Ultim 11 Mnufctured for: Pin Mngement Technologies Instruction Guide
PADS The pds tht re supplied with your Ultim 11 T.E.N.S. Unit re self-dhesive nd cn be used severl times. Skin must be llowed to brethe, so the pds should be removed periodiclly. When not in use, the pds should be plced onto the cler plstic shield. The condition of the pds does ffect the conductivity nd, therefore, the performnce of the unit. When the pds initilly lose their dhesive qulity, it is possible to rectivte their dhesiveness by pplying fine spry of wter. Once the pds hve finlly lost their dhesive qulity, newpds should be purchsed. WARNINGS Do not use ny pd which size is less thn 40mmX 40mm. Allergic rections to the self-dhesive pds cn occur, even though they re hypollergenic: Do not pply to broken skin. Do not pply pds to skin tht do not hve norml senstion. If the skin is numb, stimultion will not be felt nd too gret n intensity might then be used ccidentlly. 25
to 73Vin steps of 3.5Vroughly. E. Pek pulse output current The pek pulse output current of two chnnels cn be djusted individully in 20 steps. For 500-ohm lod, the output voltge cn be chnge from12ma to150mainstepsof 7mAroughly. RED& BLACK FASTENERS ON LEADS At the end of the leds supplied with your unit, you will find red nd blck dpters. These re Cthode nd Anode respectively. The following generl points re mde for your informtion: 1. More senstion tends to come from the blck dpter (Cthode). 2. Where pplicble plce the blck dpter closer to the spinl column; e. g. if the rm is to be treted, plce the blck dptor higher up the rmthn the red dptor. GENERAL INFORMATION Sttement: This T.E.N.S. Unit hs been tested for EMC requirement ccording to EN 60601-1-2 24 UserMnul forultim11t.e.n.s.unit PRESCRIBING INFORMATION FOREWORD Red this User Mnul crefully before you strt using your Ultim 11 T.E.N.S. unit. The mnufcturer strongly recommends crefully reding of the Wrnings nd Cutions nd Chpters of this User Mnul. WARNINGS AND CAUTIONS Prescription lbeling: Federl lw restricts this device to sle or use by or on the order of prctitioner so licensed by the stte. Contrindictions: 1. Do not plce the pds on the crotid sinuses locted t the two sides of the neck, (where doctor feels for pulse), or over the eyes. 2. Do not use this T.E.N.S. unit if you hve hert pcemker or serious hert rhythm problem. 3. Any electrode plcement tht cuses current to flowtrnscerbrlly(through the hed). 1
4. Theuseof T.E.N.S. wheneverpinsyndromes reundignosed, until etiologyisestblished. (3). Mono-Phsic rectngulr wveform AmpAlitude WARNINGS 1. Do not use this T.E.N.S. unit during the pregnncy or t nytime on the bdomen during pregnncy. 2. This T.E.N.S. unit is not effective for pin of centrl origin. (Include hedche). 3. T.E.N.S. unit should be used only under the continued supervision of physicin. 4. T.E.N.S. unit hs no curtive vlue. 5. T.E.N.S. is symptomtic tretment nd s such suppresses the senstion of pin, which would otherwise serve s protective mechnism. 6. The user must keep the device out of the rech of children. 7. Electronic monitoring equipment my not operte properly when T.E.N.S. stimultion isinuse. 8. Do not use T.E.N.S. unit if you re driving or operting mchinery. 9. If you hve epilepsy, consult your doctor 2 B. Pulse durtion Except Mode B, Mode D nd Mode E, which pulse durtion cn not be djusted, by pressing PW+or PW- key, thepulsewidthcnbedjusted from50μsto250μsinstepsof 10μS. C. Pulse frequency Except Mode B nd Mode E with fixed pulse rte, by pressing PR+ or PR- key, the pulse rte cn be djusted to one of the following vlues (Hz): 1,2,3,4,5,10,12,14,16,18,20,25, 30,35,40,45,50,60,70,80,90, 100,110,120,130,140,150. D. Output voltge rnge 23 Time The output voltge of two chnnels cn be djusted individully in 20 steps. For 500-ohm lod, theoutput voltgecnbechngedfrom6v
16. When the unit intensity levels re 0 on both chnnels, nd it hs not been in use for 5 minutes, the unit will be shut off utomticlly. Detil informtion regrding to the Wveform, Pulse durtion, Pulse frequency, Output voltge rnge, nd Pek pulse output current: A. Wveform There re 3 types of wveforms: (1). Symmetricl Bi-Phsicrectngulr wveform AmpAlitude Time (2). Asymmetricl Bi-Phsicrectngulrwveform AmpAlitude 22 Time before using T.E.N.S. PRECAUTIONS 1. Isolted cses of skin irrittion my occur t the site of electrode plcement following long-termppliction. 2. Effectiveness is highly dependent upon ptient selection by person qulified in the mngement of pin ptients. ADVERSE REACTIONS Skin irrittion nd electrode burns re potentil dverse rections. GENERAL WARNINGS 1. Do not immerse T.E.N.S. units in wter. 2. Do not plce the T.E.N.S. unit close to excessive het. 3. Do not use ny pd which size is less thn 40mmX40mm. 4. Use only the specified btteries: 2x 1.5volt AA Alkline (LR6). The use of ny other bttery could dmge the unit. 5. Remove btteries if unit is not used for long period of time. 3
6. Do not use the unit while sleep. 7. Keep the unit wy from sources of high mgnetic fields such s TV S, microwve ovens nd hi-fi spekers, s these my ffect the LCDscreen. 8. Temperture & R.H. of storge: -20 --+80, 8%--80% R.H. 9. Temperture & R.H. of trnsporttion: -20 --+80, 8%--80% R.H. 4 the polrity of the symmetricl bi-phsic rectngulr nd mono-phsic rectngulr wveformisreversed, ndthecorresponding symbol is flshed. 12. When the tretment timer is set, it will begin to count down one minute by one minute; Once it count down to zero, the unit will utomticlly shut off. 13. When the pulse rte, pulse width or intensity is being djusted, the uto-repet function is vilble, when the key is held down over 1 second, it will utomticlly increse/decrese 1 step per 1/4 second. 14. By pressing wveformkey nd Ch2 down key simultneously for 2 seconds, the unit will be Doctor-locked or Doctor-unlocked in toggle. While the unit is Doctor-locked, ll prmeters cnnot be djusted except timer nd intensity but lso the mode cnnot be chnged. By removing btteries or pressing ON/OFF key cnnot chnge the sttus of Doctor-locked/Doctor-unlocked. 15. When one or both of the electrodes does not touch the skin or it is opened, the output level of the corresponding chnnel will go immeditely down to zero (this feture is limited to the model Ultim 11). 21
cnnot chngethesttus of locked/unlocked. 6. The tretment time will be ccumultive recorded when the output level is bove zero, by pressing ch2 down key nd timer key for 2 seconds the tretment time ccumulted in minute cn be displyed, or return bck to the previous norml disply in toggle; by pressing mode key & timer key for 2 seconds will cler the tretment time to zero. 7. When the btteries re low, the symbol of bttery is flshing in 2 Hz indicting tht the btteries should be replced. 8. Symbols A - B - C will show the pssed phse (if permnently ON) of the progrms Acute Pin nd Chronic Pin. 9. Symbols Hz or/nd μswill flsh when the respective shown vlue is different from the Defult. Whenever the M key is pressedfor 2seconds, thedefult prmeters of the current mode cn be recovered; when the unit is in locked mode, the Defult vlue will not be restored. 10. By pressing the wveform key, the form of the stimultion wve is chnged nd the chnge is directly felt by the user. 11. By pressingthewveformkey for 2seconds 20 CONTENTS Prescribing Informtion Contents Operting Instruction for Physicin Instruction For Use Howto Assemble Your Unit After Use Opertion of the T.E.N.S. Unit Specifiction Fetures Generl Informtion 1 5 6 6 7 12 13 17 19 24
OPERATING INSTRUCTIONS FOR PHYSICIAN INTENDED USE T.E.N.S. Stnds for (Trnscutneous Electricl Nerve Stimultion). This T.E.N.S. system is used to provide symptomtic pin relief for chronic, cute or post-opertive pin. HOWDOES T.E.N.S. WORK T.E.N.S.isbelievedtoworkbystimultingyour body'sownnturl defensesginst pin. The unit produces gentle stimulus through pds normlly plced over the re of pin. This stimulus helps the body to produce nturl pin relievers clled endorphins. The correct positioning of the pds is importnt. Some people feel immedite benefit from T.E.N.S. However some my only chieve benefit fter repeted tretment sessions nd over n extended period of time. INSTRUCTIONS FORUSE Your Ultim 11 T.E.N.S. Pin Relief unit hs been designed to be simple nd esy to use. 6 the completed phse. Acute Pin (Preset) Both Pulse-Rte nd Pulse-Width re preset to pply sequence of 3 progrms ( A, B, C ), optimized to tret the Acute pin. Tretment timer: Continuous, 15min, 30min, 45min, 60min, 90min selectble. FEATURES 1. When mode chnges, the intensity will utomticlly go down to zero. 2. When the unit is turned on, it will utomticlly enter the mode tht the unit hdworkedinbeforetheunit wsturnedoff. 3. Symbols MANUAL nd PRESET, on the LCD disply, will switch-on ccording the progrm. 4. Symbols Gte Control nd Endorphins will show utomticlly if Gte Control or Endorphins techniques re pplied. 5. By pressing wveform key nd Ch1 down keysimultneouslyfor 2seconds, the unit will be locked or unlocked in toggle. Whiletheunit is locked, ll prmeters cnnot be djusted except timer nd intensity. By removingbtteries or pressingon/offkey 19
1s on, 2s off. Both Pulse Rte nd Pulse Width will be freely djustble. Burst 2 One trin ny 1.5 seconds, 0.5s on, 1s off. Both Pulse Rte nd Pulse Width will be freely djustble. Burst 3 One trin ny 0.75 seconds, 0.25s on, 0.5s off. Both Pulse Rte nd pulse Width will be freely djustble. Modultion SW Pulse Rte Sweep Modultion. Pulse Rte is utomticlly modulted within bsic frequency F1=5Hz nd F2=20Hz (djustble from1to150hz). Modultion 2F Pulse Rte Dul Frequencies Modultion. Pulse Rte is utomticlly chnged, ny 5 seconds, between F1=70Hz (djustble) nd F2=5Hz. Modultion SW (Preset) Frequency & Pulse Rte Sweep Modultion. Frequency increses from 50Hz to 100Hz while pulse width decrese from200μsto50μs, within 5 seconds. Chronic Pin (Preset) Both Pulse - Rte nd Pulse - Width re preset to pply sequence of 3 progrms ( A, B, C ), optimized to tret the chronic pin. The symbols A, B or C will flsh, showing the phse in use of will be ON to show the completed phse. 18 CONTENT INTHE PACK Your T.E.N.S. pckshouldcontinthefollowing: 1 x T.E.N.S. Unit 2 x Leds 4 x Self Adhesive Pds with Connectors (size: 40mm X 40mm) 2 x Alkline AA1.5V (LR6) Btteries 1 x Instruction Booklet (which you re reding) Hving checked ll the contents re correct plese proceed to ssemble the unit. HOWTOASSEMBLE YOUR UNIT Assembly of the Ultim 11 T.E.N.S. Pin Relief unit is very simple nd requires only five steps. STEP 1 BATTERIES Removethebtterycoverndinsert twobtteries, s shown on the digrm inside the bttery comprtment. Replce the bttery cover. 7
EsyMed R Note: Your unit will not function if the btteries re inserted incorrectly. To check, press the button once nd the LCD disply will strt up. Hving mde this check press the button gin to switch the unit off. CAUTION There is risk of explosion if the btteries re fitted incorrectly. Replce with AA Alkline 1.5 volt btteries (LR6). Do not mix old nd new 8 1 2 Model: Ultim 11 Pulse Rte: Wveform: Mode: SPECIFICATION Chnnel: Dul Output: Mximum 130mA (pek vlue) cross 500 Ohmlod Pulse Width: From50μSto250μSdjustble From1Hz to 150Hz Adjustble Symmetricl Bi-phsicrectngulr Asymmetricl Bi-phsicrectngulr Monophsic rectngulr 11 Modes re vilble Constnt 1 Both Pulse Rte nd pulse Width will be freely djustble. Defult vlues re PR=3Hz nd PW=250μS. Constnt 2 Both Pulse Rte nd pulse Width will be freely djustble. Defult vlues re PR=20Hz ndpw=150μs. Constnt 3 Both Pulse Rte nd pulse Width will be freely djustble. Defult vlues re PR=70Hz ndpw=50μs. Burst 1 Onetrinny3seconds, 17
min EsyMed R M PR+ PW+ 70US Ch1 Ch2 EsyMed R 70US BURST II btteries. Do not dispose of the btteries in fire nd keep them out of rech of children. The btteries must be removed from the unit if unit is not used for long period of time. Ch1 min PR- PW- Ultim 11 M PR+ PW+ PR- PW- Ch2 STEP 2 LEADS Decide whether you wish to use the unit with one led or two. If usingtwoleds, insert theplugs intobothjcks on the plugs of the unit. If only using one led, insert into the ch1 jck s mrked on the unit. LED light On/Off Wveform 11modes re vilble for selection Timer for Tretment Continuous 15/30/45/60/90 min Selectble Intensity Up Ch1 Pulse Rte Up Pulse Width Up Intensity Up Ch2 Intensity Down Ch1 Pulse Rte Down Pulse Width Down Intensity Down Ch2 BURST II 3 4 Plese red the following detil specifiction crefully before using the T.E.N.S. Unit. 16 9
STEP 3 PADS Remove pds from the bg nd connect to the leds. 6 5 PR+ PR- PW+ PW- Press this key to set the tretment time. Press this key to djust the intensity of every chnnel, left side is for the ch1, right side is for ch2--- increse the intensity.--- decrese the intenstity. Stnds for Pulse Rte Up, press this key to increse the frequency. Stnds for Pulse Rte Down, press this key to decrese the frequency. Stnds for Pulse Width Up, press this key to increse the Pulse Width. Stnds for Pulse Width Down, press this key to decrese the Pulse Width. 7 10 15
Press the key respectively to select the wveform. The following wvefrom symbols will be displyed for 2 seconds when you press the key. Symmetricl Bi-phsicrectngulr STEP 4 PLACEMENT OF PADS Ensure wherever you intend to plce the pds, tht the skin is clen nd thoroughly dry. Remove the pds from the cler plstic shield nd position on your body s required. Asymmectricl Bi-phsicrectngulr Monophsic rectngulr NOTE In very smll percentge of people, using T.E.N.S. in Monophsic Rectngulr wveform cn excerbte the symptoms of pin. If this occurs, stoptretment inthis wveformimmeditely. M Press this key to select mode, totl 11 modes re vilble: - Constnt 1 - Constnt 2 - Constnt 3 -Burst1 -Burst2 -Burst3 - Modultion SW - Modultion 2F - Modultion SW - Chronic Pin -AcutePin 14 9 STEP 5 READING Red section on Opertion of the T.E.N.S. Unit, nd decide howto use the T.E.N.S. unit 11 8
for the tretment. NOTE: AFTER USE Alwys ensure tht the unit is switched OFF before removing the pds. After use, return the pds to the cler plstic shields. There is no need to seprte the pds unit from the leds nd pds. dhesive qulity in order not to ffect the efficiency of the unit. OPERATIONOF THE T.E.N.S. UNIT Ultim 11 T.E.N.S.Unit is esy to operte by pressing the key s following digrm. 10 12 M PR+ PR- PW+ PW- 11 WHAT DOES EACHKEYDO Life of the pds: When the pds initilly lose their dhesivequlity, it ispossibletorectivte their dhesiveness by pplying fine spry of wter. Replce the pds when they lose their 12 This key switches the unit on nd off. Press once nd the unit is on, the LED light (green color) nd the LCD disply locted t the front of the unit will light up, there will be no feeling from either led t this point s the intensity lwys strts t zero. Press this key gin nd the unit will switch off. 13