Neotek DT8003TP Instructions Manual Download Page 1

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CAUTION: Federal Law restricts this device to sale by or on the

order of a physician or licensed practitioner

Neo Tek

Combo

Digital TENS/EMS Combo Stimulator

DT8003TP

INSTRUCTION MANUAL

Summary of Contents for DT8003TP

Page 1: ...P S CAUTION FederalLawrestrictsthisdevicetosalebyoronthe orderofaphysicianorlicensedpractitioner Neo TekTM Combo Digital TENS EMS Combo Stimulator DT8003TP INSTRUCTION MANUAL ...

Page 2: ...will however be published in a new edition of this manual All Rights Reserved DT8003TP Rev V1 0 2014 01 03 United States Federal Law restricts this device to sale by or on the order of a physician or licensed practitioner Declaration of conformity TENS PROS declares that the DT8003TP complies with following normative documents IEC60601 1 IEC60601 1 2 IEC60601 2 10 IEC62366 ISO10993 5 ISO10993 10 I...

Page 3: ...RESENTATION 3 SPECIFICATION 4 INSTRUCTION FOR USE 5 PROGRAM LIST AND WAVEFORM 6 CLEANING AND CARE 7 TROUBLESHOOTING 8 DISPOSAL 9 GLOSSARY OF SYMBOLS 10 IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY EMC 4 14 16 17 22 25 27 29 29 30 ...

Page 4: ...ccording to the needs of each individual patient 1 2 Indications for use The Neo TekTM Combo Stimulator TENS and EMS may be used for the following conditions For TENS mode 1 Symptomatic relief of chronic intractable pain 2 Post traumatic pain 3 Post surgical pain For EMS mode 1 Relaxation of muscle spasms 2 Increase of local blood flow circulation 3 Prevention or retardation of disuse atrophy 4 Mu...

Page 5: ...y recommended by doctors physiotherapists and pharmacists throughout the world Transcutaneous Electrical Nerve Stimulation TENS is a noninvasive drug free method of controlling pain TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception TENS does not cure any physiological problem it only helps control the pain TENS does not work for everyone however in m...

Page 6: ...cles to prevent atrophy in affected muscles and improving muscle tone and blood circulation How EMS works The EMS unit sends comfortable impulses through the skin that stimulate the nerves in the treatment area When the muscle receives this signal it contracts as if the brain has sent the signal itself As the signal strength increases the muscle flexes as in physical exercise Then when the pulse c...

Page 7: ...lt in minor or moderate injury to the user or patient or damage to the device or other property CAUTION DANGER This stimulator must not be used in combination with the following medical devices Internally transplanted electronic medical devices such as a pacemaker Electronic life support equipment such as respirators Electronic medical devices attached to the body such as electrocardiographs Using...

Page 8: ...perly when the electrical stimulation device is in use Do not use on open wounds or rashes or over swollen red infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins or on top of or in proximity to cancerous lesions Do not use over areas of skin that lack normal sensation Do not use on the opposite sides of your head since the effects of stimulation of the brain...

Page 9: ...ur physician in order to confirm that it is advisable for you to use this TENS Stimulator WARNINGS REGARDING THE ELECTRODE PADS Apply pads to normal healthy dry clean skin of adult patients because it may otherwise disrupt the healing process If you experience any skin irritation or redness after a session do not continue stimulation in that area of the skin NEVER APPLY THE PADS TO The head or any...

Page 10: ...electrode pads put the electrode pads only on the skin or on the plastic film provided Place the electrode pads at least 1 inch apart on your skin The electrode pads should never touch each other Always place clean electrode pads on your body according to the user manual or on the advice of your physical therapist Make sure the components are connected well and the electrode pads are fixed on the ...

Page 11: ...battery life Do not pull on the electrode cord during treatment Do not use the device while wearing electronic devices such as watches as this may damage the device Do not use near a cell phone as this may cause the stimulator to malfunction Do not bend or pull the end of the cord When pulling out the cord from the device hold the plug and pull Replace the cord when broken or damaged Do not throw ...

Page 12: ...isease you should follow precautions recommended by your physician If you have suspected or diagnosed epilepsy you should follow precautions recommended by your physician Use caution if you have a tendency to bleed internally such as following an injury or fracture Consult with your physician prior to using the device after a recent surgical procedure because stimulation may disrupt the healing pr...

Page 13: ... and sore You may experience skin irritation and burns beneath the stimulation electrodes applied to your skin You may experience headache and other painful sensations during or following the application of electrical stimulation near your eyes and to your head and face You should stop using the device and consult with your physician if you experience adverse reactions from the device ...

Page 14: ...g status of channel 2 3 LCD Display Shows the operating state of the device 4 P Button 1 Allows user to select a therapeutic program 2 Restores the original time setting 5 CH1 Button 1 Increases the output intensity of channel 1 2 Use to select treatment time in the setting mode 6 CH1 Button 1 Decreases the output intensity of channel 1 ...

Page 15: ... the output intensity of channel 2 2 Use to select treatment time in the setting mode 9 CH2 Button 1 Decreases the output intensity of channel 2 2 Use to select treatment time in the setting mode 10 Output socket for channel 1 electric signal output after connection of the cable with the adhesive electrodes to channel 1 11 Output socket for channel 2 electric signal output after connection of the ...

Page 16: ... x W x H Treatment time 15min 30min 60min and continuous Operating conditions 5 C to 40 C 41 to 104 with a relative humidity of 30 80 atmospheric pressure from 700 to 1060 hPa 10 C to 55 C 14 to 131 with a relative humidity of 10 90 atmospheric pressure from 700 to 1060 hPa The amplitude level will be reset to 0mA when the amplitude level is 12mA or greater and an open circuit at either channel is...

Page 17: ...tment cover and press to close 6 If replacing the battery slide the battery compartment cover to open Pull up the battery following the direction of the arrow indicated on the photo Insert the battery according to the above step 2 5 CAUTION 1 Swallowingabatterymaybefatal Therefore keepthebatteryandtheproductoutofthereachof children Ifabatteryisswallowed consultmedicalassistanceimmediately 2 Ifabat...

Page 18: ...res Insert the lead wire connector into the electrode connector standard 0 08 inch female connection Make sure no bare metal of the pins are exposed after connecting Connection Cables Transparent Film 4 3 Connect lead wires to device P S ...

Page 19: ...owersupplysocket 4 4 Electrode Placement Remove the clear transparent film from the back of the electrode pad Place electrode pads on clean dry and healthy skin near or surrounding the area with pain at least 1 apart Do not let them touch Make sure there is a linear path between the two electrode pads WARNING Make sure the device is turned off or the intensities are set to 0 before placing the ele...

Page 20: ...e Press the set button S button to enter time setting mode The lowercase min will flash on the screen You may select treatment time through the intensity buttons CH1 CH1 CH2 CH2 To save your selection in this program press the S button again to save NOTE To restore original settings press the P button while in the setting mode 4 8 Adjust intensity and start treatment Press CH1 or CH2 to increase t...

Page 21: ...ration in the panel for 30 seconds the lock indicator will display on the LCD This is a safety feature to prevent accidental changes to your settings and to prevent accidental increasing of the output intensity level Press either the CH1 or CH2 button to unlock 4 10 Low battery indicator When the low power indicator flashes on the LCD replace the batteries in the device with new batteries as soon ...

Page 22: ... Treatment time min Remark S Synchronous stimulation of both channels occurs synchronously A Alternate the stimulation of the CH2 will occur after the 1st working of CH1 is completed D Delay the stimulation of the CH2 will occur after the 1st working of CH1 is started Delay time 01 02 03 04 05 06 07 08 09 10 Neck Shoulder Back Waist Buttock Knee Ankle Foot Elbow Hand 75 55 65 55 75 75 75 75 65 50 ...

Page 23: ...ecreased from 120Hz 100us to 2Hz 200us and then increased back to 125Hz 100us 03 04 M 30 M 30 80 Back 330 200 The frequency is fixed at 80Hz The pulse width is changed between 330us and 200us The cycle time is 1s Waist 80 75 10 70 65 250 The pulse width is fixed at 250us The frequency changes from 80Hz 75Hz 10Hz 70Hz and 65Hz 05 06 Buttock 100 330 200 M 30 30 The frequency is fixed at 100Hz The pu...

Page 24: ...100 N Both channels are operated at the same fixed frequency and pulse width 10 M 30 200 Hand 80 The stimulation of one channel will occur 10s later than the other In this program the ON time is equal to OFF time ON time 2s Ramp up 6s Contraction 2s Ramp down Remark N Normal parameters of the waveform is fixed M Modula one of the parameters of the waveform is varied M1 Modula1 more than one parame...

Page 25: ...e chemicals like thinner benzene Do not allow water to get into the internal area Note This device and accessories including the electrodes do not require sterilization 6 2 Cleaning the electrode pads 1 Turn the power off and remove the lead wires from the electrode pads 2 Wash the electrode pads when the adhesive surface becomes dirty and or the electrode pads are difficult to attach Wash the ele...

Page 26: ... under the electrodes 8 Always use electrodes that have been cleared for marketing in the United States by the FDA 6 3 Storing the electrode pads and lead wires 1 Turn the device off and remove the lead wires from the unit 2 Remove the electrode pad from your body and pull out the lead wires from the electrode pads 3 Place the electrode pads onto the plastic film and then store in a sealed package...

Page 27: ...o close Damaged or worn electrodes or lead wires Decrease intensity Reposition the electrodes Replace If your device does not seem to be operating correctly refer to the chart below to determine what may be wrong Should none of these measures correct the problem the device should be serviced by a certified dealer Electrode active area size is too small May not be operate the device according to th...

Page 28: ...placed firmly an securely on the skin The electrodes are dirty Clean the electrode pads with a damp lint free cloth or replace with new electrode pads The surface of the electrode was scratched Replace with new electrode Re position the electrodes If at any time you feel pain or discomfort stop using immediately The electrode pads come off accidentally The power of the batteries has been exhausted...

Page 29: ...gal obligation in your local area 9 Glossary of symbols Type BF Applied Part Please refer to instruction manual because of the higher levels of output Electrical devices are recyclable material and should not be disposed of with household waste after their useful life Help us to protect the environment and save resources and take this device to the appropriate collection points Please contact the ...

Page 30: ...es the levels of immunity to electromagnetic interferences as well as maximum levels of electromagnetic emissions for medical devices Medical devices manufactured for TENS PROS conforms to this IEC60601 1 2 2007 standard for both immunity and emissions Nevertheless special precautions need to be observed The use of accessories and cables other than those specified by TENS PROS as replacement parts...

Page 31: ...lEC 61000 3 3 Group 1 Class B Not Applicable Battery Operated Device Not Applicable Battery Operated Device Guidanceandmanufacturer sdeclaration electromagneticimmunity Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Elect...

Page 32: ...oTekTM Comboelectricalstimulatorsareintendedforuseintheelectromagneticenvironmentspecifiedbelow ThecustomersortheusersoftheseElectricalstimulators shouldassurethatitisusedinsuchenvironment Immunity test IEC 60501 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables than t...

Page 33: ... the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from 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 t...

Page 34: ...mitter in watts W accordable to the transmitter manufacturer NOTE I At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people ThedeviceisintendedforuseinanelectromagneticenvironmentinwhichradiatedRFdisturbancesare...

Page 35: ...e which has arisen during transport from the manufacturer to the consumer or during transport to the service center Accessories which are subject to normal wear and tear 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 Note 1 Shelf life is most influenced by several factors exposure to light and he...

Page 36: ...Manufactured for TENS PROS 3814 Woodbury Drive Austin TX 78704 U S A TEL 1 888 724 1121 E mail manager tenspros com ...

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