I-Tech UT2 User manual

USER MANUAL
Ultrasound therapy

III
INDEX
INDEX III
TECHNICAL INFORMATION 4
INFORMATION ON THE USER MANUAL 4
MANUFACTURER 5
DECLARATION OF CONFORMITY 5
CLASSIFICATION 6
PURPOSE AND SCOPE 6
TECHNICAL FEATURES 7
DEVICE AND COMMANDS DESCRIPTION 8
LABELLING 11
Package content 12
HOW TO USE 13
CONTRAINDICATIONS 13
Side effects 13
WARNINGS 14
USE OF THE DEVICE 16
Installation 16
Patient preparation 17
Ultrasound treatment 18
Programs features and main applications 20
DEVICE CARE 26
MAINTENANCE 26
TROUBLESHOOTING 27
DISPOSAL 28
WARRANTY 29
Support 30
Spare part 30
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 31

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Technical Information
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 UT2.
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.
Partial or complete non-observance of the recommendations may lead to
malfunction and damage of the device, and therefore the warranty will no
longer be valid.
Following the provisions and the recommendations supplied by the
manufacturer scrupulously is the only way of achieving the best results and to
benefit from a quick and efficient technical assistance if needed.
The limits of this manual:
-the user manual cannot replace actual user experience;
-for particularly demanding operations, this instruction manual only
represents a remainder of the main operations.
This user manual must be considered an integral part of the equipment and
must be preserved for future reference until the device is dismantled. The
instruction manual must be available for reference at the place of use of the
device and preserved carefully.
The manufacturer declines all responsibility for:
-improper use of the machine;
-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;

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-exceptional events.
To get further information, consult the manufacturer.
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.
0068/QCO-DM/235-2020 from the Notified Body n° 0068 MTIC InterCert S.r.l.).
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 UT2
UMDNS Code: 11248
has 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 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
Compliance of the concerned product with the Directive 93/42/EEC has been
assessed and certified by the Notified Body:
0068 – MTIC InterCert S.r.l.
Via G. Leopardi 14, Milano (MI) 20123, Italia
Certified number: 0068/QCO-DM/235-2020
following the certification procedure according to Annex II (excluding point 4)
of the Directive 93/42/EEC.
________________ _____________________
Place, date Legal Representative
MASSIMO MARCON
Martellago, 03/08/2020

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Classification
The I-TECH UT2 has the following classification:
•class IIa equipment (Directive 93/42/CEE, Annex IX, rule 9 and
following modifications/additions);
•class I applied part type BF (classif. EN 60601-1);
•IPX0 equipment not protected against liquid and dust penetration.
IPX7 only for ultrasound head;
•equipment and accessories not subject to sterilization;
•equipment unsuitable for use in presence of a flammable anesthetic
mixture containing air, oxygen and nitrous oxide;
•continuous operating mode equipment;
•equipment not suited to be used in external.
Purpose and scope
Clinical intended use: Therapeutic and aesthetic
Environmental intended use: Ambulatory
I-TECH UT2 is a medical device for ultrasound therapy. The ultrasound modality
allows an ideal treatment of the muscular and nervous pathologies and for the
rehabilitation post-trauma, both in case of chronic and acute pathologies.
Ultrasound treatment is indicated for several chronic and sub-chronic
treatments as:
•Muscle pains and contractures
•Contractures
•Capsulitis
•Bursitis
•Myositis
•Soft tissues diseases
•Tendinitis
•Tendinosis
In fact, the ultrasound therapy is indicated for the antalgic pathologies and the
relax of the tensed musculature, in the treatment of neuritis and sciatica,
articular calcifications, tendinitis, hematomas and contractures.
This modality is recommended a lot in the esthetic field, in particular for the
cellulite blemishes, tissue regeneration, vascularization and lymphatic
drainage. For more details, the pathologies that can be treated, the specific
application modalities and programs use, refer to the paragraph dedicated to
the use of the device.
The device can be used both in clinics (on adult patients of both sexes, adults
unless otherwise indicated by doctors), unless the operator is qualified to use

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such equipment and the conformity to the statements declared in the manual
is respected.
Technical features
Characteristics
Specifications
Power supply
Input: 100-240V, 47-63Hz, 1.35A
Output: 15V DC, 3A max
Dimensions: 143x73x40mm
Classification
(EN 60601-1)
Class I
Applied part
(EN 60601-1)
Type BF
Dimensions
(length x height x
depth)
250x82x185mm
Output power (±20%)
0.5W-10.0W, when duty cycle ≥80% for 5cm²
ultrasound head
0.5W-15.0W, when duty cycle ≤70% for 5cm²
ultrasound head
0.1W-2.0W, when duty cycle ≥80% for 1cm²
ultrasound head
0.1W-3.0W, when duty cycle ≤70% for 1cm²
ultrasound head
Ultrasound wave
frequency
1MHz ±10%, 3MHz ±10%
Duty cycle
10%-100%, stepping 10%
Working frequency
100Hz ±10%
Therapy time
Adjustable, max 30 minutes
Timer accuracy
±3%
Effective radiating
area (Aer)
1.0cm² ±20% (optional)
5.0cm² ±20%
Effective intensity
3.0W/cm² ±20%
Accuracy
±20% for each setting above 10% of the maximum
value

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Characteristics
Specifications
RBN (Max)
5.0
Beam type
Collimated
Material of
ultrasound head
Aluminum
IP Protection
IPX7 only for ultrasound head
Environmental
conditions for use
Temperature
10÷40°C
Relative humidity
30÷85%
Atmospheric pressure
800÷1060hPa
Environmental
conditions for storage
Temperature
-10 ÷ +55°C
Relative humidity
10÷90%
Atmospheric pressure
700÷1060hPa
WARNING! The device has an output current over 10mA or 10V over
a period of 5 seconds.
Useful life of the device and its accessories: 2 years.
Device and commands description

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(1) Program selection button
(2) Frequency selection button
1/3MHz
(3) Duty cycle selection button
(4) Time selection button
(5) LCD display
(6) STOP button
(7) Intensity selection knob and
PAUSE
(8) Handle selection button
(5cm² and 1cm²)
(9) 5cm² handle socket
(10) 1cm² handle socket
(11) Power supply socket
(12) ON/OFF button
1. Program indicator
2. Frequency indicator 1/3MHz
3. Duty cycle indicator
4. Timer indicator
5. Output intensity/power indicator
6. Ultrasound head detector
7. PAUSE therapy indicator
8. Treatment ultrasound head type

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ON /OFF button
Polarity of Power Supply
Stop treatment
Start/Pause button (7)
Ultrasonic beam intensity (6)
Ultrasound handle state (handle/skin contact) (6)
Ultrasound intensity (5)
Choice of handle to use
Ultrasound power
Therapy time (4)
Socket for the handle connection
1. Ultrasound head
2. LED for head/skin detection
3. Handle applicator

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Labelling
Symbols
Description
Manufacturer’s logo
Product CE certification released by Notified Body n°0068
Manufacturer
Manufacturing date (YYYY-MM)
Read instructions for use

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Symbols
Description
WEEE Directive for the disposal of electronic waste
Applied part type BF
IPX7 Degree of protection of the head of the device from the
entry of liquids and dusts
Ultrasound handle lot
Serial number of ultrasound handle
Package content
The I-TECH UT2 package contains:
-n° 1 I-TECH UT2 device;
-n° 1 medical power supply;
-n°1 ultrasound head with 5cm²area;
-n°1 ultrasound head with 1cm²area;
-n° 1 power supply cable;
-n° 1 ultrasound gel;
-n° 1 transport bag;
-n° 1 user manual.
All the accessories are available as spare parts.
LOT
SN

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How to use
Contraindications
Do not use I-TECH UT2 if the source of the pain is unknown or not diagnosed.
Use the device ONLY after having a diagnosis.
It is absolutely forbidden to use I-TECH UT2 in those areas affected by
thrombophlebitis not to make the thrombus move. Avoid treating patients
with deep vein thrombosis, embolism or arteriosclerosis or that have
previously been treated with X rays or other radiations. This device should not
be used near testicles or over neoplastic lesions, on the carcinogenic areas and
over a healing fracture. Do not use ultrasounds on the stellate ganglion, on the
spinal column after a laminectomy, on the area surrounding the main nerves
or the cranium, over cardiac area and in anesthetized areas or in patients with
bleeding problems. This device should not be used on ischemic tissues in
individuals with vascular disease where the blood supply would be unable to
follow the increase in metabolic demand and tissue necrosis might result. This
device should not be used over the thoracic area if the patient is using a cardiac
pacemaker in order to avoid interferences between the ultrasound device and
the pacemaker.
Avoid using ultrasounds near bone growth centers in kids/growing children.
Ultrasound therapy must not be performed near the uterus on pregnant
women or those who suspect they might be pregnant. Therefore, the
ultrasound beam should not be used in this area without ensuring that the
patient is not pregnant.
Side effects
If the handpiece moves too slowly the patient may experience sharp and/or
deep peripheral pain. If it moves too quickly, or if the handpiece is not held
correctly, the therapeutic effects of the ultrasound might be reduced.
Some patients might be particularly sensitive to ultrasound and might
therefore experience undesired reactions such as hot flushes in the treated
area. Check the treated area before, during and after the treatment and
suspend it in case of undesired effects.
Make sure that the handpiece is in contact with the skin using a specific
ultrasound gel. Any substance used for this purpose must be highly conductive.
Air is a terrible conductor of ultrasound waves.
Patients with arterial or venous thrombosis or thrombophlebitis are at risk of
developing embolisms when electrical stimulation is applied over or adjacent
to the vessels containing the thrombus.

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With ultrasound therapy inflammation temporary increases can happen in
treatment area, and so pain temporary increase, traumas due to more dosage,
nervous system reactions, sanguine coagulation. If this occurs, suspend the
treatment and consult a doctor.
Warnings
It is recommended:
•to control position and meaning of all the labels and symbols on the
equipment;
•the device doesn’t produce or receive electromagnetic interferences from
other devices. However, it’s recommended to keep a distance of at least 3
meters from televisions, monitor, mobile phones or other electronic
devices (which can lead to abnormal device behavior). Care must be taken
when operating this equipment around other equipment. Potential
electromagnetic or other interference could occur to this or to the other
equipment;
•to avoid the use of the device by persons who did not read carefully this
manual;
•not to wear metal objects during treatment (both for the operator and
both for the patient);
•to use ONLY accessories supplied by device manufacturer. It is
recommended to use the device only with the supplied power supply
MPU50-160. I-TECH UT2 is tested and guaranteed for use with the
supplied accessories.
It is forbidden:
•to use the device in the presence of MRI equipment and patient
monitoring equipment, of electrosurgical (possible bruises and burns) or
shortwave or microwave therapy equipment or other equipment that
sends electrical impulses into the body and in general in combination to
other medical devices;
•to use the device by persons known to be unsound-minded, or suffering
from sensibility disorders, permanently or temporarily disabled unless
assisted by qualified personnel (e.g. a doctor or therapist); by persons
younger than 12 years old or not adequately educated about the device
use by an adult person;
•ultrasounds should not be used on areas with reduced sensitivity or
circulation. Patients experiencing reduced sensitivity may not be able to
warn their therapist/doctor when the ultrasound is too intense. Patients
experiencing circulation problems may suffer from an excessive increase
of temperature in the treated area;

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•to use the device in presence of signs of deterioration of the device itself,
cables and/or accessories: please contact the dealer or the manufacturer
following the instructions given in the paragraph Support. Control
carefully the integrity of the device before each use;
•to use the device close to flammable substances/gas/explosives, in
environments with high concentrations of oxygen, with aerosol-therapy
devices or in wet environments (use of the device is prohibited in
bathroom or shower areas or while showering/bathing);
•absolutely use a device that has been wet or has come into contact with
liquids before it has been checked by the manufacturer and / or service
center. Take care to prevent liquids from entering the ventilation slots;
•to use the device while driving or during the operation and control of
equipment/machinery;
•the use of the device in hyposensitive areas, on the carotid sinuses
(carotid), genitals, near the uterus and abdomen, in the area of the body
in which glands are present, on cancerous lesions. Do not direct the beam
towards or near the eyes;
•maintain the ultrasound head stationary on one point during the
therapy. We advise moving the head if the intensity is more than 0,5
W/cm²;
•to use pointed or sharp objects on the ultrasound head and the control
panel of the device.
Warning:
•before administering any treatment to a patient, you should become
acquainted with the operating procedures for each mode of treatment
available, as well as the indications, contraindications, warnings and
precautions. Consult other resources for additional information regarding
the application of Ultrasound;
•ultrasound should be routinely checked before each use to determine
that all controls function normally, especially that the intensity control
does properly adjust the intensity of the ultrasonic power output in stable
manner. Also, determine that the treatment time control does actually
terminate ultrasonic power output when the timer reaches zero;
•handle the handpiece with care to preserve its characteristics;
•the tendency to bleed is increased by the heat as more blood flows in the
area. Be careful when treating patients with bleeding disorders;
•avoid heating or overheating the capsule in cases of acute and subacute
arthritis.;
•pay attention to use connection cables with children/young people:
strangulation danger;

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•do not mix connection cables up with earphones or other devices and do
not connect the cable to other equipment;
•the device is not intended for outdoor use;
•the device is not intended for use in home environments.
The manufacturer considers himself responsible for the performances,
reliability, safety and security of the device only if:
•any addition, modification and/or repair are carried out by authorized
personnel;
•the environmental electrical installation to which I-TECH UT2 is connected
is compliant to the national laws;
•the instructions for use contained in this manual are strictly followed.
Should any foreign materials penetrate the device contact the retailer or
manufacturer immediately. If dropped down, check that the housing is not
cracked or damaged in any way; if so, contact the retailer or manufacturer.
Should you notice any changes in the device’s performance during treatment,
interrupt the treatment immediately and consult the retailer or manufacturer.
In case of undesired effects, suspend the therapy, stop using the device straight
away and contact your doctor.
The ultrasound therapy controls unit is not designed to prevent the
ingress of water or liquids. Ingress of water of liquids could cause
malfunction of internal components of system and therefore create
risk of injury to the patient/user.
If the patient feels a deep and sharp pain during the treatment, the
intensity must be reduced to a comfortable level
Consult a doctor before using I-TECH UT2 with metallic osteosynthesis
devices.
IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT
YOUR DOCTOR.
Use of the device
Installation
Remove the device and ala accessories from shipping cartons. Check the device
equipment.
Before the installation and the connection of the device to the mains supply,
check that the voltage and the frequency correspond with the available mains
supply and with the information in this user manual.
Follow the instructions below for a correct installation:
•connect the power supply cable to the power supply;
•connect the power supply to the device connector;

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•connect the power supply plug to the wall socket.
Press on ON/OFF button to switch on the device.
If it is connected correctly, display will show the picture below:
If it is connected in wrong way, display will show the picture below:
Patient preparation
Immediately after switching on, the device carries out a self-test. At the end of
the self-test a beep is heard and display shows the picture as described in
previous paragraph. When an error is found an error code will appear on the
display: please read the paragraph Troubleshooting to get more details.
Before starting the ultrasound treatment, please, check the following
indications:
•make sure that the patient is in a comfortable position. The treatment
area should be completely exposed and relaxed.
•Inform the patient about the objective of the treatment and the
sensation he/she should feel during therapy.
•Make sure that there are no contraindications to therapy.
•Inspect accurately the treatment area for abrasion, irritation, surface
veins, etc.
•Clean the treatment area with a soap or alcohol at 70%. In case of
excessive hairy skin, it is suggested to shave the zone to get optimal
treatment.
During treatment:
1. The ultrasound head has to be moved constantly when intensity is
higher than 0.5W/cm².

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2. Ask about his/her sensation during treatment. If necessary, adjust
ultrasound intensity, by reducing it if the treatment is not
comfortable.
3. In case of indications of wrong contact, it is recommended to add the
contact gel or reposition the ultrasound-head.
4. During the treatment if the ultrasound head works correctly, the
applicator LED will light; if there is no contact, the applicator LED will
blink light. When the treatment is in PAUSE, the applicator LED will be
turned off and the countdown will also be stopped.
WARNING:
→The treatment should be performer with a regular movement of
the ultrasound head, not too slow to avoid inducing heat, not too
fast to prevent a bad contact which would reduce the
effectiveness of the treatment.
→If it is needed to replace the handle, turn the power switch off
and disconnect the device from power supply.
After the treatment clean the skin of the treated area as well as the ultrasound
head by using a dry towel. The ultrasound-head should be cleaned up with a
70% alcohol solution. Check the patient conditions and the treated area (pain,
circulation, etc.).
The patient should reveal any complaint/reaction before starting the
treatment after.
Ultrasound treatment
After performing the preliminary operations listed in the previous paragraph,
start the session making sure to follow these steps:
1. Press PROGRAM keys to select the program: scroll up/down
the programs with the arrows.
2. Select the frequency 1 or 3 MHz by pressing the button FREQUEN.
.
3. Select the ultrasound head 1 CM² or 5 CM² by pressing the button
. ATTENTION: The user can select the ultrasound head 1 cm
or 5 cm only if both heads are connected. The device recognizes

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automatically the ultrasound head when only one handle is
connected.
4. Select duty cycle (10-100%) by pressing the buttons DUTY CYCLE
(up arrow and down arrow).
5. Select therapy time (1-30 minutes) by pressing the buttons TIME (up
arrow and down arrow) .
6. Put a good quantity of conductive gel on the area to be treated. It is
recommended to use a CE conductive gel.
7. Regulate the intensity of the treatment using the knob (7). Press any
of the PROGRAM, FREQUEN., DUTY CYCLE or TIME buttons during
the treatment to visualize W (Watts) or W/cm² (Watt/sq cm).
8. Keep the head in constant contact with the skin and make sure that
the part is covered in gel so that the therapy is effective. The green
LED located next to the head on the handpiece lights up when the
device is working.
9. The device has a head/skin coupling system for safety reasons. If the
contact is not correct and if the intensity is set above 0,5W, the LED
on the handpiece and the symbol on the display will start
flashing. The system is not available on the 1cm head because of the
reduced contact area: the device emits an ultrasound beam even if
the head is not in contact with the skin. This is not a defect but rather
a technical choice, as it would be impossible to perform therapies on
small and irregular areas like toes or fingers with such a system.
10. It’s possible to stop temporary the therapy at any time pressing the
knob (7). Press again the knob to continue the treatment.
11. Press the orange button to stop immediately the treatment
in progress
We advise handling the handpieces with care in order to preserve them.
In order to ensure efficient transfer of energy, a contact means is required
between the ultrasound head and the body. Air causes virtually total reflection
of the ultrasound energy. The best means for the transfer of ultrasound energy
is the ultrasound gel. Put a quantity of conductive gel on the area to be treated.
Move the ultrasound head during therapy session in a circular motion. The
treated area should be twice the ultrasound head area.

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If the body surface is very irregular, making it difficult to obtain good contact
between the ultrasound head and the body (e.g. ankle or foot), or if direct
contact must be avoided (e.g. due to pain), the affected area may be treated
under water (subaqual method). Use two liters of water, with a temperature
not higher than 25 ° C. The water should be degassed (by previous boiling) in
order to prevent air bubbles that could decrease the effectiveness of the
treatment.
WARNING. Never apply the gel to the ultrasound head. The treatment
head will register this as contact and may emit ultrasound energy,
which could damage the ultrasound head. Always use the gel
certificated with the requirements of the medical, such as with CE
mark.
WARNING. The device can be used to perform immersion
treatments. The handle and its cable are protected from damage by
water infiltration according with the gradeIPX7.
Programs features and main applications
Refer to the following table for programs features. All parameters are
adjustable by the user.
PROG.
Medical
Progr.
Yes/No
FREQ. DUTY
CYCLE TIME SUGGESTED INTENSITY
U-01
Yes
1MHz
80%
10min
1.0W/cm²
U-02
Yes
1MHz
50%
10min
1.0W/cm²
U-03
Yes
1MHz
50%
20min
1.5W/cm²
U-04 Yes 1MHz 50% 15min
1.0W/cm²
1.5W/cm²
2.0W/cm²
U-05
Yes
3MHz
80%
15min
1.0W/cm²
U-06
Yes
1MHz
30%
15min
1.5W/cm²
U-07 Yes 1MHz 80% 15min
1.0W/cm²
1.5W/cm²
U-08
Yes
1MHz
80%
8min
1.5W/cm²
U-09
Yes
1MHz
50%
12min
1.5W/cm²
U-10
Yes
3MHz
80%
10min
1.0W/cm²