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Summary of Contents for Current Solutions SoundCare Plus
- Page 1 INSTRUCTION MANUAL SoundCare™ Plus Pain Relief Device Operating instructions Medical device for pain treatment based on ultrasound www.currentsolutionsnow.com...
- Page 2 SoundCare™ Plus Pain Relief Device Contents 1. FOREWORD…………………………………………………..…...3 2. SAFETY PRECAUTIONS…………………………………………...3 3. INDICATIONS AND CONTRAINDICATIONS…………………...6 4. PRESENTATION…………………………………………………..7 5. SET UP……………………………………………………………... 9 6. OPERATION……………………………………………………...12 7. MAINTENANCE……………..…………………………………...14 8. DIAGNOSTICS………………………………….………………..15 9. SPECIFICATIONS AND TECHNICAL DATA…………..……….. 16 10.STORAGE ………………………………………………………...17 11.AND DISPOSAL……………………...…………………………..18 12.STANDARDS AND REQUIREMENTS………….………………...18 13.GUIDANCE AND MAUFACTUER’S DECLARATION…….…..18 14.WARRANTY…………………………………………………….…...
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Page 3: Foreword
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 however be published in a new edition of this manual . - Page 4 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. Warning: Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage.
- Page 5 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. Warning WARNING Care must be taken when operating this equipment around other equipment.
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Page 6: Indications And Contraindications
SoundCare™ Plus Pain Relief Device 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.” Indications and Contraindications 1) Application of therapeutic deep heat for the treatment of Indications selected sub-chronic and chronic medical conditions such as:... -
Page 7: Presentation
SoundCare™ Plus Pain Relief Device PRESENTATION Presentation of the device PROGRAM FREQUENCY POWER DUTY CYCLE TIMER 1) Program adjustment button 1MHz and 3MHz adjustment button Duty cycle adjustment button Timer adjustment button Liquid crystal display button 6) Stop Output intensity adjustment knob 8) Treatment head select button Liquid crystal... - Page 8 SoundCare™ Plus Pain Relief Device Treatment head 1) Sound head The component of the Applicator which makes contact with the patient during the Ultrasound therapy treatment of the time. Applicator LED The component of the Applicator which indicates if the Sound head is working or Nonworking on the treatment area.
- Page 9 SoundCare™ Plus Pain Relief Device PAUSE ULTRASOUND OUTPUT POWER ULTRASOUND OUTPUT INTENSITY TREATMENT TIME ON/OFF Switch With this button the SoundCare™ Plus is turned on or off. Function Pause Knob Pause/Restore treatment working Intensity Knob Rotating the intensity control Knob to start treatment ...
- Page 10 SoundCare™ Plus Pain Relief Device 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.
- Page 11 SoundCare™ Plus Pain Relief Device Mode Down key: Press this button to choice program PROGRAM PROGRAM PROGRAM PROGRAM PROGRAM 5.5.2 Freq up key: Press this button to choice the Ultrasound Frequency Choice/ FREQUENCY FREQUENCY Select the Ultrasound Frequency: 1MHz or Freq Down key: Press this button to choice the Ultrasound Frequency 3MHz FREQUENCY...
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Page 12: Operation
SoundCare™ Plus Pain Relief Device DUTY CYCLE DUTY CYCLE 5.5.5 Time up key: Press this button to increase the treatment time Setting TIMER TIMER TIMER treatment time:1 min-30min, stepping TIMER TIMER 1 min Time up key: Press this button to decrease the treatment time TIMER TIMER TIMER... - Page 13 SoundCare™ Plus Pain Relief Device The treatment-head has to be moved constantly in a slow tempo, also 6.1.2 in case of the semi-statically method. During Ask the patient regularly about his/her experiences. If necessary, the treatment can be adjusted. By using knob [6], the intensity can be treatment reduced.
- Page 14 SoundCare™ Plus Pain Relief Device 6.2.3 The ultrasound intensity is adjusted with intensity control knob. The Ultrasound ultrasound intensity can only be adjusted during the treatment. The intensity 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 ) 6.2.4 Press the knob [6] to pause the treatment.
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Page 15: Maintenance
SoundCare™ Plus Pain Relief Device MAINTENANCE Switch off the apparatus and disconnect it from the mains supply. Cleaning The apparatus can be cleaned with a damp cloth. Use lukewarm water of the and a non-abrasive liquid household cleaner (no abrasive, no alcohol apparatus content solution). -
Page 16: Specifications And Technical Data
SoundCare™ Plus Pain Relief Device Figure 1 Check the connected plug of ultrasound applicator. The contact control fails PROGRAM to operate FREQUENCY Figure 2 DUTY CYCLE TIMER SPECIFICATIONS AND TECHNICAL DATA Technical date of Treatment head Electrical Acoustic Frequency: date 1MHz±10%,3MHz±10% Output Power: Pluse repetition rate:... -
Page 17: Storage
SoundCare™ Plus Pain Relief Device Technical data of power supply Supply voltage: 100V-240V Frequency: 47Hz-63Hz Power: Output voltage: 13-16V Output current: 1.35A 143mm(L)x73mm(W)x40mm(H) Dimensions: Environmental conditions for use ℃ Environment temperature: 10-40 Relative humidity: 30%-85% Atmospheric pressure: 800-1060hPa Environmental conditions for storage ℃... -
Page 18: Standards And Requirements
DISPOSAL 96/EC WEEE (Waste Electrical and Electronic Equipment). If you have any queries, please refer to the local authorities responsible for waste disposal. Current Solutions™, LLC declares that the device STANDARDS complies with following normative documents: IEC/EN60601-1, IEC/EN60601-1-2, IEC/EN60601-2-5, REQUIREMENTS IEC/EN61689, IEC60601-1-4,IEC62304,ISO10993-5, ISO10993-10, ISO10993-1,ISO14971. - Page 19 SoundCare™ Plus Pain Relief Device 13.2 Guidance and manufacturer's declaration-electromagnetic Declaration - immunity electromagnetic The SoundCare™ Plus device is intended for use in the electromagnetic immunity environment specified below. The customer or the user of the SoundCare™ Plus should assure that it is used in such an environment. Immunity Electromagnetic Compliance...
- Page 20 SoundCare™ Plus Pain Relief Device 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...
- Page 21 SoundCare™ Plus Pain Relief Device 13.4 RF communications equipment and the SoundCare™ Plus device Recommended Recommended separation distances between portable and mobile separation distances RF communications equipment and the SoundCare™ Plus device between The SoundCare™ Plus device is intended for use in an electromagnetic portable and mobile environment in which radiated RF disturbances are controlled.
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Page 22: Warranty
SoundCare™ Plus Pain Relief Device 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. -
Page 23: Normalzed Symbols
SoundCare™ Plus Pain Relief Device NORMALZED SYMBOLS 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) IPX7 Only for treatment head: Protected against the effects of temporary immersion water Complies with the European Medical Device 0123... - Page 24 Manufactured for: Current Solutions LLC 3814 Woodbury Drive Austin,TX 78704 Ph:(800)871-7858 www.currentsolutionsnow.com...
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