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Current Solutions SoundCare Plus, Instruction Manual

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Current Solutions SoundCare Plus Instruction Manual Download Page 18

TENSPros

11. 
DISPOSAL

Please dispose of the device in accordance with the directive 2002/
96/EC    WEEE  (Waste  Electrical  and  Electronic  Equipment).  If  you 
have any queries, please refer to the local authorities responsible for
waste disposal.

12. 
STANDARDS 
AND 
REQUIREMENTS

Current Solutions™, LLC declares that the device  
complies with following normative documents:
IEC/EN60601-1, IEC/EN60601-1-2, IEC/EN60601-2-5, 
IEC/EN61689, IEC60601-1-4,IEC62304,ISO10993-5,
ISO10993-10, ISO10993-1,ISO14971.

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

RF emissions 
CISPR 11

Group 2

The SoundCare™ Plus device uses RF 
energy only for its internal function. 
Therefore, its RF emissions are very 
low and are not likely to cause any 
interference in nearby electronic 
equipment.

RF emissions 
CISPR11

Class B

Harmonic 
emissions 
lEC 61000-3-2

Not 
applicable

Voltage 
fluctuations / 
flicker emissions 

lEC 61000-3-3

Not 
applicable

The SoundCare™ Plus device is 
suitable for use in all 
establishments other than 
domestic and those directly 
connected to the public 
low-voltage power supply 
network that supplies buildings 
used for domestic purposes. 

18 

SoundCare™ Plus Pain Relief Device

Summary of Contents for SoundCare Plus

Page 1: ...T E N S P r o s SoundCare Plus Pain Relief Device Operating instructions Medical device for pain treatment based on ultrasound www currentsolutionsnow com INSTRUCTION MANUAL ...

Page 2: ...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 22 15 NORMALZED SYMBOLS 23 SoundCare Plus Pain Relief Device ...

Page 3: ...t head The ultrasound treatment heads for the SoundCare Plus are so called multi frequency heads This treatment head can now supply both 1 and 3MHz 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 tre...

Page 4: ...agnetic 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 determine that the treatment time control does actually terminate ultrasonic power output when the timer reaches zero Do not use sh...

Page 5: ...traindications warnings and precautions Consult other resources for additional information regarding the application of Ultrasound Only use the device for the recommended applications The device should be used medical supervison 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 ...

Page 6: ...hould 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 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 dis...

Page 7: ...stment knob 8 Treatment head select button 4 2 Liquid crystal display 1 Program indicator 2 Frequency indicator 3 Duty cycle indicator 4 Timer indicator 5 Output intensity power 6 Ultrasound output indicator 7 Pause indicator 8 Treatment head type 7 SoundCare Plus Pain Relief Device 5 PROGRAM FREQUENCY DUTY CYCLE TIMER POWER SET MHz w cm2 7 6 1 2 3 4 8 1cm2 5cm2 PROGRAM FREQUENCY DUTY CYCLE TIMER ...

Page 8: ...the treatment area 3 Applicator The assembly that connects to the System and incorporates the Sound Head 4 4 Symbol definitions Below are the definitions for all of the symbols used in the Ultrasound therapy device Study and learn these symbols before any operation of the system STOP TREATMENT START PAUSE BUTTON ULTRASOUND INTENSITY ULTRASOUND APPLICATOR STATE POLARITY OF POWER SUPPLY THE CONNECTI...

Page 9: ...rol Knob to the prescribed level Clockwise Increase Intensity Counterclockwise Decreases 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 Reception of equipment and accessories Remove the Therapy System and all accessories from shipping cartons Visually in...

Page 10: ... with main unit by the manufacturer Please do not use other type of applicator Caution For your health if you change the AC DC adaptor it must conform to the requirement of the standard medical electrical equipment 5 3 Connect the treatment head Connect the supplied mains adapter to the connector Connect the mains adapter to a wall socket 5 4 Switching on and self test Switch on the device using t...

Page 11: ... by treatment head select button SoundCare Plus Pain Relief Device 5 5 4 Choice Select the duty cycle 10 100 stepping 10 Duty up key Press this button to increase the duty cycle DUTY CYCLE DUTY CYCLE DUTY CYCLE DUTY CYCLE DUTY CYCLE Duty Down key Press this button to decrease the duty cycle DUTY CYCLE DUTY CYCLE DUTY CYCLE 1cm2 5cm2 1cm2 5cm2 1cm2 5cm2 2 2 CAUTION The user can select the treatment...

Page 12: ...ly supported and exposed and perfectly relaxed Inform the patient on the purpose of the treatment and the sensation he 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 It is advisable to shave areas of excessive h...

Page 13: ...st 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 6 2 2 Adjusting parameters Press the buttons 1 2 3 4 to select a parameter 13 SoundCare Plus Pain Relief Device 6 1 2 During the treatment The treatment head has to be moved constant...

Page 14: ...tal reflection of the ultrasound energy The best medium for the transfer of ultrasound energy is a gel But the ultrasound gel is expected by the user to buy their own Liberally apply transmission gel to the treatment area on the patient Move the treatment head during therapy session in a circular motion The area treated should be two times the diameter of the treatment head If the body surface is ...

Page 15: ... adapter is connected to the 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 8 2 Error 15 SoundCare Plus Pain Relief Device 7 MAINTENANCE 7 1...

Page 16: ...al date of Treatment head Acoustic Frequency Output Power Pluse repetition rate Duty factor Timer Effective radiating area AER Actual intensity RBN Max Beam type Material of applicator Waterproof Grade 1MHz 10 3MHz 10 100Hz 10 10 100 Stepping 10 Max 30 minutes 2 5 0cm 20 2 3 0W cm 20 1 0MHz 2 3 0W cm 20 3MHz 5 0 Collimated Aluminium IPX7 Only for treatment head 16 SoundCare Plus Pain Relief Device...

Page 17: ...U 05 U 06 U 07 U 08 U 09 U 10 Frequency 1MHz 1MHz 1MHz 1MHz 3MHz 1MHz 1MHz 1MHz 1MHz 3MHz Duty Cycle 80 50 50 50 80 30 80 80 50 80 Treatment Time 10 minutes 10 minutes 20 minutes 15 minutes 15 minutes 15 minutes 15 minutes 8 minutes 12 minute 10 minutes Suggest Intensity 2 1 0W cm 2 1 0W cm 2 1 5W cm 2 1 0W cm 2 1 5W cm 2 2 0W cm 2 1 0W cm 2 1 5W cm 2 1 0W cm 2 1 5W cm 2 1 5W cm 2 1 5W cm 2 1 0W c...

Page 18: ...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 RF emissions CISPR 11 Group 2 The SoundCare Plus device uses RF energy only for its internal function Therefore its RF emissions are very low and are not like...

Page 19: ...omagnetic immunity Guidance and manufacturer s declaration Electromagnetic immunity The SoundCare Plus device is intended for use in the electromagnetic environment specified below The customer or the user of the SoundCare Plus should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF lEC 61000 4 6 Rad...

Page 20: ...m structures objects and people a 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...

Page 21: ...nications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m ...

Page 22: ...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 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 Defects in material or workmanship will b...

Page 23: ...ctrical safety meet the CB system requirements Manufacturer s name and address 15 NORMALZED SYMBOLS Batch code LOT SN 0123 Complies with the European Medical Device Directive 93 42 EEC Notified body is TUV SUD 0123 23 SoundCare Plus Pain Relief Device Disposal in accordance with Directive 2002 96 EC WEEE Date of manufacture IPX7 Only for treatment head Protected against the effects of temporary im...

Page 24: ...T E N S P r o s Manufactured for TM Current Solutions LLC 3814 Woodbury Drive Austin TX 78704 Ph 800 871 7858 www currentsolutionsnow com ...

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