rich-mar therasound 3 series ultrasound …(therapeutic ultrasound) rich-mar ultrasound devices are...
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RICH-MAR THERASOUND 3 SERIESULTRASOUND OPERATIONHANDBOOK AND MANUAL
Part # MN 2430Rev. I
Batch 001
CAUTION
This device is not designed to be connected with any electrical equipment unless manufactured and ap-proved by Rich-Mar.
NOTE: This includes whirpools and carbon electrodes NOT manufactured by Rich-Mar.
CAUTION: When using carbon electrodes with any Rich-Mar stimulator, a moistened interface (cloth orsponge) MUST be utilized between these electrodes and the patient to avoid skin irritation and/or electricalburns.
TABLE OF CONTENTS
Therasound 3 Series Warranty..........................................6Ultrasound Indications for Treatment...............................7Ultrasound Contraindications & Warnings........................7Introduction....................................................................8Therasound 3 Series Operation........................................8
Therasound 3.1/3.2, 3.4, and 3.5 Front Panel Illustrations.........9Combining Therasound 3 Units with Stimulation........................10
Ultrasound Calibration & Tuning Procedure.....................11Trouble Shooting............................................................ 13Therasound 3 Series Specifications..................................13Changing the Voltage of the Therasound 3 Series..............14
Appendix AUltrasound Technical Information
Appendix BTherasound 3 Series Parts List
Appendix CTherasound 3 Series Schematics
LIMITED WARRANTY
This equipment is sold under an exclusive two-year warranty from date of sale, which warrants it to be freefrom defects in material and workmanship. We agree to repair or replace at the point of manufacture,without charge, all parts showing such defects, provided the unit is delivered to us, prepaid to our factory,intact for our examination, within two years from date of sale, and provided such examination discloses inour 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, has beendamaged by excess voltage or has been repaired or altered outside our factory or if the equipment has hadits 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 without incurringany liability to modify or change equipment previously delivered, or to supply new equipment in accordancewith earlier specifications. This warranty will be honored only if the enclosed card is filled out and returnedto 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, nor autho-rize any other person to assume for us, any other liability in connection with the sale or use of this equip-ment. In no event shall we be liable for consequential or special damages. We make no warranty whatso-ever in respect to accessories or parts not supplied by us.
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7
Ultrasound Indications for Treatment(Therapeutic Ultrasound)
Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following condi-tions:1) Relief of pain.2) Muscle spasms.3) Joint contractures.
But not for the treatment of malignancies.
WARNING - Federal law restricts this device to sale by or on the order of a physician or any other practitio-ner licensed by the law of the state in which said person practices.
Ultrasound Contraindications
ContraindicationsUltrasound should not be used in the following areas: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 the pregnant uterus.6) Directly over the spinal column.7) Over growing bone in children.8) Where the skin suffers from any sensory impairment.9) Over areas of malignancies.10) In the area of visceral plexus and large autonomous ganglion.11) Over the thoracic area if the patient is using a cardiac pacemaker.12) Over a healing fracture.13) Over ischemic tissues in individuals with vascular disease where the blood supply would be unable tofollow the increase in metabolic demand and 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 performed over an area of the spinal cord following laminectomy (i.e.-when major covering tissues have been removed).
Caution1) Excessive doses of ultrasound may cause damage to tissue. Periosteal pain is an indication of excessintensity and if it occurs, the power should be reduced; the transducer should be moved more rapidly over thearea being treated; or a lower pulsed duty cycle should be used.2) If the soundhead has been operated unloaded for an extended period of time, the transducer will get hot. Ifthe soundhead is applied to the patient while the transducer is hot, a burn may result.
WarningDo not operate the soundhead in an unloaded condition. It is possible that unrepairable damage may occur tothe transducer in an unloaded state.
To pause treatment, press the “Pause” button. Timewill stop flashing and the intensity will begin to flash.Notice that the ultrasound active indicator is no longerilluminated, indiacting that the treatment has beenpaused. To resume treatment, press the “Resume”button and the time will flash and the ultrasound activeindicator will illuminate. When the treatment time ends,a loud beep will sound and time will stop flashing andrevert to the last treatment time entered. The intensitywill revert to zero and the ultrasound active light willextinguish.
To stop a treatment, press the “Stop” button. Time willstop flashing and revert to the last treatment timeentered. Intensity will revert to zero and the ultrasoundactive light will extinguish.
All most recently used parameters, with the exceptionof intensity, will remain saved as the default param-eters after a treatment ends. To use the same treat-ment again, enter the desired intensity and press the“Start” button to begin.
Therasound 3.4 Operation (see Fig. 2, page 9)The Therasound 3.4 device is a dual-frequency (1MHzand 3MHz) ultrasound utilizing a 5cm2 transducer.
The unit is operated in the same manner as theTherasound 3.1, except that the user is able to choosebetween the 1MHz and 3Mhz frequencies. Afterchoosing the desired duty cycle, select the frequencyby pressing the corresponding button.
Therasound 3.5 Operation (see Fig. 3, page 9)The Therasound 3.5 device is a dual-frequency (1MHzand 3MHz) ultrasound utilizing the patented “TherapyHammer” 2cm2/5cm2 transducer. Continue with theoperation instructions for the Therasound 3.1.
The unit is operated in the same manner as theTherasound 3.1, except that the user is able to choosebetween the 1MHz and 3MHz frequencies and the2cm2 and 5cm2 transducers. After choosing thedesired duty cycle, select the frequency by pressingthe corresponding button. Then select the desiredtransducer (2cm2 or 5cm2) by pressing the “Trans-ducer” button. Continue with the operation instructionsfor the Therasound 3.1.
When finished making changes, return to the openingscreen by pressing stop/clear or start treatment bypressing the start button.
8
IntroductionThe Rich-Mar Therasound 3 series was designed toprovide therapy professionals with the best technologyat affordable prices. The Therasound 3 series offersthe most flexible treatment possibilities in a convenient,easy-to-use package.
This manual is meant to familiarize the user with thecontrols, operations, and ultrasound therapies availablein the Therasound 3 units. The simple control of theunits allow the user to master the units’ vast capabili-ties quickly and easily.
Therasound 3.1/3.2 Operation (see Fig. 1, page 9)The Therasound 3.1 ultrasound is a 1MHz unit utilizinga 5cm2 transducer and the Therasound 3.2 ultrasoundis also a 1MHz unit utilizing a 10cm2 transducer. Tooperate the unit, make sure that the power cord isplugged into the power receptacle on the back of theunit. The power receptacle is located below the On/Off switch. Turn the switch to the “1,” or on position.The device should then activate.
The Therasound unit will then go through a quickdiagnostic check where some letters and numbersappear on the display. This is normal. After the diag-nostic check green digits will appear in the time andintensity windows.
To set up a treatment, select the parameters desired bypressing their corresponding buttons. A beep will soundevery time a button is pressed on the device. Select theduty cycle (100%, 50%, 20%, or 10%) by pressing theDuty Cycle Select button. Then select the desiredtreatment time by pressing the “+” or “-” buttons in the“Time Set” area. Select how the intensity will bedisplayed, either in W/cm2 or Watts, by pressing theSelect button in the “Intensity” area. Set the intensityby using the “+” or “-” buttons in the “Intensity” area.
Once all treatment parameters have been set asdesired, apply ultrasound-coupling lotion or gel to thepatient and place the transducer on the patient. Pressthe “Start” button and the “Time” indicator will start toflash. This indicates that the treatment is running andtime is counting down. Notice that the green “Ultra-sonic Active” indicator light next to the soundheadcable on the front of the unit has activated. Thisindicates that the device is outputting ultrasound.
Please note that any treatment parameter may bemodified or changed while the device is operatingsimply by pressing the button corresponding to theparameter to be changed.
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Fig. 1 Therasound 3.1/3.2 front panel
Fig. 2 Therasound 3.4 front panel
Fig. 3 Therasound 3.5 front panel
NOTE: Ultrasonic Active LED is located next to the soundhead cable exiting below the front panel.
100%
10%20%50%
Select
Duty Cycle Pause/ResumeStart/Stop
Time - Minutes
Select
Intensity
Watts
W/cm2
Frequency
Select
Time - Minutes
Duty Cycle
100%
10%20%50%
3 MHz
1 MHzSelect
Start/Stop
Intensity
Select
WattsW/cm 2
Pause/Resume
Duty Cycle
Time - Minutes
50%20%10%
100%
Select
Start/Stop
Intensity
Select
W/cmWat t s
2
Pause/ResumeFrequency
3 M H z
1 M H zSelect
Transducer
Select5cm
2cm 2
2
Combining Ultrasound withRich-Mar Stimulation
The Rich-Mar Therasound 3 Series ultrasounds aredesigned to be connected to any Rich-Mar musclestimulator, thus enabling the user to provide combina-tion therapy to patients.
To connect the Therasound unit to a stimulator, simplyplug an electrode lead from the stimulator into the jackon the lower right rear side of the Therasound ultra-sound unit.
Using the indifferent electrode of the stimulator tocomplete the circuit with the soundhead of theTherasound, the user will be able to provide electricalstimulation as well as ultrasound through the trans-ducer.
CAUTION: When using a combination treatment, notethat both faces of the “Therapy Hammer” transducerwill output stimulation.
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Disinfecting RecommendationsTo disinfect the soundhead between therapy treat-ments, Rich-Mar recommends using a disinfectantcleaner for ultrasound. OSHA addresses the need forprudent infection control (OSHA Instruction CPL 2-2.33C) to include decontamination of equipmentbetween patients.
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Ultrasound Calibration andTuning Procedure
Ultrasound Service InformationRich-Mar Corporation recommends that all Rich-Marultrasonic therapy products be returned to the factoryor to a servicing Rich-Mar distributor for service orcalibration. It is recommended that the device becalibrated annually or when any major component ischanged.
CautionCalibration and peaking adjustments must not beattempted unless the person performing these adjust-ments has the proper test equipment, which mustinclude an acceptable ultrasonic wattmeter, such as theOhmic UPM-30 or equivalent. Degassed water mustbe used to obtain accurate readings (4 parts per millionof oxygen).
WarningUse of controls or adjustments or performance ofprocedures other than those specified herein mayresult in hazardous exposure to ultrasonic energy.
Calibration and Tuning Procedure
Tuning Frequency and Setting Voltage5cm @ 1MHz (applies to Therasound 3.1, 3.4, 3.5)1) Install the 5cm soundhead into the wattmeter
making sure that only the face of the transducer issubmerged. Zero the wattmeter.
2) Hold down the Start/Stop switch and turn on theunit. The software version should appear on thescreen.
3) Let off the Start/Stop switch and the frequency willappear on the screen for 5cm@1MHz. Find thefrequency peak and add 5kHz.
Note: Normal range of operation is 930 to 960.
4) Press Start/Stop switch and the voltage will appear.Set maximum output to 10 watts.
* If Therasound 3.1 see “Setting Thermistor Value” onnext page to complete calibration.
5cm @ 3MHz (applies to Therasound 3.4 and 3.5)1) ) Press the Start/Stop switch.
2) Find the frequency peak for 5cm @3MHz and add7kHz.
Note: Normal range of operation is 3050 to 3150.
3) Press the Start/Stop switch and the voltage willappear. Set maximum output to 10 watts.
* If Therasound 3.4 see “Setting Thermistor Value” onnext page to complete calibration.
2cm @ 1MHz (applies to Therasound 3.5 only)1) Press the Start/Stop switch.
2) Find the frequency peak for 2cm @ 1MHz and add5kHz.
Note: Normal range of operation is 950 to 980.
3) Press the Start/Stop switch and the voltage willappear. Set maximum output to 4 watts.
2cm @ 3MHz (applies to Therasound 3.5 only)1) Press the Start/Stop switch.
2) Find the frequency peak for 2cm @ 3MHz and add5kHz.
Note: Normal range of operation is 3050 to 3150.
3) Press the Start/Stop switch and the voltage willappear. Set maximum output to 4 watts.
* If Therasound 3.5 see “Setting Thermistor Value” onnext page to complete calibration.
Note:Therasound 3.1 - you need to complete only the
5cm @ 1MHz portion.Therasound 3.2 - you need to complete only the
10cm @ 1 MHz portion.Therasound 3.4 - you need to complete both the
5cm @ 1 MHz and the 5cm@3 MHzportions.
Therasound 3.5 - you need to complete the 5cm @1MHz, 5cm @ 3MHz, 2cm @ 1MHz, and2cm @ 3MHz portions.
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Cable DiagnosticTherasound units are equipped with a diagnosticfeature that will detect a broken cable. The diagnosticcheck is run when the device is powered on. If thedevice detects a variation in cable connection it willdisplay 7E S7 (test) on the display for 2 seconds.If this occurs, conduct the water test outlined in theOutput Trouble section on page 9. If the water doesnot cavitate, or bubble, the device may have a brokencable or it may need to be tuned and calibrated. If thedevice is outputting ultrasound, there may have been aslight variation in the diagnostic. Rich-Mar recom-mends that the device be calibrated at least once everyyear.
10cm @ 1MHz (applies to Therasound 3.2 only)1) Install the 10cm soundhead into the wattmeter
making sure that only the face of the transducer issubmerged. Zero the wattmeter.
2) Hold down the Start/Stop switch and turn on theunit. The software version should appear on thescreen.
3) Let off the Start/Stop switch and the frequency willappear on the screen for 10cm@1MHz. Find thefrequency peak and add 5kHz.
Note: Normal range of operation is 900 to 950.
4) Press Start/Stop switch and the voltage will appear.Set maximum output to 20 watts.
Complete calibration by Setting the Thermistor Value.
Setting the Thermistor Value1) After the last frequency and voltage calibration has
been made, press Start/Stop. Verify that thesoundhead temperature thermistor value is set at“H0 73.”If so, press Start/Stop to enter this number.
If not, set at H0 73, using the “+” or “-” switches toobtain the correct reading. Once setting is correctpress Start/Stop twice.
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Therasound 3 Series Specifications
Therasound 3.1/3.2Dimensions: 7.5"W x 7.5"D x 4"H
Weight: 5.5 lbs.
Power Input: 115 VAC, 1.0 A, 60Hz or230 VAC, 0.5A, 50Hz
Output: 0-2 w/cm2
SoundheadERA: 5cm2 - 3.1
10cm2 - 3.2
Frequency: 1MHz
BNR: 5.5:1 maximum
Therasound 3.4Dimensions: 7.5"W x 7.5"D x 4"H
Weight: 5.5 lbs.
Power Input: 115 VAC, 1.0 A, 60Hz or230 VAC, 0.5 A, 50Hz
Output: 0-2 w/cm2
SoundheadERA: 5cm2
Frequency: 1MHz & 3MHz
BNR: 5.5:1 maximum
Therasound 3.5Dimensions: 7.5"W x 7.5"D x 4"H
Weight: 5.5 lbs.
Power Input: 115 VAC, 1.0 A, 60Hz or230 VAC, 0.5 A, 50Hz
Output: 0-2 w/cm2
SoundheadERA: 2cm2 & 5cm2
Frequency: 1MHz & 3MHz
BNR: 5.5:1 maximum
Trouble-ShootingRich-Mar Corporation takes pride in its TechnicalSupport Hotline: 1-918-543-2222. We have an out-standing staff ready to take your calls and help withdiagnosing and troubleshooting problems. Listed beloware several options for troubleshooting the Therasound3 Series.
1.) The device fails to turn on.Check to verify that the power cord is fully pluggedinto the corcom power entry module below the ACswitch on the rear of the device. Also verify that thepower cord is fully plugged into the AC wall outlet.
Check the fuse to verify that it has not blown.CAUTION: To ensure personal saftey, unplug the unitbefore checking the fuse.
2.) Ultrasonic Active LED fails to illuminateVerify that the soundhead connections are pluggedfirmly into the main board.
3.) Display reads “HEAd.”The “HEAd” warning is a safety feature wherein thesoundhead temperature shuts off to avoid overheating.This warning occurs when the soundhead overheats,usually due to an un-coupled or poor coupling situation.Turn the device off for 3-4 minutes to allow it to resetand turn it back on and begin treatment. If the“HEAd” warning is still displayed, please call thefactory.
When using the Therasound 3.5, check that thesoundhead in use is active. Also, be sure to use anadequate amount of coupling gel or lotion specificallydesigned for ultrasound transmission.
Output TroubleshootingRich-Mar suggests that ultrasound output be testedonce a week. To do this, turn on the device and start atreatment at 100% output. The outputting head shouldbe facing up towards the user. Pour some water on thesoundhead and increase the intensity. If the device isoutputting ultrasound, the water should cavitate, orbubble, on the soundhead.CAUTION: Do not operate the ultrasound in an“unloaded” condition for more than one minute atintensities greater than 1.0 W/cm2. It is possible thatthe transducer may overheat and damage the unit.
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Changing the Voltage from 115V to 230VWARNING: RISK OF ELECTRICAL SHOCK.
Unplug unit prior to changing the voltage from 115 to 230.
1. After unplugging the unit, openthe outlet cover with a flatheadscrewdriver by inserting it into thenotch on the top.
2. Once the outlet cover is open,insert the flathead screwdriver intothe notch on the top of the redvoltage converter.
6. Finally, close the outlet cover, ensuring that thedesired voltage appears through the window in theoutlet cover. Also be sure to use an adapter forthe AC plug to suit local wall outlets in use.
3. Holding the regulator so that115V is right-side up, remove the1amp slow blow fuse from the rightside.
4. Rotate the regulator until 230Vis right-side up. Remove the clipfrom the right-hand side and inserttwo .5amp slow-blow fuses, oneon each side.
5. SAVE THE CLIP AS IT IS NEEDED TO SWITCH BACK TO115V. After correct fuses are inserted into each side, insert the regulatorinto the slot with 230V reading right-side up.
115V to 230V Quick Check, Take out 1amp slow blow fuse and remove clip on back of 230V side., SAVE CLIP, Insert two .5 amp slow blow fuses., Insert regulator with 230V appearing through the window in outlet cover.
Changing the Voltage from 230V to 115VWARNING: RISK OF ELECTRICAL SHOCK.
Unplug unit prior to changing the voltage from 230 to 115.
1. After unplugging the unit, openthe outlet cover with a flatheadscrewdriver by inserting it into thenotch on the top.
2. Once the outlet cover is open,insert the flathead screwdriver intothe notch on the top of the redvoltage converter.
3. Remove the two .5 amp slowblow fuses from the voltageregulator.
4. Hold the regulator so that230V is right-side up. Insert theclip into the right-hand side of theregulator.
5. Rotate the regulator so that 115V is right-side up and insert one 1amp slow blow fuse into the right side. Insert the regulator into the slotin the unit with 115V reading right-side up.
6. Close the outlet cover, ensuring that 115V appears through thewindow in the outlet cover. Also be sure to use an adapter for theAC plug to suit local wall outlets in use.
230V to 115V Quick Check, Take out the two .5 amp slow blow fuses., INSERT THE CLIP INTO THE RIGHT HAND SIDE OF THE 230V REGULATOR, Insert one 1 amp slow blow fuse., Insert regulator with 115V appearing through the window in outlet cover.
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APPENDIX AULTRASOUND TECHNICAL INFORMATION
Near Field Distribution
Beyond this point, the beam has a more uniform intensityand is called the “far field”. Below is shown the far fielddistribution at 16cm from the transducer face.
Far Field DistributionThe preceding descriptions apply for radiation emittedinto the equivalent of an infinite medium of distilled,degassed water at 30°C and with line voltage variationsin the range of +/-10% of the rated value
Transducer Parameters and Tolerances:The Rich-Mar ultrasound units operate at frequencies ofeither 1MHz or 3MHz +/- 10%. The effective radiatingareas (ERA) of the transducers are ten, five,
Ultrasound TechnicalInformation
Applicator Type:The ultrasonic radiation fields produced by Rich-Martherapeutic ultrasound transducers are of the planewave type and are essentially cylindrical in shape. Thistype of applicator is referred to as a collimatingapplicator.
Applicator Label:Each Rich-Mar applicator is labeled to provide the userwith information on its applicable parameters. Thefollowing 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 intensity alongthe central axis of the beam produced by the applica-tor, the intensity distribution shows maxima and minimanear the applicator and then a gradual decline beyondthe last maximum intensity.The “interference” or “near field” is the area in theultrasound beam extending from the applicator surfaceto the location of the most distant intensity maximum.In this area, maxima and minima of intensity arelocated close to each other. This is the area in whichmost therapeutic application occurs. This is shown inthe following figure measured 0.5cm from the trans-ducer face.
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or two square centimeters, depending upon the size ofthe transducer being used. The tolerance for the ERAis +/-25% on the 2 and 5 square centimeter transduc-ers. The tolerance for the 10 square centimetertransducers is +0. -25%. The Beam-Nonuniformity-Ratio (BNR) of any Rich-Mar transducer is 5.5:1 orless.
100% ModeWhen operated in the 100% mode, the generatorproduces a non-interrupted sinusoidal waveform of oneor three MHz. The peak power and average powerare 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, which equals+/- 20%.
Pulsed ModeWhen operated in the pulsed mode, the generatorproduces a square-wave burst of sinusoidal waveformof 1MHz or 3MHz of 2.5 milliseconds in duration.Depending upon the Rich-Mar model of therapeuticultrasound in use, the duty cycle can be chosen be-tween 5% and 95% duty. This then implies the repeti-tion rate is selectable between 20 and 380 pulses persecond. (This is computed by taking the inverse of theduty cycle 1/380 = .95, 1/20 = .05). The tolerance forthe 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% allowingfor an allowable 6% error in the wattmeter, whichequals +/-20%.
Timer AccuracyThe Food and Drug Administration requires that thetreatment timer accuracy is to within 0.5 minutes forthe preset duration of emission for settings less thanfive minutes, to within 10% of the preset duration ofemission for settings from five to ten minutes, and towithin one minute of the preset duration of emission forsettings greater than ten minutes.
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 Rtpa is calculated in the following manner: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 duty cycleas well as the 100% modulation is whatever is indi-cated on the meter.
The temporal average intensity for each duty cycle willbe the meter indication multiplied by the percentageduty 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) = 0.35 Watts/cm2
The pulse width (On time) of all Rich-Mar therapeuticultrasound devices is 2.5 milliseconds (mS). The timebetween pulses (Off time) in milliseconds is calculatedas 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 as inthe 100% modulated mode.Unless otherwise stated, all technical parameters areaccurate within +/- 20%.When in the pulse modes the unit is still generatingtherapeutic heat, although it is an amount reduced by afactor directly related to the duty cycle. The pulserates are used to allow the practitioner to treat areas ofbony prominences without creating periosteal 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 UL Stan-dards 544 for medical devices and the CanadianStandards Association (CSA No. 125).
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APPENDIX BPARTS LIST
The
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8364
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PIN
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1660
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The
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ts L
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r(s)
Par
t Num
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ries
Par
ts L
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Ref
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ce D
esig
nato
r(s)
Par
t Num
ber
Des
crip
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Q
ty/B
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52
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51
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52
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53
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51
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51
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The
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3 Se
ries
Par
ts L
ist
Ref
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ce D
esig
nato
r(s)
Par
t Num
ber
Des
crip
tion
Q
ty/B
oard
.U
16IS
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1016
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SP, 6
4K G
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8-B
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8402
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100
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080
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