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IV

LECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES

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Summary of Contents for UE

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

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Page 3: ...e 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 MOD...

Page 4: ...IV ELECTROMAGNETIC INTERFERENCES AND ELECTROMAGNETIC COMPATIBILITY TABLES 50...

Page 5: ...est 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 operatio...

Page 6: ...esponsibility 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 modif...

Page 7: ...d 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 Ult...

Page 8: ...ors 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...

Page 9: ...20 5 0cm2 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 fo...

Page 10: ...nutes 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...

Page 11: ...Hz 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 1...

Page 12: ...arameter 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...

Page 13: ...e 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...

Page 14: ...rasound 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 El...

Page 15: ...IACER Srl 15 MNPG118 02 Labelling 1 Ultrasound head 2 LED for head skin detection 3 Handle applicator...

Page 16: ...m 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 elec...

Page 17: ...power supply cable 12 n 1 electrotherapy cable 13 n 1 single plug cable for combined electrotherapy 14 n 1 ultrasound head with 5cm2 area n 1 ultrasound gel n 1 transport bag n 1 user manual n 1 posit...

Page 18: ...ing 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 mus...

Page 19: ...ent 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 significa...

Page 20: ...rom 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...

Page 21: ...ction of the carotid sinuses to position the electrodes near genitals and in those areas that have poor sensibility to stimulate the thyroid or apply stimulation on the neck and mouth as this stimulat...

Page 22: ...ion cables up with earphones or other devices and do not connect the cable to other equipment keep right distance between electrodes the contact between electrodes could cause wrong stimulations or ir...

Page 23: ...nnector connect the power supply plug to the wall socket Use in the ultrasound therapy mode Patient preparation Before starting the ultrasound treatment please check the following indications make sur...

Page 24: ...el 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 complaint reaction before st...

Page 25: ...en 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...

Page 26: ...drops under 41 C WARNING Only in the ultrasound mode the handpiece can be used for immersion treatments The handpiece and its cable are the only parts protected against water damage with an IPX7 level...

Page 27: ...5cm 1 0W cm 1 5W cm 10 15 Fingers arthritis P 01 10 Hand fingers 1MHz 40 15min 5cm 1 5W cm 2W cm 10 15 Arthrosis P 01 10 Affected area 1MHz 50 15min 5cm 1 5W cm 2W cm 10 15 Bursitis P 01 10 Affected...

Page 28: ...fected area 1MHz 70 20min 5cm 2W cm 4 6 Cruralgy P 01 10 Internal thigh 1MHz 40 15min 5cm 2W cm 10 15 Discopathy P 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Strains P 01 10 Affected...

Page 29: ...1 10 Affected area 1MHz 40 15min 5cm 2W cm 3W cm 10 15 Epicondylitis P 01 10 Elbow 1MHz 40 15min 5cm 1 0W cm 1 2W cm 10 15 Epitrocleitis P 01 10 Internal elbow 1MHz 40 15min 5cm 1 0W cm 1 2W cm 10 15...

Page 30: ...ne 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Radiculitis P 01 10 Affected area 1MHz 50 15min 5cm 1 0W cm 1 5W cm 10 15 Muscle recovery P 01 10 Affected area 1MHz 70 20min 5cm 2W cm Free Rizarthrosis P 0...

Page 31: ...area 1MHz 60 15min 5cm 2W cm Free Indications regarding intensity and number of sessions can vary depending on the opinion of your personal doctor or therapist In particular the indications on intensi...

Page 32: ...adhere anymore on the skin it can lead to skin redness that can last also a few hours after the end of the treatment In such cases consult a doctor Refer to the indications given on the electrodes pac...

Page 33: ...density in relation with the prescribed treatment Properly dispose of electrodes after the use In case of doubts about the electrodes integrity it is suggested to replace them with new ones Do not st...

Page 34: ...uctive gel on the rubber electrode surface before placing it on the skin Note use only CE marked gel or supplied by the manufacturer 4 Use elastic belts to keep the electrodes in the right position Op...

Page 35: ...t least 5 seconds 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 co...

Page 36: ...top temporary the therapy at any time pressing the knob 3 Press again the knob to continue the treatment 12 Press the orange button to stop immediately the treatment in progress ATTENTION For safety p...

Page 37: ...0 45 4 0kHz 110Hz 100Hz 0min 6 1 CC 0 45 4 0kHz 110Hz 100Hz 15min 2 CC 0 45 4 0kHz 110Hz 100Hz 15min 3 CC 0 45 4 0kHz 110Hz 100Hz 15min 7 1 CC 0 45 4 0kHz 110Hz 100Hz 15min 2 CC 0 45 4 0kHz 110Hz 100H...

Page 38: ...kHz 150Hz 90Hz 15min 2 CC 2 5kHz 150Hz 90Hz 0min 3 CC 2 5kHz 150Hz 90Hz 0min 5 1 CC 2 5kHz 110Hz 100Hz 15min 2 CC 2 5kHz 110Hz 100Hz 0min 3 CC 2 5kHz 110Hz 100Hz 0min 6 1 CC 2 5kHz 110Hz 100Hz 15min 2...

Page 39: ...4 1 CC 80Hz 100 s 30min 2 CC 80Hz 100 s 0min 3 CC 80Hz 100 s 0min 5 1 CC 180Hz 30 s 16min 2 CC 180Hz 30 s 0min 3 CC 180Hz 30 s 0min 6 1 CC 120Hz 70 s 14min 2 CC 120Hz 70 s 14min 3 CC 120Hz 70 s 14min...

Page 40: ...4 1 CC 80Hz 100 s 30min 2 CC 80Hz 100 s 0min 3 CC 80Hz 100 s 0min 5 1 CC 180Hz 30 s 16min 2 CC 180Hz 30 s 0min 3 CC 180Hz 30 s 0min 6 1 CC 120Hz 70 s 14min 2 CC 120Hz 70 s 14min 3 CC 120Hz 70 s 14min...

Page 41: ...0s 1s 0min 3 CC 2 5kHz 50Hz 50 10s 10s 1s 0min 5 1 CC 2 5kHz 50Hz 50 5s 5s 1s 20min 2 CC 2 5kHz 50Hz 50 5s 5s 1s 0min 3 CC 2 5kHz 50Hz 50 5s 5s 1s 0min 6 1 CC 2 5kHz 50Hz 50 10s 10s 1s 10min 2 CC 2 5k...

Page 42: ...ct the cable when the device is switched off 6 Switch on the device pressing ON OFF button placed laterally next to power supply socket IT IS RECOMMENDED TO TURN OFF THE DEVICE BEFORE CONNECTING ALL T...

Page 43: ...e value by using the knob 3 14 Press FREQ DUTY B8 button and select the working frequency 1 or 3 MHz by using the knob 3 15 Press B8 button to regulate the duty cycle it s possible to select the value...

Page 44: ...or patient safety the device will stop ultrasound treatment and LED starts flashing on the handle if the temperature is above 42 C It will start again when the temperature goes down to 41 C NOTE for m...

Page 45: ...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 devi...

Page 46: ...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...

Page 47: ...hows the error E4 Excessive temperature of internal parts The device will stop treatment automatically please wait at least 30 minutes before restart treatment Display shows the error E5 Internal memo...

Page 48: ...ormation 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 The warranty...

Page 49: ...power supplies 7 Warranty does not apply to wearing parts 8 Warranty does not include transportation costs which have to be covered by the purchaser 9 After the warranty period the warranty is no mor...

Page 50: ...gy and is adequately immune to radiated electromagnetic fields under such conditions it does not detrimentally harmful interfere with radio electric communications electro medical equipment for monito...

Page 51: ...ly 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 declar...

Page 52: ...power suppl 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 U...

Page 53: ...la distanza di separazione raccomandata in metri m Le intensit di campo dei trasmettitori a RF fissi come determinato da un indagine elettromagneticaa del sito potrebbe essere minore del livello di co...

Page 54: ...50kHz to 800 MHz from 80MHz to 800 MHz from 800MHz to 2 7GHz 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...

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