RICH-MAR THERATOUCH 7.7OPERATION HANDBOOK AND MANUAL

Part # MN 2427Rev. K

Batch 001

CAUTION

This device is not designed to be connected with any electrical equipment unless manufactured andapproved by Rich-Mar.

NOTE: This includes whirlpools and accessories NOT manufactured by Rich-Mar. These includepatient lead cords, self-adhesive electrodes, and carbon electrodes.

CAUTION: When using carbon electrodes with any Rich-Mar stimulator, a moistened interface (clothor sponge) MUST be utilized between these electrodes and the patient to avoid skin irritation and/orelectrical burns.

TABLE OF CONTENTS

Theratouch 7.7 Warranty................................................. 7Stimulation Indications for Treatment...............................8Microcurrent Indications for Treatment............................8Ultrasound Indications for Treatment...............................8Stimulation Contraindications & Warnings....................... 9Microcurrent Contraindications & Warnings.................... 10Ultrasound Contraindications & Warnings....................... 10Introduction................................................................... 11Theratouch 7.7 Operation............................................... 11

Logo Screen............................................................................ 11Main Menu.............................................................................. 11QuikSets................................................................................. 11Presets.................................................................................... 12Wave.......................................................................................12System.................................................................................... 12Ramps..................................................................................... 12Setting QuikSets & Presets...................................................... 13Stimulation Operation...............................................................13Ultrasound & Combination Operation...................................... 14Downloading to the Theramini 1 Stimulator............................... 14

Lead Cord Tester........................................................... 14Electrode Site Preparation & Guidelines.......................... 15Patient Electrode Connection.......................................... 16Waveform Specifications................................................ 17Ultrasound Calibration & Tuning Procedures................... 20Trouble Shooting............................................................ 22Theratouch 7.7 Specifications & Accessories List........... 22

Appendix AUltrasound Technical Information

Appendix BTheratouch 7.7 Parts List

Appendix CTheratouch 7.7 Schematics

LIMITED WARRANTY

This equipment is sold under an exclusive one-year warranty from date of sale, which warrants it to befree from defects in material and workmanship. We agree to repair or replace at the point of manufac-ture, without charge, all parts showing such defects, provided the unit is delivered to us, prepaid to ourfactory, intact for our examination, within one year from date of sale, and provided such examinationdiscloses in our final judgement that it is defective.

This warranty does not apply if the equipment has been subject to misuse, neglect, accidents, incorrectwiring (not our own), improper installation, or put to use in violation of instructions furnished by us, hasbeen damaged by excess voltage or has been repaired or altered outside our factory or if the equipmenthas had its serial number altered or removed.

Changes: Rich-Mar reserves the right to modify or change the equipment in whole or in part, at any timeprior to delivery, in order to include refinements deemed appropriate by the Company but withoutincurring any liability to modify or change equipment previously delivered, or to supply new equipment inaccordance with earlier specifications. This warranty will be honored only if the enclosed card is filledout and returned to the factory. This warranty is valid only to original purchaser.

This warranty is expressly in lieu of all other warranties expressed or implied including the warranties ofmerchantability and fitness for use and all other obligations on our part, and we neither assume, norauthorize any other person to assume for us, any other liability in connection with the sale or use of thisequipment. In no event shall we be liable for consequential or special damages. We make no warrantywhatsoever in respect to accessories or parts not supplied by us.

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Rich-Mar Muscle Stimulator Indications for Treatment(For Biphasic, Monophasic,and Russian Waveforms)

Rich-Mar stimulation devices are indicated for the following conditions:1) Relaxation of muscle spasms.2) Prevention or retardation of disuse atrophy.3) Increasing local blood circulation.4) Muscle re-education.5) Maintaining or increasing range of motion.6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

If the device has Quadpolar Interferential or Bipolar Interferential output capabilities they are also indi-cated for the following conditions:7) Symptomatic relief of chronic, intractable pain.8) Management of pain associated with post-traumatic or post-operative conditions.

Rich-Mar Microamperage Pulsed Current Indications forTreatment(Microcurrent)

Rich-Mar stimulators that have microcurrent output are indicated for the following conditions:1) Symptomatic relief of chronic, intractable pain.2) Management of pain associated with post-traumatic or post-operative conditions.

Ultrasound Indications for Treatment(Therapeutic Ultrasound)

Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions:1) Relief of pain.2) Muscle spasms.3) Joint contractures.

But not for the treatment of malignancies.

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Rich-Mar Muscle StimulatorContraindications and Warnings

(For Quadpolar, Bipolar, Biphasic,Monophasic & Russian Waveforms)

WARNING - Federal law restricts this device tosale by or on the order of a physician or any otherpractitioner licensed by the law of the state inwhich said person practices.

ContraindicationsThis device should not be used in the followingareas:1) On persons wearing a cardiac pacemaker.2) On persons who have known or suspectedmalignant lesions. This includes cancer patients.3) Over the cartoid sinus area.4) Trancerebrally.5) Over the pregnant uterus.

Warnings1) The long-term effects of chronic electricalstimulation are unknown.2) Adequate precautions should be taken whenstimulation is used on persons with suspected heartproblems.3) Adequate precautions should be taken whenstimulation is used on persons with suspected ordiagnosed epilepsy.4) Severe spasm of the laryngeal and pharangealmuscles may occur when the electrodes arepositioned over the neck or mouth. The contractionsmay be strong enough to close the airway or causedifficulty in breathing.5) Electrical stimulation should not be used inelectrically sensitive areas.6) Electrical muscle stimulation (EMS) should notbe used over swollen, infected, or inflamed areas ofskin eruptions (e.g., phlebitis, thrombo phlebitis,varicose veins).7) Caution should be used in the transthoracicapplication of electrical muscle stimulation (EMS) inthat the introduction of electrical current into theheart may cause arrythmias.8) Electrical muscle stimulation (EMS) devicesshould be kept out of the reach of children.9) Safety has not been established for use ofelectrical stimulation during pregnancy.10) This device should be used only under thecontinued supervision of a physician.

11) Transcutaneous Electrical Nerve Stimulation(TENS) is a symptomatic treatment and as suchsuppresses the sensation of pain, which wouldotherwise serve as a protective mechanism.

PrecautionsPrecautions should be taken when using a Rich-Mar muscle stimulator in the presence of one ormore of the following conditions:1) When there is a tendency to hemorrhage follow-ing acute trauma or fracture.2) Following recent surgical procedures whenmuscle contractions may disrupt the healing pro-cess.3) Over the menstruating uterus.4) When sensory damage is present by a loss ofnormal skin sensation.5) When using this device at current outputs above40mA, extra caution should be observed to avoidburns by using an adequate conductive medium andby frequently using an alternate electrode place-ment.6) Isolated cases of skin irritation may occur at thesite of electrode placement following long-termapplication.

Adverse ReactionsAdverse reactions to electrical stimulation areusually limited to sensations of discomfort. Exces-sive stimulation can cause muscle spasms as wellas soreness such as can be expected with exces-sive natural exercise. In all cases, treatment shouldnot exceed the patient’s comfortable tolerance tothe stimulation level.NOTE: Skin irritation and burns beneath theelectrodes have been reported with the use ofmuscle stimulators.

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Contraindications and Warnings(For Microamperage Pulsed Current

Waveform/ Microcurrent)

ContraindicationsThis device should not be used in the followingareas:1) On persons wearing a cardiac pacemaker.2) On persons who have known or suspectedmalignant lesions. This includes cancer patients.3) Over the cartoid sinus area.4) Trancerebrally.5) Over the pregnant uterus.6) Whenever pain syndromes are undiagnosed, untiletiology has been established.

Warnings1) This device is not effective for pain of thecentral origin (this includes headaches).2) The long-term effects of chronic electricalstimulation are unknown.3) Safety has not been established for the use ofmicrocurrent during pregnancy.4) Adequate precautions should be taken in thecases of persons with suspected or diagnosedseizures or heart problems.5) This device is to be used as asymptomatictreatment for pain and has no curative value.6) Patients should be cautioned and their activitiesregulated if pain is suppressed that would otherwiseserve as a protective mechanism.7) Electronic monitoring equipment (such as ECGmonitors and ECG alarms) may not operate prop-erly when the stimulation is on.8) This device should be used only under thecontinued supervision of a physician.9) The user MUST keep the device out of thereach of children.

Precautions1) Isolated cases of skin rash may occur at the siteof electrode placement, following long-term applica-tion. The irritation can usually be reduced by use ofan alternate electrode placement and/or an alterna-tive conductive medium.2) Effectiveness of this treatment is dependentupon patient selection.

Adverse ReactionsSkin irritation and burns beneath the electrodeshave been reported with the use of transcutaneousnerve stimulators.

Ultrasound Contraindications

ContraindicationsUltrasound should not be used in the followingareas:1) Near or over the heart.2) Near or over the eyes.3) On the head.4) Near or over reproductive organs.5) On the lower back during pregnancy or over thepregnant uterus.6) Directly over the spinal column.7) Over growing bone in children.8) Where the skin suffers from any sensoryimpairment.9) Over areas of malignancies.10) In the area of visceral plexus and large autono-mous ganglion.11) Over the thoracic area if the patient is using acardiac pacemaker.12) Over a healing fracture.13) Over ischemic tissues in individuals withvascular disease where the blood supply would beunable to follow the increase in metabolic demandand tissue necrosis might result.

PrecautionsPrecautions should be taken when used:1) Over anesthetized areas.2) On patients with hemorrhagic diastheses.3) Ultrasound treatment should not be performedover an area of the spinal cord following laminec-tomy (i.e.- when major covering tissues have beenremoved).

Caution1) Excessive doses of ultrasound may causedamage to tissue. Periosteal pain is an indication ofexcess intensity and if it occurs, the power shouldbe reduced; the transducer should be moved morerapidly over the area being treated; or a lowerpulsed duty cycle should be used.2) If the soundhead has been operated unloaded foran extended period of time, the transducer will gethot. If the soundhead is applied to the patient whilethe transducer is hot, a burn may result.

WarningDo not operate the soundhead in an unloadedcondition. It is possible that unrepairable damagemay occur to the transducer in an unloaded state.

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S t a t u s S c r e e n

1 2 3 4

T o u c h S c r e e n /

D i a l

S t o p /

D i r e c t o r

C l e a r

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IntroductionThe Rich-Mar Theratouch 7.7 is a powerful andeasy-to-use stimulator and ultrasound, providing themost flexible selection of electrotherapy for treat-ment. This manual is meant to give a brief introduc-tion to the Theratouch 7.7 and its operation.

The Theratouch 7.7 offers six stimulation wave-forms and two different sized ultrasound transduc-ers with the ability to output both 1MHz and 3MHz.The Theratouch 7.7 touch-screen and director dialare the main controls for operation.

User InterfaceThe Theratouch units are meant to use, not con-fuse. Paramount to their design was an interfacethat actually made treatment set up less dauntingand more efficient. To facilitate this, the main inputcontrols are the touch screen, the director dial, andthe stop/clear button.

Touch-Screen/Status ScreenThe 7.7 utilizes a touch-screen to navigate thesoftware-driven operation of the Theratouch. Thetouch-screen is activated by a moderate amount ofpressure to any of the buttons on the screen. Afterpressing each button, an audible beep will sound tosignify that a choice has been accepted.

Director DialThe director dial is a very useful and powerful inputtool for the 7.7. Its basic function is the “twist andclick”. The dial allows precise control over param-eters that it requires, such as intensity, balance,pulse rates, time, etc. Another feature of thedirector dial is its accept mechanism which acti-vates by “clicking down” on the dial. Thus, when

setting intensity, turn the dial to an acceptable leveland click down to accept or select. The Theratouch7.7 will beep when the information has beenaccepted. The dial icon will appear on the 7.7screen when the dial is active for an application(i.e.- to set a pulse rate or scroll through treatmentchoices).

Stop/Clear ButtonThe stop/clear button is a touch-sensitive buttonthat will stop treatment and clear the screen back tothe main menu when pressed. This button func-tions as the immediate treatment override.

Theratouch OperationLogo ScreenFirst, turn the unit on by pressing the switch on theback of the device. Screen 1 will appear with theRich-Mar logo, Theratouch name, and the softwareversion of the unit. After five seconds, the mainmenu will automatically be painted.

Main MenuThe main menu for the Theratouch 7.7 will appearnext. From this menu, any combination of treat-ments, frequencies, and waveforms can be utilized,including alternating, surged, and pulsed rate chainoptions as well as one and three MHz. There arethree basic Theratouch forms of treatment. Eachwill be explained along with instructions for set upand the parameters involved. The three formsinclude: QuikSets, Presets, and Wave(form)treatments.

QuikSetsThe QuikSets are the first three buttons from the

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left of the channel indicator. They are labeledQuik1, Quik2, and Quik3. By selecting one of theQuikSets, treatment is completely set up for theuser. Only the intensity will need to be set. TheQuikSets are ideal for most common treatments.Simply enter the QuikSet’s parameters once, or usethe factory settings. Each QuikSet can also benamed (up to five characters). Using differentQuikSets on different channels will allow the userto perform a stimulation, ultrasound, or combinationtreatment. The “Defaults” section will furtherexplain how to set parameters and name QuikSets.

PresetsThe preset button will allow access to a menu of sixpreset treatments that work in the same manner asthe QuikSets, with both stimulation and ultrasoundoptions. Each of the presets can be programmedwith specific names. By selecting the preset button,the user can scroll through the preset menu set-tings. Once a preset is selected and intensity is set,set up is complete. The “Defaults” section willfurther explain set up of Presets.

WaveThe wave button shows all the waveforms availablein the Theratouch if selected on channels onethrough four and all ultrasound parameters ifselected on the ultrasound channel. Once a wave-form is selected, all parameters will appear for thatchoice, including mode, time, pulse rate, vector,phase duration, phase interval, etc., depending uponthe waveform. The same flow is used with theultrasound except the parameters are soundheadsize, frequency, and duty cycle. The QuikSets andPresets allow a set treatment to be accessed veryquickly, whereas the wave button allows the user tocustomize and adjust all parameters of a particulartreatment. Operation of the wave button will beexplained in greater detail in the “General Opera-tion” section.

SystemSelect the system button at the bottom of the mainmenu . The ramps and low flow monitor buttonswill appear.

Ramp up and Ramp DownThe ramp up button allows the user to adjust theamount of time it takes to achieve the set treatmentintensity in a surged or alternating mode. Forexample, if the ramp up is set at four seconds, it willtake four seconds of on time to reach the treatment

intensity. The same applies to the ramp down. If setfor three seconds, it will take three seconds of offtime for the intensity to decrease to zero in a surgemode. Ramp up is adjustable from one to fiveseconds and ramp down is adjustable from zero tofive seconds. These are adjusted by selecting theappropriate button, rotating the dial to select ramptime, and clicking down to enter.

3-D ButtonsBelow the low flow monitor button is the 3-Dbuttons button. This control allows the user totoggle the appearance of the buttons on theTheratouch. When this button is on, the 3-D optionwill activate. If turned off, all buttons will revert toblack and white.

Ultrasound UnitsThis button will allow the user to choose how theultrasound intensity is displayed (i.e., either watts orwatts/cm2).

Screen ContrastIf this button is selected, use the dial to change thepercentage of screen contrast. NOTE: The stop/clear button will also allow a screen contrastchange by pressing down and turning the dial to thedesired contrast.

DefaultsIn the main menu, select the defaults button next tothe system button. The defaults set up menu allowsthe user to customize the Theratouch via QuikSetsand Presets set up.

Setting QuikSets and PresetsCustomizing QuikSets and Presets is very simple.To start, select the Quik3 button. All parameterswill appear to customize the Quik3 treatment. If thewaveform button is selected, the knob icon willappear in the upper-right corner of the screen. Thisindicates that the knob should be used to scrollthrough the waveform options. Click down on theknob to accept the desired option.

StimulationOnce a waveform is chosen for a QuikSet orPreset, the Theratouch will display availabletreatment parameters. For example, if the Biphasicwaveform is chosen the phase width (duration) anda fixed or scan pulse rate must be set. However, ifthe Bipolar waveform is chosen the phase widthwill not be an option, but options to have a fixed or

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scan pulse rate will appear as well as the option tovector the output. The Theratouch treats eachwaveform as a separate entity with its own specificfeatures. Once the parameters for a QuikSet havebeen chosen, it can be named. Simply select TMTNAME. Then rotate the dial to the desired letter ornumber and click down to accept each until com-plete (Up to five characters). Once completed andnamed, select the exit button and the choices will besaved.

UltrasoundSetting the ultrasound of the QuikSet is done in thesame manner as the stimulation. The parameterscan be set to use a specific combination with theQuik3 stimulation parameters or as an ultrasound-only treatment. The head size, frequency, and dutycycle can each be selected. The treatment time forthe ultrasound treatment will be the same as thestimulation setting.

General OperationStimulation

QuikSets and Presets OperationWhen a treatment is running with the QuikSets orPresets, the time and intensity can be adjusted orthe user can independently end the treatment byusing the buttons on the right hand side of thescreen.

Wave OperationThe Theratouch 7.7 has six available stimulationwaveforms. They are Quadpolar Classic Interfer-ential, Premodulated Bipolar Interferential,Monophasic (High Volt), Biphasic (Low Volt),Russian, and Microcurrent.

Each of these waveforms has different parametersto some degree, but generally follow the same pathfor set up in the wave and/or default menus.

Select WaveformOnce the wave button is pressed on any of the fourstimulation channels, the desired waveform can beselected. Once selected, specific parametersavailable to that waveform can be chosen.

Treatment ModeModes available in the Theratouch 7.7, dependingupon the waveform selected include continuous,surge, alternate, and chain.- Continuous will output continuously from onechannel (two for Quadpolar) at a single pulse rateor scan.

- Surge will output intermittently on one channel ata single pulse rate scan with a stated on and offtime.- Alternate mode will output the same pulse rate orscan between two different channels alternating ata set time. It is capable of outputting differentintensities for each channel.- Chain mode will allow the user to treat with onepulse rate or scan for an entered time and thenswitch to a different pulse rate or scan for anotherentered time. It will continue to switch between thetwo pulse rates or scans as long as treatment timeremains, if the sum of the two times is less than thetreatment time.

Treatment TimeTo select the treatment time, select one of thepreset buttons or enter a different number with thedial.

Pulse RateSelect any of the preset rates or scans, or selectscan or fixed, which will allow the user to enter adifferent number with the dial. When entering ascan, use the dial to enter the low end, click downon the dial, enter the high end, and click the dialdown to accept that scan. To select fixed, enter thefixed pulse rate with the dial and click down toaccept.

Vector and PhaseDepending upon the chosen waveform, one of thefollowing may need to be entered:- If Quadpolar or Bipolar Interferential are selected,vector selection options will include depth andspeed. Depth options include shallow, normal, deepand none. If none is selected, the vector is turnedoff. If depth is chosen, a speed of vector depthmovement must be selected. Vector speed choicesare slow, medium, and fast.- If a phasic waveform was selected (Monophasicor Biphasic), the phase duration and phase intervalmust be selected (interval on Biphasic only). Thescreen will display the following: “PD 50/100/50”.This means that the first phase duration is 50µS, theinterphase interval is 100 µS, and the second phaseduration is 50 µS. Phase duration is adjustable onlyin Biphasic. Interphase intervals are adjustable inboth Biphasic and Monophasic.

Set IntensityThe final step is to set intensity and press the dialdown to accept.

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UltrasoundQuikSet and Preset Operation- Ultrasound Only- If a QuikSet or Preset is selected on the bottomultrasound channel, the user will be asked to choosewhether to do a combination or ultrasound treat-ment. If ultrasound is selected, then the intensity ofthe treatment must be set.- Combination TreatmentIf a QuikSet or Preset is selected on the bottomultrasound channel and the combo button is se-lected, the stimulation intensity must be set first.Please note that any combination treatment will usechannel four for stimulation, (three and four forquadpolar stimulation), using the white-ended leadon channel four for the electrode. Make sure thatthe pads are placed and note that the soundheadtakes the place of the red pin for channel fouroutput. Set stimulation intensity and press the dial toaccept. Remember to always keep thesoundhead moving during any ultrasoundtreatment.

CAUTION: Do not operate the soundhead in anunloaded condition (without a coupling lotion andpatient contact). This can cause the transducer toget very hot and may cause unrepairable damage tothe transducer.

NOTE: When administering an ultrasound treat-ment, be sure that treatment area of the patient hasan ample quantity of Rich-Mar lotion or gel as acoupling medium. The quantity and quality of thecoupling medium used has a direct bearing on theamount of ultrasonic energy transmitted to thetreatment area.

CAUTION: When operating the Theratouch 7.7 incombination, note that both the metal faces of theTherapy Hammer will output stimulation.

Ultrasound - Wave Operation- Ultrasound Only- If the wave button is selected on the ultrasoundchannel, the user will be asked to choose combo orultrasound. If ultrasound is selected, the soundheadand frequency desired must be chosen. The userwill also have the option of selecting a pulsed dutycycle or continuous output. The treatment time andintensity must then be set.- Combination- If the wave button is selected on the bottomultrasound channel and combo is selected, the

stimulation can be set up on channel four (three &four for Quadpolar) in the same manner as de-scribed in the “Stimulation - Wave Operation”section. Again, be sure that the pads and soundheadare correctly positioned before increasing intensity.Once the stimulation is running, the soundhead sizeand ultrasound frequency should be selected. Then,select pulsed or continuous output.CAUTION: When operating the Theratouch 7.7 incombination, note that both the metal faces of the“Therapy Hammer” will output stimulation.

Downloading Waveforms and/or Treatments toTheramini 1 “Satellite” StimulatorsThe Theratouch 7.7 provides the unique ability ofdownloading a waveform and/or treatment to aportable Theramini 1 “satellite” stimulator.

To download a waveform and/or treatment, connectthe special “Theralink” cable to the data port in theback of the Theratouch 7.7 and the data port in theback of the Theramini 1.

Once completed, select the defaults button on theTheratouch 7.7 and select a QuikSet or Preset todownload to the Theramini 1. To change thewaveform or any other parameters of treatment, doso on the Theratouch. The “Theramini Link” buttonshould appear in the bottom left of the screen.Once changes to the QuikSet and Preset have beencompleted, press the Theramini link button. Thebutton should then read “Linking” and “Tmini LinkComplete”. The Theramini 1 should have thatwaveform and parameters entered. If a messagereading, “Tmini Link Failed”, check the connectionsand try again.

Lead Cord TesterThe Theratouch units come with a convenient andtime-saving lead cord tester incorporated into theunit. To access it, go to the system screen andpress “Lead Test”.The warning to disconnect the leads from thepatient will appear. Once this has been completed,press start.Select one of the lead cords that is plugged in. Takethe two ends of that lead cord and press themtogether. If the lead cord is still functioning cor-rectly, a constant tone will sound and the graphicsfor that channel will come together. Repeat thesame process for the other lead cords and chan-nels. Press the stop button to stop the test. Pressexit to return to the system menu.

Electrical StimulationSite Preparation, Electrode

Attachment, and MaintenanceGuidelines

1) Know the stimulation characteristics, indications,and contraindications of the desired waveform. Formost patients, the Micro amperage current will besub-sensory. However, if stimulation sensation isperceived, be sure it is set at a level that is comfort-able for the patient. On all other muscle stimulationand interferential current therapy, be sure that theintensity is set to a comfortable level. DO NOTBRING UP THE INTENSITY UNTIL THEFOLLOWING PROCEDURES HAVE BEENOBSERVED.2) Clean the area(s) of the skin to be treated withsoap and water or an alcohol wipe.3) Excessive hair may be trimmed, but shaving isnot recommended immediately prior to electrodeplacement.4) Choose the appropriate size electrode(s) for thebody part being treated.5) Be sure that the electrodes are securely attachedto the lead wires. See the illustration on the follow-ing page for the appropriate patient lead wireconnections.6) Avoid placing an electrode over areas of brokenskin, scars, moles, or unusual areas of skin discol-oration. Also avoid skin folds/creases or areas ofimpaired sensation.7) The single patient self-adhesive electrodes arewell suited for most body areas in which electricalstimulation would be used. Remove the electrodesfrom the pouch and save it for subsequent storageof the product. Carefully peel the electrodes fromthe release backing and apply it to the chosen site.Press firmly to ensure uniform and secure contactwith the skin and begin stimulation treatment.

Electrode Storage and MaintenanceIMPORTANT: The adhesive properties of theseelectrodes may be affected by ambient or patientskin conditions. While out of the package, extremevariations in humidity levels may affect the adhe-sive properties of these electrodes.

To increase the adhesive properties of the elec-trodes, add a few drops of water to the electrodesconductive surface and spread evenly. Allow acouple of minutes for the increase in tack.

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REMOVAL AND STORAGE OF ELECTRODES:Turn off the stimulation device and disconnect thecabling. Remove the electrodes from the skin andreapply to the plastic backing. Place in the pouch andreseal for storage to maintain proper adhesive qualitywhen not in use. If possible, store the electrodes in arefrigerator to maintain adhesive.

CAUTION: In multiple, consecutive treatments of apatient, the electrodes should be discarded andreplaced if damaged, or when proper adhesive tackor comfort can no longer be achieved. Electrodesshould be replaced when they lose their adhesivequality, or when a change in stimulation intensity isnoticed, or if the gel is separated. If in doubt aboutthe integrity or proper function, replace the electrodebefore proceeding. In any instance, Rich-Marrecommends that the self-adhesive electrode NOTbe used for more than 20 consecutive treatments.

Electrode Types and SizesThe Rich-Mar Corporation recommends the use ofour self-adhesive electrodes with this device. Eitherthe Blue Stim or Super Stim self-adhesive willprovide the proper conductive properties. The BlueStim electrodes come in sizes of 1.75" x 1.75" or3.75" x 3.75". The sizes of the Super Stim electrodesare 1.75" x 1.75", 3.75" x 3.75", and a 2" diameterround electrode.

Patient Lead Cord MaintenanceRich-Mar Corporation recommends that yourpatient lead cords be replaced annually.

Please note that your patient lead cords bear a labelwith a space provided to write in the date that thelead cord was put into service (“Date in Service”).There is also a space to write in the replacement duedate (“Replace By”), which will be one year fromthe date the lead cord was put into service.

Please take the time to write in these dates with apermanent marker. This will serve as a convenientreminder of the age of your lead cords.

Some Rich-Mar muscle stimulators are equippedwith a feature that allows you to check lead cordcontinuity. If your device is equipped with thisfeature, it is recommended that the lead cords bechecked at least monthly. Checking lead cords on aroutine basis, and replacing them annually, will ensureyour patient’s comfort, safety, and the effectivenessof the treatment.

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Patient Electrode Connection

Red Shielded End

White Shielded End

Insert pin end of lead cord firmly intopatient electrode-

Make sure no metalis showing between

patient electrode andpin end of the lead cord

Patient Electrode

Plug shielded ends of lead cord into the output jacks on the device(red end into red jack and white end into white jack for each channel)

Lead Cord

WaveformsThe Theratouch 7.7 represents the most sophisti-cated electrical waveform generation ever devel-oped in electrotherapy. The waveforms are soft-ware generated by an extremely sophisticatedcomputer that resides in each Theratouch. Becauseof this generation, the Theratouch 7.7 can growwith the future of electrotherapy.

Each waveform has particular characteristics thatare particularly well suited to a physiologicalresponse. Classic, or Quadpolar Interferential, is themost conventionally thought to provide the smooth-est “feeling” current available for sensory stimula-tion. Symmetric, Square-Wave Biphasic current isconventionally thought to provide the smoothestmuscle contraction. Monophasic current provides anet charge effect, when needed, provides lowcurrent density stimulation, and historically has beenused when an ultrasound combination is utilized.The Russian waveform is thought to be the bestwaveform for motor contraction.

Within each waveform, a particular pulse rate or“beat” frequency can be chosen. Low pulse rates(0-10) are thought to be the best for indicationsinvolving chronic problems, while higher pulse rates(80-200) are thought to be best for indicationsinvolving acute problems. A pulse rate of 50 Hz isthought to provide the best motor stimulation(contraction) without rapid fatigue.

Broad base protocol conventions exist for allelectrical stimulation as described above, but withineach waveform, certain parameters are the key toeliciting a particular response.

The Theratouch 7.7 has been programmed to havethe most common treatment options as factorysettings. However, the Theratouch 7.7 is designedto provide the most sophisticated and customizedtreatments imaginable.

Helpful Hint:If you desire further information regardingwaveform descriptions, recommended reading tosupplement this section isELECTROTHERAPEUTIC TERMINOLOGY inPhysical Therapy, published by the AmericanPhysical Therapy Association. For more infor-mation, contact the APTA, 1111 North FairfaxStreet, Alexandria, VA 22314-1488.

Quadpolar Interferential(four pads)

Electrical stimulation at higher frequencies (5000Hz)penetrates the skin easily (due to capacitive effects ofthe skin) but has little therapeutic effect. Lowerfrequencies (0-200) are therapeutic, yet produceirritation or even pain if applied directly. Interferentialcurrent utilizes two high frequencies to pass throughthe skin barrier and then mixes the two frequencies toproduce a low frequency within the tissues.

Quadpolar mode is named such because two channelstotaling four (quad) electrodes work in conjunction toprovide treatment of one site.

The Theratouch 7.7 provides Quadpolar Interferentialby producing two separate sine wave outputs. Bycrossing these electrodes, the two sine waves mix andproduce a “beat” frequency within the tissue. Thisbeat is the difference in the two sine wave outputs.

The Theratouch 7.7 produces 5000Hz sine wavesfrom channels one and three and produces between5000 and 5200Hz sine waves and channels two andfour. Channels one and two operate in concert to treatone site. Channels three and four also operate togetherto treat one site. The user may select a fixed “beat” orpulse rate between zero and 200. The user may alsoselect a scan setting which scans between a low“beat” and a high “beat” setting.

Quadpolar Interferential Parameters:Carrier Frequency: 5000HzBeat Frequency Fixed: 0-200HzBeat Frequency Scan Low: 0Hz to 200HzBeat Frequency Scan High: 0Hz to 200HzPulse Rate Chain: 0-200Hz, either Fixed and/or ScanVector Options: Shallow, Normal, DeepVector Speeds: Slow, Medium, FastAlternating Rate:* Not AvailableSurge Rates:* On: Not Available, Off: Not AvailableRamp On: Variable 1-5 SecondsRamp Off: Variable 0-5 Seconds

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Bipolar InterferentialThe Total Output Current = 30mA rms. The metershown on the screen of the Theratouch is listed asrms current. To convert rms to peak current,multiply rms by 2.34 (1.414/.707). Examples aregiven below:

Meter Reading (ms) Peak CurrentMilliamps (mA) Conversion (mA)

5 11.710 23.415 35.120 46.825 58.530 70.1

BiphasicThe Theratouch 7.7 also has the capability toproduce a Symmetric Square-Wave Biphasicstimulation having two phases per pulse - a positivephase, followed by a negative phase. This producesa net charge of zero.

Biphasic Parameters:Carrier Frequency: Not ApplicableBeat Frequency Fixed: 2-200HzPulse Rate Chain: 2-200Hz, either Fixed and/orScanPhase Duration: 50, 100, 150, 200µSInterphase Interval: 50, 100, 150, 200µSAlternating Rate: 2-99 SecondsSurge Rates: On: 2-99 seconds, Off: 2-180 secondsRamp On: Variable 1-5 SecondsRamp Off: Variable 0-5 Seconds

Quadpolar InterferentialThe Total Output Current = 50mA rms. The metershown on the screen of the Theratouch is listed asrms current. To convert rms to peak current,multiply rms by 1.414. Examples are given below.

Meter Reading (ms) Peak CurrentMilliamps (mA) Conversion (mA)

5 7.110 14.115 21.220 28.225 35.430 42.435 49.540 56.645 63.650 70.7

Bipolar InterferentialBipolar Interferential operates with a carrierfrequency but it is premodulated within theTheratouch 7.7. This enables a single channel (two-electrode) system to be used. Bipolar Interferentialcan select a pulse rate or a “beat” frequencybetween five and 200Hz.

Bipolar Interferential Parameters:Carrier Frequency: 5000HzBeat Frequency Fixed: 0-200HzBeat Frequency Scan Low: 5Hz to 200HzBeat Frequency Scan High: 5Hz to 200HzPulse Rate Chain: 5-200Hz, either Fixed and/orScanVector Options: Shallow, Normal, DeepVector Speeds: Slow, Medium, FastAlternating Rate: 2-99 SecondsSurge Rates: On: 2-99 seconds, Off: 2-180 secondsRamp On: Variable 1-5 SecondsRamp Off: Variable 0-5 Seconds

18

MonophasicThe Theratouch 7.7 also has the capability toproduce a Symmetric Square-Wave Monophasicstimulation having two equal positive phases perpulse. This results in a net charge effect. Thepolarity of monophasic can be either positive ornegative (referring to the red pin for each channel).The Theratouch has the ability to change polarity“on-the-fly”. To change polarity of the waveformselect the +/- button at any time while adjusting theintensity of the monophasic waveform. The polaritychange utilizes a one-second “comfort ramp” downand back up in intensity to make the polarity changemore gradual and comfortable.

ADDITIONAL METERINGThe Theratouch 7.7 displays three meters for eachmonophasic waveform. The peak reading is shownto the right of the bar. Below and left of the bar(while treating) is a meter that shows averagecharge per second. This will vary with the numberof pulses-per-second. The third meter is to the rightand below the bar (while treating) and is an accu-mulative net charge meter. It works much like anodometer, multiplying average charge meter time bythe treatment time. Most experts say that this is anexcellent way to determine the amount of totalcurrent a site has received.

Monophasic Parameters:Carrier Frequency: Not ApplicablePulse Rate: 2-200HzPulse Rate Chain: 2-200Hz, either Fixed and/orScanPhase Duration: 50µSInterphase Interval: 50, 100, 150, 200µSAlternating Rate: 2-99 SecondsSurge Rates: On: 2-99 seconds, Off: 2-180 secondsRamp On: Variable 1-5 SecondsRamp Off: Variable 0-5 Seconds

Micro CurrentMicro current is a pulsed waveform that produces50µS phases from .3-1000 pulses-per-second. The

Microcurrent Parameters:Carrier Frequency: Not ApplicablePulse Rate: Fixed .3-1000HzPulse Rate Chain: Fixed Low, Fixed HighPhase Duration: 50µSInterphase Interval: Dependent upon pulse ratePositive/Negative Interval: 2.7 secondsAlternating Rate: Not ApplicableSurge Rates: Not ApplicableRamp On: Not ApplicableRamp Off: Not Applicable

RussianRussian is a 2500Hz time-modulated waveformhaving a sinusoidal frequency that is burst modu-lated at 50% duty. Russian is not available in acontinuous mode, but it is available in surge, alter-nating, and continuous modes.

Russian

Russian Parameters:Carrier Frequency: 2500HzBeat Frequency: Fixed 5-200HzScan: Low 5Hz to 200Hz, High 5Hz to 200HzPulse Rate : 5-200Hz, FixedAlternating Rate: 2-99 secondsVector Options: Not AvailableSurge Rates: On 2-99 seconds, Off 2-180 secondsRamp On: Variable 1-5 secondsRamp Off: Variable 0-5 seconds

19

phases alternate from positive to negative every2.7seconds. The amplitude is adjustable from zeroto 1000µA.

Ultrasound Calibration andTuning Procedure

Ultrasound Service InformationRich-Mar Corporation recommends that all Rich-Mar ultrasonic therapy products be returned to thefactory or to a servicing Rich-Mar distributor forservice or calibration. It is recommended that thedevice be calibrated annually or when any majorcomponent is changed.

CautionCalibration and peaking adjustments must not beattempted unless the person performing theseadjustments has the proper test equipment, whichmust include an acceptable ultrasonic wattmeter,such as the Ohmic UPM-30 or equivalent. De-gassed water must be used to obtain accuratereadings.WarningUse of controls or adjustments or performance ofprocedures other than those specified herein mayresult in hazardous exposure to ultrasonic energy.

Calibration and Tuning ProcedureScreen Calibration1. Hold down the selector knob and turn the unit on.2. Release the knob when the combination safeicon appears on the display.3. By adjusting the knob, dial in 07. Select thesetting by pressing down on the knob. Now dial in40 and select the setting. Dial in the final setting, 36,and select. The unit should chime and enter factorymode. If it does not, reenter the combination.4. Select the button “CAL PANEL.” A small “X”will appear in the lower left corner of the display.5. Use a dull, pointed object and press the center ofthe “X”. The “X” will move to the next corner.Repeat the procedure until all four corners havebeen reset. Select the button “THERA SKETCH.”Use a dull, pointed object to depress any section ofthe touch screen. Pixels in the display shoulddarken wherever the screen is touched. The screencan be erased by pressing down on the knob. PressStop/Clear to return to the Factory Mode menu.Annual Ultrasound Calibration Check1. Place the transducer to be tested in an OhmicUPM-30 wattmeter, or equivalent.2. Set up an ultrasound treatment to activate thetransducer at either 1MHz or 3Mhz and 100% dutycycle.

3. Increase the intensity to maximum.4. If the 2 cm transducer is being tested, it shouldbe emitting at least 3.2 and no more than 4.8 watts.The 5cm transducer should emit at least 9 and nomore than 11 watts. If this is not the case, performthe full calibration procedure listed in the followingsection.

Full Calibration Procedure1. Hold down the selector knob and turn the unit on.2. Release the knob when the combination safeicon appears on the display.3. By adjusting the knob, dial in 07. Select thesetting by pressing down on the knob. Dial in 40and select the setting. Dial in the final setting. 36,and select. The unit should chime and enter factorymode. If it does not, reenter the combination.4. Clamp the transducer being calibrated into theultrasound wattmeter.5. Select one of the transducer and frequencybuttons located in the bottom half of the display.6. If the transducer or portions of the RF Generatorhave been changed, go through the crystal peakingprocedure. Otherwise, skip to step 11.(Crystal Peaking Procedure)7. Select the “CAL AT VOLTS” button. Adjust thereading to 10.0 volts and select the setting bypressing down on the knob.8. Select the “RES FREQ” button. While observingthe wattmeter adjust the frequency setting until themaximum power reading is measured by thewattmeter.9. Advance the frequency 5kHz for 2cm transduceror 10kHz for the 5cm transducer. (For example, ifthe frequency of maximum output is .938MHz thenset the frequency to .988MHz.) Record this settingon the “Calibration Parameters” chart on thefollowing page.10. Select the “POWER CORR” button.11. While observing the wattmeter, increase thevolts setting until the appropriate watt reading ismeasured. Record this reading on the “CalibrationParameters” chart. NOTE: 4 watts for the 2cm and10 watts for the 5cm.12. Select the setting by pressing down on the knob.13. Press Stop/Clear to get back to the factorymode menu.14. Repeat the calibration procedure for theremaining transducer and frequency combinations.15. After each transducer and frequency combina-tion has been set, press Stop/Clear to return the unitto treatment mode.

20

Theratouch 7.7 UltrasoundCalibration Parameters

2cm - 1MHz _______ MHz _______ Volts2cm - 3MHz _______ MHz _______ Volts

5cm - 1MHz _______ MHz _______ Volts5cm - 3MHz _______ MHz _______ Volts

Cal. at Volts: 10.0 Volts

NOTE: When resetting calibration parameters, theCal. at Volts setting must be set to 10.0 Volts.

21

Disinfecting RecommendationsTo disinfect the soundhead between therapytreatments, Rich-Mar recommends using a disinfec-tant cleaner for ultrasound. OSHA addresses theneed for prudent infection control (OSHA Instruc-tion CPL 2-2.44C) to include decontamination ofequipment between patients.

22

Trouble-ShootingRich-Mar Corporation takes pride in its TechnicalSupport Hotline: 1-800-762-4665. We have anoutstanding staff ready to take your calls and helpwith diagnosing and troubleshooting problems.

If the screen is not bright enough:Try adjusting the screen contrast by pressing“System” (at the bottom of the regular screen).The screen will change. Press “SCRN Contrast”and a dark outline will appear over the box. Turnthe knob until the desired contrast is achieved andthen press “SCRN Contrast” again until the darkoutline is under the box.

Theratouch 7.7 SpecificationsDimensions: 17"W x 10"D x 5"H

Weight: 18 lbs.

Power Input: 110 VAC, 60Hz220 VAC, 50 Hz

Power Consumption: 110 Watts

Fuse: 1 Amp

Line Leakage: Less than 50 mA

Theratouch 7.7 AccessoriesThe accessories that come standard with theTheratouch 7.7 as well as the optional accessoriesavailable for the unit are listed below. Their partnumbers are included for easy reordering.

Standard Accessory Package2) White pin lead cords LC1718A2) Red pin lead cords LC1719A

2 packages of one of the following:SuperStim self-adhesive electrodes(1.75" x 1.75") PD1071(2" Round) PD1072(1.75" x 3.75") PD1073

Optional Accessory Package8) 4" round carbon electrodes PD10428) 4" round sponges for PD1042 PD10548) 2" x 30" Velcro straps VS2105

Other AccessoriesBlueStim self-adhesive electrodes(1.75" x 1.75") PD1031(1.75" x 3.75") PD1033

SuperStim self-adhesive electrodes(1.75" x 1.75") PD1071(2" Round) PD1072(1.75" x 3.75") PD1073

Banana to Pin adapter(set of two) LC1720

Pin to Banana adapter(set of two) LC1721

Sponge electrodes (4"x 4") PD1036

Sponge electrodes (3" x 3") PD1039

Carbon electrodes (2.5" round) PD1044

Sponges for PD1044 PD1055

Micro-Current Probes(Set of two) PR6713

Handle CH3750

APPENDIX AULTRASOUND TECHNICAL INFORMATION

Near Field Distribution

Beyond this point, the beam has a more uniformintensity and is called the “far field”. Below is shownthe far field distribution at 16cm from the transducerface.

Far Field Distribution

The preceding descriptions apply for radiation emittedinto the equivalent of an infinite medium of distilled,degassed water at 30°C.

Transducer Parameters and Tolerances:The Rich-Mar ultrasound units operate at frequenciesof either 1MHz or 3MHz +/- 10%. The effectiveradiating areas (ERA) of the transducers are ten, five,

Ultrasound TechnicalInformation

Applicator Type:The ultrasonic radiation fields produced by Rich-Mar therapeutic ultrasound transducers are of theplane wave type and are essentially cylindrical inshape. This type of applicator is referred to as acollimating applicator.

Applicator Label:Each Rich-Mar applicator is labeled to provide theuser with information on its applicable parameters.The following abbreviations are used on the label.

Gen: The Rich-Mar ultrasonic generatorfor which the applicator is intended.

f: The operating frequency in MHz forthe applicator.

Area: The effective radiating area of theapplicator in square centimeters.

BNR: The Beam Nonuniformity Ratio.

Type: Coll-means collimating applicator.

Near Field/ Far Field:If measurements are made of the sound intensityalong the central axis of the beam produced by theapplicator, the intensity distribution shows maximaand minima near the applicator and then a gradualdecline beyond the last maximum intensity.The “interference” or “near field” is the area in theultrasound beam extending from the applicatorsurface to the location of the most distant intensitymaximum. In this area, maxima and minima ofintensity are located close to each other. This is thearea in which most therapeutic application occurs.This is shown in the following figure measured0.5cm from the transducer face.

or two square centimeters, depending upon the sizeof the transducer being used. The tolerance for theERA is +/-25% on the 2 and 5 square centimetertransducers. The tolerance for the 10 squarecentimeter transducers is +0. -25%. The Beam-Nonuniformity-Ratio (BNR) of any Rich-Martransducer is 5.5:1 or less.100% ModeWhen operated in the 100% mode, the generatorproduces a non-interrupted sinusoidal waveform ofone or three MHz. The peak power and averagepower are therefore the same.The error in indication of radiated power in intensityfor the continuous mode does not exceed +/- 14%allowing for a 6% error in the wattmeter, whichequals +/- 20%.Pulsed ModeWhen operated in the pulsed mode, the generatorproduces a square-wave burst of sinusoidal wave-form of one or three MHz of 2.5 milliseconds induration. Depending on the Rich-Mar model oftherapeutic ultrasound in use, the duty cycle can bechosen between 5% and 95% duty. This thenimplies the repetition rate is selectable between 20and 380 pulses per second. (This is computed bytaking the inverse of the duty cycle 1/380 = .95, 1/20 = .05). The tolerance for the pulsed mode is +/-20%.See the following chart for second comparison on%Duty Cycle to pulses.

% Duty Cycle Pulses/Second (Indicated on front panel of device)

5 2010 4015 6020 8025 10030 12035 14040 16045 18050 20055 22060 24065 26070 28075 30080 32085 34090 36095 380

The error in indication of radiated power in intensityfor the pulsed mode does not exceed +/- 14%allowing for an allowable 6% error in the wattme-ter, which equals +/- 20%.Timer AccuracyThe Food and Drug Administration requires that thetreatment timer accuracy is to within 0.5 minutesfor the preset duration of emission for settings lessthan five minutes, to within 10% of the presetduration of emission for settings from five to tenminutes, and to within one minute of the presetduration of emission for settings greater than tenminutes.Ratio of Temporal Peak to Temporal Average(Rtpa):The ratios of temporal peak to temporal averageintensities (Rtpa) will vary with the pulse rate of thedevice. Depending upon the Rich-Mar model oftherapeutic ultrasound in use, the duty cycle can bechosen between 5% and 95% duty.The ratios of temporal peak to temporal averageintensities (Rtpa) is calculated in the followingmanner:Rtpa = (1/Duty):1Example 5% duty = .05 (min. duty, max. Rtpa)Rtpa = (1/.05):1Rtpa = 20:1Example 95% duty = .95 (max. pulsed duty, min.Rtpa)Rtpa = (1/.95):1Rtpa = 1.05:1See the following chart for %Duty Cycle to Rtpacomparison.

% Duty Cycle Rtpa (Indicated on front panel of device)

5 20:110 10:115 8.33:120 5:125 4:130 3.33:135 2.86:140 2.5:145 2.22:150 2:155 1.82:160 1.66:165 1.54:170 1.43:175 1.33:180 1.25:185 1.18:190 1.11:195 1.05:1

The Rtpa tolerance does not exceed +/- 20%.The temporal maximum intensity for each dutycycle as well as the 100% modulation is whateveris indicated on the meter.

The temporal average intensity for each duty cyclewill be the meter indication multiplied by thepercentage duty cycle.

Temporal Average = (Duty) x (Meter Indication)Example, 5 Watts, 35% DutyTemporal Average = .35 x 5 Watts = 1.75 Watts

The Spatial Average Intensities for each of thesesetting will be divided by the transducer’s EffectiveRadiating Area (ERA)

Spatial Average = (Temporal Average)/(ERA)Example, 5 Watts, 35% Duty, 5cm2 Transducer

Spatial Average = (1.75 Watts)/(5cm2) = 0.35Watts/cm2

The pulse width (On time) of all Rich-Mar thera-peutic ultrasound devices is 2.5 milliseconds (mS).The time between pulses (Off time) in millisecondsis calculated as follows:

Pulse width (On time) = 2.5mSOff time = [2.5-2.5(%Duty cycle)]/(%Duty cycle)Where %Duty cycle is represented as a decimal.

Please see the following example for computing theOff time for a 10% Duty cycle:Off time=[2.5-2.5(0.10)]/(0.10)=22.5 milliseconds.

Additional Technical Notes:The peak power is the same in the pulsed modes asin the 100% modulated mode.Unless otherwise stated, all technical parametersare accurate within +/- 20%.When in the pulse modes the unit is still generatingtherapeutic heat, although it is an amount reducedby a factor directly related to the duty cycle. Thepulse rates are used to allow the practitioner totreat areas of bony prominences without creatingperiosteal pain.The line leakage is tested in both the forward andreverse polarities to be less than 50 microamperesexceeding all standards for medical devices in thisclass.The device is designed to meet or exceed ULStandards 544 for medical devices and the Cana-dian Standards Association (CSA No. 125).

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APPENDIX CSCHEMATICS