I-Tech UT2 User Manual Download

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IACER Srl

MNPG117-02

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

Summary of Contents for UT2

Page 1: ...USER MANUAL Ultrasound therapy ...

Page 2: ......

Page 3: ...RIPTION 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...

Page 4: ...ously 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 ...

Page 5: ...e 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 h...

Page 6: ... 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 ...

Page 7: ...th 250x82x185mm Output power 20 0 5W 10 0W when duty cycle 80 for 5cm ultrasound head 0 5W 15 0W when duty cycle 70 for 5cm ultrasound head 0 1W 2 0W when duty cycle 80 for 1cm ultrasound head 0 1W 3 0W when duty cycle 70 for 1cm 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...

Page 8: ...l 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 ...

Page 9: ...n 7 Intensity selection knob and PAUSE 8 Handle selection button 5cm and 1cm 9 5cm handle socket 10 1cm 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 ...

Page 10: ...nt 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 ...

Page 11: ...IACER Srl 11 MNPG117 02 Labelling Symbols Description Manufacturer s logo Product CE certification released by Notified Body n 0068 Manufacturer Manufacturing date YYYY MM Read instructions for use ...

Page 12: ... 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 5cm area n 1 ultrasound head with 1cm area 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 ...

Page 13: ...iac 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 S...

Page 14: ...th 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 microwa...

Page 15: ... 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 cm 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 we...

Page 16: ...ediately 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 t...

Page 17: ...agraph 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 ther...

Page 18: ...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...

Page 19: ...he 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 s...

Page 20: ...uld 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 adju...

Page 21: ...in 5cm 1 0W cm 1 5W cm 10 15 Fingers arthritis U 01 10 Hand fingers 1MHz 40 15min 1cm 1 5W cm 2W cm 10 15 Arthrosis U 01 10 Affected area 1MHz 50 15min 5cm 1 5W cm 2W cm 10 15 Bursitis U 01 10 Affected area 1MHz 30 15min 5cm 2W cm 10 15 Brachialgia U 01 10 Trapezium and arm 1MHz 30 15min 5cm 2W cm 10 15 Capsulitis U 01 10 Shoulder 1MHz 30 15min 5cm 2W cm 10 15 Cavitations U 01 10 Affected area 1MH...

Page 22: ...Affected area 1MHz 70 20min 5cm 2W cm 4 6 Cruralgy U 01 10 Internal thigh 1MHz 40 15min 5cm 2W cm 10 15 Discopathy U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Strains U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Articular pain U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Intercostal pain U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 ...

Page 23: ...itis U 01 10 Elbow 1MHz 40 15min 5cm 1 0W cm 1 2W cm 10 15 Epitrocleitis U 01 10 Internal elbow 1MHz 40 15min 5cm 1 0W cm 1 2W cm 10 15 Slipped disc U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Gonarthrosis U 01 10 Knee 1MHz 50 15min 5cm 1 5W cm 2W cm 10 15 Lymphoedema U 01 10 Affected area 1MHz 30 15min 5cm 2W cm 10 15 Lypolisis U 01 10 Affected area 1MHz 60 15min 5cm 2W cm 30 Lu...

Page 24: ... Thumb area 1MHz 30 15min 5cm 1 5W cm 10 15 Rizopathy U 01 10 Dorsal area 1MHz 60 15min 5cm 1 5W cm 10 15 Wrinkle U 01 10 Affected area 3MHz 30 15min 5cm 1 5W cm Free Sciatalgy U 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Stretch marks U 01 10 Affected area 3MHz 40 15mi 5cm 2W cm Free Venous stasis U 01 10 Extremities limbs 1MHz 50 15min 5cm 2W cm Free Sprains U 01 10 Affected are...

Page 25: ...al doctor or therapist In particular the indications on intensity do not consider the width of the area to be treated If this is very wide the intensity of the ultrasound can be increased by 20 with respect to what indicated above or vice versa it can be reduced if the area is small Similarly the movement on the area must be appropriate to the heat felt by the patient the slower it s been moved th...

Page 26: ...aked in solution of water well squeezed ATTENTION No alcohol content solution If a more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner Device not subject to sterilization Note Never use solvents for cleaning Cleaning agents cause damage to the device Attention to the need for periodic maintenance especially inspection of main body for cracks which may allow the ingr...

Page 27: ... to the following environmental conditions In operation temperature 10 40 C relative humidity 30 85 pressure 800 1060hPa Inside the supplied carrying bag temperature 10 55 C relative humidity 10 90 pressure 700 1060hPa Troubleshooting I TECH UT2 was designed and manufactured using advanced technological solutions and high quality components for an efficient and reliable use Any type of work on I T...

Page 28: ...he treatment Possible head failure Contact the manufacturer Possible failure of the device current generator circuit Disposal The I TECH UT2 device was designed and engineered to have minimal negative environmental impact in consideration of its performance and safety requirements following the disposition given by the European Directive 2012 19 EU regarding the waste of electrical and electronic ...

Page 29: ...vene promptly if necessary as a result of manufacturing defects The warranty conditions are those described in the following paragraph Warranty conditions The warranty is provided by IACER WARNING In the event of non shipment the manufacturer declines all responsibility if corrective action on the equipment is necessary Should you need to return the goods then please pack the device and all the ac...

Page 30: ...s costs 10 The court of Venice has exclusive jurisdiction over any dispute Support The manufacturer is the one and only allowed to operate with technical assistance For any technical assistance contact I A C E R S r l Via S Pertini 24 a 30030 Martellago VE Tel 041 5401356 Fax 041 5402684 Technical documentation related to repairable parts could be attached but only with previous authorization from...

Page 31: ...th radio electric communications electro medical equipment for monitoring diagnosis therapy and surgery office electronic devices such as computers printers photocopiers fax machines etc or any electric or electronic equipment used in these environments as long as the equipment complies with the ELECTROMAGNETIC COMPATIBILITY directive In any case in order to avoid any interference problems it is r...

Page 32: ...upply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Compliant Guidance and manufacturer s declaration ELECTROMAGNETIC IMMUNITY FOR ALL EQUIPMENT AND SYSTEMS The I TECH UT2 is intended for use in the electromagnetic environment specified below The customer or the user of the device should assu...

Page 33: ...ì input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5s 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5s UT2 con un gruppo di continuità UPS o con batterie Main power quality should be that of a typical commercial or hospital envi...

Page 34: ...put power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the symbol above Note 1 At 80 MH...

Page 35: ... 800 𝑀𝑀𝑀𝑀𝑀𝑀 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓 80𝑀𝑀𝑀𝑀𝑀𝑀 𝑡𝑡𝑡𝑡 800 𝑀𝑀𝑀𝑀𝑀𝑀 𝑓𝑓𝑓𝑓𝑓𝑓𝑓𝑓 800𝑀𝑀𝑀𝑀𝑀𝑀 𝑡𝑡𝑡𝑡 2 7𝐺𝐺𝐺𝐺𝐺𝐺 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum o...

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