New Age Hi-Laser Beta LASER User manual

ßLASER
MANUAL
Instructions for use
New Age Italia srl
Via De Brozzi, 3 - 48022 Lugo (RA)
Tel.:[phone] - Telefax: +39-0545.369028
Web: www.newageitalia.it -E-mail: [e-mail]
This document is property of New Age Italia srl. All rights are reserved. Any copy or
reproduction of it through any means, including total or partial photocopy of the contents, is
prohibited without the written consent of New Age Italia srl.

Rev. 00 of 14/01/10
2/24

Rev. 00 of 14/01/10
3/24
INDEX
Cap.1 –PRESENTATION .......................................................................5
1.1 –Biological effects of ß LASER...................................................6
1.2 –Who is ß LASER for?..................................................................7
1.3 –Fields of application..................................................................7
1.4 –Contraindications......................................................................7
Cap.2 –OPERATION..............................................................................8
2.1 –Turning device on .....................................................................9
2.2 –Selection of program type .......................................................9
2.2.1 - Free manual mode ........................................................................9
2.2.2 - Reset program mode ....................................................................9
2.2.3 - Personal program mode...............................................................9
2.3 –Start of stimulation.................................................................10
2.4 –Setting time and intensity of emission.................................10
2.5 –Interrupt / end therapy ..........................................................10
2.6 –Turning device off...................................................................10
2.7 –Configuration ..........................................................................10
Cap.3 –PRE-SET PROGRAMS.............................................................11
Cap.4 –FREE PROGRAMS...................................................................12
4.1 –Setting a new program...........................................................12
4.2 –Use and modification of a personal program......................12
Cap.5 –APPLICATIONS.......................................................................13
5.1 –Therapy sessions .....................................................................13
5.2 –Adjusting emission power output.........................................13
5.3 –Posture to be kept during the sessions ................................14
Cap.6 –SYMBOLS................................................................................14
Cap.7 –MAINTENANCE......................................................................15
7.1 –Knob..........................................................................................15
7.2 –Device .......................................................................................15
7.3 –Immediate maintenance:........................................................15
Cap.8 –WARNINGS ............................................................................16
Cap.9 –TECHNICAL FEATURES..........................................................17

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9.1 –Power supply ...........................................................................17
9.2 –Output features..........................................................................17
9.3 –Output features..........................................................................17
9.4 –Other features..........................................................................17
Cap.10 –BASIC SUPPLY AND ACCESSORIES....................................18
10.1 –Basic supply ...........................................................................18
10.2 –Accessories and consumption material..............................18
ATTENTION:
READ THIS INSTRUCTION MANUAL CAREFULLY
BEFORE USE.
IT IS RECOMMENDED TO SEEK THE ADVICE OF
MEDICAL PERSONNEL FOR THE THERAPEUTIC
INDICATIONS REQUIRED.

Rev. 00 of 12.06.09
5/20
Cap.1 –P RE SEN TA T I O N
In 2010 New Age Italia enters the world of LASER therapy with a new aim.
To have the full control of the parameters constituting LASER therapy.
In the LASER New Age devices it is possible to set power, time, frequency from
100Hz to 20KHz, duty cycle 20%-100% (continuous).
The absolute novelty of the New Age machines is in the possibility of
performing therapies simultaneously using 3 LASERS with different wave
lengths: 808 nm 980 nm 1064 nm
This unique feature enables treating different tissues and depth at the same time,
concretely limiting the treatment times.
The colour display with touch-screen technology and the rotary encoder
provided with push button, enable an easy and immediate approach to using the
machine. The real time viewing on display of the transmitted energy, total
energy and average transmitted power, guarantee full therapy control, thus
supplying the operator with the best instruments.
New Age also makes available its experience in the physiotherapy field through
the various programs that each appliance owns; this enables the operator to be
operational and efficient, right from the first applications, obtaining the best
results in the least possible time.
The high powers of the LASER New Age modules enabling to quickly reach the
therapeutical energy dosing, thus reducing the time of each therapeutical session.
To obtain spot LASER with different diameter, the classical method envisions
the use of various length interchangeable spacers, positioned between patient
and knob, differently the R&D New Age department has developed an
innovative knob provided with a lens system able to focus and defocus the
LASER ray from a minimum spot of 8 mm to a maximum of 20 mm, simply by
turning the ring nut present on the knob, thus eliminating interchangeable
components and enabling a more accurate regulation of the spot.
New Age only uses first choice materials to manufacture the appliances, such
to guarantee maximum efficiency and reliability to the customer.
All this translates in the utmost decision-making freedom for the operator and,
therefore, the best results in shorter times.

Rev. 00 of 12.06.09
6/20
1 . 1 –B i o l o g i c a l e f f e c t s o f ß L A S E R
The LASER radiation, penetrating the tissues, causes photochemical reactions at
cellular level that induce different effects.
Mitochondrial Stimulation: one of the most therapeutical effects of the
LASER, consists in stimulating cellular mitochondrion. Mitochondrions are the
energy generators of each cell, responsible for the production of ATP (adenosine
triphosphate) that constitutes energy reserve of the cell. The ATP is produced by
ADP (adenosine diphosphate) plus Pi (phosphate) plus E(energy) therefore,
ATP=ADP+P+E.
The more ATP is present in a cell, the healthier and more energetic it is.
It has been proven that cells stimulated by LASER light increase their
production of ATP and, therefore, if inflammatory or degenerative processes are
in progress, they have sufficient energy to quickly recover the optimal health
state.
Activation of the microcirculation: One of the effects deriving from using the
high power LASER, is the distinct vasoactive effect on the microcirculation. The
activation of the microcirculation entails greater oxygenation and nutritional
input, as well as greater drainage of the catabolite from the tissues.
Activation of the lymphatic peristalsis: The LASER light accelerates the
lymphatic peristalsis, which facilitates absorption of interstitial liquids and the
reduction of oedemas of phlogistic and post-traumatic origin.
Hyperpolarisation of the membranes of the nervous fibres: Experimental
studies have proven that the therapeutical LASERS determine the
hyperpolarisation of the membranes of the nervous fibres. This effect appears to
be linked to the closing of the membrane channels for potassium, due to
amendments of the superficial lipoprotein. The hyperpolarisation causes the
elevation of the excitement threshold of the pain receivers.
Transforming prostaglandin in prostacyclin: The therapeutical LASERS
stimulate the forming of prostaglandin in PG12 prostacyclin, which have
antiphlogistic, anti-edemigenous and analgetic action.

Rev. 00 of 12.06.09
7/20
1 . 2 –W h o i s ß L A S E R f o r ?
The medical field (especially physiotherapy) is the sector most suited for ß
LASER to fully express its potentialities.
1 . 3 –F i e l d s o f a p p l i c a t i o n
The most common pathologies treated with LASER therapy are those of the
locomotory apparatus and of the derma. In particular, the LASER is successfully
used for treating:
Arthralgias of various nature, rheumatic and degenerative (inflammatory and
degenerative arthropathy, epicondylitis, knee pain with and without shedding,
myositis, polyarthritis, arthritis, arthrosis, sciatica, lumbago).
General traumatology articular sprains, tendonitis, tenosynovitis, muscle
strains, bruises, bursitis, enthesitis, torn muscles, pathologies of overload,
muscular injuries and tendon, Torn muscles and tendon, Muscular bruises
post surgery or post forced inactivity motor rehabilitation
Dermatology psoriasis wound healing, bedsores
oedemas, arteriopathy;
Circulatory deficit
We recommend consulting a doctor for the diagnosis and control of the therapy.
1 . 4 –C o n t r a i n d i c a t i o n s
Magnetic fields have some contraindications in common with other physical
equipment which acts by means of endogenous heat production:
Neoplasms (tumours);
sensitivity alteration.
area with acute haemorrhage
photosensitivity

Rev. 00 of 12.06.09
8/20
Cap.2 –O P ERA TI O N
NOTE: check the contraindications and follow indications
carefully before applying LASER therapy.
2- Knob + push button
6-Stop button
1-Touch screen display
3-safety key
4- Optical fibre output
5- Emergency Button

Rev. 00 of 12.06.09
9/18
2 . 1 –T u r n i n g d e v i c e o n
To activate ß LASER, switch-on the rear switch, check that the emergency
button is released, turn the switch-on key. An initial screen appears on the
display presenting the device including: the name of the appliance version,
the START key and the CONFIGURE key.
2 . 2 –Sel e c t i o n o f p r o g r a m t y p e
ßLASER can operate in 3 different modes:
1- Free manual mode
2- Pre-set program mode
3- Personal program mode
2.2.1 - Free manual mode
Press START on the initial screen to access the manual mode area. In this
area, by TURNING THE KNOB you can vary the value of the parameter
selected, whereas by PRESSING THE KNOB you pass from one parameter
to the next. The concerned parameters are: type of emitted wave, supplied
power, therapy duration, duty cycle of the generated wave.
2.2.2 - Reset program mode
Press START on the initial screen (touch screen) to access the work area.
Then press PROGRAMS (on touch screen)to enter the Menu for choosing
specific protocols where first of all the therapy to be used is selected, by
turning the encoder and then pressing ENTER (touch screen) or else
PRESSING THE KNOB to confirm the program selected.
2.2.3 - Personal program mode
The custom-made programs are at the bottom of the list of pre-set programs.
Press START on the initial screen (touch screen) to access the work area.
Then press PROGRAMS (on touch screen)to enter the Menu for choosing
specific protocols. At the bottom of the list first of all the therapy to be used
is selected, by turning the encoder and then pressing ENTER (touch screen)
or else PRESSING THE KNOB to confirm the program selected.

Rev. 00 of 12.06.09
10/18
2 . 3 –S t a r t o f s t i m u l a t i o n
Once selected a pre-set program or after having regulated the parameters in
the manual functioning area, the display shows START. Press the relative
START to begin the therapy.
After having pressed START , the device places itself a stand-by state;
during this phase the machine will wait 30 seconds for the pedal arming the
LASER to be pressed.
Having pressed the pedal once passes to LASER ARMED state, in this
situation the LASER emits only the red pointing light.
Pressing the pedal a second time passes to EMISSION state where the
therapeutical LASER also is emitted.
2 . 4 –S e t t i n g t i m e a n d i n t e n s i t y o f e m i s s i o n
The duration of the therapy and the intensity can be set at any time by
rotating the encoder. PRESS THE KNOB repeatedly to pass from the
intensity parameter to the time parameter and vice versa. The minimum
density increase is of 1% and the maximum settable intensity is 100%, the
minimum time increase is of 1 minute.
2 . 5 –I n t e r r u p t / e n d t h e r a p y
Treatment emission is interrupted automatically when the Timer reaches 0
and an acoustic signal is heard. If you wish to interrupt treatment before the
end, press the pedal or STOP (on touch screen) (on the front panel). After the
pause, to restart treatment press the pedal twice.
2 . 6 –T u r n i n g d e v i c e o f f
In order to turn the device off, turn the key or press the switch on the back of
the device.
2 . 7 –C o n f i g u r a t i o n
The LASER devices can be set-up according to personal requirements.
Press CONFIGURE (on touch screen) to access the setting area.
This section displays the following entries:
1) language: Italian, English, French, German, Spanish, Portuguese
2) brightness of display: from 0 to 10
3) volume of buzzer: from 0 to 10

Rev. 00 of 12.06.09
11/18
4) Operator time out: time the operator has to press the pedal after the start
key has been pressed.
5) unblocking code: to enter before turning the device on the first time
6) Maximum power output: indicates the maximum power output of the
device and it’s given by the sum of the average powers of the waveforms
delivered.
Cap.3 –P R E -S ET P R OGRAM S
LASER therapy has long been used for the treatment of some pathologies
which can benefit from the effects of electromagnetic fields: chronic
pathologies, articular problems, oedemas, etc. This chapter lists the programs
pre-set inside the device.
ßLASER has 30 different pre-set programs, as well as the possibility of
memorising up to 20 free protocols.
N.
NAME
1
Hands ARTHRITIS
2
Knee ARTHRITIS
3
Ankle ARTHRITIS
4
Elbow ARTHRITIS
5
Wrist ARTHRITIS
6
Shoulder ARTHRITIS
7
Hip ARTHRITIS
8
TRIGEMINAL NERVE
9
INJURY OUTLINE
10
INJURED AREA
11
1 cm deep FRACTURE
12
2 cm deep FRACTURE
13
3 cm deep FRACTURE
14
4 cm deep FRACTURE
15
5 cm deep FRACTURE
16
ARTHROSIS
17
BRUISES
18
TEARS
19
MUSCULAR ATROPHY

Rev. 00 of 12.06.09
12/18
20
NEURALGIA
21
TENDINOPATHY
22
POST SURGERY RESULTS
23
BURNS OUTLINE
24
BURNT AREA
25
VARICOSE ULCERS OUTLINE
26
VARICOSE ULCER AREA
27
SORE OUTLINE
28
SORE AREA
29
FACIAL PARALYSIS
30
ACNE
Cap.4 –F R EE P R O GRA MS
4 . 1 –S e t t i n g a n e w p r o g r a m
From the program section, press NEW (on touch screen) to enter the Free
Program menu. By rotating the encoder you can choose which of the 20
custom-made programs available you wish to set. Press CHANGE (on touch
screen) to enter the section for setting the name. TURN THE KNOB to
change the letter and PRESS THE KNOB to move the letter selection
cursor. Once you have chosen the name, pass on to the parameter setting
phase. Press PARAMETERS (on touch screen) to move the cursor in the
work phase setting section. In this zone, ROTATE THE KNOB to set the
parameter value and PRESS THE KNOB to pass from one parameter to
another. With ß LASER it is possible to set up to 3 consecutive work phases,
where in each it is possible to use: different wave lengths, different intensity
values and timing. To move from one phase to another, scroll all parameters
of a phase, after passing the last parameter of a phase, the first parameter of
the successive phase appears. When the parameters have been set, the name
of the program can be modified once again. Press NAME (on touch screen),
save the program by pressing SAVE (on touch screen) or else exit without
saving by pressing EXIT (on touch screen).
4 . 2 –U s e a n d m o d i f i c a t i o n o f a p e r s o n a l
p r o g r a m
To amend carry out the instructions in paragraph 4.1

Rev. 00 of 12.06.09
13/18
Cap.5 –A P P L I C AT IONS
5 . 1 –T h e r a p y s e s s i o n s
Apply the LASER therapy according to medical prescriptions.
Applications are done every other day or 2-3 days. Use the most suitable
program for the patient until the ailment disappears or considerably
decreases.
5 . 2 –A d j u s t i n g e m i s s i o n p o w e r o u t p u t
Intensity adjustment is a main component for the good result of the therapy.
It differs based on the type of program being used, the duration of the
application and the characteristics of the patient. The intensity can be
changed during the program to increase its affects. It can also be decreased in
case of overheating or if pain is felt.
The device is endowed with a special function that allows to have safer
treatments: it’s the “Maximum power output”, you can find it in the
configuration page, and it allows to set the maximum power output of the
device. Consequently during work phase the sum of the power of the
different sources cannot exceed the value set during configuration, therefore
avoiding dangerous power levels during treatment.
If inadvertently the operator tries to set higher values, the device
automatically limits itself.
The device shows that the threshold has been passed in two ways: if the
operator is adjusting the duty cycle, the device limits the power bar and it get

Rev. 00 of 12.06.09
14/18
red; if the operator is adjusting the bar power, then the device limits the duty
cycle value showing it as red.
NOTE: if the intensity set or its regulation cause excessive heating or pain in
the treated zone, the intensity of the stimulation must be reduced immediately
or the application must be stopped.
5 . 3 –P o s t u r e t o b e k e p t d u r i n g t h e s e s s i o n s
The ideal posture is to be relaxed, lying on ones back or facedown depending
on the zone of application. This position must be maintained during the entire
session to facilitate the effects produced by the laser beam, especially the
increased the blood flow due to dilation of the blood vessels, During
treatment, the knob must maintain a perpendicular position to the treated
area.
–POWER SUPPLY
ß LASER must be powered by the electrical mains –Precautions for use
(1) Do not short-circuit the terminals.
(2) Do not set off sparks or flames.
Cap.6 –S Y M B O L S
BF DEVICE
ATTENTION, CONSULT THE ATTACHED DOCUMENTATION
THIS DEVICE IS MARKED CE IN COMPLIANCE WITH
0476 DIRECTIVE EEC 93/42.
DO NOT DISPOSE OF IN COMMON WASTE

Rev. 00 of 12.06.09
15/18
Cap.7 –M A I N TE N A N CE
7 . 1 –K n o b
The connection cable must be periodically checked for cracks, possible cause
of dispersion.
7 . 2 –D e v i c e
Use a cloth moistened in water and alcohol to clean the device. Do not use liquids
at all since there is not protection against their entrance (IP20).
7 . 3 –I m m e d i a t e m a i n t e n a n c e :
Immediate maintenance at New Age Italia or by authorised personnel if:
the device has been subject to external mechanical stress (e.g.. serious
drops);
the device has been overheated excessively (e.g. if left near intense heat
sources;
you doubt that liquids may have penetrated inside;
the power supply, the cover or other parts are damaged, broken or missing;
it appears that the features of the device have been changed.
for safety purposes, do not operate with accessories (e.g. knobs and
power supply) other than those included in the basic supply.
The frequency of maintenance, functional checkups and inspection for
compliance with safety standards EN60601-1 for medical devices carried out
with secur-tester is yearly. The useful life span of the instrument is
guaranteed by the company only if maintenance is carried out regularly.
N. B.: have inspections carried out only by New Age Italia. The device can
be sent directly to company assistance workshops or delivered to the dealer
where the device was purchased.
Assistance centre:
New Age Italia srl - Via De Brozzi, 3 - 48022 Lugo (RA)
Tel.:[phone] - Telefax: +39-0545.369028
Web: www.newageitalia.it - E-mail: [email protected]

Rev. 00 of 12.06.09
16/18
Cap.8 –W A RNING S
Pay special attention to use of the knobs in order not to jeopardise the
effectiveness of the treatment.
Use the device only with electrical systems compliant with Safety
Standards in force.
The device has IP20 protection rating (see chap. “Technical features”). It
must not be used in the immediate vicinity of liquids because it is not
protected from their entrance.
Do not use the device in the immediate vicinity of mobile phones (keep
them at least a few meters away).
Operating near (for example 1 metre away) a short wave or microwave
therapy device can cause instability in the output of the stimulator.
Do not connect the patient with ß LASER and an HF surgical device at
the same time, to avoid danger for the patient and for the device itself.
The device works according to its specifications if the atmosphere is kept
at a temperature between 5° and 40° C and less than 80% humidity. The
same conditions must be maintained during transportation and storage.
In case of malfunctioning and failures, do not use the device but send it to
be repaired.
Do not operate near flammable substances.
Do not use gel and accessories other than those supplied.
It is of the utmost importance to inform the patient about the type of
sensations which must be perceived during the therapy. Should he
perceive that the sensation is no longer the correct one, you must
intervene immediately, stopping the session by the controls and
disconnecting the solenoids.
If the intensity of the output set or its regulation cause excessive heating
or pain in the treated zone, the intensity must be reduced immediately or
the application must be stopped.
Keep the device out of the reach of children.
Both the patient and the operator must compulsory always wear
protective goggles included in the basic supply.
The device must only be used inside closed premises, adequately
protected against random access of unauthorised personnel

Rev. 00 of 12.06.09
17/18
Cap.9 –T E C H NICA L F E A TUR E S
9 . 1 –P o w e r s u p p l y
Internal power supply: ROAL-MCA600
PRI: 100 - 240V 47 - 63Hz SEC: 15V- 10A; 12V-12,5A; 5V-24A
9 . 2 –Output features
LASER:MDL4-13W980-7W808-10W1064-RP-PD
9 . 3 –Output features
LASER:MDL4-13W980-7W808-RP-PD
808 nm: 7W
980 nm: 13W
9 . 4 –O t h e r f e a t u r e s
EN 60601-1 (2010) –Medical electrical equipment: General safety
standards
EN 60601-1-1 (2003) –Collateral safety standard
EN 60601-1-2 (2003) –Collateral standard: Electromagnetic compatibility
–Provisions and tests
EN 60601-1-4 (1997): Collateral standard: Programmable electrical
medical systems
EN60601-1-4/A1 (2000) General requirements for safety of
programmable devices.
EN 980-2003 and EN 1041 –Graphical symbols for labelling of electrical
medical devices
EN 60601-2-22- Safety of Laser equipment
EN60825-1 Classification of laser equipment
EN60601-1-6 Usability
Series number (S.N)
Identification code of ßLASER
S.N. ßLS AA XXXX
Identification number of device
Year of manufacture

Rev. 00 of 12.06.09
18/18
Cap.10 –B A S I C S U P P L Y A N D A C C E S S O RIE S
1 0 . 1 –B a s i c s u p p l y
ß LASER is complete of:
N. 1 Appliance
N. 1 protective goggles for the operator
N. 1 protective goggles for the patient
N. 1 knob
1 power cable
1 User manual
N. 1 Trolley
1 0 . 2 –A c c e s s o r i e s a n d c o n s u m p t i o n m a t e r i a l
The following is the list of accessories which can be purchased apart to
increase the supply of the device or to replace worn elements:
-knob
-protective goggles for the operator
-protective goggles for the patient
-Use manual
-Trolley