I-Tech UE User Manual
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I-Tech UE User Manual

I-Tech UE User Manual

Ultrasound therapy and electrotherapy
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USER MANUAL
Ultrasound therapy and electrotherapy

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Summary of Contents for I-Tech UE

  • Page 1 USER MANUAL Ultrasound therapy and electrotherapy...
  • 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 NSTALLATION SE IN THE ULTRASOUND THERAPY MODE Patient preparation Operative instructions Programs features and main applications...
  • Page 4 LECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES...

  • Page 5: Technical Information

    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.

  • Page 6: 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...

  • Page 7: Purpose And Scope

    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.

  • Page 8: Technical Features

    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.
  • Page 9 Characteristics Specifications 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% a stepping 10% Working frequency 100Hz ±10% Therapy time Adjustable, max 60 minutes Timer accuracy ±3% Effective radiating area...
  • Page 10 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)
  • Page 11 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 0÷100mA (CC at 1kOhm load) Output 0÷100V (CV at 1kOhm load) Duty cycle 10%, 20%, 30%, 40%, 50% Therapy time Adjustable 1÷60 minutes Contraction/recovery...
  • Page 12 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 •...
  • Page 13 • 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 • A.M. – Amplitude modulation • CC – Constant current output •...
  • Page 14 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...
  • Page 15 1. Ultrasound head 2. LED head/skin detection 3. Handle applicator Labelling IACER Srl MNPG118-02...
  • Page 16 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;...
  • Page 17 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 5cm area;...
  • Page 18 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.
  • Page 19 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.
  • Page 20 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 •...
  • Page 21 • 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.
  • Page 22 • any addition, modification and/or repair are carried out by authorized personnel; the environmental electrical installation to which I-TECH UE is connected • is compliant to the national laws; the instructions for use contained in this manual are strictly followed.

  • Page 23: Installation

    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 UE with metallic osteosynthesis devices. IF YOU HAVE ANY DOUBTS REGARDING THE DEVICE USE CONSULT YOUR DOCTOR.
  • Page 24 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.
  • Page 25 7. Press B7 button to regulate therapy time: it’s possible to adjust therapy time from 1 to 30 minutes (by steps of 1 minute) by using the knob (3). 8. Put a good quantity of conductive gel on the area to be treated or on the ultrasound head.
  • Page 26 degassed (by previous boiling) in order to prevent air bubbles that could decrease the effectiveness of the treatment. WARNING. Do not apply directly on the head of the handle the gel: it could emit the ultrasound beam, therefore ruining the head itself. Always use a CE marked gel.
  • Page 27 HANDLE DUTY SUGGESTED APPLICATION TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBER Affected Acne P-01/10 3MHz 15min 5cm² 1.5W/cm² Free area Affected Muscle fatigue P-01/10 1MHz 20min 5cm² 2W/cm² area Affected 1.0W/cm² - Algodystrophy P-01/10 1MHz 10min 5cm² 10-15 area 1.5W/cm²...
  • Page 28 HANDLE DUTY SUGGESTED APPLICATION TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBER Cervical and 1.0W/cm² - Whiplash P-01/10 dorsal + 1MHz 15min 5cm² 10-15 1.5W/cm² front zone Affected 1.0W/cm² - Condropathy P-01/10 1MHz 15min 5cm² 10-15 area 1.5W/cm² Muscle Affected P-01/10 1MHz 20min...
  • Page 29 HANDLE DUTY SUGGESTED APPLICATION TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBER 1.0W/cm² - Dorsalgy P-01/10 Dorsal area 1MHz 15min 5cm² 10-15 1.5W/cm² Affected Drainage P-01/10 1MHz 15min 5cm² 2W/cm² area Affected 1.0W/cm² - Eczemas P-01/10 3MHz 15min 5cm² 10-15 area 1.5W/cm²...
  • Page 30 HANDLE DUTY SUGGESTED APPLICATION TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBER Affected 1.0W/cm² - Mialgy P-01/10 1MHz 15min 5cm² 10-15 area 1.5W/cm² Mononeuropathy P-01/10 Pain zone 1MHz 15min 5cm² 1.5W/cm² 12-15 Affected 1.0W/cm² - Neuralgia P-01/10 1MHz 15min 5cm² 10-15 area 1.5W/cm²...
  • Page 31 HANDLE DUTY SUGGESTED APPLICATION TREATMENT FREQ TIME HEAD POSITION CYCLE INTENSITY NUMBER Affected Muscle sprains P-01/10 1MHz 15min 5cm² 2W/cm² 8-10 area 1.0W/cm² - Tallonitis P-01/10 Heel 1MHz 15min 5cm² 10-15 1.5W/cm² Affected 1.0W/cm² - Tendinitis P-01/10 1MHz 15min 5cm² 10-15 tendons 1.5W/cm²...

  • Page 32: Patient Preparation

    Use in the electrotherapy mode Electrodes Use only CE marked electrodes and strictly follow the user instructions on the packaging. The electrodes supplied by the manufacturer are top-quality, pre-gelled and ready to be used, particularly indicated for the electrostimulation treatments. Their wide flexibility allows an easy application over the different areas of treatment.
  • Page 33 WARNING: → Keep at a proper distance the electrodes during treatment. Electrodes that come in contact with each other could lead to unwanted stimulations and/or burns. → The current intensity depends on the electrodes’ dimensions. Improper application can lead to damage to the patient. In case of any doubts on the proper electrodes’...
  • Page 34 3. The electrodes should be placed on the treatment area and hold down using the elastic belt supplied with the device. Insert the cable with the Red (+) connector into one rubber electrode. Insert the cable with the Black (-) connector into the other rubber electrode.
  • Page 35 4. 4. Immediately after switching on, the device carries out a self-test (around 10 seconds). At the end of the self-test display shows the last performed treatment. 5. Press WAVEFORM MODE (B1) button to show : this icon indicates ELECTROTHERAPY treatment. 6.
  • Page 36 10. Place the electrodes on the area to be treated following the instructions of electrodes position manual. In case of treatment with 4 poles interferential waveform place the electrodes as shown in the picture on the right. 11. Select the two channels intensity by using the knobs (1-2) placed on the left upper side of the front panel.
  • Page 37 High Carrier Vector Vector Freq. Freq. Phase Freq. Time (Auto) (Manual) (Beat. (Beat. (C.F.) 45° 4.0kHz 50Hz 50Hz 0min 45° 4.0kHz 50Hz 50Hz 10min 45° 4.0kHz 150Hz 90Hz 15min 45° 4.0kHz 150Hz 90Hz 0min 45° 4.0kHz 150Hz 90Hz 0min 45° 4.0kHz 110Hz 100Hz...
  • Page 38 Interferential waveform with 2 poles – IF-2P Carrier High Phase Frequency Frequency Frequency Time (C.F.) (Beat. H) (Beat. L) 2.5kHz 110Hz 100Hz 15min 2.5kHz 110Hz 100Hz 0min 2.5kHz 110Hz 100Hz 0min 2.5kHz 150Hz 100Hz 10min 2.5kHz 150Hz 100Hz 0min 2.5kHz 150Hz 100Hz 0min...
  • Page 39 TENS Width impulse Prg. Phase CC/CV Freq. Time (P. Dur.) 120Hz 70µs 14min 120Hz 70µs 0min 120Hz 70µs 0min 200Hz 60µs 20min 200Hz 60µs 0min 200Hz 60µs 0min 10Hz 180µs 20min 10Hz 180µs 0min 10Hz 180µs 10min 80Hz 100µs 30min 80Hz 100µs 0min...
  • Page 40 Width impulse Prg. Phase CC/CV Freq. Time (P. Dur.) 120Hz 70µs 14min 120Hz 70µs 0min 120Hz 70µs 0min 200Hz 60µs 20min 200Hz 60µs 0min 200Hz 60µs 0min 10Hz 180µs 20min 10Hz 180µs 0min 10Hz 180µs 10min 80Hz 100µs 30min 80Hz 100µs 0min 80Hz...
  • Page 41 Russian waveform or Kotz Carrier Duty Contraction/ Phase freq. Freq Ramp Time cycle Recovery (C.F.) 2.5kHz 50Hz 10s/10s 10min 2.5kHz 50Hz 10s/10s 0min 2.5kHz 50Hz 10s/10s 0min 2.5kHz 50Hz 4s/12s 10min 2.5kHz 50Hz 4s/12s 0min 2.5kHz 50Hz 4s/12s 0min 2.5kHz 50Hz 4s/12s 10min...
  • Page 42 Use in the electrotherapy mode Operative instructions Follow the indications below to start the combined treatment. 1. In combo mode ultrasound probe works as negative of channel 2, you should connect electrotherapy cable with 1 derivation (red cable) to the green cable on the output 2.
  • Page 43 11. In the S programs display shows the phases total number and the number of the phase you want to set the parameters: press B3-B7 buttons and the knob (3) to select programs parameters (contraction, recovery, width impulse, frequency, etc.) for each phase (please see the following instructions regarding each parameter).
  • Page 44 handpiece and the symbol on the display will start flashing. 22. It’s possible to stop temporary the therapy at any time pressing the knob (3). Press again the knob to continue the treatment 23. Press the orange button to stop immediately the treatment in progress.

  • Page 45: Maintenance

    CLEANLINESS Switch off I-TECH UE 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 46: Transportation And Storage

    There is no particular precaution to be taken during transportation of the device, since I-TECH UE is a portable device. In any case it is recommended to store I-TECH UE and its accessories in the supplied carrying bag after each treatment.
  • Page 47 Possible failure of the Contact the manufacturer drop in the device current generator effectiveness of circuit. the treatment. Disposal The I-TECH UE, device was designed and engineered to have minimal negative environmental impact, in consideration of its performance and safety IACER Srl MNPG118-02...

  • Page 48: Warranty

    Warranty IACER Srl guarantees a warranty period from the purchasing date for I-TECH UE 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 49 Warranty conditions 1) Should assistance be needed, enclose the purchasing receipt when sending the device to the manufacturer. 2) The warranty period is valid only on the electronic parts. The warranty will be granted by the shop or directly by the manufacturer. 3) The warranty covers only the product damages, which causes its malfunctioning.
  • Page 50 The I-TECH UE equipment has been designed and manufactured according to the TECHNICAL NORM 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 51: Electromagnetic Compatibility Tables

    ALL EQUIPMENT AND SYSTEMS The I-TECH UE device is intended for use in the electromagnetic environment specified below. The customer or the user of the I-TECH UE should assures that it is used in such an environment. Electromagnetic environment -...
  • Page 52 Guidance and manufacturer’s declaration – ELECTROMAGNETIC IMMUNITY – FOR ALL EQUIPMENT AND SYSTEMS The I-TECH UE 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 53 EQUIPMENT AND SYSTEMS THAT ARE NOT LIFE-SUPPORTING The I-TECH UE device is intended for use in. the electromagnetic environment specified below. The customer or the user of the I-TECH UE should assure that it is used in such an environment.
  • Page 54 Recommended separation distances between portable and mobile radio equipment for I-TECH UE not sustaining vital functions I-TECH UE is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of I-TECH UE can help prevent...

This manual is also suitable for:

17908

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