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Clinical Health Services TENS 3N1R, Instructions For Use Manual

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Clinical Health Services TENS 3N1R Instructions For Use Manual Download Page 35

35

NOTE   U

T

 is the a.c. mains voltage prior to application of the test 

level.
Guidance and manufacture’s declaration – electromagnetic immu-

nity
The device is intended for use in the electromagnetic environment 

specified below. The customer or the user of device should assure 

that it is used in such an environment.

Immunity 

test

IEC 60601 

test level

Compli-

ance level

Electromagnetic environment - 

guidance

User manual for R-C3 V1.0 zkg.indd   35

User manual for R-C3 V1.0 zkg.indd   35

2020/7/28   11:12:04

2020/7/28   11:12:04

Summary of Contents for TENS 3N1R

Page 1: ...e TENS 3N1R Stimulator Please read all the instructions completely before use and save this manual for future reference Therapist s Choice is a registered trademark of Clinical Health Services Inc User manual for R C3 V1 0 zkg indd 1 User manual for R C3 V1 0 zkg indd 1 2020 7 28 11 11 53 2020 7 28 11 11 53 ...

Page 2: ...ual All Rights Reserved TENS 3N1R Rev V1 0 2020 printed in Aug 20 2020 Declaration of conformity Clinical Health Services Inc declares that the device com plies with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 1 11 IEC60601 2 10 IEC62304 ISO10993 5 ISO10993 10 ISO10993 1 ISO 14971 User manual for R C3 V1 0 zkg indd 2 User manual for R C3 V1 0 zkg indd 2 2020 7 28 11 11 53 2020 7...

Page 3: ...INSTRUCTIONS FOR USE 21 7 CLEANING AND MAINTENANCE 28 8 TROUBLESHOOTING 30 9 STORAGE 32 10 DISPOSAL 32 11 ELECTROMAGNETIC COMPATIBILITY EMC TABLES 33 12 NORMALIZED SYMBOLS 39 13 WARRANTY 40 TABLE OF CONTENS User manual for R C3 V1 0 zkg indd 3 User manual for R C3 V1 0 zkg indd 3 2020 7 28 11 11 53 2020 7 28 11 11 53 ...

Page 4: ...cy and pulse width Based on simulating the body s natural 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 dual channel can be adjusted independently and can be applied individually to one body part This dual channel device can be used with four pieces of el...

Page 5: ...S TENS TENS Transcutaneous Electrical Nerve Stimulation is ef fective in relief of pain It is daily used and clinically proven by physiotherapists caregivers and top athletes 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 th...

Page 6: ...scle vibra tion to loosen tight muscles 2 SAFETY INFORMATION 2 1 Intended use TENS mode It is used for temporary relief of pain associated with sore and aching muscles in the neck shoulder back upper extremities arm and lower extremities leg due to strain from exercise or normal household work activities EMS mode This mode is designed to be used for stimulate healthy muscles in order to improve an...

Page 7: ... present in the treatment area 3 Stimulation should not be applied over swollen in fected inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc 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 foll...

Page 8: ...perly 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 10 Apply stimulation only to normal intact clean healthy skin 11 The long term effects of electrical stimulation...

Page 9: ... in contact with each other 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 2 TENS is not a substitute for pain medications and other pain management therapies 3 ...

Page 10: ...ed 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 any improper use may be dangerous 15 Rare cases of skin irritation may occur at the site of the electrode placement fol...

Page 11: ...le reduce the stimulation Intensity to a comfortable level and contact your physician if problems continue 3 GETTING TO KNOW YOUR DEVICE 3 1 Accessories No Description QTY 1 The COMBO Stimulator 1pcs 2 Electrode pad 50mm 50mm 4pcs 3 Electrode wires 2pcs 4 USB cable 1pcs 5 User manual 1pcs 3 2 LCD display No Function description No Function description 1 Treatment mode 8 Key locking symbol User man...

Page 12: ... 14 Timer sign 3 3 Device illustration No Description 1 LCD display 2 ON OFF M button At power saving mode press the ON OFF M button to turn on the device At standby mode press the ON OFF M button to select treatment mode At standby mode press and hold the ON OFF M button to turn off the device At treating mode press the ON OFF M button to stop the treat ment User manual for R C3 V1 0 zkg indd 12 ...

Page 13: ...on to unlock the keys At setting mode press the button to decrease the corresponding data for the treatment time 6 button At standby or treating mode press the button to increase the intensity of CH2 At setting mode press the button to increase the corresponding data for the treatment time 7 Charger indicator When the device is charging the indicator light will be yellow When charging is completed...

Page 14: ... 15 93 atmospheric pressure from 700 hPa to 1060 hPa Operating condition 10ºC to 55ºC with a relative humidity of 10 95 atmospheric pressure from 700 hPa to 1060 hPa Dimension 142 50 21 4mm L x W x T Weight About 85g Automatic shutoff 1 minutes Classification BF type applied part internal power equip ment IP22 Size of electrodes pad 50x50mm square Output precision 20 error is allowed for all the o...

Page 15: ...ector 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 wires to device Before proceeding to this step be sure the device is com pletel...

Page 16: ...outinely replaced when they start to lose their adhesiveness If you are unsure of your electrode adhesive properties please order new replacement elec trodes Replacing electrodes should be re ordered under the advice of your physician or the device manufacturer to en sure proper quality Follow application procedures outlined on electrode packing when using the new replacement elec trodes to mainta...

Page 17: ...ommended that at minimum 1 97 x 1 97 self adhesive square electrodes are used at the treat ment area 6 Never remove the self adhesive electrodes from the skin while the device is still on 5 3 3 Electrode placement TENS 3N1R 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 Conducting exercise ...

Page 18: ...18 Shoulder Arm Hand Back 1 1 2 2 Abdomen Hip Leg 1 ２ User manual for R C3 V1 0 zkg indd 18 User manual for R C3 V1 0 zkg indd 18 2020 7 28 11 11 58 2020 7 28 11 11 58 ...

Page 19: ... elbow Joint ankle Joint wrist Position of electrode placement under EMS programs Neck 1 2 1 2 Shoulder 1 1 2 2 User manual for R C3 V1 0 zkg indd 19 User manual for R C3 V1 0 zkg indd 19 2020 7 28 11 11 58 2020 7 28 11 11 58 ...

Page 20: ...20 Arm Hand Back Abdomen Hip Leg Foot User manual for R C3 V1 0 zkg indd 20 User manual for R C3 V1 0 zkg indd 20 2020 7 28 11 11 59 2020 7 28 11 11 59 ...

Page 21: ... 2 Select treatment mode Press the ON OFF M button to select which treatment mode TENS EMS MASS you will use The LCD displays as follows 6 3 Select treatment program Based on your need press P button to select the treat ment program The LCD displays as follows User manual for R C3 V1 0 zkg indd 21 User manual for R C3 V1 0 zkg indd 21 2020 7 28 11 11 59 2020 7 28 11 11 59 ...

Page 22: ...ress ON OFF M button to return to the standby mode 6 5 Start treatment Press the button of CH1 to increase the channel 1 inten sity press the button of CH2 to increase the channel 2 intensity The LCD disaplays as follows User manual for R C3 V1 0 zkg indd 22 User manual for R C3 V1 0 zkg indd 22 2020 7 28 11 11 59 2020 7 28 11 11 59 ...

Page 23: ...e shown on the LCD If you feel it too strong you can press button to decrease the intensity to a lower level each time When the output intensity of both channels decrease to zero the stimulator will return to the standby mode The LCD displays as fol lows Caution If you feel or become uncomfortable reduce the stim ulation intensity to a more comfortable level and con sult with your medical practiti...

Page 24: ...ntensity is above level 4 If it hasn 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 twinkles And the stimulator returns to the standby mode 6 9 Low battery detection When the battery is low the icon will twinkle to indicate it stop the device and charge the battery User manual for R C3 V1 0 zkg indd 24 User...

Page 25: ... recharging rundown cycles it undergoes and how these cycles are performed The following suggestions will help prolong the life of the bat tery Whenever the device is not used frequently charge the bat tery once a month For longer battery life discharge the battery as much as pos sible 6 10 Safety lock feature The lock function automatically activates after there is no operation in the panel for 2...

Page 26: ...Please avoid using them by different persons 5 The electrode must connect entirely to the skin surface to prevent hot spots which may lead to skin burns 6 Do not use the electrode pads for more than approx 10 times as connection between the electrodes and the skin deteriorates over time 7 The adhesive force of the electrodes depends on the skin properties storage condition and the number of appl i...

Page 27: ...dard If application is not successful con tact 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 of them 4 Make sure that the region r...

Page 28: ... the picture on Section 5 4 3 2 1 2 treatment per day about one week as a period of treatment 3 We advise you use the device for one session per time If you feel discomfort during treatment you can either pause the session or decrease the intensity of the out put 7 CLEANING AND MAINTENANCE Fully comply with the following necessary daily mainte nance requirements to make sure the device is intact a...

Page 29: ...happen use the device again only when it is completely dry 7 1 8 Do not clean the device during treatment Be sure that the device is turned off before cleaning 7 2 Maintenance 7 2 1 The manufacturer didn t authorize any maintenance agencies abroad If your device has any problem please contact the distributor The manufacturer will not be responsible for the results of maintenance or repairs by unau...

Page 30: ...tailer 8 TROUBLESHOOTING Should any malfunction occur while using the device check whether the parameters are set appropriately for therapy and adjust the control correctly Please see the fol lowing table Malfunction Common reasons Countermeasure No display The battery is exhaust ed Instant charge to the unit device User manual for R C3 V1 0 zkg indd 30 User manual for R C3 V1 0 zkg indd 30 2020 7...

Page 31: ...kin 2 Instant charge to the unit device Rash or tickle on the skin occurs in treatment 1 The treatment time lasts too long 2 The electrode does not stick well to the skin 3 The interface of the electrodes is dirty or dry 4 The skin is sensitive to the electrode 1 Do the treatment once a day and shorten the treat ment time 2 Check and stick the electrode well 3 Wipe the electrode with a wet cotton ...

Page 32: ...ren 10 DISPOSAL Spent batteries do not belong to the household wastes Dispose of the battery according to the current regulations As a consumer you have the obligation to dispose of batteries correctly Consult your municipal authority or your dealer for information about disposal At the end of the product lifecycle do not throw this prod uct into the normal household garbage but bring it to a coll...

Page 33: ...pply network that supplies to buildings power used for domestic purposes Harmonic emis sions lEC61000 3 2 Not appli cable Voltage fluctua tions Ficker emissions lEC61000 3 3 Not appli cable 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 the device should assure that it is...

Page 34: ...y input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec not applica ble not applicable For INTERNAL LY POWERED ME EQUIPMENT Power frequency 50Hz 60Hz magnetic field IEC 61000 4 8 10V m 10V m Powerfrequencymag neticfieldsshouldbe atlevelscharacteristic ofatypicallocationin atypicalcommercial orhospital...

Page 35: ...tended for use in the electromagnetic environment specified below The customer or the user of device should assure that it is used in such an environment Immunity test IEC 60601 test level Compli ance level Electromagnetic environment guidance User manual for R C3 V1 0 zkg indd 35 User manual for R C3 V1 0 zkg indd 35 2020 7 28 11 12 04 2020 7 28 11 12 04 ...

Page 36: ...o the transmitter 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 com pliance level in each frequency range b Interference may occur in the vi cinity of equipment marked with the following symbol NOTE 1 At80MHzand800MHz thehigherfrequencyrangeapplies NOTE 2 The...

Page 37: ...d additional measures may be necessary such as reorienting or relocating the Blood Pressure Monitor 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 ...

Page 38: ...VEL the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a Forsomeservices onlytheuplinkfrequenciesareincluded 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 act...

Page 39: ...estion Applied part of type BF Refer to instruction manual IP22 The first number 2 Protect against solid for eign objects of 12 5 mm Ф and greater The second number Protect against vertically falling water drops when enclosure titled up to 15º Vertically falling drops shall have no harm ful effects when the enclosure is titled at any angle up to 15º on either side of the vertical Manufacturer info...

Page 40: ...cement parts 3 The following cases are excluded under the warranty All damages that arise due to improper operation e g nonobservance of the user instruction 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 41: ...41 User manual for R C3 V1 0 zkg indd 41 User manual for R C3 V1 0 zkg indd 41 2020 7 28 11 12 05 2020 7 28 11 12 05 ...

Page 42: ...42 User manual for R C3 V1 0 zkg indd 42 User manual for R C3 V1 0 zkg indd 42 2020 7 28 11 12 05 2020 7 28 11 12 05 ...

Page 43: ...43 Manufactured for Clinical Health Services Inc Tampa FL 33684 User manual for R C3 V1 0 zkg indd 43 User manual for R C3 V1 0 zkg indd 43 2020 7 28 11 12 05 2020 7 28 11 12 05 ...

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