Manual BTL Hi Laser Inglés
Manual BTL Hi Laser Inglés
Manual BTL Hi Laser Inglés
HIGH INTENSITY
LASERUSRS MANUAL
USERS MANUAL
v200TR2013/02/18EN
Dear Customer,
PAGE 2 OF 33
CONTENTS
1 GENERAL CHARACTERISTICS OF THE DEVICE ............................................................................................................... 4
1.1 BTL6000 High Intensity Laser........................................................................................................................................... 4
1.2 Laser Light and Its Characteristics ...................................................................................................................................... 4
1.3 Sources of the Laser Light .................................................................................................................................................. 5
1.4 Biological Effects of High Intensity Laser ............................................................................................................................ 5
1.5 Advantages of High Intensity Laser Treatment ................................................................................................................... 6
1.6 Possible Side Effects of High Intensity Laser Treatment ..................................................................................................... 6
1.7 Contra-indications for High Intensity Laser Treatment ........................................................................................................ 6
1.7.1 Contraindications ............................................................................................................................................................. 6
1.7.2 Other Warnings and Precautions ..................................................................................................................................... 6
1.7.3 Skint test evaluation according to Fitzpatrick .................................................................................................................... 7
2 INSTRUCTIONS FOR OPERATION ...................................................................................................................................... 8
2.1 The Front Panel of the BTL-6000 High Intensity Laser ....................................................................................................... 8
2.2 Handpiece of the BTL-6000 High Intensity Laser ................................................................................................................ 8
2.3 The Rear Panel of the BTL-6000 High Intensity Laser ........................................................................................................ 9
2.4 Footswitch .......................................................................................................................................................................... 9
2.5 Assembly and Set-Up ....................................................................................................................................................... 10
2.5.1 Installing the Handpiece Holder...................................................................................................................................... 10
2.6 Basic Displays and Operating of the Device ..................................................................................................................... 12
2.6.1 Initial Screen and Types of Tabs .................................................................................................................................... 12
2.6.2 Touch Screen................................................................................................................................................................. 12
2.6.3 Numeric Keypad ............................................................................................................................................................ 13
2.7 Setting of Therapy ............................................................................................................................................................ 13
2.7.1 Setting Therapy Parameters Via the diag Button .......................................................................................................... 13
2.7.2 Setting Therapy Parameters Via the 'prog' Button .......................................................................................................... 13
2.7.3 Setting Therapy Parameters Manually (User Setup) Via the man' Button ...................................................................... 13
2.7.3.1
Setting the Therapy Mode ....................................................................................................................................... 15
2.7.3.2
Setting the Output Power ........................................................................................................................................ 15
2.7.3.3
Setting of the Dosage ............................................................................................................................................. 15
2.7.3.4
Setting of the Treatment Area ................................................................................................................................. 15
2.7.3.5
Setting of the Frequency ......................................................................................................................................... 15
2.7.3.6
Setting of the Pulse Width ....................................................................................................................................... 15
2.8 Course of Therapy ............................................................................................................................................................ 16
2.8.1 Start, Interruption and End of Therapy ........................................................................................................................... 16
2.8.2 Screen During Therapy .................................................................................................................................................. 17
2.8.3 End of Therapy .............................................................................................................................................................. 17
2.9 Application of Laser Light ................................................................................................................................................. 18
2.10 Unit Settings: The menu Button ...................................................................................................................................... 18
2.10.1 Accessories ................................................................................................................................................................... 18
2.10.2 Encyclopaedia................................................................................................................................................................ 18
2.10.3 Unit Settings .................................................................................................................................................................. 19
2.10.3.1
Password Setting .................................................................................................................................................... 19
2.10.3.2
Sound Setting ......................................................................................................................................................... 19
2.10.3.3
Screen Saver and Auto Switch-Off .......................................................................................................................... 19
2.10.3.4
Colour Setting ......................................................................................................................................................... 19
2.10.3.5
Setting of Display Contrast...................................................................................................................................... 20
2.10.3.6
Date and Time Setting ............................................................................................................................................ 20
2.10.3.7
Language Setting.................................................................................................................................................... 20
2.10.3.8
Touch Panel Calibration.......................................................................................................................................... 20
2.10.3.9
User Options........................................................................................................................................................... 20
2.10.3.10 Setting of HW Key .................................................................................................................................................. 20
2.10.3.11 Unit Information ...................................................................................................................................................... 20
2.10.3.12 Unlock Code ........................................................................................................................................................... 20
2.10.3.13 Service Functions ................................................................................................................................................... 20
2.10.4 Specific Settings ............................................................................................................................................................ 21
2.10.4.1
Sound During Therapy ............................................................................................................................................ 21
2.10.4.2
Calibration .............................................................................................................................................................. 21
3 LIST OF STANDARD AND OPTIONAL ACCESSORIES .................................................................................................... 22
4 MAINTENANCE AND SAFETY INSTRUCTIONS ................................................................................................................ 23
4.1 General Safety Precautions .............................................................................................................................................. 24
4.2 Troubleshooting................................................................................................................................................................ 27
4.3 Labels .............................................................................................................................................................................. 28
4.4 Used Symbols .................................................................................................................................................................. 30
5 TECHNICAL PARAMETERS .............................................................................................................................................. 31
5.1 Manufacturer .................................................................................................................................................................... 33
PAGE 3 OF 33
Laser Unit: BTL-6000 High Intensity Laser contains the main microcomputer and software for controlling
the entire system. It also includes the user encyclopaedia and the therapy guide. The unit is password
secured and safety interlock is obligated to be connected.
Handpiece: ergonomic and extremely light-carrying handpiece with three removable ending spacers for
precise adjustment of the treatment area. The laser light is delivered to the handpiece from the main unit
using a permanently attached optical fibre.
Footswitch control: for safety reasons the units laser source can only be activated via foot switch control.
Coherency: it is absolutely oriented in time - maxima and minima of all waves are identical in time and the
waveforms are the same
Analgesic effect
Biostimulation effect
Antiphlogistic effect
Antioedematous effect
Vasodilatation effect
All these effects are based on positively established and verified mechanisms:
Acceleration of microcirculation
Increased fibroblast activity (for keloid scars these activated fibroblasts are able to perform resorption of
fibrin)
Phagocytosis activation
Activation of metabolic processes in the cell: partly through the Na/K pump and Ca transport affection,
partly through direct activation of the mitochondrial system
Extremely well targeted application into defined therapeutic area and depth of the tissue
1.7.2
CONTRAINDICATIONS
Applications in the area of eyes possibility of direct eye irradiation and retina damage
Epilepsy
Pregnancy
Irradiation of freckles
Photosensitive medication
All the patients should receive skin type assessment according to Fitzpatrick (see 1.7.3). The therapy
parameters have to be adjusted accordingly to this assessment.
Scar tissue is associated with poor circulation and reduced cooling through heat transport by blood. Power
settings may have to be reduced to avoid heating.
Tender or Sensitive Skin: Patient may be hypersensitive to heat. Reduce power as necessary to ensure
comfort during treatment.
Swelling/inflammation: Patient may be sensitive to heat. Reduce power as necessary to ensure comfort
during use.
Redness: can be associated with increased temperature and an increase in absorption properties of the
skin. Reduce power as low as necessary to maintain comfort during use.
Excessive fat tissue is known to transmit heat without much attenuation. Reduce power as necessary.
Implants: Different materials will respond differently to the laser energy and heat. Be aware of any implants
and location. Avoid direct exposure of the implant site to laser or heat.
No ointments, creams, lotions or heating lotion patches should be used at the site or on close proximity.
No therapies that could change body temperature (ultrasound, thermotherapy and electrotherapy) should
be used prior to laser treatment.
No treatment over the articles of clothing. Only direct application to the uncovered skin surface is
acceptable.
All persons present in the operatory must wear protective laser eyewear.
All reflective materials and windows in the treatment room must be covered in order to prevent reflection of
the laser beam or unwanted irradiation outside.
WARNING: Do not aim the laser at metallic or reflective surfaces. If aimed directly at these surfaces, the laser
beam will reflect and create a potential hazard.
WARNING: Patients must be monitored for pain or discomfort throughout the entire procedure. In case the patient
does not tolerate the therapy, discontinue the treatment immediately.
1.7.3
Type I Skin white; very fair; freckles; typical albino skin. - Always burns, never tans
Type III Skin beige; very common. - Sometimes mild burn, gradually tans to a light brown
Type IV Skin beige with a brown tint; typical Mediterranean Caucasian skin. - Rarely burns, tans with ease
to a moderate brown.
Type V Skin dark brown - Very rarely burns, tans very easily
Type VI Skin black - Never burns, tans very easily, deeply pigmented.
Important: Patients evaluated as skin type V. and VI. must be treated with special precautions. Patients with skin
type V. and VI. may be treated only with pulsed laser light. Monitoring of discomfort and unpleasant sensations of
warming must performed during the whole treatment procedure with special care!
1.
2.
3.
4.
5.
6.
7.
touch screen
select knob (to select individual parameters)
enter key
esc key
laser stop: emergency laser stop button
on/off switch (back lit, in blue, when the control unit is on )
USB port in the space of the devices grip for use only in compliance with IEC 60950-1
The USB port serves only for service purposes such as upload of firmware; it is not designed for therapy
use!
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
2.4 FOOTSWITCH
19.
20.
21.
connection cable
footswitch safety metallic cover
footswitch bellows
Install the handpiece holder using the procedure described in the section 2.5.1.
2.
First connect the device to the mains supply using power cord cable, which you will connect to the connector
on the rear panel (11) of the device and to 100 V 240 V mains socket. Plug the device directly into the
mains socket. Do not use any multi-connection extension cables or two-socket adaptors.
3.
Connect the footswitch control cable (19) to the connector in the rear panel (13).
4.
Connect the safety interlock to the connector in the rear panel (15).
5.
Then switch on the power switch (12) in the rear panel of the device.
6.
Press the on/off switch located on the front panel of the device.
Note:
After switching the device on, the device will run a self-diagnostic of its internal circuits and its functions for about
10 to 15 seconds. If any fault is detected, the screen will display a warning message. If necessary; the control unit
will lock itself into a secure mode. If this situation occurs, please contact your authorized BTL distributor.
2.5.1
1x handpiece holder
Procedure:
1.
Install the handpiece holder using the 2 torx screws M5x16 and the supplied torx screwdriver. The
handpiece holder can be attached to either the left or the right side of the device.
2.
The initial screen after the device is switched on contains the tab displaying information about the instrument
model:
During therapy, this tab displays information about the therapy in progress:
2.6.2
TOUCH SCREEN
The touch screen can display several graphic elements. Some are only for informative purposes but others can
be pressed and activated. These basic elements include:
Informative text
The items on the touch screen can be pressed by a finger or by a touch-pen, which is included in the accessories
of the device. The touch screen must not come in contact with any sharp objects, ball pens etc.
2.6.3
NUMERIC KEYPAD
In addition to the setting of the numerical values with the select knob on all the screens, the numeric keypad"
can be used for the faster setting of values.
This is the icon for the opening the numeric keyboard window:
Press the numeric keypad button to display the window with the numeric keypad for the parameter with the
pressed light button. Set the required values and return to the previous screen by pressing the enter button. If
you do not want to enter any values or change the selected parameter, leave the window with the numeric keypad
by pressing the esc button.
If you enter a value out of the allowed range of values (stated above the entering box) or the device cannot set it,
then the value is rounded to the nearest lower allowed value.
2.7.2
2.7.3
SETTING THERAPY PARAMETERS MANUALLY (USER SETUP) VIA THE MAN' BUTTON
The therapy parameters screen for the manual setting will be displayed by pressing the man button. All
specifications of the therapy can be set and possibly saved as a user program or a user diagnose.
Power
Output power of the emitted laser light in Watts (W). This parameter is available in all three therapy modes.
Dosage
2
Therapeutic dosage in Joules per cm (J/cm ). This parameter is available only in the analgesic and biostimulation
therapy modes.
Area
2
Therapeutic area in square centimetres (cm ). This parameter is available only in the analgesic and biostimulation
therapy modes.
Frequency
Frequency of the pulsed laser light in Hertz (Hz). This parameter is available only in the analgesic therapy mode.
Pulse width
Width of the single pulse emitted in milliseconds (ms). This parameter is available only in the single pulse therapy
mode.
Therapy time
Automatic calculation of the therapy time in minutes and seconds (m:s). The therapy time is calculated using the
Total energy and Power. This parameter is indicated only in the analgesic and biostimulation therapy modes.
NOTE: The maximum Therapy time is limited to 99 minutes 59 seconds.
Energy per pulse
Automatic calculation of the energy in Joules (J) delivered by a single emitted pulse. This parameter is indicated
only in the single pulse therapy mode.
2.7.3.1
2.7.3.2
analgesic mode: repetitive pulsed laser emittion with duty cycle of 25 % and adjustable frequency;
single pulse mode: single pulse laser emition with adjustable pulse width.
2.7.3.3
2.7.3.4
2.7.3.5
2.7.3.6
In analgesic and biostimulation mode the laser light will be emitted until the footswitch control is
released. The therapy in progress is indicated by the device by yellow backlight around the laser stop
button and by beeping sound.
2.
In single pulse mode by pressing the footswitch control, the device will emit one laser light pulse.
During the pulse generation, the backlight around the laser stop button is yellow and the device makes
a beeping sound. Hold the footswitch until the pulse generation is complete. For another emission the
footswitch control must be pressed again.
During the therapy the device continues to emit the red aiming beam.
The therapy laser is invisible to human eye.
To stop the laser emission before the therapy is over, release the footswitch control. To interrupt/pause the
therapy press pause button on the therapy screen. To resume the interrupted paused therapy press the
continue key on the screen. To stop the therapy, press esc.
The laser power can also be changed during therapy by turning the select knob to the right to increase the
intensity or to the left to decrease the intensity.
For immediate discontinuation of the laser unit activity in case of emergency press the red laser stop emergency
button on the front panel of the unit.
2.8.2
Output power
setting
Indication of the
remaining
energy to be
delivered
Indication of the
remaining
therapy time
Screen during therapy when the single pulse therapy mode is selected:
Name of the
selected therapy
/ program and
the set
parameters
Output power
setting
Indication of the
delivered energy
2.8.3
Number of
applied pulses
END OF THERAPY
In analgesic and biostimulation modes, the therapy will end automatically when the calculated therapy
time/total energy decrease to zero.
To stop emitting of the laser release the footswitch control. To interrupt/pause the therapy, press the pause
button on the therapy screen. To resume the interrupted paused therapy press the continue key on the
screen. To stop the therapy, press esc.
In single pulse mode by pressing the footswitch control, the device will emit one laser light pulse. During the
pulse generation, the backlight around the laser stop button is yellow and the device makes a beeping sound.
Hold the footswitch until the pulse generation is complete. For another emission the footswitch control must be
pressed again.
For immediate discontinuation of the laser unit activity in case of emergency press the laser stop emergency
button on the front panel of the unit.
10 mm length for applications in proximity of the skin of the patient. Spot diameter 12 mm.
30 mm length standard spacer, defining therapeutic area suitable for most common applications. Spot
diameter 20 mm.
60 mm length optimum size when large areas are to be treated. Spot diameter 35 mm.
Accessories
Encyclopaedia
Unit settings
Specific settings
2.10.1 ACCESSORIES
Displays information about the laser handpiece such as its operating wavelength.
2.10.2 ENCYCLOPAEDIA
The encyclopaedia provides information about the preset clinical protocols, therapeutic possibilities and examples of
how to use the device. An electronic version in the device is accessible from most screens and from the device menu.
2.10.3.1
Password setting
Sound setting
Colour setting
Language setting
User options
Setting of HW key
Unit information
Unlock code
Service functions
Password Setting
Allows change of the devices password which is required by the device after it is switched on. Without entering
the password, further work with the device is impossible.
2.10.3.2
Sound Setting
Allows the setting of the acoustic signalling for when buttons or the touch screen are pressed as well as for
certain operations such as therapy start, therapy interruption, end of therapy etc.. The device includes a set of
standard sounds from the manufacturer, for example the signalling the therapy operations. All audio tones can be
muted (no sound) or modified as required.
Allows editing of the individual audio schemes, the creation of new ones and the modification of the audio tones
for each operation separately. The users own settings will always be displayed at the end of the list of sound
schemes.
The sound volume can be set under the User options menu.
2.10.3.3
2.10.3.4
Colour Setting
Allows setting of the colours of the controls displayed on the screen. There are 5 preset colour schemes available
to choose from.
2.10.3.5
2.10.3.6
2.10.3.7
Language Setting
Allows the setting of the preferred language of the texts displayed on the devices screen. The factory default is
English.
2.10.3.8
2.10.3.9
User Options
This submenu allows the setting and displaying of the following parameters:
sound volume
repair of files
Checks the file storage system of the device, the system of saved information. It will repair possible errors, delete
empty files, etc. We recommend using this feature in the event of a lack of memory space, if the device rejects
saving any data, or if you are in doubt that some data may have been lost.
Should be used only if the repair of damaged files feature did not help. Unfortunately, when this feature is used
the entire memory is re-formatted and all the user-data and the user setup of the device will be lost.
Restores all functions of the device to the factory default settings. However, all userdata related to clients,
programmed therapies, etc. will stay saved.
2.10.4.2
Calibration
It is recommended to calibrate the laser source every 3 months. The calibration process is automatic and takes
about 10 seconds. Calibration has to be done without any spacer attached to the handpiece. The procedure is as
follows.
1.
Place the ending part of the handpiece without the spacer into the calibration window in the back of the unit.
2.
3.
4.
Press and hold the footswitch until the device indicates on the screen that the calibration is finished.
5.
Release the footswitch and remove the handpiece from the calibration window.
Standard accessories:
1x laser handpiece
1x footswitch control
1x safety interlock
2x safety eyewear
1x handpiece holder
1x power cord
1x touch pen
2x fuse 2T2A,250V
Optional accessories:
communication cable
Take care to avoid shocks or jarring movements to the device during transportation. This device should only be
transported and stored under the conditions defined in the Technical Parameters section.
All operatory entrances must be marked with an appropriate laser warning sign included with shipment.
All personnel must be properly trained before using the device. This training should include the operating
technique, maintenance, verification of proper functioning and safety precautions associated with using the
device.
Protect the device against unauthorized use. The device can be protected by switching the device off (a
password is required to switch on the device) or by removing the supplied safety interlock from the
connector on the back of the unit.
Do not operate in the presence of explosive or flammable materials. Flammable anaesthetics or oxidizing
gases such as nitrous oxide (N2O) and oxygen should be avoided. Solvents of adhesives and flammable
solutions used for cleaning and disinfecting should be allowed to evaporate before laser is used. Attention
should also be drawn to the danger of ignition of endogenous gases.
All persons present in the operatory must wear protective laser eyewear. Use only protective eyewear
designed for the BTL-6000 High Intensity Laser. Periodically inspect the protective eyewear for any damage.
Do not use damaged protective eyewear!
For replacement or additional protective laser eyewear, please use only eyewear from your authorized
dealer.
All reflective materials and windows in the treatment room must be covered in order to prevent reflections of
the laser beam or unwanted radiation outside the room.
WARNING: Do not aim the laser at metallic or reflective surfaces, such as surgical instruments. If aimed
directly at these surfaces, the laser beam will reflect and create a potential hazard.
The device does not use any drugs, creams, gels or other substances which are an integral part or which
are applied by its use.
Use only accessories supplied by the manufacturer. Accessories from other manufacturers will not work with
the device and might damage it.
The product complies with Class A emissions according to CISPR11, IEC 60601-1-2.
Portable and mobile high-frequency communication devices (such as mobile phones) may affect the function of
the device.
The electrical cables which are to be connected to the device must be installed and tested according to the
existing valid standards (IEC 364). If it is not known whether cables are safe and/or correct, then they should
be checked and/or upgrade by an inspection engineer.
Check whether the parameters of the mains power supply correspond to the requirements of the device
according to Technical Parameters section.
The device requires the environmental conditions that are stated in the Technical Parameters section. It
must not be used in an environment where there is a danger of explosion or of water penetrating the device.
The device cannot be in connection with flammable anaesthetics or oxidizing gasses (O2, N2O, etc.).
Do not place the device in direct sunlight or near strong electromagnetic fields to prevent mutual functionality
influence. If this happens, move the device further away from the source of interference or contact an
authorized BTL service department.
Do not twist or bend sharply the optical fibre leading to the handpiece. It might damage the optical fibre.
Inspect the device thoroughly before each use. Look for loose cables, cracked cable and/or fibre cable
insulation, cracks in the laser handpieces housing and functional behavioural differences in the display or
the operating elements. If any anomalies or inconsistencies are found, stop using the device and contact an
authorized BTL service department. If the behaviour of the device shows any divergences from the
functionality procedures described in this users manual, stop using the device and contact an authorized
BTL service department.
If the device shows any defects or if there are any doubts concerning its correct and safe functioning,
terminate the therapy immediately. If the source of the concern can be determine after a thorough study of
the user's manual, then contact an authorized BTL service department immediately. If the device is not used
in accordance with this manual or if it is used when the device exhibits functional differences from those
stated in this manual, then BTL is not responsible for any damage to or caused by the device.
As the aiming beam passes down the same delivery system as the therapy laser light, it provides a good
means of checking the integrity of the optical fibre. If the aiming beam is not present at the output of the
handpiece or its intensity is reduced, this is a possible indication of a damaged or malfunctioning of the
optical fibre.
Do not try to open, remove protective covers, or dismantle the device for any reason. There is a danger of
electrical shock and/or serious injury. Even the replacement of the lithium battery must be done an
authorized BTL service department only!
All material and parts which come into direct contact with the client's body (such as cleaning agents, and the
handpiece) must respectively comply with the standards related to irritants, allergens, toxins, geotaxis and
carcinogens (ISO 10993-1, ISO 10993-3, ISO 10993 5). The user is responsible for all these materials and
parts if they were not supplied by an authorized BTL equipment supplier.
The connectors for accessories, as well as the other connectors, must not be used for connecting anything
else other than what they are designed for. There is a danger of electrical shock and/or serious damage to
the device.
The device does not use or emit any toxic substances during its operation, storage or transport under the
stated conditions.
Before the start of therapy make sure that all set parameters comply with your requirements.
To terminate operation, do not use the main power switch! Instead, press the "on/off" button. In case of
emergency, use the laser stop button for immediate stop of laser emission and device shutdown.
The time interval between turning off the main power switch and turning it back on must be at least
3 seconds.
If it is necessary to discard the device, the lithium battery must be removed. The removed battery must be
disposed according to local hazardous waste disposal requirements. Do not place the device in municipal
waste containers. The device itself does not contain any toxic materials which could harm the environment
when disposed of ecologically.
The device and its accessories must be used in compliance with this manual.
The device does not contain any components, except for the fuse, which can be repaired or replaced by the
user. Do not remove the cover from the control unit. All repairs must be done by an authorized BTL service
department.
CAUTION: Use of controls or adjustments or performance of procedures other than those specified in this
manual may result in hazardous radiation exposure.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
During the therapy the operator must not touch other electrical equipment.
Dissipate static electricity before manipulating with the safety interlock and/or door lock sensor by
touching a grounded metal object, such as the devices unpainted metal chassis.
4.2 TROUBLESHOOTING
The table below shows the list of error messages which can be fixed by the user in most cases.
Fault
Possible cause
Corrective actions
Power failure
Device malfunction
not lit
Door open
start therapy
Temperature alarm
Calibration failed
Error message
System exception
4.3 LABELS
Footswitch label
Warning: the values of laser light energy used during therapy exceed safe values.
Electric and electronic equipment. Do not use municipal waste to dispose of the
unit. Its disposal is subject to the 2002/95/EC Directive.
5 TECHNICAL PARAMETERS
Identification of the device
Laser specifications
Laser classification
Wavelength
Maximum output power
Power accuracy
Beam divergence
Nominal Optical Hazard Distance
(NOHD)
Spot size
10 mm spacer
30 mm spacer
60 mm spacer
Maximum power density
10 mm spacer
30 mm spacer
60 mm spacer
Class 4
= 600 nm 2000 nm (actual wavelength is specified on the explanatory
label)
up to 15 W (actual maximum power is specified on the explanatory label)
20 %
35
2.42 m (at 15 W)
2
12 mm (1.13 cm )
2
20 mm (3.14 cm )
2
35 mm (9.62 cm )
2
Up to 13.3 W/cm
2
Up to 4.8 W/cm
2
Up to 1.6 W/cm
Class 3R
650 nm
5 mW
Operation modes
Biostimulation (continuous mode)
Power
Dosage
Treatment area
Analgesic
Power
Frequency
Duty cycle
Dosage
Treatment area
Single pulse
Power
Pulse duration
Classification
Applied part type
Class according to
MDD 93/42/EEC
Power supply
Maximum input
Mains voltage
Mains frequency
Equipment protection class
External exchangeable fuses
Power switch according to
IEC 60601-1
BF
IIb
160 VA
100 240 V AC
50 60 Hz
I (acc. IEC 536)
2T2A,250V, tube safety fuse 5 20 mm, in accordance with IEC 127-2
On the back of device, positions 0 (off) and I (on). To disconnect from the
mains, unplug main power cable from the mains socket outlet
Display elements
Graphic colour touch screen
Indicators
Operating conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Position
Type of operation
Transport and storage conditions
Ambient temperature
Relative humidity
Atmospheric pressure
Position of the main unit
Storage time
Design
Weight of the main unit including
the handpiece
Main unit dimensions (w h d)
IP code according to EN 60 529
+ 10 C to + 34 C
30 % to 75 %
700 hPa to 1060 hPa
horizontal on legs
permanent
- 30 C to + 70 C
10 % to 100 %
500 hPa to 1100 hPa
horizontal
Transport only in the original container
max. 8 kg
320 190 280 mm
IP 20
5.1 MANUFACTURER
This product is manufactured in accordance with the EU Medical Devices Directive by:
BTL Industries Ltd.
161 Cleveland Way
Stevenage
Hertfordshire
SG1 6BU
United Kingdom
E-mail: [email protected]
http://www.btlnet.com
For service, please contact our service department at [email protected].
All rights reserved. No part of this manual may be reproduced, saved or transferred by any means including
electronic, mechanical, and photographic without the prior written approval from BTL Industries Limited.
BTL Industries Limited operates on a policy of continuous development. Therefore, we reserve the right to make
changes and/or improvements to the product described in this manual without any prior notice.
Except as required by applicable law, no warranties of any kind, either expressed or implied, are made for the
accuracy, reliability or contents of this document. BTL Industries Limited reserves the right to revise or withdraw
this document at any time without prior notice.