the connection to the battery is indicated by orange flashing of the on/off button on the front
panel.
The battery charge is shown in percents of full charge or as remaining time. You can set this option by pressing
menu-unit settings-advanced settings-battery indication mode.
It is possible to start up to three therapies at a time when the device is connected to the mains. This is different when
the device is powered from the battery pack. Then you can run only electrotherapy or ultrasound therapy or laser
therapy. Combination of two electrotherapy channels when using battery pack is possible only in case of 4-pole
interference. Combination of electrotherapy and ultrasound therapy when using battery pack is possible only in case
of combination therapy.
1x electrode cable – light grey (twin cable, cable length: 280 ± 6 cm) for channel 1
1x electrode cables – dark grey (twin cable length: 280 ± 6 cm) for channel 2
4x plate electrodes 7 x 5 cm
4x electrode pads for electrodes 7 x 5 cm
1x set of elastic straps for the fixation of the electrodes
plate electrodes 12 x 8 cm
electrode pads for electrodes 12 x 8 cm
adhesive electrodes 40 x 40 mm, REF PG871/40W
adhesive electrodes 50 x 50 mm, REF PG871/50W
adhesive electrodes 75 x 140 mm, REF PG477W
adhesive electrodes 32 mm, REF PG479/32W
adhesive electrodes 50 mm, REF PG479/50W
ball electrode:
o ball electrode tip – diameter 2 mm
o ball electrode tip – diameter 6 mm
vacuum unit BTL-Vac II
2
1x ultrasound head 5 cm (cable length: 220 ± 1.5 cm)
1x ultrasound gel in a 300 ml packing
2
ultrasound head 1 cm (cable length: 220 ± 1.5 cm)
HandsFree Sono 4, HandsFree Sono 6 – applicators for operator independent ultrasound therapy
(cable length: 220 ± 1.5 cm)
set of elastic straps for the fixation of the HandsFree Sono applicator, magnetic frame
ultrasound gel in a 1 l packing
plastic holder for HandsFree Sono
laser probes – red and infrared (cable length: 220 ± 1.5 cm)
laser clusters – red, infrared and combined (cable length: 220 ± 1.5 cm)
optical attachments for laser probes
laser probe holder
warning labels
protective goggles for laser therapy, protection grade L3 and higher
disc applicator
double disc applicator
multi disc applicator
solenoid 30 cm
solenoid 60 cm
solenoid 70 cm (only for the magnetotherapy couch)
couch with a magnetotherapy applicator
linear applicator
ring applicator
Before any maintenance switch off the device and unplug it from the mains! Observe all safety
principles listed in the Chapter Safety Precautions. Never dismantle the device and its accessories during cleaning!
The recommended intervals for inspection of the device are 24 months after installation, subsequently each 12
months. The intervals may differ according to the local regulations. The inspection shall be performed according to
procedure authorized by BTL.
The laser equipment does not require any user settings or adjustment. Its inspection is performed during the periodic
recalibration of the device by the authorized BTL service.
7.1 CLE ANING OF THE SURF ACE OF THE DEVICE AND ACCESSORIES
For the cleaning of the device and its accessories use a soft cloth slightly moistened with water or a 2% detergent
solution. Never use agents containing alcohol, chlorine, ammonia, acetone, benzine or thinners. The touch screen
shall be cleaned very gently using a dry soft cloth. The cloth may be slightly moistened with a commercially available
screen cleaner. Never apply the agent cleaner directly onto the screen!
Never use abrasive materials for the cleaning, otherwise the surface of the device or accessories could get damaged.
7.2 CLE ANING OF THE ACCESSORIES COMING INTO CONTACT WITH THE
P ATIENT
After each use, the accessories that come into direct contact with the patient’s body (electrodes and electrode pads,
ultrasound heads and HandsFree Sono ultrasound applicator) shall be cleaned and disinfected with a solution
approved for the use in health service. Do not use agents containing chlorine or those with a high alcohol content
(more than 20 %). If you do not want to use the electrode pads immediately for next therapy, let them dry completely
on a dry and airy place after the cleaning. The ultrasound heads and HandsFree Sono applicators shall be cleaned
from remaining ultrasound gel by a paper towel or a soft cloth and rinsed in a clear water at first. In case of
HandsFree Sono applicator, the plastic frame covering peripheral part of the active surface shall be also removed
before the cleaning.
After the disinfection it is necessary to rinse the accessories with clean water so as to prevent undesirable allergic
reaction!
The device accessories are designed for non-invasive use, therefore they do not need to be sterile. They cannot be
sterilized (with the exception of the optical attachments of the laser probes which, if necessary, may be sterilized for
20 minutes at 180 °C).
Clean the laser aperture of laser probes and clusters with a soft cloth. The laser probe/cluster is not waterproof.
protection class II for devices with adaptor I for devices with adaptor
SA160D-24U-M HPU101-108
device on/off button on the front panel, marked on/off
Internal chemical sources
battery lithium battery CR2430
BTL-4000 Adaptor
Model: SA160D-24U-M
Power adaptors alternative BTL-4000 Adaptor
Model: HPU101-108
BTL-4000 Adaptor
Model: GSM60B24-BTL2
supply voltage ~ 100 V to 240 V AC
frequency 50 Hz to 60 Hz
cable length 150 cm 190 cm
rated voltage / current / input power 24 V / 2.5 A / 60 W 24 V / 4.16 Amax / 90 W
protection class II I (Caution: the equipment must always
be connected to the protective ground)
fuse internal
IP20 - protects against penetration of solid objects of a diameter of
covering grade
12.5 mm and more.
Reserve battery Model:
of 12.5 258-BATTPACK
mm and more.
Design
weight – device only max. 3 kg (6.1 lb)
weight – including packing and accessories max. 6 kg (13.2 lb)
dimensions (W x H x D) 380 mm x 190 mm x 260 mm (15“ x 7.5“ x 10.2“)
packing dimensions (W x H x D) 435 mm x 365 mm x 335 mm (17.1“ x 14.4“ x 13.2“)
covering grade IP20 – protects against penetration of solid objects of a diameter of
12.5 mm and more.
Display elements
display – BTL-4000 Smart LCD colour, 480 x 272, diagonal 10.9 cm (4.3“)
display – BTL-4000 Premium LCD colour, 800 x 480, diagonal 17.8 cm (7“)
Classification
applied parts of type BF
class according to MDD 93/42/EEC IIb
Therapy time
for electro and laser therapies 0 to 100 minutes
for ultrasound therapies 0 to 30 minutes
Device models containing electrotherapy, ultrasound therapy and laser therapy generators:
Ultrasound Laser
Model Device label Electrotherapy
therapy therapy
BTL-4620 Smart,
x
BTL-4625 Smart
BTL-4620 Premium,
x
BTL-4625 Premium
BTL-4710 Smart x
BTL-4710 Premium x
BTL-4110 Smart x
BTL-4110 Premium x
BTL-4820S Smart,
x x
BTL-4825S Smart
BTL-4820S Premium,
x x
BTL-4825S Premium
BTL-4820L Smart,
x x
BTL-4825L Smart
BTL-4800SL Smart x x
BTL-4820SL Premium,
x x x
BTL-4825SL Premium
Magneto Magneto
Laser Electro
Model Device label therapy therapy
therapy therapy
2 channel 4 channel
BTL-4920 Smart x
BTL-4920 Premium x
BTL-4940 Smart x
BTL-4940 Premium x
BTL-4825M2 Smart x x
BTL-4825M2 Premium x x
BTL-4800LM2 Smart x x
BTL-4800LM2 Premium x x
8.2.2.1 TENS
Type asymmetric
Intensity - CC mode 0 to 140 mA
Intensity - CV mode 0 to 100 V
Pulse 0.2 to 1,000 ms
Frequency 0.1 to 700 Hz
Modulation See Current Modulation below in this Chapter.
Type monophasic
Intensity - CC mode 0 to 90 mA
Intensity - CV mode 0 to 100 V
Pulse 2 ms
Pause 5 ms
Frequency 143 Hz
Modulation See Current Modulation below in this Chapter.
8.2.2.16 Leduc
Type monophasic
Intensity - CC mode 0 to 140 mA
Intensity - CV mode 0 to 100 V
Pulse 1 ms
Pause 9 ms
Frequency 100 Hz
Modulation See Current Modulation below in this Chapter.
8.2.2.18 H-waves
Type symmetric
Intensity - CC mode 0 to 140 mA
Intensity - CV mode 0 to 100 V
Pulse 2 x 5.6 ms
Frequency 0.1 to 87.7 Hz
Modulation See Current Modulation below in this Chapter.
Channel mode See Channel Mode below in this Chapter.
DF
MF
MM
CP
LP
RS
CP-
ISO
LP-
ISO
LP-ISO type parameters*: alternation of DF and MF with the amplitude 82 % of DF
8.2.2.21 Microcurrents
8.2.2.25 NPHV
8.2.2.26 IG pulses
1. SECTION
Current TENS
Type asymmetric
Pulse 150 µs
Frequency 60 Hz
Mode CC
Modulation trapezoid surges
Rise/stimulation/fall/pause 2/4/1/23
Time 2 minutes
2. SECTION
Current TENS
Type asymmetric
Pulse 150 µs
Frequency 55 Hz
Mode CC
Modulation trapezoid surges
Rise/stimulation/fall/pause 2/5/1/22
Time 2 minutes
3. SECTION
Current TENS
Type asymmetric
Pulse 150 µs
Frequency 50 Hz
Mode CC
Modulation trapezoid surges
Rise/stimulation/fall/pause 2/6/1/21
Time 2 minutes
4. SECTION
Current TENS
Type asymmetric
Pulse 150 µs
Frequency 45 Hz
Mode CC
Modulation trapezoid surges
Rise/stimulation/fall/pause 2/7/1/20
Time 2 minutes
Adjustable values
Maximum intensity -
0.1 to 2 W/cm 30 % for the output intensity higher than 0.2 W/cm
2 2
continuous operation
Maximum intensity -
0.1 to 3 W/cm 30 % for the output intensity higher than 0.2 W/cm
2 2
pulse operation
Working frequency 1 MHz 5 % and 3.1 MHz 5 %
Modulation frequency 10 Hz to 150 Hz 5 %
Duty factor* 5 % to 100 % 5 % of the set value
Duty factor - presets 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 13.2 W 20 %
*) the duty factor can only be set in the pulse mode, in the continuous mode it is always 100 %
Parameters of pulses
frequency 10 Hz frequency 50 Hz frequency 100 Hz frequency 150 Hz
Duty period 100 ms period 20 ms period 10 ms period 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 the emission of laser radiation green indicator light on the probe, supplementary lighting of the
probe/cluster, sound, therapy time running on the display
Indication of the readiness for emission indication on the screen
Indication of not being ready for emission indication on the screen
Additional safety means warning labels on the device housing and on the probe/cluster
label on the entrance door of the workplace
connector of the safety door contact
Adjustable values
Frequency* 0 – 10,000 Hz with the BTL-458 laser probe,
0 – 500 Hz with the BTL-455 laser cluster
accuracy of frequency 10 % of the set value
2
Dose 0.1 – 100 J/cm
accuracy of dose 20% (according to IEC 60601-2-22)
2
Area** 0.1 – 100 cm
accuracy of area see BNR
Output** 5.0 – 400 mW (depending on the connected laser probe)
20 – 1,500 mW (depending on the connected laser cluster)
accuracy of output 20 % (according to IEC 60601-2-22)
Duty factor *** 35 – 90 %, 100 %
accuracy of duty factor 5 % of the range of duty factor
*) Zero frequency means the continuous operation of laser.
**) The stated values are maximum. The actual values depend on the type of the connected accessories.
***) Adjustable only in the pulse mode, in the continuous mode it is always 100 %.
8.4.4 Warning Labels Placed on the Housing of the Device and on the Applicators
8.4.4.1 Label placed on the housing of the device, warning about the occurrence of visible and invisible radiation of
class 3B
8.4.4.2 Label placed on the body of the probe and cluster, warning about the proximity of the aperture of laser and
informing about the presence of the “EMERGENCY LASER STOP” button
Adjustable Values
Max. intensity of magnetic field max. 128 mT / 1280 Gauss* (max. value on the surface of applicator)
Mode of magnetic field continuous, pulsed, series of pulses
Shape of magnetic pulses rectangular, rectangular protracted, exponential, triangular, sinusoidal
Pulse frequency 0 to 166 Hz 5 %
Modulation none, burst, sine/ trapezoid/ symmetric surge
Random frequency yes / no
Accuracy
amplitude of magnetic field 30 %
time parameters 10 %
*) The stated value is maximum for disc applicator. The actual value depends on the type of the connected applicator
and on the settings of the device.
BTL-239-2 – Solenoid 30
Dimensions 340 x 340 x 300 mm
Inner diameter 295 mm
Weight 5.75 kg
Max. intensity of pulsed magnetic field 9.3 mT (93 Gauss)
Resistance of the applicator 3.5
BTL-239-3 – Solenoid 60
Dimensions 620 x 540 x 300 mm
Inner width 580 mm
Inner height 480 mm
Weight 10.0 kg
Max. intensity of pulsed magnetic field 8.6 mT (86 Gauss)
Resistance of the applicator 6.2
If any of the following functions fails, do not use the device and contact the service.
Device turn-off.
The displayed numerical values of ultrasound therapy parameters (i.e. the values of output power and
intensity) correspond to the actual values of the therapeutic output.
No unwanted ultrasound radiation occurs at the sides of the head.
The ultrasound radiation intensity does not exceed 3 W/cm .
2
The ultrasound accessory surface temperature does not exceed the maximum permissible value of 43 °C.
Once a month it is suitable to check that the device resets after holding the on/off button for at least 10 seconds
pressed.
Checking of the device including the ultrasound generator is done within the regular service inspections - see
Maintenance of the Device.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.
WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Rated maximum output 150 kHz to 80 80 MHz to 800 800 MHz to 2.7
150 kHz to 80 MHz
power of transmitter W MHz MHz GHz
d = [3.5/V1]√ P
d = [3.5/V1]√ P d = [3.5/E1]√ P d = [7/E1]√ P
V1=3V
V1=6V E1= 3 V/m E1= 3 V/m
0.01 0.12 0.06 0.12 0.23
0.1 0.37 0.18 0.37 0.74
1 1.2 0.58 1.2 2.3
10 3.7 1.8 3.7 7.4
100 12 5.8 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
E-mail: sales@btlnet.com
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Date of last revision: 26 May 2020
ID: 058-80MANEN02102
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Limited.