IACER I-TECH LA500 User manual

USER MANUAL
MNPG127rev.0210/03/19
Laser therapy

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Summary
SUMMARY I
TECHNICAL INFORMATION 1
INFORMATION ON THE USER MANUAL 1
MANUFACTURER 2
DECLARATION OF CONFORMITY 2
CLASSIFICATION 3
PURPOSE AND SCOPE 3
TECHNICAL FEATURES 4
DEVICE AND COMMAND DESCRIPTION 6
LABELS 6
Package content 7
NOTES 8
PURPOSE 9
INTRODUCTION TO THE TECHNOLOGY 9
INDICATIONS 10
CONTRA-INDICATIONS 11
WARNINGS 12
PATIENT PREPARATION 13
INSTRUCTION FOR USE 13
Therapeutic indications 16
!Warning! 17
DEVICE’S CARE 19
MAINTENANCE 19
TROUBLESHOOTING 20
DISPOSAL 21
WARRANTY 22
Support 23
Spare part 23
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 24

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Technicalinformation
Information on the user manual
This manual is addressed to:
-machine user;
-owner;
-managers;
-handling personnel;
-installers;
-users;
-maintenance personnel.
It contains general information on the operation, precautionary practices,
and maintenance information of the device I-TECH LA500.
This is an essential reference guide for users. It is essential to read the
manual carefully before installing and using the device and to keep it at hand
for quick reference.
The manufacturer declines all responsibility for:
-improper use of the device;
-use contrary to specific national laws;
-incorrect installation;
-defective power supply;
-improper maintenance;
-unauthorised modifications and interventions;
-use of material or spare parts that are not specific for the model;
-partial or complete non-observance of the instructions supplied;
-exceptional events.
To get further information, consult the fabricant.
WRITING CONVENTIONS
Certain sections of the manual have been underlined to highlight their
importance.
NOTE
These contain important information and useful tips for the utilization of the
equipment.

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CAUTIONS
The CAUTION message appears before operations, which, if not correctly
performed, may cause damage to the machine and/or its accessories.
!WARNING!
This signals operations or situations, which, if unknown to the operator, or
incorrectly carried out, may harm the operator.
Manufacturer
I.A.C.E.R. S.r.l.
Via S. Pertini, 24/a • 30030 Martellago (VE)
Tel. [phone] • Fax [phone]
IACER Srl. is an Italian manufacturer of medical devices (certified CE no.
MED24021 from the Notified Body no. 0476, Kiwa Cermet Italia Spa).
Declaration of conformity
I.A.C.E.R. S.r.l
Via S.Pertini 24/A –30030 Martellago (Ve), Italia
herewith declares under its own responsibility, that the product
I-TECH LA500
UMDNS Code: 12299
Batch no.:
Series no.:
has been designed and manufactured according to the European
Medical Device Directive 93/42/EEC (transposed in Italy by the D.Lgs.
46/97), as modified by the Directive 2007/47/EC (D.Lgs.37/2010) and
further modifications/integrations.
The product has been assigned to class IIa, according to Annex IX, rule
9 of the Directive 93/42/EEC (and further modifications/integrations)
and bears the mark

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Compliance of the concerned product with the Directive 93/42/EEC
has been assessed and certified by the Notified Body
0476 - Kiwa Cermet Italia S.p.a.
Via di Cadriano 23 –40057 Cadriano di Granarolo (BO), Italia
Certificate no.: MED24021
following the certification procedure according to Annex II (excluding
point 4) of the Directive 93/42/EEC.
________________ _____________________
Place, date Signature
Classification
The I-TECH LA500 has the following classification:
•class IIa (Directive 93/42/EEC, Annex IX, rule 9, 10 and further
amendments);
•class I with B type applied part (classification EN 60601-1);
•class 3B laser (classification EN 60825-1);
•equipment unsuitable for use in presence of a flammable
anesthetic mixture containing air, oxygen and nitrous oxide;
•equipment suitable for continuous operation;
•equipment unsuitable for outdoors use.
Purpose and scope
Clinical intended use: Therapeutic
Environmental intended use: Ambulatory and in hospitals
I-TECH LA500 is an electro-medical device that delivers treatments of laser-
therapy, with the help of power laser up to 500mW for the provision of
treatment though a specific probe.
I-TECH LA500 is an active therapeutic device, not invasive, used especially
by physiotherapists, physicians and pain therapists.
The use of I-TECH LA500 is indicated for professional user in clinics/hospitals.
MASSIMO MARCON
Martellago, 14/09/2018

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In order to guarantee the safety and security of the user, it is mandatory to
strictly follow the instructions in this manual.
The device can be used both in hospitals and in clinics, unless the operator
is qualified to use such equipment and the conformity to the statements
declared in the manual is respected.
Technical features
Characteristic
Specification
Power supply
AC 230V, 50-60Hz
Protection fuse
1.5A
Maximum absorbed power
30VA
LCD display
Icons
Maximum Power
500mW ± 20%, spot diam. ≤10mm
Laser diode wavelength
810 ± 30nm
Laser classification
3B
DNRO (m)
2,3
Divergence
260mrad
Impulse duration
Set
Emission
CONTINUOUS
Adjustable percentage of emitted
power
0% - 100%
Emission frequency
Set
Pulsed mode
ON/OFF (sec)
Pointing led
Red light 650nm±30nm
Classification in compliance with the
directive 93/42/EEC
IIa

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Characteristic
Specification
Output channels
1
Class of isolation/parts applied
according to the rule EN 60601-1
I B
Protection level against liquid’s
penetrations according to the rule EN
60601-1
IPX0
Command of execution of the
treatment
Button
Configuration of the laser probe
Diode probe
Defocused
Connection specific for the device
Adjustable treatment time
0-30 minutes
Dimensions (Length * Height * Depth)
30x15x12cm
Weight main body
5.2Kg
Conditions of use
Environmental
temperature
+5 - +40°C
Relative humidity
< 80 % without condensation
Storage/transport
conditions
Environmental
temperature
+5 - +40°C
Relative humidity
<93% without condensation
Atmospheric
pressure
700-1060hPa
The useful life of the device is 5 years.

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Device and command description
Labels

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Label
It resumes the principal information of the device plus the sybols, whose
meaning is reported below.
Warning label regarding the laser beam, placed on
the back of the device.
Closse to the exit laser
beam.
Close to the emergency button, it indicates the
emergency stop.
On the back of the device,
warning of the beam.
Symbol
Meaning
Warning, see document in attachment with the
product.
Manufacturer’s logo.
CE product mark released by the Notification Body
no. 0476.
Class of isolation I with applied part type B
according to EN 60601-1 ed. III^.

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Symbol
Meaning
Manufacturer information.
Manufactured date (YYYY-MM).
The product must be disposed as “electronic
waste”, in accordance to WEEE Directive on waste
electrical and electronic equipment.
Read instructions for use.
Wear protection glasses.
Package content
The I-TECH LA500 box contains:
•N°1 mainframe;
•N°2 safety keys;
•N°1 probe;
•N°1 power cable;
•N°1 user manual;
•N°1 protective goggle.
Notes
PRELIMINARY NOTES
−The installation of the device does not require any special care, is
therefore simple and immediate.
MAINTENANCE
−For an optimal use of the device and to guarantee its maximum
performance, it is recommended to perform maintenance at the
correct time and suggested ways.

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Purpose
Introduction to the technology
The evolution of light
The new Laser I-TECH LA 500 is equipped with a new probe that allows beam
laser application directly to the treatment area. Thus, you can make sure
that the laser performs its therapeutic action as an impressive regenerative
stimulation in chronic pathologies, in the acceleration of the inflammation
resolution and of the edema in acute pathologies, and in the rapid resolution
of painful articular, muscular, neurogenic and soft tissues syndromes, both
acute and chronic.
I-TECH LA500 allows an immediate improvement in the symptoms of
inflammatory and degenerative pathologies in the orthopedic, neurologic,
dermatologic domain and a reduction of recovery times and presents itself
as an indispensable therapy, especially in Sports Medicine, since it allows
rapid recovery for many sportsmen, for whom time is a determining factor
in their career.
The advantages of Laser therapy
Laser therapy is not based on the generation of heat, but on photochemical
and photo-biological effects on cells and tissues. Observations have shown
that if the laser light is supplied in the right quantities, you will obtain a
stimulation of certain cellular functions, especially in the presence of cells
with functional deficiencies. The biological action in using the Laser therapy
produces a series of effects on the cells in function of a “stimulating” action
on mitochondrial functions with a higher production of ATP.
The applications of the I-TECH LA500 laser produce several effects on the
treated tissues:
1. increase in hematic flow: vasodilatation of capillaries and arteries
2. biostimulation: tissue regeneration, stimulation of the protein
synthesis, stimulation of the production of ATP, stimulation of the
fibroblast mitosis, increase in collagen and elastin;
3. anti-inflammatory effect;
4. anti-edematous effect, with stimulation of the lymphatic system;
5. analgesic effect: increase in the perception threshold of nerve
endings.

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I-TECH LA500 is therefore a laser with the following characteristics:
-thanks to the power adjustable up to 500mW and to the 810 nm
wavelength, it allows the stimulation of the deepest layers of the
treated tissue, thus favoring a rapid and diffused cellular re-
generation;
-with I-TECH LA500 it is possible to obtain a deep tissue stimulation
and this makes possible to treat the most internal tissues and
structures (such as the femoral joint) and chronic pathologies such
as arthrosis;
-it may be used in many fields such as sports medicine, orthopedics,
neurology, dermatology, rheumatology, odontology (conservative
parodontology, medical treatment by implants, oral pathology,
surgery, removal of tartar with pain) and acupuncture;
-crucial in acute, chronic and degenerative inflammations such as
knee arthritis.
I-TECH LA500 carries out an important therapeutic action for the
regeneration of chronic pathologies, for the acceleration of the healing
process in the acute pathology of edema inflammation. Furthermore, it is
very effective in the fast resolution of painful articular, muscle, neurogenic
syndromes and soft tissues.
Indications
The application fields that can profit from using the laser-therapy I-TECH
LA500 are the following:
1. Arthro-rheumatic pathology
Arthrosis, sciatica, scapular and humeral periarthritis, arthropathy
of hands and feet, epicondylitis, hip arthrosis at its initial stage,

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gonalgia with or without effusion, myogenic stiff neck, lumbago,
myositis, chronic and acute pathologies etc.
2. Rehabilitative therapy
Articular motor rehabilitation after removing plaster apparatuses
or after orthopedic surgical operations.
3. General medicine and dermatology
Decubitus ulcers, keloid, torpid sores for its well-known bio-
stimulating and anti-infectious effects.
Contra-indications
-Direct radiation in the eyes: the human eye is extremely sensitive to
laser radiation and can be permanently damaged from direct or
reflected laser beams. The special safety glasses must be worn by both
patient and the operator.
-Pregnancy: the laser is contraindicated for use over the pregnant
uterus. It can still be used in pregnant women with the foresight to
not radiate over the abdomen.
-Neoplasms: you must not use the laser on a primary lesion or
secondary non-diagnosed. Laser treatment may be granted to relieve
pain during the terminal stages of the disease, but it is recommended
to be performed only with the full consent of the patient.
-Thyroid: the laser should not be used in any case above this gland.
-Bleeding: vasodilatation due to laser effect may worsen the bleeding.
-Immuno-suppressive therapy: laser therapy is contraindicated in
patients who have undergone such type of drug therapy.
-In the skin and injuries suspects: never laser radiate on angiomas,
black points or injuries suspects on the skin.
-Treatments over the sympathetic ganglia, the vagus nerve and among
the heart in patients with heart disease: laser therapy can significantly
affect the heart neural functions; therefore it is contraindicated to be
used on this area in patients with heart disease.
Other:
-Atopic dermatitis and eczema in the acute phase.
-Inflammatory processes in place at the site to be treated.
-Abrasions or bruises.
-Photoallergy.
-Photodermaititis.

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-Recent surgery or cryotherapy in cutaneous sites to treat.
!Warning!
-Photosensitivity reactions: some kind of drugs are well-known to be a
potential cause of photosensibilization reactions in patients who take
them. However, it is not clear how the combination of laser and drugs
triggers this response. It is recommended that patients at allergic risk,
or patients with a history of such reactions are "tested" with a
minimum time of treatment.
-Means of fixation, metal plates, plastic DO NOT constitute
contraindication to the use of lasers, which can be safely used on
metallic implants, sutures and plastics.
Warnings
-The customer is liable for all damage caused by inadequate
packaging of the material. Keep the original packaging of the unit:
it will be needed if the unit is returned to the company.
-Do not use the equipment in places where it might get wet.
-Before operating, check carefully the correctness of the
connections according to the instructions.
-Do not use accessories other than the ones provided: they might
damage the unit, causing the warranty to become void. In case you
have any problems or difficulties with installation, contact IACER Srl
technical support.
-If using the same extension for the unit and other units, make sure
that the total current being absorbed by the connected units does
not exceed the maximal current allowed for that type of cable and
that, however, it does not exceed 15A.
-It is not possible to define a suggested number of sessions to
evaluate the effectiveness of the treatment, since they are related
to the power delivered to the treated patient. The physician is in
charge of the decision on the number of therapy sessions, which
will be related to the requirement of the ongoing case, in order to
ensure the patient of the treatment effectiveness and its safety
conduction
-Always control the integrity of the cable and of the
probe/applicator connector: they must not be damaged or worn.

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USE
-The laser radiation in output from the device is dangerous: always
use the appropriate glasses, always avoid the exposition of the eyes
to the direct or reflected laser beam. Before beginning any
treatment both operator and patient must wear the PROTECTIVE
GLASSES.
-Before switching the device on, be sure that the INTERLOCK key
that allows to start up the machine is connected.
-For security reasons, the software to be downloaded in the devices
are only the ones specific to the device in question. In case of
wrong software installation, the device could immediately stop its
functions, requiring the intervention of IACER Srl technical
assistance.
Patient preparation
Before applying the laser therapy, it is necessary to prepare the skin of the
patient. This will allow the laser light to reach better the areas to be treated
and to reduce the risk of skin irritation.
To prepare the skin of the patient for the therapy, carry out the following
operations:
1. wash the skin using soap and mild soap or alcohol where the head
of the laser will be positioned;
2. dry well the skin.
We recommend cleaning accurately the probe cover (output lens) using
alcohol and a piece of cotton at the end of each treatment to avoid the
steamed up and the incrustations of the lens. Pay attention not to pour the
liquids into the handle head.
Instruction for use
CONNECTIONS
On the back of the machine is placed the power plug, which is composed of
the main plug for the power supply cable and the fuse holder with two fuses
(check Technical information).
Insert the cable in the power plug, check if the cable is correctly plugged in
the power plug.
Connect the interlock to the plug placed on the back of the machine.
Connect the probe laser cable to the proper plug placed on the front of the
machine.

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STARTING
After the machine has been placed and installed using the instructions given
in the previous paragraphs, plug the power cable into the wall socket (230V
AC) and switch on the device moving the key button on the “ON” position,
which is placed on the front of the machine.
This operation prepares I-TECH LA500 for use, determining the switching on
of the LCD display that shows that the equipment is ready to operate. The
default program is pre-set on CONTINUOS mode and the treatment time last
3 minutes.
Select the operation mode (CONTINUOS or CYCLE) using the buttons on
the right side of the front panel (picture below).
With CYCLE mode it is possible to select the ON time (from 1 to 9 seconds)
and the OFF time (from 1 to 9 seconds) using the buttons on the right side
of the front panel (next two pictures).
Select the treatment time using the TIME + and TIME –buttons placed on
the left side of the front panel of the machine (picture below). You can select
the treatment time from 30 seconds to 30 minutes.
You can set treatment intensity with the POWER + e POWER –buttons
placed on the left side of the front panel. The default power is set to 200mW

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and the range is adjustable from 10mW to 500mW in according to treatment
needs.
After the power set-up, place the laser probe on the area to be treated and
fasten it with the elastic belt.
Press the WAIT button to confirm all the adjusted values: at this time, it will
be not possible to modify the treatment time and the power. Press the
START button to start treatment.
When the treatment will be finished, the machine will emit an intermittent
signal. If you need to stop the treatment before the end, press the STOP
button and the device will stop immediately the laser emission.
In case of an emergency stop press the red button placed on the back of the
machine.

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After the treatment switch off the device moving the key switch on the OFF
position (upper picture).
Take away the key from the machine to avoid the use by unauthorized
personnel.
Please do not switch off the device unplugging the cable from the power
socket to avoid any type of damage to the device.
Therapeutic indications
The following table shows the suggested values for the main therapeutic
applications considering 20 J/cm2and with a continuous emission). The
same values can be applied with a pulsed emission (by changing the duty
cycle) with longer treatment time.
The given indications can be changed depending of the discretion of the
therapist.
PATHOLOGY
POWER
Watt
TIME for each
point (1 cm2)
TOTAL TIME
(4 trigger
points)
PAIN RELIEF (acute pain)
0,1
200s
00s
PAIN RELIEF (chronic pain)
0,5
40s
160s
NEK PAIN (acute pain)
0,1
200s
800s
NEK PAIN (chronic pain)
0,5
40s
160s
LUMBALGY
0,4
50s
200s
BURSITIS
0,3
66s
264s
BAKER’S CYST
0,3
66s
264s
DE QUERVAIN SYNDROME
0,2
100s
400s
OEDEMA
0,3
66s
264s
HEMATOMA
0,3
66s
264s
EPICONDYLITIS
0,4
50s
200s
HERNIATED DISC
0,4
50s
200s
TENDINITIS
0,2
100s
400s
CARPAL TUNNEL SYNDROME
0,3
66s
264s