MNPG116-00 _I-TECH UT1 ENG_ - I
Contents
1. Power supply socket 0 ON OFF button I A C E R Srl I TECH DISPLAY LCD MANIPOLI I A C E R Srl Program indicator Frequency indicator 1 3MHz Duty cycle indicator Timer indicator Output intensity power indicator Ultrasound head detector PAUSE therapy indicator NOU 1 Ultrasound head 2 LED for ultrasound head detector 3 Handle applicator I TECH LABELS MODEL Power supply DC 15V 3 0A Adaptor LA C E R Srl via S Pertini 24 A 30030 Martellago VE ITALY ULTRASOUND Waveform Pulsed Continuous Acoustic Frequency IMHz 10 3MHz 10 I TECH UT1 Duty factor 10 100 ReMax 50 le 3 0W cm t20 Beam type collimated Modulation wave shape 100Hz 10 WEE Regulations Applied part type IN 0476 Product in compliance with Directive 93 42 EEC MDD I TECH SN 000001 1MHz 3MHz 7 0cm IPX7 5 0 t20 15 0W 20 R Max 5 0 Beam type collimated 9 Q ON OFF button HEI Polarity of Power Supply QD Stop treatment Start Pause button IPX7 Protected against the effects of immersion for ultrasound handle Ultrasound intensity Ultrasound applicator state contact head skin Indicator of connection socket of treatment head o 3 Ultrasound output intensity Ultra2. DUTY CYCLE TIME HEAD SUGGESTED INTENSITY NUMBERS Acne U 01 10 Affected area 3MHz 3090 15 min 5 cmq 1 5W cm Free Muscle fatigue U 01 10 Affected area 1MHz 70 20 5 2 W cm 2 3 Algodystrophy U 01 10 Affected area 1MHz 5090 10 min 5 cmq 1 0W cm 1 5W cm 10 15 Anti inflammatory U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Arthritis U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Fingers arthritis U 01 10 Hand fingers 1MHz 4096 15 min 1cmq 1 5W cm 2W cm 10 15 Arthrosis U 01 10 Affected area 1MHz 50 15 5 1 5W cm 2W cm 10 15 Bursitis U 01 10 Affected area 1MHz 30 15 5 2W cm 10 15 Brachialgia U 01 10 Trapezium and arm 1MHz 3096 15 min 5 cmq 2W cm 10 15 Capsulitis U 01 10 Shoulder 1MHz 3096 15 min 5 cmq 2W cm 10 15 Cavitations U 01 10 Affected area 1MHz 7096 20 min 5 cmq 2W cm 3W cm 20 30 T T headache U 01 10 Cervical area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 T T headache U 01 10 Massetere 1MHz 50 15 5 1 5W cm 10 15 Cervicalgias U 01 10 Cervical area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Whiplash U 01 10 Cervical and dorsal 1MHz 50 15 min 5 cmq 1 0W cm 1 5W cm 10 15 front zone Condropathy U 01 10 Affected area 1MHz 60 15 5 1 0W cm 1 5W cm 10 15 Muscle contractures U 01 10 Affected area 1MHz 7096 20 min 5 cmq 2W
3. managers handling personnel installers users maintenance personnel It contains general information on the operation precautionary practices and maintenance information of the device I TECH UT1 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 This manual reflects the current state of machine technology and shall not be considered obsolete solely because updated at a later date on the basis of acquired experience The manufacturer reserves the right to update the prod
4. To get more information about the original accessories and spare parts contact A C E R Srl authorized centers After cleaning the external box dry all of the parts carefully before turning on the device Do not disassemble the device to clean or check it there is no need to clean the inside of the machine and in any case this operation should be performed by skilled technical personnel authorised by I A C E R srl When not using the device for a long time place it together with all its accessories in a dry place away from dust direct sunlight and protected from the weather Do not place other objects on top of the device OPERATION TROUBLES I TECH UT1was designed and manufactured using advanced technological solutions and high quality components for an efficient and reliable use Anyway should there be any problems during functioning please refer to this guide before contacting an authorised service centre PROBLEM POSSIBLE CAUSE SOLUTION Display does not Wrong failed connection Check if the mains adapter is switch on with power supply connected to the device and to power supply Check the integrity of all plugs sockets and connection cables Display shows Error during the self test the following Remove any applicators switch the apparatus off and on again If the error problem persists contact the fabricant E LI Display shows No handle is connected the following
5. 5W cm Free Sciatalgy U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Stretch marks U 01 10 Affected area 3MHz 4090 15 min 5 cmq 2W cm Free Venous stasis U 01 10 Extremities limbs 1MHz 5096 15 min 5 cmq 2W cm Free Sprains U 01 10 Affected area 1MHz 4096 15 min 5 cmq 2W cm 4 6 Muscle sprains U 01 10 Affected area 1MHz 4096 15 min 5 cmq 2W cm 8 10 I A C E R Srl 14 Tallonitis U 01 10 Heel 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Tendinitis U 01 10 Affected tendons 1MHz 5090 15 min 5 cmq 1 0W cm 1 5W cm 10 15 Stiff neck U 01 10 Cervical area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Carpal tunnel syndrome U 01 10 Internal wrist 1MHz 40 15 min 5 cmq 1 0W cm 1 5W cm 10 15 Vascularisation U 01 10 Affected area 1MHz 60 15 5 1 0W cm 1 5W cm Free Active principle vehiculation U 01 10 Affected area 1MHz 60 15 5 2W cm Free Indications regarding intensity and number of sessions can vary depending on the opinion of your personal doctor or therapist In particular indications on intensity do not consider the width of the area to be treated If it is very wide the intensity can be increased by 2096 with respect to what indicated and it can be reduced if it is a small area Similarly the movement on the area must be appropriate to the heat fel
6. attention to the following suggestions e Put the patient in a comfortable position The area to be treated should be properly supported and exposed and perfectly relaxed e Inform the patient on the purpose of the treatment and the sensation he will perceive during the treatment e Ensure there no contraindications to treatment e Inspect the patient s skin accurately for any abrasions inflammation surface veins etc Clean the area to be treated with a 70 alcohol or soap e Itis suggested to shave areas of excessive hair growth Durante il trattamento 1 The ultrasound head has to be moved constantly when intensity is higher than 0 5 W cmq 2 Ask the patient about his her sensation during the 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 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 When the treatment is in PAUSE the applicator LED will be turned off and the countdown will also be stopped I A C E R Srl 9 f Mr ATTENTION The treatment should be performer with a regular movement of the ultrasound head not too slow to avoid inducing heat not too fast to prevent a bad contact which would reduce the effective
7. blood supply would be unable to follow the increase in metabolic demand and tissue necrosis might result This device should not be used over a healing fracture Avoid using ultrasounds near bone growth centres in kids growing children Precautions Ultrasounds should not be used on areas with reduced sensitivity or circulation Patients experiencing reduced sensitivity may not be able to warn their therapist doctor when the ultrasound is too intense Patients experiencing circulation problems may suffer from an excessive increase of temperature in the treated area If the patient feels a deep and sharp pain during the treatment the intensity must be reduced to a comfortable level The tendency to bleed is increased by the heat as more blood flows in the area Be careful when treating patients with bleeding disorders We advise moving the head if the intensity is more than 0 5 W sq cm Avoid heating or overheating the capsule in cases of acute and subacute arthritis This device should not be used for symptomatic local pain relief unless etiology is established or unless a pain syndrome has been diagnosed This device should not be used when cancerous lesions are present in the treatment area Cautions should be used for patients affected by the following diseases areas of the spinal column which underwent a laminectomy anesthesised areas patients with bleeding disorders Ultrasound should be routinely checked before each use to determin
8. must be installed and commissioned in compliance with the EMC provided in this manual I A C E R Srl 3 Portable devices can affect the functioning of the device Do not use mobile phones other devices that emit electromagnetic fields nearby This may result in incorrect operation of the unit Only use the device for the recommended applications Do not use the device in presence of inflammable anesthetic mixture and in environments with high concentrations of oxygen will not be held responsible for any accident if the above instructions are not complied with in full Warnings Make sure of the device connection to an electrical system in conformity with the current National laws Care must be taken when operating this equipment around other equipment Potential electromagnetic or other interference could occur to this or to the other equipment Try to minimize this interference by not using other equipment in conjunction with I TECH UT1 Before administering any treatment to a patient you should become acquainted with the operating procedures for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of Ultrasound To avoid the risk of electric shock disconnect the device from the electrical system before maintenance service Use of accessories transducers and cables oth
9. 090 for 1cmq ultrasound head Effective radiating area Aer 20 1 0cmq optional 5 0cmq Input 100V 240V 47Hz 63Hz 1 35A Output 15VDC 3A max Dimensions 143mmx73mmx40mm Power supply Effective intensity 3 0W cmq 20 Device Dimensions 250mmx185mmx82mm Temperature from 10 C to 40 C Relative humidity 30 85 Atmospheric pressure 800 1060hPa Environmental conditions for use Accuracy 20 when value gt 10 maximum value Rbn Max 5 0 Beam type Collimated Material of ultrasound head Aluminium IP Protection IPX7 only for ultrasound head Temperature from 10 C to 55 C Relative humidity 10 90 Atmospheric pressure 700 1060hPa Environmental conditions for storage Maximum adjustable therapy time 30 minutes Timer accuracy 3 Classification EN 60601 1 Class I A C E R Srl 17 SYMBOLS EM COMPATIBILITY EMC TABLES ON OFF button Polarity of power supply Stop treatment Start Pause button Protected against the effects of immersion for ultrasound handle WEE Regulations Applied part type BF Use the I TECH UT1 device at least 3 metres away from televisions monitors mobile phones WIFI routers or any other electronic device as they may affect its functioning The device must be installed and commissioned in compliance with the information
10. Check the connection of applicator s to the socket s If the problem picture persists contact the fabricant B we I A C E R Srl 16 I TECH MEDICAL DIVISION devices are designed and manufactured to have minimum negative impact on the environment in compliance with the functioning and safety needs We follow the criteria to minimise waste toxic material noise undesired radiations and energy consumption A careful research on the performance of the device guarantees a significant reduction of consumption in line with the concept of energy saving This symbol indicates that the product must not be disposed of with normal domestic waste en Please dispose of the device in accordance with the directive 2002 96 EC WEEE Waste Electrical and Electronic Equipment TECHNICAL FEATURES Caratteristiche generali Applied part Type BF Ultrasound features Ultrasound wave frequency 1MHz 10 3MHz 10 Duty cycle 10 100 a stepping 10 Working frequency 100Hz 10 Therapy time Adjustable max 30 minutes Output power 20 0 5W 10 0W when duty cycle gt 80 for 5 cmq ultrasound head 0 5W 15 0W when duty cycle S 7096 for 5cmq ultrasound head 0 1W 2 0W when duty cycle 2 8096 for 1cmq ultrasound head 0 1W 3 0W when duty cycle S 7
11. I TECE MEDICAL DIVISION TECHUT 7 ZU MNPG116 Rev 0 01 08 2013 USER MANUAL INDEX USER MANUAL T 3 SAFETY INFORMATION ccccsssessscsssessscscsessccsessececsessscecsesssosessssucsesssoussesssonsees 3 USE uo cccscssescsssessececsseesccsssssnecsessnccsseescacseesececseessoeseessnacsesssoussessnacsesssoucseessousesesoags 5 CONDITIONS OF USE and EQUIPMENT ccscsseeeseseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 5 DEVICE DESCRIPTION 6 INSTALLATION aa 9 PRELIMINARY OPERATIONS ene rice se narice sane ze nie na nice 9 ULTRASOUND TREATMENT 10 CLEANING MAINTENANCE AND 5 16 OPERATION TROUBLES 16 ENVIRONMENT PROTECTION 4 17 TECHNICAL rene 17 uel 18 EM COMPATIBILITY EMC TABLES 18 WARRANTY rice se nerina nane zine ene rece ne nane nice einen ee na rice seni ne nie na 20 HERE fhe m i i USER MANUAL This manual is addressed to machine user owner
12. PI 2 975 Attention Consult operating instructions Harmonic emissions IEC 61000 3 2 establishments other than domestic and those directly connected to the publiclow voltage LOT Ultrasound handle lot powersupply network that supplies buildings Voltage fluctuations used for domestic purposes flicker emissions IEC 61000 3 3 N A 2 Serial number of ultrasound handle Guidance and manufacturer s declaration electromagnetic Immunity The I TECH UT1 device is intended for use in the electromagnetic environment specified below The customer or the user of the I TECH UT1 should assure that it is used in such an environment I A C E R Srl 18 Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 6kV contact 8kV air 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 96 Guidance and manufacturer s declaration Electromagnetic immunity FOR EM DEVICES THAT ARE NOT INTENDED FOR LIFE SUPPORT The I TECH UT1 device is intended for use in the electromagnetic environment specified below The customer or the user of the I TECH UT1 should assure that it is used in such an environment Immunity IEC 60601 Compliance Ele
13. aused by accidental causes or the buyer s negligence with particular reference to external parts 6 The warranty does also not apply to damage to the equipment caused by incompatible power supplies 7 Parts subject to wear after use are excluded from the warranty 8 The warranty does not include transport costs to be paid by the purchaser in relation to the method and speed of transport 9 The warranty empire after 24 months 12 months for professional user After such time repair work will be carried out at the rates currently in force for the parts replaced and the labour and transport costs 10 Any controversy will fall within the exclusive jurisdiction of the Venice courts I A C E R Srl 20 I TECH I TECH UTI All rights riserve I TECH UT1 logo are owned by and are registered I A C E R Srl 21 I TECH I A C E R Srl 22 I TECH I A C E R Srl 23 Sede Amministrativa e magazzino 30030 MARTELLAGO VE Via S Pertini 24 A Tel 0039 041 5401356 Fax 0039 041 5402684 Cod Fisc P IVA IT 00185480274 R E A VE N 120250 M VE001767 e mail iacer iacer it Internet www itechmedicaldivision com
14. cm 4 6 I A C E R Srl 12 Coxarthrosis U 01 10 Hip 1MHz 60 15 min 5 2W cm 10 15 Cramps U 01 10 Affected area 1MHz 7096 20min 5cmq 2W cm 4 6 Cruralgy U 01 10 Internal thigh 1MHz 4096 15 min 5 cmq 2W cm 10 15 Discopathy U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Strains U 01 10 Affected area 1MHz 5090 15 min 5 1 0W cm 1 5W cm 10 15 Articular pain U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Intercostal pain U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Menstrual pain U 01 10 Abdomen 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Muscle pain U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Rheumatic pain U 01 10 Affected area 1MHz 5090 15 min 5 1 0W cm 1 5W cm 10 15 Dorsalgy U 01 10 Dorsal area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Drainage U 01 10 Affected area 1MHz 60 15 min 5cmq 2W cm 30 Eczemas U 01 10 Affected area 3MHz 5090 15 min 5 1 0W cm 1 5W cm 10 15 Oedemas U 01 10 Affected area 1MHz 30 15 min 5 cmq 2W cm 10 15 Hematomas U 01 10 Affected area 1MHz 4090 15 min 5 2W cm 3W cm 10 15 Epicondylitis U 01 10 Elbow 1MHz 40 15 min 5 cmq 1 0W cm 1 2W cm 10 15 Epitrocleitis U 01 10 Internal elbow 1MH
15. ctromagnetic test test level level environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the I TECH UT1 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Electromagnetic environment guidance 3V effective Portable and mobile RF Conducted RF IEC from 150kHz 3V V4 communications equipment 61000 4 6 80MHz should be used no closer to any part of the I TECH UT1 device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter av Recommended separation Radiated RF IEC 61000 i 80MHz to 3V m Ej distance 4 3 Sub d 1 2 VP from 150kHz to 80MHz d 1 2 from 80 MHz to 800 MHz d 2 3 from 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter In watts W according to the Transmitter manufacturer and d Is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site a survey should be less than the compliance level b in each frequency range Interference may occur In the vicinity of equipment marked with the following A NOTE At 80 MHz ends 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situa
16. d by the manufacturer or the authorised dealer The warranty conditions are those described under Warranty Regulations In accordance with the Medical Devices Directive 93 42 the manufacturer must be able to trace the devices at any time in order to intervene promptly in case of manufacturing faults In the event of future repairs under warranty the equipment must be packaged to prevent damage during transport and sent to the manufacturer together with all of the accessories The purchaser only has the right to repair under warranty when the equipment is returned to the manufacturer complete with the receipt or invoice proving the correct origin of the product and purchase aate Warranty regulations 1 In the event f repairs under warranty the purchaser must include in the package the receipt or invoicing proving the purchase date 2 The electronic parts are covered by a 24 months 12 months for professional user warranty The warranty is given through the point of sale or directly from the manufacturer 3 The warranty covers exclusively product damage causing operational defects 4 The warranty covers exclusively the repair or replacement free of charge including labour of components found to be defective in terms of manufacture or material 5 The warranty does not apply to damage caused by neglect or use not complying with the instructions provided damage caused by work carried out by unauthorized personnel or damage c
17. e that all controls function normally especially that the intensity control does properly adjust the intensity of the ultrasonic power output in stable manner Also determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero Handle the handpiece with care to preserve its characteristics Before using the device pay attention to the appllicators and head integrity in order to avoid the ingress of liquids 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 Unwanted effects I A C E R Srl In case of undesired effects suspend the therapy stop using the device straight away and contact your doctor Follow the instructions in order to minimise the undesired effects of the ultrasound therapy I TECH If the handpiece moves too slowly the patient may experience sharp and or deep peripheral pain If it moves too quickly or if the handpiece is not held correctly the therapeutic effects of the ultrasound might be reduced 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 tha
18. er than those specified here even as internal spare parts may result in EM immunity reduction or in EM emissions increase The device must not be used in the same environment where magnetic resonance devices are working or are installed Contraindications 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 This device should not be used over the thoracic area if the patient is using a cardiac pacemaker in order to avoid interferences between the ultrasound device and the pacemaker Do not direct the beam towards or near the eyes This device should not be used over cardiac area This device should not be used over neoplastic lesions Do not use near testicles not to increase their temperature The treatment with ultrasounds should be avoided in those areas affected by thrombophlebitis not to make the thrombus move Avoid treating patients with deep vein thrombosis embolism or arteriosclerosis Tissues that have previously been treated with X rays or other radiations should not be treated with ultrasounds Using ultrasounds on the stellate ganglion on the spinal column after a laminectomy on the area surrounding the main nerves or the cranium should be avoided This device should not be used on ischemic tissues in individuals with vascular disease where the
19. ness 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 complaint reaction before starting the treatment after ULTRASOUND TREATMENT After performing the preliminary operations listed in the previous paragraph start the session making sure to follow these steps PROGRAM 1 Press PROGRAM keys CH programmes with the arrows to select the program scroll up down the FREQUENCY 2 Select the frequency 1 or 3 MHz by pressing the button FREQUEN m DUTY CYCLE 3 Select duty cycle 10 100 by pressing the buttons DUTY CYCLE up arrow down arrow TIMER 4 Select therapy time 1 30 minutes by pressing the buttons TIME up arrow and down arrow 5 Put a good quantity of conductive gel on the area to be treated It is recommended to use a CE conductive gel CE 6 Regulate the intensity of the treatment using the knob 7 Press any of the PROGRAM FREQUEN DUTY CYCLE or TIME buttons during the treatment to visualise W Watts or W cm Watt sq cm 7 Keep the head in constant contact with the skin and make sure that the part is covered in gel
20. ng to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output From 150kHz to From 80MHz to From 800MHz to 2GHz power of transmitter W soMHzd 1 2 800MHz d 1 2 2 3 VP 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 meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W accordable to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 Theseguidelinesmaynotapplyinallsituations Electromagneticpropag ationisaffectedbyabsorptionandreflectionfromstructures objectsan dpeople The device has a 2 year warranty starting from the purchase date covering electric and electronic parts for household use In case of purchase from professional operators purchase with an invoice the warranty is 12 months All of the parts subject to normal wear and tear ultrasound head are not covered by warranty as well as all the parts that are defective due to negligence improper maintenance tampering or repair work carried out by personnel that has not been authorise
21. on electromagnetic compatibility supplied in this manual Also see the EMC Charts paragraph Using accessories transducers and cables other than those specified except for those transducers and cables sold by the manufacturer as spare parts for internal components may result in increased emissions or decreased immunity of the device The device should not be placed next to or on top of other devices Should it prove necessary to place it next to or on top of other devices supervision is essential at all times to control its normal functioning Product in compliance with Directive 93 42 Guidance and manufacturer s declaration electromagnetic emissions FOR ALL EM DEVICES Device can supply a current 10mA r m s or 10V r m s for a period of 5 seconds The I TECH UT1 device is intended for use in the electromagnetic environment specified below The customer or the user of the I TECH UT1 should assures that it is used in such an environment Fabricant name and address Emissions test Compliance Electromagnetic environment guidance The I TECH UT1 device uses RF energy only for its RF emissions Group 1 internal function Therefore its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment Manufacturing date month year RF emissions Class B CISPR11 The UT1 device is suitable for use in all C OE E
22. so that the therapy is effective The green LED located next to the head on the handpiece lights up when the device is working 8 The device has a head skin coupling system for safety reasons If the contact is not correct and if the intensity is set above 0 5W the LED on the handpiece and aq 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 system 9 It s possible to stop temporary the therapy at any time pressing the knob 7 Press again the knob to continue the treatment 10 Press the orange button to stop immediately the treatment progress We advise handling the handpieces with care in order to preserve them In order to ensure efficient transfer of energy a contact means is required between the ultrasound head and the body Air causes virtually total reflection of the ultrasound energy The best means for the transfer of ultrasound energy is the ultrasound gel I A C E R Srl 10 Put a quantity of conductive gel on the area to be treated Move ultrasound head during therapy session in a circular motion The treated area should be twice the ultrasound head area If the body surface is ver
23. sound output power Treatment time Fabricant name and address 2 Manufacturing date month year I A C E R Srl I TECH Attention Consult operating instructions LOT Ultrasound handle lot 9 Serial number of ultrasound handle INSTALLATION Remove the device and all accessories from shipping cartons Check the device equipment Before the installation and the connection of the device to the mains supply check that the voltage and frequency correspond with the available mains supply and indicated in this user manual We recommend that you use the MPUS50 160 type power supply Follow the instructions below for a correct installation e Connect the power supply cable to the power supply e Connect the power supply to the device connector e Connect the power supply plug to the wall socket Press on ON OFF button to switch on the device If itis connected correctly display will show the picture below If it is connected in wrong way display will show the picture below PRELIMINARY OPERATIONS Immediately after switching on the device carries out a self test At the end of the self test a beep is heard and display shows the picture as described in previous paragraph When an error is found an error code will appear on the display please read the paragraph Operation troubles to get more details Before starting treatment please pay
24. t by the patient The slower it moves the stronger the heat If the patient complains about the heat we advise reducing the intensity or moving the head faster I A C E R Srl 15 CLEANING MAINTENANCE AND STORAGE Before cleaning switch off the device and disconnect it from the mains supply Disconnect all cables and accessories The dust can be removed with a dry cloth To clean persistent dirt use a non abrasive liquid household cleaner no abrasive no alcohol content solution If a more sterile cleaning is needed use a cloth moistened with an antimicrobial cleaner ATTENTION Do not immerse the device into liquids Should the device accidentally become submersed contact the fabricant and or Authorized Service center immediately Do not attempt to use a system that has been wet inside until inspected and tested by the fabricant or the Service Technician Certified by Authorized Service center Do not allow liquids to enter the ventilation holes in the optional modules In case of irritations or reddening suspend the treatment and consult a doctor Clean the contact surface immediately after each treatment using a soft cloth or paper cloth lightly wet if needed Make sure that no ultrasound gel remains on the ultrasound head Aggressive clearing agents could damage the rubber insulation and shorten the life of the cables Store the handpiece applicators cables with care at the end of each treatment
25. t the handpiece is in contact with the skin using a specific ultrasound gel Any substance used for this purpose must be highly conductive Air is a terrible conductor of ultrasound waves USE I TECH UT1 is a device for ultrasound therapy 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 Use hospital and domestic use it is recommended the use only by seasoned professional Expected lifetime time after which we suggest sending the device to the manufacturer for safety checks 2 years CONDITIONS OF USE and EQUIPMENT Environmental conditions for use Environment temperature from 10 to 40 C Relative humidity from 3090 to 8590 without condensation avoid direct sunlight chemical products and vibrations The device is equipped with the following accessories Description Power supply 15V 3A 5 Ultrasound gel 1 piece All accessories are available on demand as spare parts Moreover the ultrasound head with 1 cmq area is available on demand I A C E R Srl 5 DEVICE DESCRIPTION Program selection button Frequency selection button 1 3MHz Duty cycle selection button Timer selection button LCD display STOP button Intensity selection knob and PAUSE Handle socket 5 cmq and 1
26. tions Electromagnetic propagation is affected by absorption and reflection from structures objects and people I A C E R Srl 19 1 Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment du to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the I TECH UT1 device is used exceeds the applicable RF compliance level above should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the I TECH UT1 WARRANTY 2 Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m Recommended separation distances between portable and mobile rf communications equipment and the em devices that are not intended for life support The I TECH UE device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the I TECH UE device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the I TECH UE as recommended below accordi
27. uction and the manuals with no obligation to update previous versions The manufacturer declines all responsibility for improper use of the machine use contrary to specific national laws incorrect installation defective power supply improper maintenance unauthorised 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 exceptional events To get further information consult the fabricant SAFETY INFORMATION Cautions Read carefully the contraindications Respect the limitations and hazards associated with the use of the device Pay attention to the labels and symbols placed the unit Always follow your prescribing doctor s or therapist s recommendations Do not operate this unit in an environment where other devices are used that intentionally radiates electromagnetic energy in an unshielded manner Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel Before each use inspect applicators and cables integrity The device should not be placed next to or on top of other devices Should it prove necessary to place it next to or on top of other devices supervision is essential at all times to control its normal functioning Precautions must be taken regarding the electromagnetic compatibility of the device which
28. y irregular making it difficult to obtain good contact between the ultrasound head and the body or if direct contact must be avoided e g due to pain the affected area may be treated under water subaqual method The water should be degassed by previous boiling in order to prevent air bubbles that could decrease the effectiveness of the treatment ATTENTION The handpiece and its cable are the only parts protected against water damage with a IPX7 grade ATTENTION Never apply the gel to the ultrasound head The treatment head will register this as contact and may emit ultrasound energy which could damage the ultrasound head Always use the gel certificated with the requirements of the medical such as with CE mark Programs features and main applications Make reference to the following table for programs features parameters are adjustable by the user PROG FREQ DUTY CYCLE TIME SUGGESTED INT U 01 1MHz 8096 10 min 1 0W cm U 02 1MHz 5096 10 min 1 0W cm U 03 1MHz 5096 20 min 1 5W cm U 04 1MHz 5096 15 min 1 0W cm 1 5W cm 2 0W cm U 05 3MHz 8096 15 min 1 0W cm U 06 1MHz 3096 15 min 1 5W cm U 07 1MHz 8096 15 min 1 0W cm 1 5W cm U 08 1MHz 8096 8 min 1 5W cm U 09 1MHz 5096 12 min 1 5W cm U 10 3MHz 8096 10 min 1 0W cm I A C E R Srl 11 APPLICATIONS TREATMENT PRG HANDLE POSITION
29. z 40 15 min 5cmq 1 0W cm 1 2W cm 10 15 Slipped disc U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Gonarthrosis U 01 10 Knee 1MHz 5090 15 min 5 1 5W cm 2W cm 10 15 I A C E R Srl 13 Lymphoedema U 01 10 Affected area 1MHz 3090 15 min 5 cmq 2W cm 10 15 Lypolisis U 01 10 Affected area 1MHz 6096 15 min 5 cmq 2W cm 30 Lumbago U 01 10 Lumbar area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Massage U 01 10 Affected area 1MHz 70 20 5 2 U 01 10 Affected area 1MHz 5090 15 min 5 1 0W cm 1 5W cm 10 15 Mononeuropathy U 01 10 Pain zone 1MHz 5090 15 min 5 1 5W cm 12 15 Neuralgia U 01 10 Affected area 1MHz 5090 15 min 5 1 0W cm 1 5W cm 10 15 Periarthritis U 01 10 Shoulder 1MHz 70 15 5 1 0W cm 1 5W cm 10 15 Pubalgy U 01 10 Internal thigh 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 upper zone Radiculitis U 01 10 Affected area 1MHz 50 15 5 1 0W cm 1 5W cm 10 15 Muscle recovery U 01 10 Affected area 1MHz 70 20 5 2 W cm Rizarthrosis U 01 10 Thumb area 1MHz 30 15 min 5 cmq 1 5W cm 10 15 Rizopathy U 01 10 Dorsal area 1MHz 60 15 min 5 1 5W cm 10 15 Wrinkle U 01 10 Affected area 3MHz 30 15 min 5 1
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