I-Tech UT2 Manuel utilisateur

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. 041.5401356 • Fax 041.5402684

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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