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INSTRUCTION MANUAL

FOR

Combo Electrotherapy Device

Shenzhen Roundwhale Technology Co., Ltd.

This manual is valid for the R-C101C Stimulator

Model: R-C101C

Be sure to read this instruction manual before operate and

keep it where safe.

This user manual is published by Shenzhen Roundwhale

Technology Co., LTD.

Summary of Contents for TENS-EMS R-C101C

Page 1: ...e Shenzhen Roundwhale Technology Co Ltd This manual is valid for the R C101C Stimulator Model R C101C Be sure to read this instruction manual before operate and keep it where safe This user manual is published by Shenzhen Roundwhale Technology Co LTD ...

Page 2: ...mendments will be published in a new edition of this manual All Rights Reserved R C101C Rev V1 0 2020 printed in May 4 2021 Declaration of conformity Shenzhen Roundwhale Technology Co Ltd declares that the device complies with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 1 11 IEC60601 2 10 IEC62304 ISO10993 5 ISO10993 10 ISO10993 1 ISO 14971 ...

Page 3: ...EVICE 11 4 SPECIFICATION 13 5 OPERATING INSTRUCTION 14 6 INSTRUCTIONS FOR USE 20 7 CLEANUNG AND MAINTENANCE 29 8 TROUBLESHOOTING 31 9 STORAGE 32 10 DISPOAL 33 11 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 33 12 NORMALIZED SYMBOLS 38 13 WARRANTY 39 TABLE OF CONTENS ...

Page 4: ...tural pulses the mech anism of electrical stimulation equipment is to create electric impulses that are transcutaneous transmitted to nerves or muscle fibers through electrode The intensity of the four channel can be adjusted independently and can be applied individually to one body part This four channel device can be used with eight pieces of electrodes which allows you to stimulate one muscle g...

Page 5: ... around the world High frequency TENS currents activates the pain in hibiting mechanisms of the nervous system Electrical im pulses from electrodes placed on the skin over or near the pain area stimulate the nerves to block the pain signals to the brain causing the pain go unperceived Low frequen cy TENS currents facilitate the release of endorphins the body s natural painkillers 1 2 3 WHAT IS EMS...

Page 6: ...de 1 Relaxation of muscle spasms 2 Prevention or retardation of disuse atrophy 3 Increasing local blood circulation 4 Muscle re education 5 Immediate post surgical stimulation of calf muscles to prevent venous thrombosis 6 Maintaining or increasing range of motion The device can be used in the home or hospital using the object patient must be 18 years or older of adults 2 2 Important Safety Precau...

Page 7: ...4 Electrode placements must be avoided in the carotid sinus area anterior neck or transcerebrally through the head 5 This device should not be used in overly enervated ar eas 6 Inguinal hernia 7 Do not use on scarred areas following a surgery for at least 10 months after the operation 8 Do not use with serious arterial circulatory problems in the lower limbs 2 2 2 WARNING 1 If you have had medical...

Page 8: ...t apply stimulation while driving operating ma chinery or during any activity when electrical stimula tion can put you at risk of injury 10 Apply stimulation only to normal intact clean healthy skin 11 The long term effects of electrical stimulation are un known Electrical stimulation device cannot replace drugs 12 Stimulation should not take place while the user is connected to high frequency sur...

Page 9: ... during use 2 2 3 Precautions 1 TENS is not effective for pain of central origin including headache 2 TENS is not a substitute for pain medications and other pain management therapies 3 TENS is a symptomatic treatment and as such sup presses the sensation of pain that would otherwise serve as a protective mechanism 4 Effectiveness is highly dependent upon patient selec tion by a practitioner quali...

Page 10: ...instruction of use is listed and should be obeyed any improper use may be dangerous 15 Rare cases of skin irritation may occur at the site of the electrode placement following long term application 16 Do not use this device in the presence of other equip ment which sends electrical pulses to your body 17 Do not use sharp objects such as a pencil or ballpoint tip to operate the buttons on the contr...

Page 11: ...BO Stimulator 1PC 2 Electrode pad 50mm 50mm 8PCS 3 Electrode wires 2PCS 4 USB cable 1PC 5 User manual 1PC 3 2 LCD display No Function description No Function description 1 Treatment body part 6 Intensity of Channel3 2 Low battery indicator 7 Intensity of Channel4 3 Treatment time 8 Standby mode program num ber Set mode Pulse width 4 Intensity of Channel1 9 Pulse rate EMS adjust time 5 Intensity of...

Page 12: ...ress the S button to select the treat ment program 4 button for Channel 2 At standby and treatting mode press the button to adjust the Channel 2 output intensity At the key locking mode press the button to unlock the keys 5 button for Channel 1 At standby and treatting mode press the button to adjust the Channel 1 output intensity At the key locking mode press the button to unlock the keys 6 butto...

Page 13: ...me Combo Electrotherapy Device Model type R C101C Power sources 3 7 V Li ion battery Power supply Input 100 240V AC 50 60Hz 0 2A Output 5V DC 300mA Output Channel Four channel Waveform Bi phase square wave pulse Output current Max 120mA at 500ohm load Output intensity 0 to 40 levels adjustable Treatment mode TENS and EMS mode Program number 50 programs TENS 30 programs EMS 20 programs Pulse rate 2...

Page 14: ... into electrode connec tor Make sure they are properly connected to ensure the good performance Please refer to the picture 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 2 Connect electrode pads to electrode wires Before proceeding to this step ensure that the device is com...

Page 15: ...trode wires into any AC power supply socket 5 3 Electrode 5 3 1 Electrode options The electrodes should be routinely replaced when they start to lose their adhesiveness If you are unsure of your electrode adhesive properties please order new replace ment electrodes Replacing electrodes should be re or dered under the advice of your physician or the device manufacturer to ensure proper quality Foll...

Page 16: ...nel first in order to avoid unwant ed irritation 5 It is recommended that at minimum 1 97 x 1 97 self ad hesive square electrodes are used at the treatment area 6 Never remove the self adhesive electrodes from the skin while the device is still on 5 3 3 Electrode placement R C101C is a kind of OTC stimulator suitable for home use You only have to use according to the user manual place the electrod...

Page 17: ...17 Neck Shoulder Arm Hand Back 1 1 2 2 Abdomen Hip ...

Page 18: ...18 Leg 1 ２ Foot Knee Elbow Ankle ...

Page 19: ...19 Position of electrode placement under EMS programs Neck 1 2 1 2 Shoulder 1 1 2 2 Arm Hand Back Abdomen Hip ...

Page 20: ...he ON OFF M button to turn on the device the LCD will be lit And then it goes into the standby mode as below picture shows 6 2 Select treatment mode Press the ON OFF M button to select which treatment mode TENS EMS you will use The LCD displays as fol lows ...

Page 21: ... ment time The LCD displays as follows 6 5 Start treatment Place the electrodes on the body parts press the button of CH1 to increase the channel 1 intensity press the but ton of CH2 to increase the channel 2 intensity press the button of CH3 to increase the channel 3 intensity press the button of CH4 to increase the channel 4 intensity The LCD displays as follows 6 6 Adjust the output intensity P...

Page 22: ...econds After this you will not be able to increase the intensity of the stimulation until you press the button once you can then increase the intensity again as desired This lock function is included to prevent accidental increases in intensity levels when the device is in use If you feel it too strong you can press button to decrease the intensity to a lowere level each time When the output inten...

Page 23: ...rn off the stimulator and the LCD will be blank 6 8 Load detection It will automatically detect the load if the intensity is above Level 5 If it haven t detected the load or the electrode con tacts the skin not well enough the intensity will automati cally return to Level 0 and the symbol or twinkles And the stimulator returns to the standby mode 6 9 Set program parameter 1 In the program U1 to U1...

Page 24: ... 2 Press the S button to adjust to setting the parameter TENS mode pulse rate pulse width treatment time PROGRAM ADJUSTABLE PARAMETER P R F1 P R F2 P W P1 P W P2 Treatment Time t1 U01 U02 U03 U04 U05 U06 ...

Page 25: ...requency can be adjusted for 2Hz 120Hz the pulse width can be adjusted for 50us 400us and the treatment time can be adjusted for 5min 90min EMS mode pulse rate pulse width treatment time ramp up time continous time ramp down time rest time ...

Page 26: ...rresponding data 4 Press the T button to return to the standby mode 6 10 Low battery detection When the battery is low the icon will twinkle to indi cate it stop the device and charge the battery 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 m...

Page 27: ...t to reposition the electrode during the appli cation turn the device off first 3 The use of electrode may lead to skin irritations If you experience such skin irritations e g redness blistering or itching discontinue using them Do not use the COMBO stimulator permanently on the same body part as this may also lead to skin irritations 4 Electrode pads are private and intended for single person use...

Page 28: ...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 2 Do not use any adhesive electrodes with a size smaller than those the original manufacturer attached Otherwise the current density may be too high and cause injuries 3 The size of the adhesive pads may not be changed e g by clipping off parts o...

Page 29: ...E 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 1Pull the electrodes out of the stimulator remove the batteries and clean the device with a soft slightly damp cloth In case of heavier dirt build up you may also apply a mild detergent 7 1 2 Do not...

Page 30: ...ad If your device has any problem please contact the distributor The manufacturer will 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 wa...

Page 31: ...nsation of stimulation or weak stimulation 1 The electrode does not connect well to the skin 2 If the connection between electrode connects well to the stimulator 3 The battery is used up 4 The skin is too dry 1 Check and re paste it on skin 2 Check the connec tion 3 Charge 4 Wipe the electrode and the skin with a wet cotton cloth Automatic halt in the treatment 1 The electrode loses connection wi...

Page 32: ...ticking place or shorten the treatment time If your skin is over sen sitive you should stop the treatment or go to see a doctor 9 STORAGE 9 1 Storing the Electrode Pads and Lead Wires 1 Turn the device off and remove the lead wires from the unit 2 Remove the electrodes from your body and disconnect the lead wires from the electrodes 3 Place the electrodes into the plastic film and then store into ...

Page 33: ...te electrical and electronic equipment may have potentially harmful effects on the environment Incorrect disposal can cause toxins to build up in the air water and soil and jeopardize human health 11 ELECTROMAGNETIC COMPATIBILITY EMC TABLES Guidance and manufacture s declaration electromagnetic emis sions The device is intended for use in the electromagnetic environment specified below The custome...

Page 34: ...low The customer or the user of the device should assure that it is used in such environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guid ance Electrostatic discharge ESD IEC61000 4 2 8kV direct indirect contact 15kV air discharge 8kV direct indirect contact 15kV air discharge Floorsshouldbe wood concreteor ceramictile Iffloors arecoveredwith syntheticmateri...

Page 35: ... 61000 4 8 10V m 10V m Powerfrequencymag neticfieldsshouldbe atlevelscharacteristic ofatypicallocationin atypicalcommercial orhospitalenviron ment NOTE UT is the a c mains voltage prior to application of the test level Guidance and manufacture s declaration electromagnetic im munity The device is intended for use in the electromagnetic environment specified below The customer or the user of device...

Page 36: ...ing of the transmitter in watts W according to the trans mitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicin ity of equipment marked with the following symbol NOTE 1 At 80 MHz and...

Page 37: ...onal measures may be necessary such as reorienting or relocating the device b Over the frequency range 150 kHz to 80 MHz field strengths should be less than Vi V m Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Table 9 Test fre quency MHz Band a MHz Servicea Modula tion b Maxi mum power W Dis tance m Immu nity Test Level V m 385 380 390 TETRA 400 Pulse modu...

Page 38: ...cies are in cluded b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse mod ulation at 18 Hz may be used because it does not rep resents actual modulation It would be worst case 12 NORMALIZED SYMBOLS Electrical devices are recyclable material and should not be disposed of with household waste after use Help us to protect the enviro...

Page 39: ...ized Representative information name and address CE Marking Certificate issued by DNV GL Presafe AS NB No 2460 13 WARRANTY Please contact your dealer or the device centre in case of a claim under the warranty If you have to return the unit en close a copy of your receipt with clear statement of defect description The warranty terms is below 1 The warranty period for this device is 1 year from date...

Page 40: ...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 Device damage due to privately dissembling devices 4 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 ...

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Page 44: ...ilding 27 Dafa Industrial Park longxi community longgang street longgang district Shenzhen China Tel 86 755 23212776 Fax 86 755 23212776 Email info roovjoy com Shanghai International Holding Corp GmbH Europe Address Eiffestrasse 80 20537 Hamburg Germany ...

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