I-Tech UE User manual

USER MANUAL
Ultrasound therapy and electrotherapy

III
INDEX
INDEX III
TECHNICAL INFORMATION 5
INFORMATION ON THE USER MANUAL 5
MANUFACTURER 6
DECLARATION OF CONFORMITY 6
CLASSIFICATION 7
PURPOSE AND SCOPE 7
TECHNICAL FEATURES 8
DEVICE AND COMMANDS DESCRIPTION 12
LABELLING 15
Package content 16
HOW TO USE 18
CONTRAINDICATIONS 18
Side effects 18
WARNINGS 19
INSTALLATION 23
USE IN THE ULTRASOUND THERAPY MODE 23
Patient preparation 23
Operative instructions 24
Programs features and main applications 26
USE IN THE ELECTROTHERAPY MODE 32
Electrodes 32
Patient preparation 32
Operative instructions 34
Programs features and therapeutic indications 36
USE IN THE ELECTROTHERAPY MODE 42
Operative instructions 42
Reset 44
DEVICE CARE 45
MAINTENANCE 45
TROUBLESHOOTING 46
DISPOSAL 47
WARRANTY 48
Support 49
Spare part 49

IV
ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 50

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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 UE.
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.
This manual reflects the current state of machine technology and shall not be
considered obsolete solely because updated at a later date on the basis of
acquired experience.
The manufacturer reserves the right to update the production and the manuals
with no obligation to update previous versions.
The manufacturer declines all responsibility for:
--improper use of the machine;
-use contrary to specific national laws;
-incorrect installation;

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-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.
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 n°
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 UE
UMDNS Code: 17908
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
Certificate no.: 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 UTE 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 UE is a medical device for ultrasound therapy combined with
electrotherapy. 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.

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The electrotherapy modality allows the application of electrical micro
impulses, which create energy. Thanks to the modulation given by the different
set of the parameters, this energy can lead to many results, from the pain
reduction in case both of acute and chronic pathologies to the rehabilitation
post-trauma, from muscle strengthening to drainage, from isotonic exercises
to the treatment of the hematomas.
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
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
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
Ultrasuond
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

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Characteristics
Specifications
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% a stepping 10%
Working frequency
100Hz ±10%
Therapy time
Adjustable, max 60 minutes
Timer accuracy
±3%
Effective radiating area
(Aer)
1.0cm2±20%
5.0cm
2
±20%
Effective intensity
3.0W/cm2±20%
Accuracy
±20% for each setting above 10% of the
maximum value
RBN (Max)
<8.0
Beam type
Collimated
Material of ultrasound head
Aluminum
IP Protection
IPX7 only for ultrasound head
Interferenziale 4 poli (IF-4P)
Waveform Type
Biphasic compensated
Mode Selection
CC, constant current or CV, voltage current
Vector
Auto: 0÷100%, Manual: 0÷90°
Carrier frequency (C.F.)
4.0kHz
High frequency (Beat H.)
(Beat L.) – 150Hz
Low frequency (Beat L.)
1 – (Beat H.)
Output
0÷100mA (CC at 1kOhm load)
0÷100V (CV at 1kOhm load)
Therapy time
Adjustable 1÷60 minutes

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Characteristics
Specifications
Interferential waveform 2 poles (IF-2P)
Waveform Type
Biphasic compensated
Mode Selection
CC, constant current or CV, voltage current
Carrier frequency (C.F.)
2.5kHz
High frequency (Beat H.)
(Beat L.) – 150Hz
Low frequency (Beat L.)
1 – (Beat H.)
Output
0÷100mA (CC at 1kOhm load)
0÷100V (CV at 1kOhm load)
Therapy time
Adjustable 1÷60 minutes
Contraction/recovery
(Cycle)
Continuous, 5s/5s, 4s/12s, 10s/10s, 10s/20s,
10s/30s, 10s/50s
Ramp
2 seconds
TENS and EMS
Waveform Type
Monophasic or Biphasic compensated
Mode Selection
CC, constant current or CV, voltage current
Frequency
1÷250Hz
Frequency modulation
(F.M.)
0÷249Hz
Burst rate (Burst)
1÷10Hz
Width impulse (P. Dur.)
30÷400µs
Amplitude modulation
(A.M.)
0÷100%
Output
0÷100mA (CC at 1kOhm load)
0÷100V (CV at 1kOhm load)
Therapy time
Adjustable 1÷60 minutes
Contraction/recovery
(Cycle)
Continuous, 4s/4s, 4s/8s, 7s/7s, 5s/5s,4s/12s,
10s/10s,10s/20s,10s/30s, 10s/50s
Ramp
1 secondo

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Characteristics
Specifications
Kotz waveform (Russian)
Waveform Type
Biphasic compensated
Mode Selection
CC, constant current or CV, voltage current
Carrier frequency (C.F.)
2.5kHz
Burst Frequency (Freq.)
20÷100Hz
Output
0÷100mA (CC at 1kOhm load)
0÷100V (CV at 1kOhm load)
Duty cycle
10%, 20%, 30%, 40%, 50%
Therapy time
Adjustable 1÷60 minutes
Contraction/recovery
(Cycle)
Continuous, 5s/5s, 4s/12s, 10s/10s, 10s/20s,
10s/30s, 10s/50s
Ramp
1, 2 e 5 seconds
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.

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Device and commands description
(1) Channel 1 intensity selection knob
(2) Channel 2 intensity selection knob
(3) Programs parameters control knob and PAUSE
(4) Parameter confirm and STOP button
(5) Led indicator
(6) LCD display
(7) Parameters selection buttons:
•B1: mode selection (ultrasound, electrotherapy, combined) and
waveform selection
•B2: program selection
•B3: Burst/vector/frequency modulation selection
•B4: frequency/carrier frequency selection
•B5: Duty cycle/high frequency/width modulation selection
•B6: low frequency/impulse duration selection

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•B7: therapy time/contraction-recovery cycle/ramp up selection
•B8: frequency/ultrasound duty cycle selection
(8) Ultrasound Intensity selection knob
(9) Power supply socket
(10) ON/OFF button
(11) Handle socket
(12) Electrostimulation cable socket
•CC – Constant current output
mode
•CV – Constant voltage output
mode
•F.M. – Frequency modulation
•Burst –Burst frequency
•Freq. – Frequency
•C.F. – Carrier frequency
•Duty – Duty cycle for Russian
waveform (Kotz) for B5 button
•Beat H. – High beat frequency
selection
•A.M. – Amplitude modulation
•Beat L. – Low beat frequency
selection
•P.Dur. – Impulse duration
•Treat. – Therapy time
•Cycle – Contraction recovery cycle
•Ramp – Ramp time
•Duty – Duty cycle for ultrasound
for B8 button
•Freq. – Ultrasound frequency
ON /OFF button
Polarity of Power Supply
Stop treatment (7)

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Start/Pause button (7)
Ultrasonic beam intensity (1)
Ultrasound handle state (handle/skin contact) (1)
Ultrasound intensity (5)
Ultrasound power
Therapy time
Socket for the handle connection
Interferential waveform with 4 poles
Interferential waveform with 2 poles
Russian waveform (Kotz)
TENS/EMS waveforms
Electrotherapy channels indicators (1/2)
Electrotherapy/ultrasound/combined therapy
symbols
Program in use
Parameter indicator

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Labelling
1. Ultrasound head
2.
LED for head/skin
detection
3. Handle applicator

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Symbols
Description
Manufacturer’s logo
Product CE certification released by Notified Body n°0068
Manufacturer
Manufacturing date (YYYY-MM)
Read instructions for use
WEEE Directive for the disposal of electronic waste
Applied part type BF
IPX7 Degree of protection of the head of the ultrasound handle
from the entry of liquids and dusts
Ultrasound handle lot
Serial number of ultrasound handle
Package content
The I-TECH UE package contains:
-n° 1 I-TECH UE device;
-accessories:
1. n ° 2 silicone conductive electrode 60x90mm;
2. n° 2 silicone conductive electrode 70x110mm;
3. n° 2 sponge for silicone electrode 70x100mm;
4. n° 2 sponge for silicone electrode 80x120mm;
5. n° 2 set of electrodes 50x50mm;
6. n° 2 set of electrodes 50x100mm;
7. n° 1 elastic belt for electrodes fastening 75x1200mm;
8. n° 1 elastic belt for electrodes fastening 75x600mm;
LOT
SN

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9. n° 2 electrical stimulation cables with 2 derivations red/black;
10. n° 1 medical power supply;
11. n° 1 power supply cable;
12. n° 1 electrotherapy cable;
13. n° 1 single plug cable for combined electrotherapy;
14. n ° 1 ultrasound head with 5cm2area;
-n° 1 ultrasound gel;
-n° 1 transport bag;
-n° 1 user manual;
-n° 1 position manual.
All the accessories are available as spare parts. It is also available under
request the ultrasound handle of 1cm2.

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How to use
Contraindications
Do not use I-TECH UE (in any mode) 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 UE for ULTRASOUND THERAPY 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.
I-TECH UE for ELECTROTHERAPY should not be used over, or in proximity to,
cancerous lesions. Do not apply stimulation over open wounds or inflamed
areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). Is
forbidden to use the device on patient who have a cardiac pacemaker, suffers
from epilepsy, heart-related pathologies, anxiety or serious illnesses,
abdominal or inguinal hernias, on pregnant women (except in case of medical
prescription). Use caution if stimulation is applied over the menstruating or
pregnant uterus and over areas of skin that lack normal sensation. Electrical
stimulation is ineffective for treatment pain of central nervous system.
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.

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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.
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.
The long-term effects of chronic electrical stimulation are unknow. Pay
attention, electrical stimulation is not a substitute for pain medications and
other pain management therapies.
Since the effects of stimulation of the brain are unknown, stimulation should
not be applied across the head, and electrodes should not be placed on
opposite sides of the head.
No significant side effects related to electrotherapy are known. In some cases
of particularly sensitive people, after the treatment, redness of the skin near
the electrodes: the redness usually disappears a few minutes after the
treatment. If the redness persists, consult a doctor.
Patients may experience headache and other painful sensations during or
following the application of electrical stimulation near the eyes, head and face.
In some rare cases evening stimulation causes some difficulties in falling
asleep. In this case, 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;

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•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 the electrodes on clean and dry skin. When using the electrodes,
follow the instructions given in the manual and on the package of the
electrodes. Use only single-patient electrodes, supplied exclusively by the
manufacturer, and take care to avoid the exchange of electrodes between
different users;
•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 UE 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;
•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;