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EN109-1631750-48 IFU
Sonopuls 190
EN109-1631750-48 IFU July 9, 2020
Instructions for use
Страница 1: ...Page 1 of 34 EN109 1631750 48 IFU Sonopuls 190 EN109 1631750 48 IFU July 9 2020 Instructions for use ...
Страница 2: ...onents 6 4 Package contents 7 5 Installation 8 6 Intended use and intended user 9 7 Indications 10 8 Contraindications 11 9 Precautionary instructions 12 10 Operation 14 11 Application information 23 12 Maintenance and troubleshooting 25 13 Specifications 27 14 Contact 32 15 Product liability 33 ...
Страница 3: ...time of publication However owing to Enraf Nonius BV s policy of continual improvement changes to these specifications may be made at any time without obligation on the part of Enraf Nonius BV It is important to read the following instructions carefully before using this device properly and safely The manufacturer cannot be held responsible for the results of using this device for any purposes oth...
Страница 4: ...lowable patient leakage current and patient auxiliary current Temperature Range Indicates acceptable temperature range Humidity Limits Indicates acceptable relative humidity Atmospheric Pressure Indicates the range of atmospheric pressure to which the medical device can be safely exposed Waste electrical items that can be recycled Indicates the electrical and electronic components of the device ca...
Страница 5: ...Page 5 of 34 EN109 1631750 48 IFU Pulse frequency Continuous Duty cycle Pulse duration Ultrasound frequency Alternating current ON power OFF power ...
Страница 6: ...few seconds low energy method 5 Connector for mains cable To disconnect the device from the power line unplug the power cord 6 Type number warning sticker Provides information on the apparatus such as type and serial number as well as connection data such as mains voltage and maximum current consumption 7 Connection Ultrasound Applicator A Ultrasound applicator connection left side 8 Connection Ul...
Страница 7: ...ntact gel The article number 3442 929 however represents a box of 12 bottles Standard accessories for 1631 904 0169 842 Head holder StatUS applicator 3442 941 Gelpad StatUS 240x 3442 942 Fixation ring gelpad StatUS 3x 1631 750 Instructions for Use Sonopuls 190 CD ROM 1629 750 Instructions for Use StatUS Pack 100 CD ROM 1929 750 Information booklet StatUS Pack 100 3444 357 Mains connecting cable 16...
Страница 8: ...nit Follow the instructions given in the 0167 278 Information sheet Mounting US Head Holder Sonopuls 190 Connection to mains supply Use of any other cable other than the supplied cable is strictly PROHIBITED as it affects patient safety and the proper function of the device Do not place the device in a location where the power cord could be tripped over or pulled out during treatment Do not attemp...
Страница 9: ...ough the tissue of the body and are gradually absorbed and transformed into heat The resulting temperature increase triggers biological changes to occur in the tissue for the relief of pain relaxation of muscle spasms and reduction of joint contractures The Sonopuls 190 is intended to be used and shall only be used by or under the supervision of professional users in the field of physical therapy ...
Страница 10: ... deep heat relief of pain muscle spasms and joint contractures The objective of therapeutic ultrasound in the treatment of selected medical conditions associated with the chronic and sub chronic conditions of bursitis capsulitis epicondylitis ligament sprains tendinitis scar tissue healing and muscle strain is to reduce pain ...
Страница 11: ... ionizing radiation therapy chemotherapy or general or regional anaesthesia It may cause burns Do not use on insensitive areas or in the presence of poor circulation Large thermal doses could result in regions of thermal aseptic necrosis which could not be apparent on inspection of the skin Always ensure proper hygiene see chapter 12 Maintenance and troubleshooting Only apply the applicator on int...
Страница 12: ... the reach of children Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy Handle ultrasound applicator with care Inappropriate handling of the ultrasound applicator may adversely affect its characteristics Inspect ultrasound applicator for cracks and other mechanical defects which may allow the ingress...
Страница 13: ...d repair should be carried out by authorized personnel only The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons Medical electrical devices such as the Sonopuls 190 are subject to special precautions with regard to electromagnetic compatibility EMC and must be installed and commissioned in accordance with the EMC advice given in the instru...
Страница 14: ... with StatUSTM pack Part number 1629 901 For Sonopuls 190 Part numbers 1631 901 902 or 903 has to be connected to StatUSTM Pack 100 Part number 1629 901 in order to perform StatUS Therapy StatUSTM Pack 100 is a feature accessory for the application of StatUS Therapy Hence for 1631 901 902 or 903 this accessory will have to be purchased separately Home menu The Sonopuls 190 is equipped with touch s...
Страница 15: ... Select from the list Language Push icon Language Select your language via the icon Push OK to confirm and to return to the previous menu Set Brightness Select from the list Brightness Push icon Brightness Adjust the brightness via the icon Push OK to confirm and to return to the previous menu ...
Страница 16: ...find all information about your unit Installed software is directy displayed on the left side of the system info icon To view all other info s push the System info icon and you have all other information about hardware on the screen Push OK icon in the screen to confirm and to return to the previous menu Load Clinical Protocols The Sonopuls has 25 treatment suggestions for the most common treatmen...
Страница 17: ...or and other parameters are changeable any time Adjust the intensity level via the icon Push OK icon to return in the previous menu Place the applicator on the treatment area with gel Contact control indicator turns off and the treatment time start to countdown If there is insufficient contact the indicator will light up and treatment time will interrupt ...
Страница 18: ...ge the frequency Select the frequency by pushing the icon 1 MHz is deep 3 MHz is superficial You will return to the previous menu Continuous Pulsed Mode Push the icon 2 to select continuous or pulsed mode Push A or B A is pulsed mode B is continuous mode Push OK to confirm and to return to the previous menu If continuous pulse mode is selected no other parameters Frequency or Duty Cycle are availa...
Страница 19: ...uency via the icon There are 3 frequencies available 100 48 and 16Hz Push OK to confirm and to return to the previous menu Duty Cycle Push the icon 4 to select Duty Cycle Select the duty cycle via the icon There are 6 settings available 80 50 33 20 10 and 5 Push OK to confirm and to return to the previous menu 3 4 ...
Страница 20: ... OK to confirm and to return to the previous menu A is the left connection B is the right connection Note When no applicator is connected on the selected output a beeb will occur Units Push the icon 6 to select units Select the desired read out of the ultrasound intensity There are 2 read outs Watt cm and Watt You will return to the previous menu 5 6 ...
Страница 21: ...ct the treatment time Select the treatment time via the icon Push OK to confirm and to return to the previous menu Intensity Setting Push the icon 8 to select intensity setting Select the intensity level via the icon Push OK to confirm and to return to the previous menu 7 8 ...
Страница 22: ...and to return to the previous menu Notes Program number 0 is the default start up setting You can extend the name of the program with your own terminology Load Favorites Push the icon Favorites Select a program via the icon Place the applicator on the treatment area with gel Contact control indicator turns off and the treatment time will start countdown starts If there is insufficient contact the ...
Страница 23: ...ster this as acoustical contact and may emit ultrasound energy which could damage the applicator If the body surface is very irregular making it difficult to obtain good contact between the ultrasound applicator 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 ...
Страница 24: ...plicator with a towel or tissue To disinfect the treatment applicator we advise to use Dismozon art no 3442 438 in a solution between 0 25 and 1 5 Check for the effects that can be expected for example pain circulation and mobility Ask the patient to comment subsequently on any reactions that may occur ...
Страница 25: ...contact surface immediately after use Make sure that no ultrasound gel remains on the applicator To disinfect the treatment applicator we advise to use Dismozon in a solution between 0 25 and 1 5 We further recommend cleaning the applicator and cable daily using lukewarm water Check the applicator and cable regularly for damage Troubleshooting When the apparatus is turned on it will first execute ...
Страница 26: ...Factory Defaults You can optimize the contact control yourself by means of the maintenance menu Here you can also restore the factory defaults Note When restoring the factory defaults previously stored values can be lost 1 Push System Settings 2 Select Maintenance via the icon 3 Select the appropriate item via the icon Expected Service Lifetime This device will remain suitable for its intended use...
Страница 27: ... temporal average intensity 100 is continuous ultrasound There are 6 settings available 5 10 20 33 50 and 80 Effective Radiation Area ERA expressed in cm defines the cross sectional area of the ultrasound beam See technical specifications for details The Effective Radiation Area is fixed and defined by the size of the ultrasound applicator Ultrasound Power is the ultrasound output expressed in W T...
Страница 28: ... Hz 1 Duty cycle pulsed 5 80 Pulse duration at 100 Hz 0 5 8 ms 10 set by duty cycle Temporal Peak to Average Ratio RTPA 20 1 25 5 set by duty cycle Treatment timer 0 30 min 0 1 min linked to contact control Contact control level 65 5 cm Applicator 0 8 cm Applicator Ultrasound frequency 1 MHz 3 MHz 0 98 MHz 5 0 98 MHz 5 3 1 MHz 5 3 1 MHz 5 0 98 MHz 5 3 1 MHz 5 ERA Effective Radiation Area IEC 60601...
Страница 29: ... the cross sectional area of the ultrasound beam Its value depends on the ultrasound standard used International IEC 60601 2 5 USA 21 CFR 1050 10 The Beam Non Uniformity Ratio is the ratio of the maximum ultrasound Amplitude to the average ultrasound Amplitude measured at the Effective Radiation Area A low BNR value is indicative for the absence of high and potentially dangerous energy concentrati...
Страница 30: ... x 14 1707 1629 901 22 x 12 x 9 930 Technical modifications reserved Safety and performance standards IEC 60601 1 General requirements for the safety of electrical medical systems Safety class according to IEC 60601 1 Class I type BF IEC 60601 2 5 Particular requirements for the safety of ultrasonic therapy equipment Medical device classification IIa Rule 9 Annex IX of 93 42 EEC This equipment com...
Страница 31: ...ther than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation This device is classified as a Group 1 Class B device according to CISPR 11 Group 1 The Sonopuls 190 uses RF energy solely for its internal functioning Its RF emission is therefore ve...
Страница 32: ...e latest version in electronic or printed format of this Instructions for Use can be obtained free of charge from our website www enraf nonius com or by contacting distributor or by calling the telephone number 31 0 10 2030600 The Instructions for Use will be sent free of charge to you within 7 seven calendar days ...
Страница 33: ... of the possibility thereof and regardless of the legal or equitable theory contract tort or otherwise upon which the claim is based In any case Enraf Nonius entire liability under any provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for support of the product received by Enraf Nonius under a separate support agreement if any with the...
Страница 34: ...EN109 1631750 48 Copyright Enraf Nonius B V Vareseweg 127 3047 AT Rotterdam The Netherlands Tel 31 0 10 20 30 600 info enraf nonius nl ...
