I-Tech I-TECH LA8000 User manual

USER MANUAL
MNPG179 Rev.2of03/07/2019
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 7
Packaging content 10
NOTE 10
PURPOSE 11
INTRODUCTION TO THE TECHNOLOGY 11
INDICATIONS 13
CONTRAINDICATIONS 13
WARNINGS 14
PATIENT PREPARATION 16
INSTRUCTIONS FOR USE 16
!Warning! 16
Connections 18
Start-up and protection password 18
Main menu 19
Program selection 20
Selection of free programs 22
End of treatment 24
Last 10 programs 24
Setup 24
DEVICE’S CARE 25
MAINTENANCE 25
General indications for a proper use 28
TROUBLESHOOTING 29
DISPOSAL 30
WARRANTY 31
Support 32
Spare part 32
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 33

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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 LA8000/10000
The user manual has to be considered as part of the device and it must be
stored for future references until its disposal. The user manual must be
always kept at hand for quick reference and correctly stored.
The manufacturer declines all responsibility for:
-improper use of the device;
-use contrary to specific national laws;
-incorrect installation;
-defective power supply;
-improper maintenance;
-unauthorized 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 products
I-TECH LA8000
I-TECH LA10000
UMDNS Code: 12299
Batch no.:
Series no.:
have been designed and manufactured according to the European Medical
Device Directive 93/4/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 products have been assigned to class IIb, according to Annex IX, rule 9
of the Directive 93/42/EEC (and further modifications/integrations) and
bear the mark

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Compliance of the concerned products 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 Legal Representative
Classification
The I-TECH LA8000 e LA10000 has the following classification:
•class IIb (Directive 93/42/EEC, Annex IX, rule 9, 10 and further
amendments);
•class I with B type applied part (classification EN 60601-1);
•class 4 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 hospital
I-TECH LA8000/10000 is an electro-medical device that delivers treatments
of laser-therapy, with the help of power laser up to 8000mW (10000mW for
the LA10000 model) for the provision of treatment though a specific probe.
I-TECH LA8000/10000 is an active therapeutic device, not invasive, used
especially by physiotherapists, physicians and pain therapists.
The use of I-TECH LA8000/10000 is reserved to those professionals, who can
guarantee thanks to their training a proper and completely safe use of the
device.
MASSIMO MARCON
Martellago, 14/09/2018

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In fact, the operator must be properly qualified and must pass an adequate
training course or he/she must operate under the guidance of a qualified
physician in order to use the device in complete safe condition for the
patient under treatment.
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
Mains power supply
AC 230V; 50Hz
Maximum power consumption
40 Watt
Two delayed type fuses (T)
T2.5A
Backlit LCD display
128x64 pixel graphic display
Power
Settable from 1W to 8W
(10W) ±3%
Emission wavelength of laser diode
974nm (±3nm)
Laser classification (IEC 60825-1)
Class IV
DNRO (m)
24m ±3%
Dimensions of the SPOT with extended
spacer
10mm2±3%
Divergence of the beam
20x30 milliradians ±3%
Modulation
From 10Hz to 10000Hz
Duty-Cycle (Modulation)
From 10% to 90% (ON)
Mode
Trigger Point
From 1 to 9 points
Scanning (massage)
From 25 to 200cm2
Classification according to Directive
93/42/EEC
IIB
Output channels
1 - SMA panel socket
Classification according to EN 60601-1
Class I type B
Degree of protection against the penetration
of fluids according to EN 60601-1
IP20
Treatment activation control
External pneumatic actuator
Saved protocols
30

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Characteristic
Specification
Programmable treatment time
Between 1 second and 30min
Free memory
10
External dimensions (width x height x depth)
18x18x35cm
Weight of the body of the machine
2Kg
Distance between the laser emission point
and the skin
Around 38 mm
Spot area
Around 10mm2±3%
Operating
conditions
environmental
temperature
From +10°C to +40°C
relative humidity
From 15 to 93% without
condensation.
atmospheric pressure
500-1060 hPa
Conditions for
storage/transport
with the device in
the packaging
provided by the
company
environmental
temperature
From +5 to +40 °C
relative humidity
From 15 to 93% without
condensation.
atmospheric pressure
500-1060 hPa
The useful life of the device is 10 years.

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Device and command description

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Labels

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Label
Meaning
Label
Meaning
LABEL 1
Placed on one side of the device,
it indicates “Warning, laser
beam”.
LABEL 2
Placed on the connector’s tip, it
indicates batch number and date.
LABEL 3
Placed on the laser, under the
fiber optics connector.
LABEL 4
Placed on one side of the device, in
warns on the danger of the laser
radiation.
LABEL 5
Placed on one side of the device.
LABEL 6
Placed on the back of the device, it
resumes the principal information of
the device.
LABEL 7
Placed on the cable, indicates the
cable.
LABEL 8
Placed on the back of the device, laser
exit at the end of the fiber optics.
I-TECH Batch n........ Date:..........
Probe LA8000 - LA10000
PROBE
I-TECH
Actuator LA8000 - LA10000

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Label
Meaning
Label
Meaning
LABEL 9
It indicates the position of the
safety fuses.
LABEL 10
It indicates the power supply.
LABEL 11
It indicates the interlock socket.
LABEL 12
It indicates the emergency stop button.
LABEL 13
It indicates the position of the laser aperture.
Symbol
Meaning
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^.
Manufacturer’s information.
Manufactured date (YYYY-MM).
Consult the instructions for use.
FUSES T2.5A
230V AC, 50Hz
INTERLOCK

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Symbol
Meaning
The product must be disposed as “electronic waste”, in
accordance to WEEE Directive on waste electrical and
electronic equipment.
SN
Serial number.
Protective ground according to EN 60601-1 ed. III^.
IP20
Degree of protection against the infiltration of solids and
liquids (device protected against external bodies having a
diameter ≥12,5mm and against the vertical falling of
water drops).
Obligation to wear protective glasses.
Packaging content
The I-TECH LA8000/LA10000 box contains:
−n.1 user manual,
−n.1 power supply cable, shuko plug;
−n.2 spare fuses (see table Technical features);
−n.1 handpiece;
−n.1 pedal;
−n.1 interlock key;
−n.1 smart-card;
−n.1 protective glasses;
−n.1 case for transportation.
Control the content of the package. If some element is missing, please
contact immediately the authorized vendor.
Note
PRELIMINARY NOTES
−The laser therapy equipment can be installed quickly and with ease.
The environmental conditions for installation are as follows:
-ambient temperature: +10 to +40°C;
-relative humidity: 15% to 93% without condensation;

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-avoid direct exposure to sunlight, chemical products and
vibrations.
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.
Purpose
Introduction to the technology
The evolution of light
The new I-TECH LA8000/10000 laser with tip permits the direct application
of the laser beam to the affected area with the utmost precision. In this way,
laser therapy can be carried out to effectively stimulate regeneration in the
case of chronic diseases, and reduce inflammation and the edemas of acute
diseases, as well as quickly alleviate joint, muscular and neurogenic pain and
acute and chronic pain in soft tissue.
The I-TECH LA8000/10000, therefore, permits immediate alleviation of the
symptoms of inflammation and degeneration in the fields of orthopedics,
neurology and dermatology, and reduces healing time; it is also a valid form
of therapy especially in the field of Sports Medicine because it permits quick
recovery and healing for many professional sports-people for whom time is
of the essence.
The benefits of Laser therapy
Laser therapy is based not on the development of heat but on the
photochemical and photobiological effects on cells and tissue. It has been
observed that the administration of the correct amount of laser light can
stimulate certain cellular functions, especially in the case of cells with
functional deficits. The biological action of laser therapy stimulates the cells,
causing an increase in mitochondrial products such as ATP.
The I-TECH LA8000/10000 laser has various effects on treated tissue:
1. increase in blood flow: vasodilation of the capillary veins and
arteries;

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2. biostimulation: regeneration of tissue, stimulation of protein
synthesis, stimulation of the production of ATP, stimulation of the
mitosis of fibroblasts, increase in collagen and elastin;
3. anti-inflammatory effect;
4. anti-edematous effect, with stimulation of the lymphatic system;
5. analgesic effect: increase of the threshold of perception of the
nerve endings.
The I-TECH LA8000/10000 is, therefore, a laser with the following
characteristics:
-a power rating of up to 8000mW, in the case of the LA8000, or
10000mW, in the case of the LA10000, and a wavelength of 980nm,
permitting the deep stimulation of tissue for rapid and uniform cell
regeneration;
-the I-TECH LA8000/10000 permits deep stimulation for treating
internal tissue and structures (like the articulation of the femur)
and chronic conditions like arthritis;
-it can be used in various fields like sports medicine, orthopedics,
neurology, dermatology, rheumatology, dentistry (conservative
periodontics, implantology, oral pathology, surgery, scaling) and
acupuncture;
-it permits recovery from acute, chronic and degenerative
inflammation such as osteoarthritis.
The I-TECH LA8000/10000 can be used to effectively stimulate regeneration
in the case of chronic diseases, and reduce inflammation and the edemas of
acute diseases, as well as quickly alleviate joint, muscular and neurogenic
pain and acute and chronic pain in soft tissue.

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Indications
The fields of application of the I-TECH LA8000/10000 laser therapy
equipment are:
1. Sports traumatology
Strained or pulled muscles, sprained joints, epicondylitis, tendinitis
and enthesitis, bruising, hematomas and skin hemorrhages,
bursitis.
2. Rheumatic disorders
Arthritis, sciatica, scapular-humeral periarthritis, arthropathies of
hands and feet, epicondylitis, hip arthrosis in the early stage,
gonalgia with or without effusion, myogenic stiff neck, lumbago,
myositis, etc
3. Rehabilitative therapy
Articular motor rehabilitation after removing plaster casts or after
orthopaedic surgical operations.
4. General medicine and dermatology
Decubitus ulcers, cheloids, torpid sores treated thanks to its well-
known biostimulating and anti-infective effects.
Contraindications
-Direct exposure to eyes: class 4 lasers are potentially harmful to the
retina; although the likelihood of damage to the retina is extremely low.
The operator must, however, wear the special safety glasses (provided).
-Pregnancy: the laser must not be used above a pregnant uterus. The
laser can, however, be used for pregnant women providing it is not
directed at the abdomen.
-Neoplasia: do not use the laser on an undiagnosed primary or secondary
lesion. Laser treatment can be used to alleviate pain during the final
stage of a disease, but we recommend that this be done only with the
full consent of the patient.
-Thyroid: the laser must not, for any reason, be used above this gland.
-Hemorrhages: it is possible that vasodilation caused by the laser could
worsen the hemorrhage.
-Immuno-suppressive therapy: laser therapy is not recommended for
patients subjected to this type of pharmacological therapy.
-In the case of suspect skin lesions: strictly avoid exposing black marks
or suspect lesions on the skin to the laser.

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-Treatments over the sympathetic ganglia, the vagus nerve and the heart
region in patients with heart disease: laser therapy can affect the neural
function to a significant degree and is, therefore, counter indicated in
this region of the body in patients with heart disease.
Other contraindications:
-Atopic dermatitis and acute eczema.
-Inflammatory processes in the area to be treated.
-Cuts or scratches.
-Photoallergies.
-Photodermatitis.
-Recent surgical operations or cryotherapy in the skin areas to be
treated.
!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
Recommendations:
-Read the entire operating manual.
-The customer is held responsible for any damage due to inadequate
packaging. Keep the original packaging from the machine: you will need
this in the event of a return.
-Do not use the equipment near or on top of other equipment. If this is
not avoidable, the operator must monitor the correct operation of the
equipment.
-Do not use the equipment in the vicinity of flammable materials,
solutions or gases, or in oxygen-rich environments, in order to avoid the
risk of FIRE AND/OR EXPLOSION. Do not use the equipment in areas
where it could get wet.

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-Assess and avoid the use of accessories or of any other parts that, during
normal operation, could contain elements that might explode/ignite
(e.g. absorbent cotton saturated with oxygen) on contact with the laser
beam.
-CAUTION: to avoid the risk of electrocution, connect this equipment to
an earthed power supply system. Check the connections carefully with
reference to the instructions provided, before turning on the machine.
If using the same extension for the machine and other equipment,
check that the total power consumption of the connected devices does
not exceed the maximum permitted current for the type of cable, which
should in any case not exceed 15 A.
-Even though no particular measures are required when installing the
device, carefully insert the fiber optic in the socket of the panel of the
I-TECH LA8000, making sure not to touch the end of the fiber with your
fingers as this could dirty the laser input and prevent the correct flow
of the laser beam, causing power losses and overheating between the
connection of the tip and the I-TECH LA8000.
-After carefully inserting the fiber optic in the socket, turn the locking
ring clockwise to the end of its stroke without forcing it. In any case,
turn the locking ring to bring the reference mark on this parallel with
the one on the socket of the fiber optic.
-If the laser tip of the I-TECH LA8000 needs to be disconnected, put the
protective caps back on the tip of the fiber optic and on the panel socket
of the device. This is very important to protect the delicate optical parts
from dust and other dirt.
-It is not possible to recommend a specific number of sessions for an
efficient treatment because this depends on the amount of power used
to treat the patient. The doctor must decide on the number of sessions
for the patient according to the specific requirements involved, in order
to guarantee effective treatment over time and conditions of absolute
safety.
-Assess the quantity and type of pigment of the skin of the patient.
USE
-The laser radiation produced by the equipment is intrinsically
dangerous: always wear protective glasses, do not direct the beam at
unprotected eyes or at any optical instruments, and avoid exposing eyes
to direct or diffused radiation. Before starting any treatment, the
operator must put on PROTECTIVE GLASSES.

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-Insert the INTERLOCK key in order to run the machine.
-Do not use accessories other than the original ones provided: non-
original ones can damage the machine and render the warranty null and
void. If any problems or difficulties arise during installation, please
contact the technical assistance service at IACER srl.
-Suggestions concerning therapy are saved on the hard drive of the
machine. These cannot be deleted or modified, but the parameters can
be customized in the programs available in the "Libero" (Free) section.
Patient preparation
The skin of the patient must first be prepared for laser therapy. This is to
ensure that the laser reaches the affected areas in the best possible manner,
while also reducing the risk of skin irritation.
Prepare the patient's skin for therapy as follows:
1. clean the skin with care where the head of the laser is to be
positioned, using either water and soap or alcohol.
2. dry the skin thoroughly.
Cleaning and disinfection must be carried out systematically before treating
the patient.
Instructions for use
!Warning!
PRELIMINARY NOTES
-Utilizzare un nome diverso per ogni protocollo
personalizzato, utilizzando lo stesso nome per due
protocolli personalizzati diversi verranno salvati i due
trattamenti differenti con lo stesso nome.
-Before connecting the cable to the mains plug, check that
the equipment isn’t damaged during transport. Ensure that the power
supply specifications on the main socket correspond with the
information on the label attached to the back of the unit.
-Prima di iniziare qualsiasi trattamento è molto importante collegare il
MANIPOLO che si desidera utilizzare nell’apposito connettore del
pannello frontale.
USE
-DURING TREATMENT IN CONTINUOUS MODE, IT IS FORBIDDEN TO
HOLD THE HANDPIECE STILL IN ONE POSITION. IT IS ESSENTIAL TO