INSTRUCTION MANUAL
Contents
1. 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 SoundCare Plus 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 SoundCare Plus b Over the frequency range 150 kHz to 80 MHz field strengths should be less than V V m 13 4 Recommended separation distances between portable and mobile SoundCare Plus Pain Relief Device RF communications equipment and the SoundCare Plus device Recommended separation distances between portable and mobile RF communications equipment and the SoundCare Plus device The SoundCare Plus device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the SoundCare Plus device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the SoundCare Plus as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance ac2. 1 0W em 1 5W cm 1 0W cm 1 5W cm U 07 1 MHz 80 15 minutes 1 0W cm 1 5W cm 1 5W cm 1 5W cm 0W cm For a prolonged pause in treatment store the device with the adapter ina dry room and protect it against heat sunshine and moisture Store the machine in a cool well ventilated place Never place any heavy objects on the machine SoundCare Plus Pain Relief Device 11 Please dispose of the device in accordance with the directive 2002 DISPOSAL 96 EC WEEE Waste Electrical and Electronic Equipment If you have any queries please refer to the local authorities responsible for waste disposal 12 Current Solutions LLC declares that the device STANDARDS complies with following normative documents AND IEC EN60601 1 IEC EN60601 1 2 IEC EN60601 2 5 REQUIREMENTS IEC EN61689 1EC60601 1 4 IEC62304 15010993 5 15010993 10 15010993 1 15014971 13 GUIDANCE AND MAUFACTUER S DECLARATION 13 1 Declaration electro magnetic emissions Guidance and manufacturer s declaration electromagnetic emissions The SoundCare Plus device is intended for use in the electromagnetic environment specified below The customer or the user of the SoundCare Plus should assures that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance The SoundCare Plus device uses RF energy only for its internal function RF emissions Therefore its RF emission
3. it must conform to the requirement of the standard medical electrical equipment 5 3 Plug theapplicator s connection plug into the corresponding socket connection on SoundCare Plusinaccordance with the direction that marked Connectthe at the applicator connector If connect correctly LCD will show the picture in Figure 1 if connect error LCD will show the picture in Figure 2 1cm PRosRaM D POWER with main unit by the manufacturer Please do not use other type of applicator 5 4 Switch on the device using the ON OFF switch Switching Immediately after switching on the apparatus carries out a self test onand At the end of the self test a beep is heard When an error is found an error self test code will appear on the display See section 8 for details 5 5 SoundCare Plus has 10 kinds of treatment procedures model Users can Therapy program their own operating parameters of the treatment process system 1 Ultrasonic frequency set up 2 The treatment duty cycle 3 Treatment time Operating parameters will be stored automatically power down or shutdown will not be lost 5 5 1 e Mode up key Press this button to choice the program Choice Select PROGRAM EAI PROGRAM EA PROGRAM ULP ES uot S ua ee 0 PROGRAM p g VI PROGRAM p g ws LI UU 10 5 5 2 Choice Select the Ultrasound Frequency 1MHz or 3MHz 5 5 3 Choice Select the trea
4. time Setting the TIMER Crore TIMER erro TIMER OCT treatment oO Cna gt time 1 min 30min stepping dd 1 min D ZL LUA Time up key Press this button to decrease the treatment time TIMER TIMER x Cer V TIMER uw VI mri TUN i V1 EUM tnu 5 6 Switch off the SoundCare Plus using the mains switch Disconn Pull out the mains plug of the mains adapter from the wall socket ecting from the mains 6 OPERATION 6 1 Measures with regard to treatments 6 1 1 Put the patient in a comfortable position The area to be treated should Before be properly supported and exposed and perfectly relaxed the e Inform the patient on the purpose of the treatment and the sensation he treatment will perceive in the course of the therapy Ensure there are no contraindications to treatment 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 t is advisable to shave areas of excessive hair growth 6 1 2 During the treatment 6 1 3 After the treatment 6 2 Operating the apparatus 6 2 1 Switch on the apparatus 6 2 2 Adjusting parameters SoundCare Plus Pain Relief Device e The treatment head has to be moved constantly in a slow tempo also in case of
5. Program indicator Frequency indicator Duty cycle indicator Timer indicator Cn 1 2 4 SoundCare Plus Pain Relief Device The component of the Applicator which makes contact with the patient during the Ultrasound therapy treatment of the time The component of the Applicator which indicates if the Sound head is working or Nonworking on the treatment area The assembly that connects to the System and incorporates the 4 3 Treatment SS head 7 1 Sound head 2 Applicator LED 3 Applicator Sound Head 4 4 Symbol definitions O ON OFF SWITCH STOP TREATMENT Below are the definitions forall of the symbols used in the Ultrasound therapy device Study and learn these symbols before any operation of the system B I START PAUSE BUTTON ULTRASOUND INTENSITY ULTRASOUND APPLICATOR STATE POLARITY OF POWER SUPPLY THE CONNECTION SOCKET OF TREAMENT HEAD SoundCare Plus Pain Relief Device PAUSE ULTRASOUND OUTPUT POWER ULTRASOUND OUTPUT INTENSITY TREATMENT TIME 4 5 ON OFF Switch Key gt With this button the SoundCare Plus is turned on or off Function Pause Knob gt Pause Restore treatment working Intensity Knob gt Rotating the intensity control Knob to start treatment gt Set intensity by rotating the intensity control Knob to the prescribed level Clockwise Increase Intensity Counterclockwise D
6. SounDCARE plus INSTRUCTION MANUAL SoundCare Plus Pain Relief Device Operating instructions Medical device for pain treatment based on ultrasound www currentsolutionsnow com SoundCare Plus Pain Relief Device Contents FOREWORD SAFETY PRECAUTIONS cer INDICATIONS AND CONTRAINDICATIONS PRESENTATION OPERATION MAINTENANCE DIAGNOSTICS 7 oPECIFICATIONS AND TECHNICAL DATA 5 11 DISPOSAL eee 12 STANDARDS AND REQUIREMENTS ee 13 GUIDANCE AND MAUFACTUER S 1 4 WARRANTY 15 NORMALZED SYMBOLS CON OO WN e lA 16 TES mo 18 6 SoundCare Plus Pain Relief Device 1 FOREWORD 1 1 This manual has been written for the users of the ultrasound therapy SoundCare Plus It contains general information on the operation precautionary practices and maintenance information In order to maximize use efficiency and the life of the system please read this manual thoroughly and become familiar with the controls as well as the accessories before operating the system This user manual is published by Current Solutions LLC Current Solutions LLC does not guarantee its contents and reserves the right to improve and amend it at any time without prior notice Amendments will howev
7. cording to frequency output power of transmitter m of transmitter 1 50 kHz 80 MHzto 800 MHz to to 80 MHz 800 MHz 2 5 GHz d 1 2 P d 1 24P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 2 1 2 2 3 10 3 8 3 8 73 100 12 12 23 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 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 21 SoundCare Plus Pain Relief Device 14 Please contact your dealer or the device centre in case of a claim under WARRANTY the warranty If you have to send in the device enclose a copy of your receipt and state what the defect is A The following warranty terms apply e The warranty period for SoundCare Plus products is one years from date of purchase In case of a warranty claim the date of purchase has to be proven by means of the sales receipt or invoice e Defects in material or workmanship will be removed free of change with in the warranty period Repairs under warranty do not extend the warranty period either
8. d with an antimicrobial cleaner Caution Do not submerse the device in liquids Should the device accidentally become submersed contact the dealer or Authorized Service center immediately Do not attempt to use a system that has been wet inside until inspected and tested by a Service Technician Certified by Authorized Service center Do not allow liquids to enter the ventilation holes in the optional modules This could permanently damage the modules 7 2 The treatment heads and cables should be regularly inspected for damage Cleaning e g hairline cracks which could allow penetration by liquids Clean the of the contact surface immediately after each treatment Make sure that no treatment ultrasound gel remains on the treatment head We further recommend heads cleaning the head and cable daily using lukewarm water The treatment heads can be disinfected using a cloth moistened with 7096 alcohol 7 3 Maintenance and all repairs should only be contact with the dealer Maintenance 8 Diagnostics 8 1 Displays fail to light Up 8 2 Error agency The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons The service and or maintenance must be carried out conform the procedure described in the manual of the apparatus Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty Check if the mains adapter is connected to the
9. device and mains supply The device has discovered a fault during or after the self test The error displays the following figure 1 Remove any applicators or cables from the output sockets and switch the apparatus off and on again If the code re appears contact your supplier The device is probably defective SoundCare Plus Pain Relief Device Figure 1 D lt gt a 8 3 Check the connected plug of ultrasound applicator The contact control fails to operate Figure 2 DUTY CYCLE V1 V1 0 o e ik ERE TIMER rer 9 SPECIFICATIONS AND TECHNICAL DATA 9 1 Technical date of Treatment head Electrical Output Power 0 5W 10 0W 20 when duty tactor 80 for 5cm 0 5W 15 0W 20 when duty factor lt 70 for 5cm 0 1W 2 0W x 2096 when duty factorz 8096 for 1cm 0 1W 3 0W x 2096 when duty factor lt 70 for 1cm Effective radiating area Aer 5 0cm 2096 1 0cm 20 3 0W cm amp 2096 1 0MHz 3 0W cm 2096 3MHz 9 2 Program List Table 10 STORAGE SoundCare Plus Pain Relief Device Technical data of power supply 100V 240 A7Hz 63Hs 13 16V 1 35A 143mm L x73mm W x4Omm H Environmental conditions for use 10 40 C Relative humidity 30 85 800 1060hPo Environmental conditions for storage 20 C 55 C Relative humidity 096 9 096 Atmospheric pressure 700 1060hPa Program Frequency Duty Treatment Suggest Cycle Time Intensity 1 0W cm 0
10. e that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero Do not use sharp objects such as pencil point or ballpoint pen to operate the buttons on the control panel Before each use inspect Ultrasound Applicator for cracks which may allow the ingress of conductive fluid Inspect Applicator cables and associated connectors before each use 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 Caution should be used for patients with suspected or diagnosed epilepsy Refer to recent surgical procedures when muscle contraction may disrupt the healing process Do not use over the menstruating or pregnant uterus and over areas of the skin which lack normal sensation 2 3 WARNING 2 4 Danger SoundCare Plus Pain Relief Device SoundCare Plus should not be used on driving operating machinery or during any activity in which in voluntary muscle contractions may put the user at under risk of injury A Warning 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 it The apparatus may not be used in clo
11. ecreases Intensity Escape button Stop treatment UP and DOWN Arrows Controls used in various modality parameter screens to navigate or change a value up or down within the parameter 5 0 INSTALLATION 5 1 Remove the Therapy System and all accessories from shipping cartons Reception Visually inspect for damage Report any damage to the carrier of equipment and accessories Your ultrasound therapy is supplied with case containing Part Quantity Ultrasound therapy unit Ultrasound head with AER Ultrasound head with 1cm AER Adapter 1 35A to 100 240V Lead for adapter SoundCare Plus Pain Relief Device 5 2 Mains supply connections must comply with the national requirements Connection regarding medical rooms The equipment has a safety earth ground connection and must be connected to an earthed grounded wall socket Prior to connection of this devices to the mains supply check that the voltage and frequency stated on the type plate correspond with the available mains supply The mains adapter isa partof the supply circuit on which the device s safety partl y depends We recommend that you use the MPU50 160 type with of medical power If you can not find the same type of medical power please choose the same specifications Output DC 1 5V 1 35A medical power Connect the supplied mains adapter to the connector Connect the mains adapter to a wall socket AN Caution Foryourhealth if you change the AC DC adaptor
12. er be published in a new edition of this manual 1 2 The ultrasound therapy SoundCare Plus is an apparatus featuring an Therapy ultrasound therapy unit Pain affects the quality and enjoyment of life possibilities especially for those who suffer chronic pain SoundCare Plus is ultrasound therapy device for the treatment of chronic and acute muscular pain 1 3 The ultrasound treatment heads for the SoundCare Plus are so called multi Treatment frequency heads This treatment head can now supply both 1 and 3MHz head ultrasound The head has excellent beam characteristics fully meeting the requirements of the existing standards The excellent beam characteristics ergonomic design and effective contact control of the multi frequency treatment heads make an optimal treatment possible Standard accessories include a ultrasound head with 5cm Aer that can work at 1MHz and 3MHz User can also choose to purchase ultrasound head with 1cm Aer that can also work at 1 MHz and 3MHz 1 4 You have made a wise choice in selecting the SoundCare Plus We are Finally confident that your unit will continue to give satisfaction over many years of use Nevertheless if you have any queries or suggestions please contact your authorized distributor 2 SAFETY PRECAUTIONS 2 1 The precautionary instructions found in this section and throughout this PRECAUTION manual are indicated by specific symbols Understand these symbols and ARY their defi
13. for the device or for the replacement parts B The following is excluded under the warranty e All damage which has arisen due to improper treatment e g nonobservance of the user instruction All damage which is due to repairs or tampering by the customer or unauthorized third parities e Damage which has arisen during transport from the manufacturer to the consumer or during transport to the service centre Accessories which are subject to normal wear and tear Liability for direct or indirect consequential losses caused by the unit is excluded even if the damage to the unit is accepted as a warranty claim 22 15 NORMALZED SYMBOLS ed xt gt m gt lt C o123 CB gD E230351 SoundCare Plus Pain Relief Device Manufacturer s name and address Date of manufacture Type BF Applied Part Serial Number of product Batch code Caution Attention see instructions for use Disposal in accordance with Directive 2002 96 EC WEEE Only for treatment head Protected against the effects of temporary immersion water Complies with the European Medical Device Directive 93 42 EEC Notified body is TUV SUD 01 23 The electrical safety meet the CB system requirements Indoor use only Risk of electric shock Complies with the safety requirements of Canada and U S The certification body is UL the cerificate number is E230351 29 CURRENT SOLUTIONS Manufactured for Curre
14. in close proximity to any shortwave diathermy microwave diathermy therapeutic ultrasound diathermy or laser diathermy anywhere on their body Energy from diathermy shortwave microwave ultrasound and laser can be transferred through the implanted neurostimulation 9 SoundCare Plus Pain Relief Device 3 Indications and system can cause tissue damage and can result in severe injury or death Injury damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned off Contraindications 3 1 Indications 3 2 Contraindi cations 1 Application of therapeutic deep heat for the treatment of selected sub chronic and chronic medical conditions such as Relief of pain muscle spasms and joint contractures Relief of pain muscle spasms and joint contractures that may be associated with Adhesive capsulitis Bursitis with slight calcification Myositis Soft tissue injuries Shortened tendons due to past injuries and scar tissues 2 Relief of sub chronic and chronic pain and joint contractures resulting from Capsular tightness Capsular scarring 3 This device should be used in the hospital and home 4 This device should be operated only by the experienced physician 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 a
15. n with switch The apparatus executes a self test checking all important functions and presents itself with the start up settings The start up settings is adjustable at memory location To personalize the start up settings refer to chapter 5 5 Therapy system set up Press the buttons 1 2 3 4 to select a parameter SoundCare Plus Pain Relief Device 6 2 3 Ultrasound intensity 6 2 4 Pause 6 2 5 Emergency stop 6 3 The treatment head 6 4 The contact medium The ultrasound intensity is adjusted with intensity control knob The ultrasound intensity can only be adjusted during the treatment The ultrasound intensity can be displayed in W or W cm Press the buttons 1 2 3 4 can change the displayed W or W cm Press the knob 6 to pause the treatment Press again the knob 6 to restore the treatment Pressing button 5 simultaneously will terminate all active treatments A treatment head is a precision instrument Great care is taken in the development and production in order to obtain the best possible beam characteristics Rough treatment jarring or dropping can adversely affect these characteristics and must therefore be avoided In order to ensure efficient transfer of energy a contact medium is required between the treatment head and the body Air causes virtually total reflection of the ultrasound energy The best medium for the transfer of ultrasound energy is a gel But the ul
16. nitions before operating this equipment The definition of these DEFINITIONS symbols is as follows SoundCare Plus Pain Relief Device Caution Text with a CAUTION indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment Q Warning Text with a WARNING indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage Danger Text with a DANGER indicator will explain possible safety infractions that are imminently hazardous situations that would resultin death or serious injury 2 2 A CAUTION Caution e Read understand and practice the precautionary and operating instructions Know the limitations and hazards associated with using any ultrasound device Observe the precautionary and operational decals placed on the unit Keep yourself informed of the contraindications Never leave the patient unattended during treatment Do not operate the device when connected to any other medical devices Do not operate this unit in an environment where other devices are used that intentionally radiates electromagnetic energy in an unshielded manner Ultrasound should be routinely checked before each use to determine that all controls function normally especially that the intensity control does properly adjust the intensity of the ultrasonic power output in stable manner Also determin
17. nt Solutions LLC 3814 Woodbury Drive Austin TX 78704 Ph 800 871 7858 www currentsolutionsnow com
18. re present in the treatment area This device should not be used when open wounds are present in the treatment area This device should not be used on patients suspected of carrying serious infectious disease and or disease where it is advisable for general medical purposes to suppress heat or fevers This device should not be used over or near bone growth centers until bone growth is complete This device should not be used over the thoracic area if the patient is using a cardiac pacemaker This device should not be used over a healing fracture This device should not be used over or applied to the eye This device should not be used over a pregnant uterus This device should not be used on ischemic tissues in individuals with vascular disease where the 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 tumours SoundCare Plus Pain Relief Device 4 PRESENTATION 4 1 Presentation C BULUTIBNE of the device m POWER 1 Program adjustment button 2 1IMHz and 3MHz adjustment button 3 Duty cycle adjustment button 4 Timer adjustment button 5 Liquid crystal display 6 Stop button 7 Output intensity adjustment knob 8 Treatment head select button 4 2 Liquid D crystal display Output intensity power Ultrasound output indicator Pause indicator Treatment head type
19. s are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment RF emissions The SoundCare Plus device is Harmonic Not suitable for use in all ee applicable establishments other than IEC 61000 3 2 domestic and those directly connected to the public Voltage Not low voltage power supply network that supplies buildings used for domestic purposes fluctuations applicable flicker emissions IEC 61000 3 3 SoundCare Plus Pain Relief Device 13 2 Guidance and manufacturer s declaration electromagnetic Declaration immunity electromagnetic TRE CH The SoundCare Plus device is intended for use in the electromagnetic immunity p environment specified below The customer or the user of the SoundCare Plus should assure that itis used in such an environment Immunity IEC 60601 Compliance Electromagnetic test test level level environment guidance Electrostatic 6 kV 6 kV Floors should be wood discharge contact contact concrete or ceramic tile ESD 8 kV air 8kVair lf floors are covered with IEC 61000 synthetic material the 4 2 relative humidity should be at least 30 96 13 3 Guidance and manufacturer s declaration Electromagnetic Declaration immunity electromagnetic V mag The SoundCare Plus device is intended for use in the electromagnetic immunity p environment specified below The customer or the user of the SoundCare Plus sho
20. se proximity i e less than 2 meters to short wave equipment The apparatus may not be used in so called wet rooms hydrotherapy rooms The user must keep the device out of the reach of children Only use the device for the recommended applications The device should be used medical supervison Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy Before administering any treatment toa 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 Do not use solvents to clean the device A damaged device must no longer be used The device must only be serviced repaired and opened by authorized sales centre Dispose of the device in accordance with local regulations Keep the operating instructions with the device Pregnant and nursing women use the device cautiously The group of immaturity bone uses the device cautiously Continuous and effect treatment time is not over than 30min every day Don t use cell phone during using the device The use of sensitive coupling glue cautiously Always keep the sound head in constant motion T Patients with an implanted neuro stimulation device must not be treated with or be
21. the semi statically method Ask the patient regularly about his her experiences If necessary the treatment can be adjusted By using knob 6 the intensity can be reduced Incase of indications of pour transmission of ultrasound energy it is advised to add the contact gel or reposition the ultrasound head During the treatment if the ultrasonic applicator connected well the applicator LED will light if the ultrasonic applicator doesn t contact well the applicator LED will blink slowly the system will be think this is no load in the applicator When treatment was pause the applicator LED light will be extinguished And the countdown will also be suspended Caution The massage performed with the head should be applied with a regular movement not too slow to avoid inducing heat nor too fast to prevent a bad contact which would reduce the effectiveness of the treatment A Warning If you want to replace treatment head you need to turn the power switch OFF so that the device is in shutdown state in order to the replacement of treatment head Clean the skin of the area treated as well as the treatment head by using a towel or a tissue The treatment head should be cleaned up with a 7096 alcohol solution e Check if there are any signs of improvement e g pain circulation and mobility When entering the next treatment session the patient is instructed to report any possible reaction Turn the apparatus o
22. tment head 1cm or 5cm 5 5 4 Choice Select the duty cycle 10 100 stepping 10 SoundCare Plus Pain Relief Device e Mode Down key Press this button to choice program PROGRAM p g PROGRAM PROGRAM C end LU ug LULICI PROGRAM V 0 PROGRAM ay Quim Freq up key Press this button to choice the Ultrasound Frequency FREQUENCY FREQUENCY MHz D Nw MHz Freq Down key Press this button to choice the Ultrasound Frequency FREQUENCY 1 FREQUENCY Sq D Nw MHz Select the treatment head 1 0cm or 5 0cm by treatment head select button 1cm 1cm 1cm D 5em D QD D OD sem CAUTION The user can select the treatment head 1 0cm or 5 0cm by treatment head select button when the two types of treatment head have been connected with the device The device can default to select the treatment head automatically when only one treatment head is connected with the device e Duty up key Press this button to increase the duty cycle r Vi DUTY CYCLE 1 Vi DUTY CYCLE vU Vi 11 Wh u DUTY CYCLE U Vi DUTY CYCLE g Y Vi e Duty Down key Press this button to decrease the duty cycle DUTY CYCLE g Y Vi DUTY CYCLE Vi DUTY CYCLE V yl y ay 8 ZELUS DUTY CYCLE SoundCare Plus Pain Relief Device DUTYCYCLE DUTY CYCLE A 10 5 9 9 e lime up key Press this button to increase the treatment
23. trasound gel is expected by the user to buy their own Liberally apply transmission gelto the treatment area on the patient e Move the treatment head during therapy session in a circular motion The area treated should be two times the diameter of the treatment head e f the body surface is very irregular making it difficult to obtain good contact between the treatment 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 arising on the treatment head and the body Caution Never apply the gel to the treatment head The treatment head will register this as contact and may emit ultrasound energy which could damage the treatment head Never apply the gel to the treatment head The treatment head will register this as contact and may emit ultrasound energy which could damage the treatment head Always use the gel with the requirements of the medical such as with CE mark or are legally marketed in the US SoundCare Plus Pain Relief Device 7 MAINTENANCE 7 1 Switch off the apparatus and disconnect it from the mains supply Cleaning The apparatus can be cleaned witha damp cloth Use lukewarm water of the and a non abrasive liquid household cleaner no abrasive no alcohol apparatus content solution If a more sterile cleaning is needed use a cloth moistene
24. uld assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic test test level level environment guidance Conducted 3 Vrms Portable and mobile RF RF IEC 150 kHz to communications 61000 4 6 80 MHz equipment should be Radiated RF 3 V m used no closer to any IEC 61000 80 MHz to part of the 4 3 2 5 GHz SoundCare Plus device including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 24P d 1 2 P 80MHz to 800MHz d 2 3 P 80MHz to 2 5MHz SoundCare Plus Pain Relief Device 20 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 survey should be less than the compliance level in each frequency range Interference may occur In the vicinity of equipment marked with the following Ca NOTE I At 80 MHz ends 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios
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