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Current Solutions SoundCare Plus, Инструкция по эксплуатации

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TENSPros

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.”

3. 
Indications and 
Contraindications

3.1 
Indications

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

.

 3.2
Contraindi-
cations

• 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.
• 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

6

Содержание SoundCare Plus

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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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