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Roundwhale R-C1-K01 Instruction Manual

3-in-1 combo electrotherapy device
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INSTRUCTION MANUAL
FOR
3-in-1 Combo Electrotherapy Device
Operation Manual for Model #: R-C1-K01

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Summary of Contents for Roundwhale R-C1-K01

  • Page 1 INSTRUCTION MANUAL 3-in-1 Combo Electrotherapy Device Operation Manual for Model #: R-C1-K01...
  • Page 2 Amendments will be published in a new edition of this manual. All Rights Reserved. R-C1-K01 Rev.V1.0 © 2020, printed in Apr. 10, 2020. Declaration of conformity: Shenzhen Roundwhale Technology Co., Ltd. declares that the device complies with following normative documents:...

  • Page 3: Table Of Contents

    TABLE OF CONTENS 1. FOREWORD 2. SAFETY INFORMATION 3. GETTING TO KNOW YOUR DEVICE 4. SPECIFICATION 5. OPERATING INSTRUCTION 6. INSTRUCTIONS FOR USE 7. CLEANING AND MAINTENANCE 8. TROUBLESHOOTING 9. STORAGE 10. DISPOSAL 11. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES 32 12. NORMALIZED SYMBOLS 13.

  • Page 4: Foreword

    1. FOREWORD 1.1 Introduction The device R-C1-K01 is a dual channel output TENS, EMS and MASSAGE stimulator.Before using, please read all the in- structions in this user manual carefully and keep it safe for future use. The COMBO stimulator belongs to the group of electrical stimulation systems.
  • Page 5 1.2 Medical background 1.2.1 ABOUT PAIN Pain is an important signal in the human body warning sys- tem. It reminds us that something is wrong, without which, abnormal conditions may go undetected, causing damage or injury to vital parts of our bodies. Even though pain is a necessary warning signal of trauma or malfunction in the body, nature may have gone too far in its design.
  • Page 6 1.2.3 WHAT IS EMS ? Electrical Muscle Stimulation is an internationally accepted and proven way of treating muscular injuries. It works by sending electronic pulses to the muscle needing treatment That causes the muscle to exercise passively. It is a product deriving from the square waveform, originally invented by John Faraday in 1831.

  • Page 7: Safety Information

    2. SAFETY INFORMATION 2.1 Intended use TENS mode To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
  • Page 8 3) Stimulation should not be applied over swollen, in - fected, inflamed ares or skin eruption (e.g. phlebitis, thrombophlebitis, varicose veins, etc.). 4) Electrode placements must be avoided in the carotid sinus area (anterior neck) or tran- scerebrally (through the head). 5) This device should not be used in overly enervated areas.
  • Page 9 alarms), which may not operate properly when electri - cal stimulation device is in use. 7) Do not apply stimulation when in bath or shower. 8) Do not apply stimulation while sleeping. 9) Do not apply stimulation while driving, operating ma- chinery, or during any activity when electrical stimula- tion can put you at risk of injury.
  • Page 10 19) Keep the stimulator out of reach of children. 20) Consult your doctor if you are in any doubt whatsoever. 21) Discontinue it and do not increase the intensity level if you feel discomfort during use. 2.2.3 Precautions 1) TENS is not effective for pain of central origin including headache.
  • Page 11 11) Caution if stimulation is intended to be applied over the menstruation or pregnant uterus. 12) For single patient use only. 13) This stimulator should not be used by patients who is noncompliant and emotionally disturbed including whom with dementia or low IQ. 14) The instruction of use is listed and should be obeyed;...

  • Page 12: Getting To Know Your Device

    3. GETTING TO KNOW YOUR DEVICE 3.1 Accessories Description The COMBO Stimulator Electrode pad （50mm×50mm ) 4pcs Electrode wires 2pcs USB cable User manual 3.2 LCD display Function description Model of human body Treatment mode Program NO. Treatment time Intensity for Channel B Intensity for Channel A...
  • Page 13 3.3 Device illustration Description Device display [M] button: Select treatment mode / Pause and resume the treatment [+]/[-] button: Button to increase or decrease the intensity level of CH1 [T] button: Button to increase the treatment time [S] button: Select treatment body part [+]/[-] button: Button to increase or decrease the intensity level of CH2 [P] button: Select treatment program...

  • Page 14: Specification

    4. SPECIFICATION 4.1Technical information Device name Combo Electrotherapy Device Model/type R-C1-K01 Power sources 3.7 V Li-ion battery Input: 100-240V AC, 50/60Hz,0.2A; Output: 5V Power supply DC, 300mA Output Channel Dual channel Waveform Bi-phase square-wave pulse Output current 0-60mA (at 1000ohm load)

  • Page 15: Operating Instruction

    5. OPERATING INSTRUCTION 5.1 Charging the Battery: Proceed as follows to recharge the battery: • This device cannot be used while charging. • Make sure that the device is no longer connected to the patient (the output cables and electrodes must be dis- connected).
  • Page 16 Caution Always use the electrode pads which comply with the re- quirements of the IEC/EN60601-1, ISO10993-1/-5/-10 and IEC/ EN60601-1-2, as well as CE and FDA 510(K) regulation. 5.3 Connect electrodes wires to device Before proceeding to this step, be sure the device is com- pletely switched OFF.
  • Page 17 5.4.3 Electrode placement R-C1-K01 is a kind of OTC stimulator, suitable for home use. You only have to use according to the user manual, place the electrode on the position where you feel pain.
  • Page 18 Different programs with corresponding applicable symptoms toms as below: Position of electrode placement under TENS programs Neck Shoulder Hand Back...
  • Page 19 ２ Foot Joint (Knee) Joint (Elbow) Joint (Ankle) Joint (Wrist) Position of electrode placement under EMS programs Neck...
  • Page 20 Shoulder Hand Back Abdomen Foot...

  • Page 21: Instructions For Use

    6. INSTRUCTIONS FOR USE 6.1 Turn on Press the [ON/OFF] button to turn on the device, the LCD will be lit. And then it goes into the the standby mode as the picture shown below. 6.2 Select treatment mode Press the [ON/OFF ] button to select which treatment mode (TENS ‒EMS ‒...
  • Page 22 6.4 Quick Select Feature The Select has a [S] buttons that allow you to quickly cho- ose the most commonly used programs for a particular body part. Choices include Neck, Shoulder, Back, Arm, and Leg. The LCD display as following: 6.5 Adjust the treatment time Base on your need, Press [T] button to increase the treatme- nt time.
  • Page 23 6.7 Adjust the output intensity Place the electrodes stick the application of body parts, press the [+] button to increase output intensity. The out put intensity is increasing a level in each press [+] button, it has 60 levels output intensity. Please adjust the intensity in your fell comfortable condition.
  • Page 24 Caution: If you feel or become uncomfortable, reduce the stimu - lation intensity to a more comfortable level and consult with your medical practitioner if problems insist. 6.8 Pause / Resure the treatment At the treating mode, press the [M] button to pause the treatment, and the LCD will be display the “pause ”...
  • Page 25 6.10 Load detection When the device haven’t detect the load or the electrode with skin connect not good, it will automatically detect the load if the intensity is added over to 9 levels, if it is judged to no-load, the intensity will automatically return to zero and the “...
  • Page 26 6.13 Set program parameter 1). In the Quick Select program（Neck, Shoulder, Back, Arm,Leg）, press and hold [S] button to adjust pulse rate ->pulse width -> treatment time by setting the parameter. The LCD displays as follows: ADJUSTABLE PARAMETER PROGRAM P.R.(F1) P.R.(F2) P.W.(P1) P.W.(P2) Treatment Time(t1)
  • Page 27 6.14 Usage of electrode pads 1. The electrode may only be connected with the COMBO stimulator. Make sure that the device is turned off when attaching or removing the electrode pads. 2. If you want to reposition the electrode during the appli- cation, turn the device off...
  • Page 28 6.15 Where do I attach electrode pads? 1. Each person reacts differently to electric nerve stimula- tion. Therefore, the placement of the electrodes may deviate from the standard. If application is not success- ful, contact your physician to find out which placement techniques are best for you.

  • Page 29: Cleaning And Maintenance

    7. CLEANING AND MAINTENANCE Fully comply with the following necessary daily mainte- nance requirements to make sure the device is intact and guarantee its long-term performance and safety. 7.1 Cleaning and care for the device 7.1.1 Pull the electrodes out of the stimulator, clean the de- vice with a soft, slightly damp cloth.

  • Page 30: Troubleshooting

    not be responsible for the results of maintenance or repairs by unauthorized persons. 7.2.2 The user must not attempt any repairs to the device or any of its accessories. Please contact the retailer for repair. 7.2.3 Opening of the equipment by unauthorized agencies is not allowed and will terminate any claim to warranty.

  • Page 31: Storage

    1. The electrode loses 1. Check and place the Automatic connection with the electrode properly halt in the skin. on the skin. treatment 2. If the battery is used 2. Charge 1. Do the treatment once a day and shorten the treat- ment time.

  • Page 32: Disposal

    9.2 Storing the Unit 1. Place the unit, electrodes, lead wires and manual back into the gift box. Store the box in a cool, dry place, -10℃ ~ 55℃ ; 10% ~ 90% relative humidity. 2. Do not keep in places that can be easily reached by children 10.
  • Page 33 RF emissions Class B The device is suitable for use in all CISPR11 establishments including those directly connected to the public Harmonic Not applica- low-voltage power supply network emissions that supplies to buildings power lEC 61000-3-2 used for domestic purposes Not applica- ations/ Flicker...
  • Page 34 Voltage dips, <5% U not applica- not applicable short inter- (>95% dip in (For INTERNAL- ruptions and LY POWERED ME voltage varia- for 0.5 cycle EQUIPMENT tions on power supply input 40% U lines (60% dip in IEC 61000-4-11 for 5 cycles 70% U (30% dip in for 25 cycles...
  • Page 35 Radiat- 10V/m & 10V/m & Portable and mobile RF communi- ed RF table 9 table 9 cations equipment should be used not closer to any part of the device including cables, 61000- than the recommended separation distance calculated from the equa- tion applicable to the frequency of the transmitter.

  • Page 36: Normalized Symbols

    radio (cellular/cordless) telephones and land mobile radios, ama- teur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electro- tromagnetic site survey should be considered. If the measured the applicable RF compliance level above, the device should be observed to verify normal operation.

  • Page 37: Warranty

    15º, on either side of the vertical. Month Manufacturer information: The manufacturer Shenzhen Roundwhale Technology Co., LTD. Manufacture date 13. WARRANTY Please contact your dealer or the device centre in case of a claim under the warranty.
  • Page 38 • All damages due to repairs or tampering by the cus- tomer or unauthorized third parities. • Damage which has arisen during transport from the manufacturer to the consumer or the service centre. • Accessories which are subject to normal wear and tear. •...
  • Page 40 Shenzhen Roundwhale Technology Co., Ltd. Add: 202, 2/F, Building 27,Dafa Industrial Park，longxi community, longgang street, longgang district, Shenzhen, China. Email: info@roovjoy.com...

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