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NMES Intelect - 3B Scientific

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1. Intelect NMES INSTRUCTION MANUAL Intelect NMES Please read the instruction manual before use Caution Federal law USA restricts this device to sell by or on the order of a physician Contents Chapter Page l GENERAL INFORMATION 1 1 What is a Neuromuscular Stimulator 0 0 2 0 0 0 ccc ccc hn l 1 2 How does a Neuromuscular Stimulator work 1 2 0 0 0 ccc eee eh l E3 Ther INStPuimefit uu cerea E eons ee oe nee 0 Oe Sea EEEE CERE MERE NRAUU EER AR ONE RE KEE NaN l SAFETY 2 Cautialt oos oa tea ke AAR E EE RR E CLA Ora E E E EEE EE OTRE E RE EU COE 2 22 Indicatigns s aiaa otez Z Y ae e a Z d aca ge dee WU da eh deb UR A e Y A OA E GOAN Ao aba abe 2 2 3 WANNE 5 os e E led a area LAN DERE ere ERU T RI o b R E EAA 2 2A Precaution 244 oo 5 44 posh we oS a RT E S QR REN DORE ret A EEE E ed ANENE 3 2 5 Adverse Reactions ss ohh ee eg ee A d ek ERRARE eae Mik BE E VEM Ku egy 4 TECHNICAL SPECIFICATIONS sese en 5 CONTROLS AND INDICATORS sss hee 6 8 PREPARATION FOR USE Sell Check Battery i reete io tem iste tnn pe RR was qe SR eg Rue eim EORR Ree I Sele bin nue a a erg 9 5 2 Connect electrodes to lead wires 10 5 3 Connect lead wires to Unit our c4nke xen ee eve C See Y a TERY Y Aaa GR RO AR ERE Redi I 5 4 Place electrodes on SEIN lt 4 se svcd eee Gans en EN RAE E ANE ee Ae A WA ER CX QC Yards K 12 5 5 Adjust Outputs sess du ve e DEA nt Siete wee t va ted e era E Red aaah i diag ahs 12 5
2. However a damp cloth may be used for cleaning the outside only 4 DO NOT pull or kink the cables 5 DO NOT clean the cables with alcohol or any other solvents 6 DO NOT allow electrode gel to get into the connector holes of the electrodes DO NOT allow the electrodes to touch each other during stimulation or improper stimulation and poor battery life will result 7 DO NOT give the device to other individuals 8 DO NOT store the unit at temperatures less than 32 F 0 C or over 158 50 C 20 7 HANDLING AND STORAGE Keep this device in the carrying case and store at room temperature 8 ACCESSORIES Self Adhesive Electrodes 4 PCS 9 V Battery PC Lead Wires 2 PCS Instruction Manual PC 21 9 TROUBLESHOOTING If your unit 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 unit should be serviced The LCD indicator lights up but unit does not function properly Low Battery indicator flash None of LCD indicators light up Check all control settings Are they set to values prescribed by your medical professional Are electrodes in proper position Check lead wires Be sure all connectors are firmly sealed Replace cord set with another to check for broken wires Replace battery with a new one 22 Replace battery with a new one 10 WARRANTY U
3. 32 158 F 0 70 C Storage amp Transportation Humidity Range 20 90 RH All values have 10 tolerance The pulses of CHANNEL and CHANNEL 2 are Alternative When Channel is activated Channel 2 will be inactivated and vice versa In this mode ON TIME value should be set for more than ramp up value plus ramp down value OFF TIME value should be set for more than ON TIME value For example if you set on ramp value for 2 seconds ON TIME should be set for more than 4 seconds 2 2 and OFF TIME should be set for more than 4 seconds i e ON TIME 2 Ramp up Ramp down OFF TIME 2 ON TIME 4 CONTROLS AND INDICATORS Top View Channel 1 On Off and Amplitude Control Front View Knob Cover Channel 1 Output Receptacle Amplitude Knob Mode Battery Indicator Channel Output Pulse Rate Pulse Width Timer Increase Button Decrease Button Set Button Mode Button E s Cover Knob Cover Channel 2 On Off and Amplitude Control Channel 2 Output Receptacle d Knob Cover Clip Battery Cover Knob Cover An acrylic knob cover protects amplitude controls from accidental user touch when the unit is being used After adjusting the output remember to have the cover closed Lid Cover A panel covers the controls for Mode Set INCREASE and DECREASE adjustments Your medical professional may ask to set these controls for you and request that you leave the cover in place Ampl
4. 5 Select theqnode ues opere e N KEE E EAEE EW E l d A RUN RAPER Re Ree 13 0 dH DW 10 Chapter Page 5 7 Adjust the Ramp Time 5 erre o serbe erg tene etd sut TTT 13 5 8 Adjust Contraction ON Time III 13 5 9 Adjust Relaxation OFF Time eee d STNK KAER ct epe eaten e HEU b e at e RU EA 14 5 10 Adjust the Pulse Rate ospe sic crater news hk Rm NR ae mem mph rar E EEE R 0 A 14 5 l L Adjust the Pulse Width x 24 aa eren otote RTK a e E AAE A AAE OEE N aT EURO adita ese 14 Dal 2 Adjust Timer a sido eere eiue Ee bete dd NEATA T TTT 14 5 13 Adjust Channel Amplitude siss 60787 R 4 ZT N E a O E NE L A A A E HAA SK ETEN 15 5 4 Turri Unit Of ur ended etel e e Res etel ee te ER qe patei i ete NRI ee ate 15 5 15 Paient Compliance Timer cx xX aa 0 NR rete Y NE N g III 16 BIR Portability ios oak Y Yu Re hea Rete A A ARTA Vat A e ed le es 18 5 17 Low Battery Indicator 2 erroe EE E A AE TTT 18 5 I8 Battery wes cc ete ren oi BAe eoe eden de DU e P NTA aai H EaR gig EAO rede 18 5 19 Care of Blectrodes asoci ori RT Z REE E EE RAE Cost ace OE Eon 19 5 20 Care of Electrode cords c x K raa d Ke NR sig ie here EE Se an EEEE KR hme e eem EEEE EEE DEA 19 DO S AND DON TS Aen E E EEE NEE N Geen E ONE E EEEE oes 20 HANDLING AND STORAGE K 21 ACCESSORIES o tex SU S CET RINT entr Re de de e OS ete 8 21 TROUBLESHOOTING hs See Tepic ew RN NR acd ETE ERE 22 WARRANTY C eer quU e REL E ERR aM HERI RIVER d pd ledio ate S ibi aad
5. Hz in Hz increment and 20 120 Hz in 5 Hz increment Press SET button to enter the Pulse Rate setting mode then press INCREASE or DECREASE button to adjust Pulse Rate to the setting recommended by your prescrinbing medical professional 5 11 Adjust the Pulse Width The pulse width is adjustable 50 300us in Oys increment Press SET button to enter the Pulse Width setting mode then press INCREASE or DECREASE button to adjust Pulse Width to the setting recommended by your prescribing medical professional 5 12 Adjust Timer The timer is adjustable 5 90 minutes in 5 minute increments Continuous option is just the next step to 90 minutes i e from 5 90 minutes to continuous and then to 5 minutes is a cycle During 5 minute final 2 count down the clock symbol will flash once every one second 14 5 13 Adjust Channel Amplitude Turn Channel or 2 clockwise The output indication will be showed on the left side Channel 1 and right side Channel 2 of the LCD screen as long as the unit is in operation Slowly turn the Channel Amplitude control until you reach the setting recommended by your medical professional Repeat for the other channel if both channels are to be used Caution If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact your physician if problems persist 5 14 Turn Unit Off Turn both Channel Amplitude controls to OFF Then
6. MODE button to set the stimulation mode recommended by your physician or therapist For details about stimulation modes please refer to Sec 3 Technical Specifications Caution Consult physicians for your suitable stimulation mode 5 7 Adjust the Ramp Time except the Constant Mode From second to 8 seconds the stimulator special circuitry is designed so the electrical impulses gradually build to a peak and then level off This Ramped pulse produces a gradual muscle contraction emulating natural muscle movement It can also prevent spastic patients from reacting adversely Press SET button to enter the Ramp setting mode then press INCREASE or DECREASE button to adjust Ramp Time to the setting recommended by your medical professional 5 8 Adjust Contraction ON Time except the Constant Mode From 2 seconds to 99 seconds press SET button to enter the ON Time setting mode then press INCREASE or DECREASE button to adjust On Time to the setting recommended by your prescribing medical professional 5 9 Adjust Relaxation OFF Time except the Constant Mode From 2 seconds to 99 seconds press SET button to enter the OFF Time setting mode then press INCREASE or DECREASE button to adjust OFF Time to the setting recommended by your medical professional In order to prevent the spasticity the Relaxation Time cannot be adjusted less than the Contraction Time 5 10 Adjust the Pulse Rate The pulses rate are adjustable 2 120Hz 2Hz 20
7. Mala 23 I GENERAL INFORMATION 1 1 What is a Neuromuscular Stimulator Neuromuscular Stimulation is achieved by sending small electrical impulses through the skin to the underlying motor units nerves and muscles to create an involuntary muscle contraction Neuromuscular stimulation has many uses beyond its traditional application to prevent disuse atrophy including An increased range of motion As a substitute for passive stretching exercise performed by the patient or therapist Muscle re education for example teaching a patient how to set his or her quads 1 2 How does a Neuromuscular Stimulator work Because the transdermal stimulation of nerves and muscles may be accomplished by electrical pulses this modality can help prevent disuse atrophy Accordingly incapacitated patients can receive therapeutic treatment to create involuntary muscle contractions thereby improving and maintaining muscle tone without actual physical activity 1 3 The Instrument The Neuromuscular Stimulator is an easy to use system A marvel of miniaturized electronics the lightweight power unit transmits electrical pulses through the skin surface and stimulates motor units nerve and muscles The electrical impulses are ramped so they closely emulate natural muscle contractions 2 SAFETY 2 1 Caution Federal law USA restricts this device to sale by or on the order of practitioners licensed by the State in which they practice to use or
8. attery Make sure you insert the battery correctly 18 5 19 Care of Electrodes To avoid skin irritation and ensure good contact with your skin clean silicone rubber electrodes with soap and water frequently The electrodes must be dried completely before using The If you are using self adhesive electrodes disregard this procedure Always use the electrodes with the requirements of the EN60601 1 and EN60601 2 such as with CE mark or are legally marketed in the US under 510 K procedure 5 20 Care of Electrode cords Clean the electrode cords by wiping them with a damp cloth Coating them lightly with talcum powder will reduce tangles and prolong the life 19 wf 7i ri ey 6 DO S AND DON TS A DO 1 DO place the electrodes only as your clinician recommends 2 DO keep the stimulator clean 3 DO see your clinician if you have any problems or questions regarding your system 4 DO clean the cables only with water and mild soaps DO NOT use rubbing alcohol or any other solvents 5 DO remove the electrodes and discontinue stimulation if you experience skin irritation until the source of that irritation is determined by your clinician 6 DO turn both intensity knobs to OFF before replacing the battery B DON T 1 DO NOT damage your stimulator by bumping dropping or rough use 2 DO NOT engage in contact sports when using your stimulator 3 DO NOT get the stimulator wet
9. itude Controls It controls the INTENSITY level of stimulating pulses These controls located at the top of the unit regulate the amplitude or intensity of the stimulation and are the ON OFF CONTROL The ON indicator signal will stay lit as long as the unit is working and mimics the output of the electrical pulse Caution If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation intensity to a comfortable level and contact your physician if problems persist INCREASE control button triangle button This button increases the pulse width from 50 300us increases the pulse rate from 2 to 120Hz and increases the timer from 5 to 90 min to continuous mode DECREASE control button inverted triangle button This button decreases the pulse width from 300 50us decreases the pulse rate from 120 to 2Hz and decreases the timer from continuous mode to 90 to 5 min MODE button round button on the right side of the control panel This button selects a Stimulation Mode It displays the mode status from three types of function modes which are Synchronous Constant and Alternate SET button round button on the middle of the control panel This button set the ramp on time off time rate width and timer Press the SET button to enter a parameter setting mode including ramp on time off time rate width and timer LCD screen This LCD displays stimulating mode ramp on time off time pulse rate pul
10. nit One year 12 months from the date of the original consumer purchase Accessories consisting of lead wire AC adapter electrodes carrying case and belt clip 90 days from the date of original consumer purchase To obtain service from Chattanooga Group or the selling dealer under this warranty a written claim must be made within the warranty period to Chattanooga Group or the selling dealer Chattanooga Group shall not be held liable in any event for incidental or consequential damages Some states do not allow exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you 23 GROUP CHATTANOOGA A DIVISION OF encore MEDICAL 4717 Adams Road Hixson TN 37343 U S A 1 800 592 7329 usa 1 800 361 6661 CANADA 41 423 870 7200 outside Us A 0413 1 423 870 2046 outside U S A FAX www chattgroup com 77394A 2003 Encore Medical
11. nt compliance timer can only record up to 999 minutes for each treatment Therefore if you keep using the stimulator for over 999 minutes it will only record 999 minutes and the record time will flash to mean the treatment time is over 999 minutes 16 Cumulative treatment time When initiating the patient compliance timer press Mode to shift the record of individual treatment time with the number of times to the record of cumulative treatment time When showing the record of cumulative treatment time there will be an M mark flashing on the upper right corner of middle right screen Press and hold Mode amp Set buttons simultaneously for 3 seconds to delete all the records including individual treatment time records and cumulative treatment time records The patient compliance timer will keep the records even when the battery has no charge Only when users press and hold Set or Mode amp Set the records will be deleted 17 CARE AND MAINTENANCE 5 16 Portability Your unit is portable and may be clipped to a belt shirt pocket bra or other clothing 5 17 Low Battery indicator When the low power indicator flashes the battery should be replaced with a new one as soon as possible However c the stimulator will continue to operate for several more hours 5 18 Battery To replace battery remove battery cover and extract battery Replace with 9 V alkaline or similar rechargeable b
12. order the use of the device 2 2 Indications This NMES is intended to be used in Relaxation of muscle spasm 2 Prevention or retardation of disuse atrophy 3 Increase 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 2 3 Warnings The long term effects of chronic electrical stimulation are unknown Stimulation should not be applied over the carotid sinus nerves particularly in patients with a known sensitivity to the carotid sinus reflex Stimulation should not be applied over the neck or mouth Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difficulty in breathing Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmias Stimulation should not be applied over swollen infected or inflamed areas or skin eruptions e g phlebitis thrombophlebitis varicose veins etc Stimulation should not be applied over or in proximity to cancerous lesions Keep electrodes separate during treatment Electrodes in contact with each other could result in improper stimulation or skin burns 2 4 Precautions Safety of powered muscle stimulators for use during pregnancy has not been established Caution
13. se width and display timer The channel output will be indicated on the left side Channel and right side Channel 2 of the LCD screen The modes will be displayed on the top of the LCD panel The ramp on time off time pulse rate and pulse width will be shown on the middle right of the screen The timer and clock symbol display on the middle left of the screen the clock symbol will flash in final 5 min Battery compartment 9 Voltage battery pc 5 INSTRUCTIONS FOR FOR USE NOTE Always read this instruction manual before use PREPARATION FOR USE 5 1 Check Battery Insert a fresh 9V alkaline or rechargeable battery into the battery compartment Make sure you are installing the battery properly The battery is inserted in the casing on the back of the stimulator unit BE SURE TO MATCH THE POSITIVE AND NEGATIVE ENDS OF THE BATTERY TO THE MARKINGS IN THE BATTERY COMPARTMENT OF UNIT To remove the battery cover press and pull down following the direction of the arrow indicated on the battery cover CONNECTING THE STIMULATOR 5 2 Connect electrodes to lead wires Insert the lead wire connector into electrodes connector standard 0 08 inch female connection MAKE SURE THAT NO BARE METAL OF THE PINS IS EXPOSED Caution Always use the electrodes with the requirements of the EN60601 1 and EN60601 2 such as with CE mark or are legally marketed in US under 510 K procedure 10 5 3 Connec
14. should be used for patients with suspected or diagnosed heart problems Caution should be used for patients with suspected or diagnosed epilepsy Caution should be used in the presence of the following a When there is a tendency to hemorrhage following acute trauma or fracture b Following recent surgical procedures when muscle contraction may disrupt the healing process c Over the menstruating or pregnant uterus d Over areas of the skin which lack normal sensation Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium The irritation can usually be reduced by using an alternate conductive medium or alternate electrode placement Electrode placement and stimulation settings should be based on the guidance of the prescribing practitioner Stimulators should be kept out of the reach of children Stimulators should be used only with the leads and electrodes recommended for use by the manufacturer Machinery Operation Patient should never operate potentially dangerous machinery such as power saws automobiles etc during stimulation 2 5 Adverse Reactions Possible skin irritation or electrode burn under the electrodes may occur Possible allergic skin reaction to tape or gel may occur If the stimulation levels are uncomfortable or become uncomfortable reduce the stimulation amplitude to a comfortable level and contact your phy
15. sician if problems persist 3 TECHNICAL SPECIFICATIONS Channel Dual channels isolated between channels Pulse Amplitudel 0 80mA 0 40 Volts adjustable at 500 ohm load Pulse Frequency Hz 2 120 Pulse Width us 50 300 Contraction On Time sec 2 99 adjustable Interpretations Relaxation Off Time sec 2 99 adjustable Waveform Asymmetric biphasic square pulse Timer Control mins 5 90 mins or continuous Stimulation Modes S C A Power Supply 9V DC square shape battery Size D x W x H 0 9 x 2 3 x 40 24 mm x 59 mm x 101 mm Weight including battery 4 4 oz 124 g The pulses of CHANNEL and CHANNEL 2 are synchronous While Channel is activated Channel 2 will be activated simultaneously The pulses active and inactive duration is controlled by ON TIME and OFF TIME In this mode ON TIME value should be set for more than ramp up value plus ramp down value For example if you set on ramp value for 2 seconds ON TIME should be set for more than 4 seconds 2 2 i e ON TIME gt Ramp up Ramp down Safety standard EN EN60601 1 EN EN60601 1 2 EC 60601 2 10 Operation Ambient Temperature Range 50 95 F 10 35 C Operation Ambient Humidity Range 20 90 RH Both CHANNEL and CHANNEL 2 are continuous pulses under an adjustable pulse rate and pulse width The functions of ON TIME OFF TIME and RAMP cannot be set Storage amp Transportation Temperature Range
16. t lead wires to unit Before proceeding to this step be sure the unit is completely turned OFF Holding the insulated portion of the lead wire connector insert the angled L plug into the receptacle on the top of the main unit Ensure the leads are inserted correctly The unit has two output receptacles controlled by Channel and Channel 2 Amplitude Control knobs at the top of the unit You may choose to use one channel with one pair of lead wires or both channels with two pairs of lead wires Using both channels give the user the advantage of stimulating two different areas at the same time Vs Sel tadhesive SSS Electrodes Pads Angle L shape EP Se 11 5 4 Place electrodes on skin Apply electrodes to the exact site indicated by your prescribing practitioner following the instruction included with the electrodes labeling Before applying electrodes be sure the skin surface over which electrodes are placed is thoroughly cleaned and dried Make sure the electrodes are placed firmly to the skin and make good contact between the skin and the electrodes Place the electrodes over the skin attach them properly firmly and evenly ADJUSTING THE CONTROLS 5 5 Adjust Output Turn Amplitude Control knob for Channel or 2 clockwise You will hear a beep sound Before you increase the Amplitude you must select the mode Ramp ON Time OFF Time Rate and Width 12 5 6 Select the mode Press
17. unplug the electrode lead wires grasping them by the plug not the cord If treatment will be resumed shortly the electrodes may be left on the skin When the electrodes are removed clean the skin thoroughly with mild soap and water If there is skin irritation consult your medical professional Caution When therapy time is completed and if the user doesn t turn off the amplitude knob the unit will continue the beeping sound every 0 seconds until the amplitude knob is turned off completely 15 5 15 Patient Compliance Timer The patient compliance timer can memorize 60 sets of operation records the total record time is 999 hours After the unit is turned off you can start to use patient compliance timer First press and hold Mode button and turn on either amplitude knob simultaneously to initiate patient compliance timer Individual treatment time Press INCREASE button triangle button or DECREASE button inverted triangle button to see next record of treatment time with the number of times or previous record of treatment time with the number of times Press and hold Set button for 3 seconds to delete the showing record After the record is deleted the unit wil make a beeping sound NOTE 1 If the treatment time is under one minute it will not be recorded For example If your treatment time is 10 minutes and 30 seconds the patient compliance timer will record 10 minutes not minutes 2 The patie

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