I-Tech UT2 User Manual

I-Tech UT2 User Manual

Ultrasound therapy

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USER MANUAL
Ultrasound therapy

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Summary of Contents for I-Tech UT2

  • Page 1 USER MANUAL Ultrasound therapy...
  • Page 3 INDEX INDEX TECHNICAL INFORMATION NFORMATION ON THE USER MANUAL ANUFACTURER ECLARATION OF CONFORMITY LASSIFICATION URPOSE AND SCOPE ECHNICAL FEATURES EVICE AND COMMANDS DESCRIPTION ABELLING Package content HOW TO USE ONTRAINDICATIONS Side effects ARNINGS SE OF THE DEVICE Installation Patient preparation Ultrasound treatment Programs features and main applications DEVICE CARE...
  • Page 4: Technical Information

    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.
  • Page 5: 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...
  • Page 6: Purpose And Scope

    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.
  • Page 7: Technical Features

    such equipment and the conformity to the statements declared in the manual is respected. Technical features Characteristics Specifications Input: 100-240V, 47-63Hz, 1.35A Power supply Output: 15V DC, 3A max Dimensions: 143x73x40mm Classification Class I (EN 60601-1) Applied part Type BF (EN 60601-1) Dimensions (length x height x...
  • Page 8 Characteristics Specifications RBN (Max) Beam type Collimated Material of Aluminum ultrasound head IP Protection IPX7 only for ultrasound head Temperature 10÷40°C Environmental Relative humidity 30÷85% conditions for use Atmospheric pressure 800÷1060hPa Temperature -10 ÷ +55°C Environmental Relative humidity 10÷90% conditions for storage Atmospheric pressure 700÷1060hPa WARNING!
  • Page 9 (1) Program selection button (7) Intensity selection knob and (2) Frequency selection button PAUSE 1/3MHz (8) Handle selection button (3) Duty cycle selection button (5cm² and 1cm²) (4) Time selection button (9) 5cm² handle socket (5) LCD display (10) 1cm² handle socket (6) STOP button (11) Power supply socket (12) ON/OFF button...
  • Page 10 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.
  • Page 11 Labelling Symbols Description Manufacturer’s logo Product CE certification released by Notified Body n°0068 Manufacturer Manufacturing date (YYYY-MM) Read instructions for use IACER Srl MNPG117-02...
  • Page 12: Package Content

    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;...
  • Page 13 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.
  • Page 14 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 •...
  • Page 15 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 •...
  • Page 16: Use Of The Device

    • 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. •...
  • Page 17: Patient Preparation

    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.
  • Page 18: Ultrasound Treatment

    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.
  • Page 19 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.
  • Page 20 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).
  • Page 21 HANDLE DUTY SUGGESTED APPLICATIONS TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBERS Acne U-01/10 Affected area 3MHz 15min 5cm² 1.5W/cm² Free Muscle fatigue U-01/10 Affected area 1MHz 20min 5cm² 2W/cm² 1.0W/cm² - Algodystrophy U-01/10 Affected area 1MHz 10min 5cm² 10-15 1.5W/cm²...
  • Page 22 HANDLE DUTY SUGGESTED APPLICATIONS TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBERS Cervical and 1.0W/cm² - Whiplash U-01/10 dorsal + front 1MHz 15min 5cm² 10-15 1.5W/cm² zone 1.0W/cm² - Condropathy U-01/10 Affected area 1MHz 15min 5cm² 10-15 1.5W/cm² Muscle U-01/10 Affected area 1MHz 20min...
  • Page 23 HANDLE DUTY SUGGESTED APPLICATIONS TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBERS 1.0W/cm² - Dorsalgy U-01/10 Dorsal area 1MHz 15min 5cm² 10-15 1.5W/cm² Drainage U-01/10 Affected area 1MHz 15min 5cm² 2W/cm² 1.0W/cm² - Eczemas U-01/10 Affected area 3 MHz 15min 5cm²...
  • Page 24 HANDLE DUTY SUGGESTED APPLICATIONS TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBERS 1.0W/cm² - Neuralgia U-01/10 Affected area 1MHz 15min 5cm² 10-15 1.5W/cm² 1.0W/cm² - Periarthritis U-01/10 Shoulder 1MHz 15min 5cm² 10-15 1.5W/cm² Internal thigh 1.0W/cm² - Pubalgy U-01/10 1MHz 15min 5cm²...
  • Page 25 HANDLE DUTY SUGGESTED APPLICATIONS TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBERS Carpal tunnel 1.0W/cm² - U-01/10 Internal wrist 1MHz 15min 5cm² 10-15 syndrome 1.5W/cm² 1.0W/cm² - Vascularisation U-01/10 Affected area 1MHz 15min 5cm² Free 1.5W/cm² Active principle U-01/10 Affected area 1MHz 15min 5cm²...
  • Page 26: Maintenance

    CLEANLINESS Switch off I-TECH UT2 after each therapy session, as well as remove the cable by the specific connector. Clean the device from dust using a dry soft cloth. Resistant strains can be removed using a sponge soaked in solution of water well squeezed.
  • Page 27: Troubleshooting

    There is no particular precaution to be taken during transportation of the device, since I-TECH UT2 is a portable device. In any case it is recommended to store I-TECH UT2 and its accessories in the supplied carrying bag after each treatment.
  • Page 28 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 equipment.
  • Page 29: Warranty

    Warranty IACER Srl guarantees a warranty period from the purchasing date for I-TECH UT2 device, unless information contained in this manual regarding installation, use and maintenance is strictly adhered. The wearing parts are not included in the warranty, unless of visible manufacturing defects.
  • Page 30 5) Warranty is not applied to damages caused by negligence or use not compliant to the given instructions, by intervention on the device from personnel not authorized, accidental causes or negligence form the purchaser. 6) Warranty is not applied in case of damages caused by unsuitable power supplies.
  • Page 31 The I-TECH UT2 equipment has been designed and manufactured according to the TECHNICAL STANDARD on ELECTROMAGNETIC COMPATIBILITY legislation EN 60601-1-2:2015 with the aim of providing adequate protection from harmful interference when installed in homes and health establishments.
  • Page 32: Electromagnetic Compatibility Tables

    ALL EQUIPMENT AND SYSTEMS The I-TECH UT2 device is intended for use in the electromagnetic environment specified below. The customer or the user of the I-TECH UT2 should assures that it is used in such an environment. Electromagnetic environment -...
  • Page 33 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 assure that it is used in such an...
  • Page 34 EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING The I-TECH UT2 device is intended for use in. the electromagnetic environment specified below. The customer or the user of the I-TECH UT2 should assure that it is used in such an environment.
  • Page 35 I-TECH U1 not sustaining vital functions I-TECH UT2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of I-TECH UT2 can help prevent electromagnetic interference by maintaining a minimum distance between...

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