Dynatron 125 Service manual
Contents
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3. 35 O REC mS QUO OE RENDIR ud Dat 37 Soundhead Temperature Too eire ra det oa de e RU ad RE eda ete 37 Cooling the Sound Mead ee 37 eese aset ei ebur cas elites auta dubai 37 soundhead Temperature Too Coll 5 ssec etie e est es tue desde ue 38 Error Message mile SDA loss Icio lane r 38 Sending a Unit for Repair 39 Ret rn AuthorizatilOn ds ii 39 Why the Information is NeCESSA ceinion E A 39 Packaging and Shipping of Replacement 40 Index Dynatron 125 Installing Software Updates gt lt 41 Installing Replacement Parts 41 Medical Device Reporting gt 9 41 Schematics and QC Check 1 16065 42 Index Dynatron 125 Dynatron 125 Introduction to the Dynatron 125 Your new Dynatron 125 gives you a wide range of treatment capabilities yet it is compact convenient and simple to use You ll appreciate the user friendly touch panel for easy treatment setup With the Dynatron 125 you can select two different frequencies without changing the soundhead The 2 5 cm and 10 cm soundheads each operate at 1 and 3 MHz The desired frequency is easily selected during treatment setup Here are some additional highlights of your Dynatron 125
4. 6 6 Turn Soundhead Warming Off Or y Se po 7 Modify Lreatment ti PrOSTOSS 8 Patient S roles ee 9 Ultrasound Couplins Bar aan occi 9 Head Temperature Bar OM A a 10 HEAR ed a uns e o od 11 No Soundhead A 11 Display Watts Mi 12 Restore Factory Defaults es 12 Battery 13 14 ee e ds deleti te 14 Ultrasound With Electrical 15 Ultrasound General Information and Usage Cautions eee eee ee eren 16 Selecting the Appropriate SOU hd 16 of Ultrasound WAVES a 17 Types a 18 Treatment Te TER 18 nee A DD 18 MS e E sis oda cls shale 19 Continuous Verses Pulsed Ultrasound esu qose A 19 ele aseo D otia 20 Patient S sceptibility ii tero vx tta i NEU e UE IR RENE 20 Potential for Burns or Periosteal Pain ete esa tL Sene joa 2
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6. Ir 0 0000 C Pause appear in the POWER DISPLAY window If this error occurs check to be sure the soundhead is firmly plugged into its HEAD Error This error message indicates the soundhead is not plugged in or for some reason i not being detected by the device connector If you are unable to clear the message by reconnecting the soundhead contact Dynatronics customer service department for assistance Treatment Instructions 11 Dynatron 125 Display Watts or Watts cm Power for the Dynatron 125 may be displayed as WATTS or WATTS cm The default setting for power is WATTS cm but you may select the display you prefer at any time before or during a treatment PAUSE 9 e To change the power Press both the UP and DOWN display press both the arrow keys at the same time to POWER UP and DOWN change the display arrow keys at the same Dynatron 125 Power Display You can view power in time To change back just either WATTS cm Watts press both keys again simultaneously A non blinking decimal Power displayed Watt cmz A blinking decimal Power displayed in Watts The power display setting you choose remains in effect until you change it again e You can tell when you have selected WATTS or WATTS cm by the decimal in the POWER DISPLAY window A steadily lighted decimal means the power is displayed in WATTS cm A blinking decimal means the
7. d Select 10 Duty Cycle With the 10 LED lighted enter 0 zero as the value for Coupling The coupling feature is not available with old style soundheads 6 Store New Parameters After you have entered all parameters press START to store them in the device s memory Then press STOP to exit this mode The above procedure must be performed for each separate soundhead for the device Turn the device off before attaching the next soundhead then turn the device on again with the soundhead firmly plugged in Enter Soundhead Parameters 34 Dynatron 125 Calibration Procedure With the exception of calibration all service on the Dynatron 125 device should be performed by a Dynatronics service technician If your Dynatron 125 requires service contact Dynatronics Customer Service at 800 874 6251 The calibration procedure MUST be performed by a qualified Ultrasound technician using the proper equipment Calibration may be performed either by Dynatronics or by an Ultrasound technician in your local area When to Calibrate Dynatronics recommends that the Dynatron 125 be calibrated annually to ensure the unit is working at its peak performance What to Calibrate You must calibrate all soundheads used for this device at both 1 and 3 MHz frequencies Equipment Required You will require an Ultrasound power meter capable of accurately measuring outputs up to 3 MHz Check the manufacturer s specifications to confirm your power m
8. Annually e Annual Ultrasound calibration should be performed by a qualified technician Inspect soundhead connectors on unit and on soundhead MAINTENANCE PERFORMED BY USER 1 Inspect accessories daily for wear and damage Examine cables and connectors on the cables for any visible sign of wear or damage Replace accessories as needed 2 Examine Ultrasound heads periodically for cracks which may allow ingress of conductive fluid 3 Ifa machine or soundhead is dropped or if it sustains damage due to lightning severe power surge submersion in water or other incident that could cause damage to electronic components the device must be examined by a Dynatronics technician before being returned to clinical use 4 For older devices contact Dynatronics or your Dynatronics dealer for information and pricing for current upgrades to your device Even if the machine is functioning properly you can send it to Dynatronics for preventative maintenance service for a nominal charge call for pricing 5 Immediately report any device malfunction to Dynatronics Customer Service Department Technical Specifications 25 Dynatron 125 NOTE BEFORE sending a device to Dynatronics for service you must FIRST obtain a return authorization number Call Dynatronics Customer Service Department at 801 568 7000 or Email to info dynatron com and discuss any problems or required service to save time and ensure the machine is returned to yo
9. Customizable Duty Cycle Select from 10 20 50 percent and Continuous duty cycle options Head Warming When the device is ON but idle the soundhead is warmed automatically Head warming may be turned OFF if it is not desired Coupling Sensing If coupling becomes inadequate during a treatment the displays flash and an audible beep is sounded to notify the user that coupling should be corrected If your device is version 1 04 or above a bar graph will appear Modify Treatments in Progress You can modify treatment time power frequency or duty cycle while a treatment is in progress It is not necessary to stop the treatment e Portable The Dynatron 125 s small light weight size makes it readily portable An optional carry case is available from your Dynatronics dealer Optional Battery Operation The device may be operated with power supplied by an optional battery offering greater flexibility in treatment sites This manual provides instructions for Ultrasound setup and treatment with the Dynatron 125 Please read this manual particularly the section on contraindications warnings and precautions before treating a patient with this device About Ultrasound Ultrasound therapy is supported by a wealth of scientific literature Channeling sound waves through muscle nerve bone and connective tissue has been documented to aid in reducing pain muscle spasms and joint contractures The Ultrasound Usage Cautions in
10. should be illuminated indicating the ED 2cm2 2 soundhead is now ready to be calibrated for 5 02 5 this frequency If it is not press the toggle 10 cm2 10 key to select 1 MHz now 3 Press STOP and TIME UP ARROW Sound Heads Time Display only simultaneously to enter the Temperature E 2cm2 H2 Mode The temperature of the soundhead is 5cm2 H5 displayed in the time display window The 10 H10 soundhead must be at a temperature between 72 and 75 degrees If the soundhead is not within this range warm the water and or the head before continuing Press STOP to get out of the temperature mode At this point there is zero output from the device Zero the scale on your Ultrasound power meter now When the scale is at zero on your power meter press the START key to begin 4 Press the UP DOWN ARROW keys located next to the Power display window on the Dynatron 125 until the power meter shows 1 0 W cm 5 When the watts reading on the meter is at 1 0 W cm for the soundhead and the reading is stable press the DUTY CYCLE toggle key this is the key that selects 1096 2096 5096 or Continuous 6 The Dynatron 125 performs the calculation internally for the 7 impedance value and the coupling value These values are automatically entered and stored in the Head Parameters for the device this operation is automatic and invisible to the user Record these values on the c
11. NOTE The Dynatron 125 is accurate to within 1 of any treatment time Pursuant to FDA 21CFR 1050 10 f 1 the uncertainties in magnitude expressed in percentage error of the ultrasonic frequency effective radiating area and the ratio of the temporal maximum to temporal average effective intensity pulse duration and pulse repetition rate for the Dynatron 125 are as follows Ultrasound Regulation 28 1 2 3 4 5 Dynatron 125 Ultrasonic frequency 15 Effective Radiating Area 50 Ratio of the temporal maximum to temporal average effective intensity 20 Pulse eodeni rete 10 Pulse repetition 10 29 Ultrasound Regulation Dynatron 125 Beam Profile The following diagrams show the typical spatial distribution of the radiated field for each size of Dynatron 125 soundhead This applies to the radiation emitted into the equivalent of an infinite medium of distilled degassed water at 30 C and with line voltage variations in the range of 10 percent of the rated value 10 cm Head Near Field dein Id ge ques 4 MUS 15171 W i M Vy 7 M i TU ESTE MAE CE ed SM s A Lo eerie 2 44 vM AN x ag
12. see Ultrasound Usage Cautions in this manual Do not hold the soundhead in the air Treatment Instructions Dynatron 125 as this will cause the soundhead to overheat The device provides coupling sensing to help you know when coupling is not adequate This feature is discussed later in this manual 6 Press START When you press START power is delivered to the soundhead and the treatment timer begins counting down When the timer reaches zero output power is stopped 7 Treat Administer the treatment using your preferred Ultrasound protocol Modify any treatment parameters during the treatment if desired Maintain good coupling throughout the treatment 8 Stop Treatment At any time during the treatment you can stop the treatment by pressing STOP on the keypad When STOP is pressed during a treatment the timer goes to zero the output power is stopped and a chime sounds If you press PAUSE during the treatment the output stops and the timer stops counting down but the treatment may be resumed by pressing PAUSE again or START IMPORTANT For patient safety and comfort it is recommended that you start with 0 1 W cm and then increase power to the desired level after the treatment begins Modify a Treatment in Progress The following parameters may be modified during a treatment Frequency Press the FREQUENCY TOGGLE key Duty Cycle Press the DUTY CYCLE TOGGLE Time Press the UPDOWN ARROWS to increase
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14. RESET EAR Beam Profile 30 Dynatron 125 2 cm Head Near Field 3 MHz 1 MHz Beam Profile 3l Dynatron 125 Enter Soundhead Parameters New Smart Heads The Dynatron 125 features a new Dynatronics soundhead that has all calibration information self contained With the new Smart Head it is not necessary to enter soundhead parameters as with earlier Dynatron devices The new Smart Heads can be used with all 50 Series PLUS models Do not use Smart Heads with former Dynatron devices including Dynatron 150 850 950 800 or 300 Using Older Model Soundheads Soundheads that were designed for use with the earlier Dynatron 50 Series products may be used with the new Dynatron 125 However these earlier models do not have the calibration information self contained and it will be necessary for you to enter the unique parameters for that soundhead into the Dynatron 125 before using the soundhead The following instructions are provided only in the event you need to enter soundhead parameters Be sure to follow these steps carefully to ensure you have entered all parameters correctly The procedure utilizes keys and displays on the key pad that are normally used for other purposes but which have specialized applications in the Head Parameters Mode If you have any questions about the following instructions contact Dynatronics Customer Service Department before proceeding NOTE The following procedure IS NOT
15. Set up the Stim treatment for the appropriate channel on the Dynatron electrotherapy device Use very low stim intensity for this type of treatment 4 START the treatments at both devices During the treatment the Stim current is delivered through the soundhead and will pass between the soundhead and the electrode which was placed on the patient At the same time ultrasonic waves are introduced into patient tissue through the soundhead Avoid touching the electrode with the soundhead during the treatment and keep the Stim intensity low Ultrasound With Electrical Stim Input 15 Dynatron 125 Ultrasound General Information and Usage Cautions Ultrasound by its very nature has the ability to irritate the patient s skin While the benefits of Ultrasound far outweigh any disadvantages certain precautions should be observed to assure maximum safety and comfort for your patients A patient s tendency to have adverse reactions to Ultrasound is dependent upon several factors Some of these factors are discussed below In addition to cautions listed below read the contraindications warnings and other precautions in this manual Selecting the Appropriate Soundhead head crystal handle head 10 cm head head head crystal crystal handle 2 head handle head 5 cm head 2 head Crystal Area Size 10cm 4
16. are available in 2 cm 5 cm and 10 sizes Each soundhead operates at 1 and 3 MHz The soundheads are waterproof allowing therapy to be administered in water if desired Information regarding calibration of soundheads is provided later in this manual Installation amp Features Dynatron 125 Treatment Instructions CAUTION Use of controls adjustments or performance of procedures other than those specified herein may result in hazardous exposure to ultrasonic energy WARNING ALWAYS keep the applicator soundhead in constant motion ALWAYS keep the soundhead properly coupled to the patient s skin or submerged under water when intensity is turned ON Read and observe the contraindications warnings and precautions provided in this manual Be sure to read all instructions given in this manual before treating a patient Make sure a soundhead is firmly plugged into the device before turning ON the device When changing to a different size soundhead turn the machine OFF first remove the soundhead plug in the desired soundhead then turn the machine ON again Press the power switch on the back of the device to turn on the Dynatron 125 It is recommended that the unit remain ON throughout the day if it is used regularly If the device is being powered by the optional battery unplug the battery or turn the battery OFF after treatment has ended to save battery power When the unit is first powered ON it goes th
17. be cooled soundhead becomes too hot the HOT error messag down before the treatment can resume is displayed and the treatment is paused until the Once the soundhead is cooled press soe ads cooled PAUSE or START to resume the treatment If the soundhead is still too hot the device will not allow you to continue The soundhead will cool slowly if placed in the soundhead holder or if held exposed to the air Larger soundheads take longer to cool than smaller heads To resume the treatment right away you can place the soundhead in cool room temperature water to cool the head more quickly NEVER USE ICE OR ICE PACKS TO COOL THE SOUNDHEADS as this is likely to cause thermal shock to the electronic components of the soundhead and may necessitate costly repair Heads damaged by thermal shock are not covered by the warranty To prevent overheating of the soundhead maintain good coupling throughout the treatment For direct coupling you may need to apply more conductive gel or lotion during the treatment to achieve better coupling You can reduce the power during the treatment if you are treating an area where itis difficult to obtain good coupling No Soundhead HEAD ERROR No Soundhead If the device cannot detect a soundhead during setup or delivery of an Ultrasound TIME STAAT treatment the error message HEAD is A Maus displayed in the TIME DISPLAY A number from 0 3 will simultaneously
18. be given If the result desired has not been reached by this point Ultrasound may not be the proper choice EXCEPTION Some Chronic conditions which cause adhesions Continuous Verses Pulsed Ultrasound Ultrasound can be delivered in one of two modes Continuous means that the ultrasound energy is delivered uninterrupted form the time the intensity is raised until it is lowered again to zero Pulsed means that some of the time during every second the sound energy is interrupted The peak intensity might be set the same for two treatments one given continuously and the other given in a pulsed mode 1 Less total energy will be given in the pulsed mode 2 Pulsed sound is often used when less thermal effect is desired NOTE The same result could be accomplished by lowering the intensity in continuous mode 3 Pulsed sound may have applications for wound management Ultrasound Usage Cautions 19 Duty Cycle Dynatron 125 Duty Cycle is when the Ultrasound energy is subjected to regular and predictable interruption pulsed or no interruption continuous The Dynatron 125 can be set at 1096 2096 5096 or continuous Continuous is 10096 5096 Duty Cycle means that during every second of treatment there is as much OFF time as ON time usually microsecond pulses 2096 means there is four times as much OFF time as ON time Every second has 20 of the time when energy is flowing and 8096 when it is not 1096 means that for ev
19. electrotherapy device may be plugged into this jack The current from the Stim device is delivered through the soundhead BATTERY INPUT This input located on the back of the device provides connection to an optional battery power source Only a Dynatronics approved battery may be used TIME DISPLAY Treatment time is displayed in this window TIME SELECTION UP DOWN ARROW keys are used to set or change the treatment time Press the UP ARROW key to increase time and press the DOWN ARROW key to decrease the treatment time FREQUENCY KEY This key is pressed to select the desired frequency during treatment setup or while a treatment is in progress Select from 1 or 3 MHz Continue pressing the FREQUENCY key until the desired frequency is selected FREQUENCY DISPLAY LED lights indicate the frequency that is chosen for the current treatment Selection is made by pressing the FREQUENCY key DUTY CYCLE KEY This key is pressed to select the desired duty cycle during treatment setup or while a treatment is in progress Select from 10 20 50 percent or Continuous duty cycle Continue pressing the DUTY CYCLE key until the desired duty cycle is selected DUTY CYCLE DISPLAY LED lights indicate the duty cycle that is chosen for the current treatment Selection is made by pressing the DUTY CYCLE key START When this key is pressed the selected treatment starts The timer begins counting down and output from the soundhead is started STOP Pres
20. enter the values shown for Fl Z and TEMP Enter the numbers as follows a Select CONT Duty Cycle The CONT and 1 MHz LEDs are lighted Enter the value for F1 1 MHz by pressing the time selection keys until the desired value is displayed in the time display Use the Time Selection up down keys to enter the desired number The value you enter is displayed in the TIME display Press and hold the up or down key to move more quickly to the desired number or press and release the key to step up or down one digit at a time b Select 50 Duty Cycle With the 50 LED lighted enter the value for Z 1MHz c Select 20 Duty Cycle With the CONT LED lighted enter the value for Temp 1 MHz d Select 10 Duty Cycle With the 10 LED lighted enter 0 zero as the value for Coupling The coupling feature is not available with old style soundheads 5 Enter 3 MHz Values Press the FREQ key to select 3 MHz Make sure the 3 MHz LED is lighted Locate the 3 MHz column on the printout and enter the numbers as follows a Select CONT Duty Cycle The CONT and 3 MHz LEDs are lighted Enter the value for F1 3 MHz by pressing the time selection keys until the desired value is displayed in the time display b Select 50 Duty Cycle With the 50 LED lighted enter the value for 2 3 MHz Enter Soundhead Parameters 33 Dynatron 125 c Select 20 Duty Cycle With the CONT LED lighted enter the value for Temp 3 MHz
21. not substitute the Dynatron battery without first confirming with Dynatronics that the battery you are purchasing may be used with this device Battery Adapter Cord Cigarette lighter plug on one end to attach to the battery pack and a barrel plug on the other end to fit a 325 barrel jack The cord must be a high quality gauge wire Radio Shack carries a high quality cord that is recommended Cat No 270 1534D This cord comes with a 2 amp fuse which must be replaced with a 5 amp fast blow fuse Note If a low quality gauge cord is used you can get the BATT LO error when the battery is not low Battery Life The length of time that a unit can be used with a battery pack is dependent on several factors The amperage of the battery pack A larger amperage will provide longer use The modality used Ultrasound requires more power than stim modalities The intensity of the treatments The higher the intensity the higher the consumption of power The amount of charge remaining on the battery As a general rule the unit may be run continuously for 30 minutes to several hours depending on these factors Battery Operation 14 Dynatron 125 Ultrasound With Electrical Stim Input The Dynatron 125 allows you to combine electrical stim therapy with Ultrasound therapy The device accepts input from electrotherapy devices through the Stim Input jack found on the back of the device This jack accommodates
22. repair again writing the steps taken to repair the unit listing the parts used and recording the time taken in the repair The technician dates and signs the form The unit then receives a final quality assurance QA inspection by quality control staff member who signs the RA form indicating the QA is complete One copy of the RA form is returned to the user with the unit This tells the dealer and the user what was done to the unit while it was in for repair Why the Information is Necessary Dynatronics like all medical manufacturing companies is required by the FDA to keep records on all units sold This record consists of 1 the date the unit was sold 2 to whom it was sold 3 any problems the customer has with that unit in the field and 4 any information on repairs performed on the unit Sending a Unit in for Repair 39 Dynatron 125 The information collected also helps us improve the unit s performance It helps us to identify trends and allows us to pinpoint a manufacturing or engineering change that will make the unit function more reliably Packaging and Shipping of Replacement Parts defective or broken parts should be shipped back to Dynatronics in the original shipping container These containers are designed to withstand the punishment of shipping If the original containers are not usable find containers that are similar in protection so damage in shipping will be prevented The person or company sending the
23. this manual provide some general guidelines for Ultrasound treatment to help ensure you deliver safe and effective treatments to your patients Further information about Ultrasound may be obtained from published medical literature Before using your Dynatron 125 be sure to read the operating instructions contraindications warnings and precautions contained in this manual Introduction Dynatron 125 Installation and Features Unpacking When you receive the unit immediately unpack it and all accessories and check for possible damage obvious or concealed In case of damage immediately notify the carrier and take any steps necessary to file a claim for the damage sustained Do not destroy or discard the shipping carton The carton should be reused if the device must be shipped for any reason The carton is specially designed to protect the unit from shipping damage Improper packaging of the unit during transport can result in damage and invalidate the warranty Complete the warranty registration form found at the back of this manual and return it to Dynatronics within 30 days of purchase This is essential to insure you are not billed for services that are covered by the warranty policy Connect the AC power cord which is equipped with a hospital grade UL listed plug to a properly grounded 110 120V 60 Hz AC outlet The device will automatically switch to 220 240V 50 Hz when connected to a power source with that voltage Do
24. twice the size of the soundhead in area The full surface of the soundhead should maintain contact with the patient s skin except with underwater treatments If all or part of the soundhead is not touching the patient coupling may not be adequate and the patient will not receive the intended dosage of the ultrasonic wave and or the soundhead may warm up very quickly Ultrasound Coupling Bar Graph APPLIES ONLY TO VERSIONS 1 04 AND ABOVE During an Ultrasound treatment you can display a bar graph to indicate coupling that is whether adequate contact is being maintained between the soundhead and the patient s skin The bar graph uses the eight segments in the top half of the TIME DISPLAY with eight lighted segments indicating best conductance and one lighted segment indicating poorest conductance In the illustration below eight of the eight segments are lighted indicating best coupling Press the START and the Time UP arrow keys simultaneously during an ultrasound treatment to view a graph showing soundhead coupling Press the START key to return to the treatment time display TIME M stant E 8 5 jy Ultrasound Coupling Bar Graph Coupling Bar Graph Eight lighted segments indicate good coupling between patient and soundhead Treatment Instructions Dynatron 125 To correct poor coupling make sure you using an adequate amount of Ultrasound conductive gel
25. unit to Dynatronics is responsible for any shipping damage resulting from a poorly packaged part or unit Sending a Unit in for Repair 40 Dynatron 125 Installing Software Updates Features and function of this device may be updated from time to time by the manufacturer Such updates are installed via the port on the device using a handheld download device which is available from Dynatronics It is recommended that a Dynatronics dealer perform the software update for you This will ensure the software update is installed successfully and will save you the expense of purchasing the separate download device If you have registered your product warranty with the manufacturer you will be notified of any software updates that may become available in the future Installing Replacement Parts Since software updates for the Dynatron 125 are provided from an external connection it is not necessary to replace the EPROM in the device This device is not generally serviceable in the field If you wish to perform any service on the device or replace any internal parts you must first contact Dynatronics Customer Service for guidance Keep in mind that if the device is serviced or altered by anyone except authorized Dynatronics service personnel the warranty on the device is invalidated For service assistance contact Dynatronics Service Department at 1 800 874 6251 Medical Device Reporting Requirements Under the Safe Medica
26. 0 1 1 Clause 2 1 4 and 1 2 5 Clause 50 1 Frequency 10 3Mn 1Mhz Effective Radiating Area 20 in cm2 NES Rated Output Power within 20 inW_ 8 83 17 10 Effective Intensity at Rated Output Power 2 3 2 45 2 48 1 45 in W cm2 Beam Maximum Intensity W cm2 13 458 BNR Beam Nonuniformity Ratio 30 Beam Type collimated divergent convergent Collimated Collimated Collimated Pulse Duration repetition period duty Continuous or pulsed 100 Hz with 10 20 or 50 duty cycle factor Modulation Waveform The Dynatron 125 complies with the following FDA 21CFR 1050 c 1 1 The error in indication of the temporal average ultrasonic power shall not exceed 20 percent for all emissions greater than 10 percent of the maximum emission FDA 21CFR 1050 c 1 ii The sum of the errors in the indications of temporal maximum ultrasonic power and the ratio of the temporal maximum effective intensity to the temporal average effective intensity shall not exceed 20 percent for all emissions greater than 10 percent of the maximum emission FDA 21 1050 10 c 2 The treatment timer must be accurate to within 0 5 minute of the preset duration of emission for settings less than 5 minutes to within 10 percent of the preset duration of emission for settings of from 5 minutes to 10 minutes and to within minute of the preset duration of emission for settings greater than 10 minutes
27. 0 Index Dynatron 125 OUIpUt POW CK eu cas te sug cca ost Pied 21 COMP ee seis 21 Usage Cautions Combination a 21 Contraindications Warnings 22 22 23 WY di 23 Usage Cautions Combination Treatments 7 23 Safety Features of the Dynatron unit 23 Technical Specifications esee eese ee Pee 24 Environmental 2 20100 ehem enne 24 Dynatron 125 Care and Cleaning 25 Suggested Maintenance SCHEME ae ORIO Seno Rat 25 Routine Calibration Inspect On ses o 26 Authorized Service 26 Definition of A ari etn prt Da dtp 27 Equipment Classification tria nut va Rune itr toss So RIA 27 Disposal of Equipment and 2 2 2 0 1 47 024 4 44 442 4 2 4 4 osorno nr 27 Ultrasound R gulation etri porn OR ENDE a Rm iUe 28 6 30 Enter Soundhead 32 New smart Heads 32 Using Older Model Soundheads RUN EPA E TEE RUE 32 ode eon
28. 000 000 Head and Crystal Size Comparison 5cm2 4 000 4 000 000 000 The selection of the appropriate soundhead is based on the size of the area to be treated Ultrasound treatments should be kept specific to the tissue involved in pathology A good guideline is 2 to 4 times the size of the soundhead Ultrasound Usage Cautions 16 Dynatron 125 For example 2 cm soundhead can deliver up to 4 Watts and is appropriate for small areas i e hands fingers feet e 5 soundhead can deliver up to 10 Watts and is appropriate for medium sized areas i e extremities such as arms legs and cervical areas e A 10cm soundhead can deliver up to 20 Watts and is appropriate for large areas i e torso and back Ultrasound is a directed beam of energy Therefore not only will the average spatial intensity be a factor in the dosage the patient receives but the time delivered and area covered will matter as well For example an area of 50 cm is treated for 5 minutes Then an area of 200 cm is treated for 5 minutes Both receive the same intensity The 200 cm area however does not receive the same dosage only 4 because as the soundhead is moved around the area it has to cover represents 4 times as much tissue The Soundhead area measurement is the ERA effective radiating area Each soundhead has an effective radiating area It is not necessarily the outside diameter of the soundhead but the ar
29. REQUIRED if you are using new Smart heads 1 Head Calibration Printout Earlier soundhead models are shipped with a Head Calibration Printout sheet The following is an example of this sheet The sheet contains unique calibration numbers for a specific soundhead The soundhead serial number appears on the sheet to assist you in matching the correct soundhead with the printed parameters HEAD CALIBRATION PRINTOUT HEAD SERIAL 105000 SIZE 5 CM2 MHZ 2 MHZ 3 MHZ Enter Soundhead Parameters 32 Dynatron 125 NOTE THE NUMBERS ON THE PREVIOUS PAGE ARE PROVIDED FOR ILLUSTRATION ONLY AND SHOULD NOT BE ENTERED INTO YOUR DYNATRON DEVICE USE ONLY THE ACTUAL NUMBERS PROVIDED WITH YOUR OWN SOUNDHEAD 2 Plug in Soundhead Turn the Dynatron 125 off then plug in the new soundhead 3 Enter Head Parameters Mode To enter the Head Parameters Mode press and hold the Duty Cycle toggle key 10 20 5096 Cont key while turning the machine ON Continue holding down the Duty Cycle toggle key until the device finishes its startup sequence The unit senses and displays the head size in the Power Intensity display For example if 5 is displayed it means the device senses a 5 cm head is plugged in 4 Enter 1 MHz Values You will begin by entering the 1 MHz values from the Head Calibration Printout Make sure that the 1 MHz LED is lighted before entering these values Locate the 1 MHz column on the printout You will
30. SERVICE MANUAL Dynatrone 125 Dynatron 125 CAUTION Federal law restricts this device to sale by or on the order of a physician chiropractor physical therapist or dentist licensed by the law of the state in which said person practices to use or order the use of the device IMPORTANT Before treating a patient with the Dynatron 125 read the Contraindications Warnings and Precautions in this manual and observe these whenever treating a patient with this device INDICATIONS FOR ULTRASOUND USE Ultrasound therapy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain muscle spasms and joint contractures but not for the treatment of malignancies 21 CFR 890 5300 Dynatron 125 Service Manual Copyright 1996 Revised June 2004 Dynatronics Corporation 7030 Park Centre Drive Salt Lake City UT 84121 801 568 7000 800 874 6251 E Mail info dynatron com Internet http www dynatronics com ALL RIGHTS RESERVED Rev 06 04 01 Dynatron 125 Table of Contents Introduction to Dynatron 125 1 About Ultrasound T P O O 1 Installation and D 2 UPA 2 Standard ACCeSSOFIeS UR ILU RUP 2 Dynalron 125 Physical 3 Soundheads esc 5 Treatment
31. When using a Stim device in conjunction with the Dynatron 125 to output Stim through the soundhead observe all contraindications warnings precautions and usage cautions provided by the manufacturer for that Stim therapy along with all contraindications warnings precautions and usage cautions for Ultrasound therapy provided in this manual Safety Features of the Dynatron 125 The device senses coupling and soundhead temperature to help ensure proper delivery of the ultrasonic therapy and to protect the soundhead crystal The device provides complete isolation of patient connection from AC power line Contraindication Warnings Precautions 23 Dynatron 125 Technical Specifications Other ranges accuracy and precision values that are not provided here may be obtained from Dynatronics upon request Power requirements 110 240 V Power consumption 60 watts Power output 2 cm head 1 MHz 3 MHz 0 4 W 0 2 0 W cm 10 5 head 1 MHz 3 MHz 0 10 W 0 2 0 W cm 10 10 head 1 MHz 0 20 W 0 2 0 W cm 10 10 cm head 3 0 10 W 0 1 0 W cm 10 Fuse For 120V 0 8 For 240V 1 6 Dimensions 8 7 x 3 25 Weight 4 lbs Environmental Conditions Transport and Storage This equipment is capable while packed for transport or storage of being exposed for a period not exceeding 15 weeks to environmental conditions not outside the following ranges a an ambient temperature range o
32. a banana adapter a pin to banana adapter is attached to one output end of a patient lead The following instructions explain how to use the Dynatron 125 with Dynatronics electrotherapy devices With this type of treatment the soundhead acts as one of the electrodes in a 2 electrode stim treatment and stim is delivered through the soundhead See Usage Cautions Combination Treatments in this manual before using this option 1 Plug a patient lead into one channel of the Dynatron electrotherapy device Use a single lead with two output connectors Place a pin to banana adapter on one output end of the lead then plug that banana adapter into Stim Input jack on the back of the Dynatron 125 NOTE If you do not have a pin to banana adapter contact Dynatronics to order Attach the other lead output to an electrode use an electrode that you normally use with your Dynatron electrotherapy device and place the electrode in the desired location on the patient s body The electrode should be placed slightly outside the area where the Ultrasound will be delivered to allow full movement of the soundhead over the treatment area Remember the soundhead delivers Stim as well as Ultrasound during the treatment and therefore the soundhead acts as the second electrode Consider this when you determine where to place the electrode and the soundhead on the patient 2 Set up an Ultrasound treatment with the Dynatron 125 Do not press START 3
33. a bar graph with from 1 to 6 segments lighted The more segments displayed the hotter the soundhead This display does not provide an actual temperature reading but does give a visual indication if the soundhead is becoming too hot To return to the treatment time display press the START key Press the START and the Time DOWN arrow keys simultaneously during an ultrasound treatment to view a graph showing relative head temperature Press the START key to return to the treatment time display START A A PAUSE Head Temperature Bar Graph Temperature Bar Graph During an Ultrasound treatment press START and the TIME Down Arrow keys simultaneously to view a bar graph representing the soundhead temperature Treatment Instructions 10 Dynatron 125 Note Pressing the Time UP or DOWN ARROW keys will return the display from bar graph to the treatment time display However pressing these keys will change the treatment time as well Head Temperature Hot HOT ERROR Soundhead Too Hot If the temperature reaches the maximum level allowed the treatment POWER INTENSITY is automatically PAUSED the output power is stopped the treatment time stops counting down and the POWER INTENSITY display shows the error message HOT When this condition HOT Error During an Ultrasound treatment if the occurs the soundhead must
34. alibration sheet for future reference 7 Press the frequency toggle key to select 3 MHz The 3 MHz LED will light indicating the soundhead is now ready to be calibrated at the frequency Repeat steps 3 through 6 above 8 If you wish to cancel the calibration procedure without storing any new calculations press the PAUSE key 9 This completes the calibration of one soundhead For devices that use more than one soundhead you must calibrate each of those soundheads individually 10 To calibrate the next soundhead turn the machine off and repeat steps 1 through 10 above CAUTION Avoid unnecessary Ultrasound exposure Calibration Procedure 36 Dynatron 125 Problem Solving The following are problems that could occur with the Dynatron 125 Appropriate actions are also provided Soundhead Temperature Too Hot If coupling the effective degree at which the Ultrasound is delivered from the soundhead to the patient s body is not adequate during treatment the temperature of the soundhead rises see also Head Temperature Hot page 12 The Dynatron 125 uses several methods to inform the user of the temperature status throughout the treatment e If the soundhead approaches maximum temperature the power display begins flashing to notify the user to improve coupling or reduce the power to prevent the soundhead from becoming too hot If the soundhead reaches maximum temperature the treatment is paused the output is s
35. and the face of the soundhead is making full contact with the patient s skin To turn on the ULTRASOUND COUPLING BAR GRAPH function press PAUSE and the POWER DOWN ARROW keys simultaneously Repeat the action to toggle between ON and OFF Visible in the TIME DISPLAY window CPI indicates the bar graph is ON while CPO indicates the bar graph is OFF To display the BAR GRAPH displayed on the previous page press the START key and the TIME UP ARROW key simultaneously The treatment time continues counting down while the bar graph is displayed unless the treatment is paused for any reason You may alternate toggle back and forth between the BAR GRAPH and the treatment TIME by pressing the PAUSE and POWER DOWN ARROW keys simultaneously When you no longer require the bar graph display press the START key to turn OFF the BAR GRAPH and redisplay the treatment TIME Pressing the TIME UP or DOWN ARROW key will also change the display from bar graph to the treatment time display however pressing these keys will change the treatment time as well Changes to the treatment settings including frequency duty cycle and size of soundhead will cause some variance in the graph Head Temperature Bar Graph During an Ultrasound treatment you can view a graph showing the relative soundhead temperature by pressing START and the TIME DOWN ARROW keys simultaneously As shown in the illustration below the TIME DISPLAY shows the letter followed by
36. ea of the crystal inside therefore special care should be taken in selecting the correct size soundhead for the area to be treated according to the diameter of the crystal See the Head and Crystal Size Comparison graphic on the previous page NOTE If a patient experiences pain during a treatment the size of the soundhead may be inappropriate for the area being treated the intensity is too high or the treatment time is too long Penetration of Ultrasound Waves The correct frequency should be selected for the depth of penetration desired The amount of penetration needed is determined by the density of tissue and the depth of the site to be treated Care should be taken to select a penetration level that does not cause periosteal bone pain The frequency determines the depth of penetration of the Ultrasonic wave Select 1 MHz for deep lesions provides a Half 1MHz 2MHz 3MHz Value Distance HVD of about 5cm e Select 2 MHz for moderate depth lesions about 2 6cm HVD Deep Superficial e Select 3 MHz for superficial lesions about 1 5cm HVD HVD is the approximate point at which the Ultrasound energy is reduced to half in the average human tissue Multi Frequency Ultrasound Ultrasound Usage Cautions 17 Dynatron 125 Types of Delivery Ultrasound can be delivered in four different ways You will likely only see two of the four methods in clinical practice 1 Direct C
37. emperature Too Cold If the soundhead has been sitting in a cold room or vehicle it could be too cold to operate when you turn the device on The keypad may not respond to key presses and you will be unable to use the device until the soundhead is sufficiently warmed You must raise the temperature of the soundhead to about 60 degrees F in order for the machine to recognize that the soundhead is present and to proceed with setting up a treatment You can accomplish this with any of the following methods 1 Press the flat face of the soundhead against the palm of your hand for 30 to 60 seconds to warm it slightly This usually provides adequate warmth to the crystal to raise the temperature to the minimum acceptable level Once the crystal reaches this level you can proceed with treatment 2 Youcan also place the soundhead in room temperature water to warm the crystal However do not place the soundhead in very hot water when the crystal is this cold as it could damage the crystal Error Message in the Display Certain conditions can cause an error in operation When this occurs the machine will not allow a treatment to be set up or delivered and will display an error message in the LED displays An error message can consist of any combination of alpha numeric characters which are not normally expected at any given point in treatment setup or delivery Some errors are easily resolved by the following methods e Press STOP to stop the treat
38. ery second 1046 of the time energy is flowing and 9096 of the time it is not Patient Susceptibility Some patients skin is more sensitive to Ultrasound output This can cause a reaction similar to a heat rash Potential for Burns or Periosteal Pain It is possible for a patient to suffer a burn from Ultrasound therapy if the therapy is not administered properly This can occur for the following reasons Intensity power too high Frequency too low Holding the soundhead in one place on the patient s skin Moving the soundhead too slowly Treating an area where sensory nerve damage is present with a loss of normal skin sensation Time Caution Don t treat too long Bony prominences are especially susceptible as they reflect sound waves and increase intensity to the periosteum resulting in a burning sensation Desensitized areas can be overheated or burned without the patient realizing it so extreme care must be taken with these patients e g diabetes neural damage etc Burns can be avoided as long as the treatment causes no pain tingling excess heat or aching for patients with normal skin sensation Use sufficient coupling agent and make sure there are no bubbles in the gel When treating in water clear the bubbles off the soundhead and off the patient s skin An uncalibrated unit can also cause tingling excess heat aching or a burning sensation Ultrasound Usage Cautions 20 Dynatron 125 Output Power Co
39. eter meets this qualification Ohmic Instrument UPM DT1 or UPM DT 10 are recommended for use Water Quality Water used in the testing procedure must be degassed water with an oxygen content of four parts per million 4ppm or less The following steps are provided to assist the technician with the calibration procedure A calibration program is built into the software for the device The procedure utilizes keys and displays on the key pad that are normally used for other purposes but which have specialized applications in the Calibration Mode If you have any questions about the following instructions contact Dynatronics Customer Service Department before proceeding STEPS 1 Begin with the machine turned off Plug the soundhead to be calibrated into the Dynatron 125 Ultrasound output jack and center the soundhead over the cone in the Ultrasound power meter 2 Enter the Dynatron 125 s Calibration Mode by pressing and holding the PAUSE key while turning the machine on The display windows first show the soundhead type that is plugged into the machine see Soundhead Type Table on next page Calibration Procedure 35 Dynatron 125 Te soundhead type is displayed for about one second Next the display shows the stored Squidhead Types Table frequency values for the soundhead that is Smart Heads being calibrated The output power display is Time Displav HS set to a value of zero LED for 1 MHz lav
40. f 40 C to 70 C b a relative humidity range of 10 to 100 including condensation c an atmospheric pressure range of 500 hPa to 1060 hPa Operation This equipment complies with requirements for operation in normal use under the least favorable combination of the following environment conditions a an ambient temperature range of 10 C to 40 C b arelative humidity range of 30 to 75 including condensation c an atmospheric pressure range of 700 hPa to 1060 hPa Technical Specifications 24 Dynatron 125 Dynatron 125 Care and Cleaning Instructions Clean the outer surface of the Dynatron 125 with a slightly damp or lightly moistened cloth Mild household cleaners work well Do not spray the solution directly on the unit First moisten the cloth and then wipe the unit off Solvents caustic solutions and harsh or abrasive cleaners must never be used Soundheads should be cleaned with warm water Always keep the soundhead free from gel buildup Avoid stretching cords to full length Do not bend cords sharply Do not wrap cord tightly to store Undue stress on soundhead cords can damage connections Do not drop the unit or the soundheads as severe damage will occur Keep all food and soft drinks away from the machine and its accessories spills can cause costly damage to the machine and repairs for this type of damage are not covered by the warranty Suggested Maintenance Schedule SERVICE TO BE PERFORMED BY A TECHNICIAN
41. ing Dynatronics Customer Service Department 7030 Park Centre Drive Salt Lake City UT 84121 800 874 6251 or 801 568 7000 Fax 801 568 7711 Technical Specifications 26 Dynatron 125 Definition of Symbols Some or all of the following symbols are included in the labeling for this device The meanings of the symbols are described here Alternating Current Attention consult accompanying documents Off power disconnection from the mains On power connection to the mains Type BF patient applied part Equipment Classification This device is classified as follows e According to the type of protection against electric shock Class I e According to the type of protection against electric shock e According to the degree of protection against harmful ingress of water ordinary e According to the degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide e According to the mode of operation Continuous operation Disposal of Equipment and Accessories There is no risk posed in disposal of this equipment or its accessories These items contain no hazardous materials Technical Specifications 27 Dynatron 125 Ultrasound Regulation The following data is provided in compliance with IEC 60 IEC 6
42. l Devices Act SMDA of November 1990 the manufacturer and distributor are required to report specific incidents to the FDA In the event of any applicable incident you should report details of the incident to the Dynatronics Customer Service Department at 1 800 874 6251 Reports should be submitted to the manufacturer immediately to allow the manufacturer to report to the FDA within 10 working days Assy and Test Instructions DS009C REV 7 1 11 6 03 D125 150 Plus 153B amp G device Dynatron 125 e If you receive information that reasonably suggests a probability that a device caused or contributed to a death serious injury serious illness e If you receive information that reasonably suggests a device malfunction and recurrence will probably cause death serious injury or serious illness Definition of serious injury A serious injury is an injury that 1 is life threatening 2 results in permanent impairment of a body function or permanent damage to body structure or 3 necessitates medical or surgical intervention by a health care professional to 1 preclude permanent impairment of a body function or permanent damage to body structure or ii relieve unanticipated temporary impairment of a body function or unanticipated temporary damage to a body structure Reference Food and Drug Administration HHS 21 CFR Ch 1 4 1 90 Edition 803 9 h Schematics and QC Check Lists The fol
43. lowing pages provide the schematics and QC check lists for the Dynatron 125 Installing Software Updates 42 DYNATRONICS Device Specific Procedure DYNATRON 125 150 plus FINAL QUALITY CHECK Unit S N Software Ver Date Repair RS Production Head SN 5 10cm 2cm 1cm Verify all keys work all keys have good tactile feel Verify all LED s light up Verify output turns off when STOP is pressed Verify continuity between soundhead and stim jack Verify head temperature circuit is working Verify coupling works with 5cm smart soundhead Verify unit and soundhead serial number Verify stim jack tight Labels and Screws Verify fuse rating 1 6 amp 250V slow blow Verify ultrasound outoput power per table below 2 5 Watts 0 5 5Watts 1 0 10 Watts 2 0 10cm 5 0Watts 0 5 10 Watts 1 0 20 Watts 20 2 1 0 Watt 0 5 2 0 Watts 1 0 4 0 Watts 2 0 1 0 Watt 1 0 1 5 Watts 1 5 2 0 Watts 2 0 2 2 029 141 1 4 1 6 1 9 2 1 0 9 1 1 1 4 1 6 XXXXXXXX Ground Fault Chassis leakage not to be greater than 75uA and on leads 20uA Leakage no ground chassis leads chassis Leakage grounded chassis leads chassis Hot Return reversed chassis leads chassis FAILURES ACCEPTANCE Reason Technician TECH QC initials m RU LL m m
44. ment if any and turn the machine off then on again e Check to be sure the soundhead has not become disconnected from the machine The soundhead should be firmly plugged into its port Only Dynatronics soundheads may be used with this device If the soundhead has been dropped it may be damaged If the device operates normally with one soundhead but not with another the problem may be a damaged soundhead and you must contact Dynatronics Customer Service e Make sure the soundhead is not too hot In this case the power LED display will flash Any other display indicates a problem not related to a soundhead that is too hot For hot soundheads follow the instructions provided earlier in this section e Check to see if conditions may have caused moisture condensation in the device This could occur when the machine has become very cold for example if left outdoors in a vehicle during winter then is brought indoors to a warm humid environment such as a whirlpool room Condensation is a not a serious condition Allow the machine to sit in a dry environment until the condensation dries The machine will operate normally once the condensation is gone If you have tried all of these suggestions and the error is still displayed on the LEDs the device may require service by the manufacturer In this case contact Dynatronics Customer Service at 1 800 874 6251 for further assistance Do not send the device to Dynatronics without first contacting
45. not place the cord or the device in a place where the cord could be tripped over or accidentally pulled out of its socket during a treatment Read the operating instructions and the contraindications warnings and precautions in this manual before proceeding with a treatment Standard Accessories Qty Description 1 Dynatron 125 unit 1 Power cord 1 Operator s manual 1 Applicator soundhead Optional Accessories Additional soundheads are available in sizes 2 cm 5 or 10 cm Rechargeable battery pack Pin to banana adapter for Stim input Ultrasound coupling gel Dynatron 125 Dynatron 125 Physical Features Before operating the Dynatron 125 acquaint yourself with the control panel by reviewing the illustration Each of the features is numbered in the diagram and a description for each feature follows 3 2 1 E 7 16 8 9 10 11 12 3 Dynatron 125 Control Panel 1 POWER OFF ON SWITCH Located on the back of the unit This switch is labeled 1 and 0 Set the switch to 1 for ON set the switch to 0 for OFF 2 Electrical Stim Input Jack 3 Jack for Optional Battery Pack 1 On Off Power Switch D125 Back Panel Installation amp Features 10 11 12 13 Dynatron 125 ELECTRICAL STIM INPUT JACK This jack is used for combining Ultrasound with electrical stimulation The output end of a lead connected to a Dynatron
46. ontact Movable Here the soundhead is placed in direct contact with the patient a coupling agent is used between soundhead and the patient s skin The soundhead is moved slowly but continuously This is the method of choice The rate of speed at which the applicator moves across the skin is very important in determining how much Ultrasonic output is delivered If the rate is too slow the patient may feel periosteal pain bone ache pain It the rate is too fast or if the applicator head becomes uncoupled with the skin the amount of treatment is reduced Uncoupling can also cause the soundhead to overheat 2 Immersion Method Here the area to be treated is placed underwater The soundhead is water tight so it can be immersed with the area to be treated The water becomes the coupling agent The head is always moving around the surface area but not in contact 1 2 to 1 inch away 3 Hydrogel Disk For treating crater wounds cover the wound with a hydrogel disk and apply the soundhead to the disk This allows direct wound sonation without bringing the soundhead in direct contact with the wound 4 Stationary Soundhead This method is dangerous Hot spots can develop Do not use Treatment Time For Sub Acute Conditions area to be treated minutes of treatment 1 5 ERA For Chronic Conditions area to be treated cm minutes of treatment 1 0 x ERA For Maximal Thermal Effect area to be treated minutes of trea
47. or decrease time Power Press the UP DOWN arrows to increase or decrease power e Display Power in WATTS or WATTS cm Press both the UP and DOWN POWER DISPLAY keys simultaneously to change the display When displaying power in WATTS the decimal in the POWER DISPLAY will flash When displaying power in the decimal remains solid Pressing the PAUSE key will temporarily stop a treatment in progress this stops both the timer and the output To resume the treatment press the START or PAUSE key Pressing the STOP key terminates the treatment The output is stopped and the treatment timer is set to zero Treatment Instructions Dynatron 125 Patient Coupling The Dynatron 125 provides the feature of PATIENT COUPLING SENSING which senses the coupling between the soundhead and the patient to ensure proper delivery of the Ultrasonic therapy this feature is in effect during CONTINUOUS duty cycle only and works best at 1 0 W cm or greater Coupling contact between the soundhead and the treatment site may be provided either via a coupling agent such as a gel or lotion or in water as with underwater treatments Any material used as a coupling agent must be highly conductive of ultrasonic waves Airis a very poor conductor of ultrasonic waves Therefore avoid allowing any air between the soundhead and the treatment area During the treatment the soundhead should be moved continuously covering an area approximately
48. oundhead warming OFF or to turn it ON again These key presses are only necessary if you want to change the current state of head warming The head warming setting you select whether OFF or ON is saved and will apply to the device whenever it is used until you change the setting again Treatment Setup CAUTION Set intensity to MINIMUM POWER before pressing START The following is the sequence for setting up a treatment l Set Time Press the UP DOWN ARROW keys to set the time for the treatment When treatment starts a countdown timer displays the time remaining in the treatment Set Duty Cycle Press the DUTY CYCLE TOGGLE key one or more times to select the desired duty cycle Continuous 50 20 or 10 percent Your selection is indicated by a green light next to the selected option Choose Frequency Press the FREQ key to select the frequency 1 or 3 MHz Your selection is indicated by a green light next to the selected option Set Power Using the UPDOWN ARROW keys enter the power in watts per square centimeter W cm Valid ranges for each soundhead size are found in the Technical Specifications section of this manual For patient safety and comfort it is recommended that you start with 0 1 W cm then increase power to the desired level after the treatment begins Coupling Agent Be sure to use a coupling agent such as a gel or lotion designed for Ultrasound usage and maintain good coupling throughout the treatment
49. power is displayed in WATTS Restore Factory Defaults The Dynatron 125 has the following default settings e Soundhead Warming ON e Coupling Sensing OFF Power Display Watts cm Each of these settings may be changed by the user instructions are provided earlier in this section If you have changed the settings for this device but would like to return ALL the default settings to those that were set at the factory do the following 1 Turn the machine OFF 2 Press and hold the START key while turning the machine on The machine will display 56 in the TIME DISPLAY window and in the POWER DISPLAY window followed by a single beep indicating that the parameters have been reset Treatment Instructions 12 Dynatron 125 Battery Operation Use ONLY a Dynatronics Approved Battery Contact Dynatronics or your Dynatronics dealer to purchase the optional battery or to obtain specifications for an acceptable battery that may be used not substitute another battery without first confirming with Dynatronics that the battery you are purchasing may be used with this device Only use a battery that CANNOT be recharged while it is in use Disconnect the battery charger from the AC power source before using the battery to supply power to this device An optional battery is available for the Dynatron 125 allowing you to deliver battery powered treatments wherever power may be unavailable or unreliable To use the o
50. ptional battery do the following 1 Before use ensure the battery has been adequately charged DISCONNECT the battery charging cable from the battery while it is in use for treatment 2 Plug the battery adapter into the jack labeled BATT on the back of the Dynatron 125 device Turn the battery pack ON 3 Setup and deliver treatments as you normally do 4 When available battery power is reduced to a certain level the device will flash a message BATT LO to indicate low battery power The treatment can continue but you will probably be unable to set up and deliver another treatment when the current treatment has ended 5 When the available battery power becomes too low to continue operating the device the BATT LO message is again displayed the treatment intensity is ramped down and the machine is then shut OFF Before you can continue with battery operation of the device you must recharge the battery If battery power is fully depleted the message BATT BAD is displayed to indicate either a bad battery or to indicate the battery must be recharged Any treatments that were running at that time will stop NOTE Use the ON OFF switch on the battery pack to control power to the device during battery operation While the battery is attached the battery s ON OFF switch controls power to the device Battery Operation 13 Dynatron 125 Battery Requirements e 12 volt and at least 5 amps peak current 1 5 ampere hours minimum Do
51. rough an automatic self test and head check procedure After the calibration procedure is completed the device is available for treatment To set up a treatment press keys on the keypad to select time duty cycle frequency and power Treatment settings may be modified at any time during a treatment Before treating a patient with the Dynatron 125 you should be familiar with all the features of the device in order to deliver treatments easily effectively and safely Soundhead Warming When the Dynatron 125 is powered ON it automatically enters a default When Head Warming is head warming mode During this occurring this indicator que light appears in the upper mode the soundhead should remain in TNE portion of the TIME display its holder as a small amount of Ultrasound output is emitted from the soundhead While warming is taking place a small indicator light is seen at the top of the TIME display Head Warming Indicator The warming feature turns ON and OFF Treatment Instructions 6 Dynatron 125 automatically as needed to maintain a comfortable temperature The soundhead warming mode is automatically stopped during a treatment and resumes automatically as needed after a treatment has ended Turn Soundhead Warming Off On If you do not wish to use the head warming feature you can turn the feature OFF with a simple key press Press both the PAUSE and the STOP keys simultaneously to turn s
52. s precautions and usage cautions provided by the manufacturer for that Stim therapy along with all contraindications warnings precautions and usage cautions for Ultrasound therapy provided in this manual Ultrasound Usage Cautions 21 Dynatron 125 Contraindications Warnings Precautions Contraindications The Dynatron 125 Ultrasound should not be applied in the following conditions e Pregnancy e Acute and sub acute thrombosis and thrombophlebitis e Potentially malignant lesions tumors malignant or benign e Areas or lumps that may be suspected as cancerous or precancerous Third degree musculo tendonous lesions e Cardiac pacemaker Implants of any electrical nature Skin diseases Multiple sclerosis e Osteomyelitis e Disturbances in cardiac rhythm e Tissue or bone with acute sepsis e Arteriosclerosis or weakened blood vessels e Hemophilia e Where sensory nerve damage is present with a loss of normal skin sensation The Dynatron 125 Ultrasound should not be applied to the following areas e Transcerebrally To the eye e To the ear e Over a carotid sinus the heart To major subcutaneous nerves and blood vessels To the spinal cord e Around the bulbar area of the spinal cord e To reproductive organs e Over viscera stomach spleen liver Over epiphyseal areas of the bones in growing children e Over stellate ganglion and subcutaneous major nerves tissues previou
53. sing this key stops the output to the applicator head resets the timer to zero and ends the treatment PAUSE This key is pressed to pause an Ultrasound treatment in progress When the treatment is paused the treatment timer is stopped an LED on the PAUSE key is lighted and the output power is stopped Pressing the START key or the PAUSE key will resume the treatment the timer resumes counting down power is delivered to the soundhead and the PAUSE LED light will be off POWER DISPLAY This display shows the power selected for the current treatment Power is displayed in watts per square centimeter WATT cm WATT cn is the intensity of the Ultrasound at the head surface it is the total watts divided by the effective radiating area of the head The display may be changed to WATTS if desired by pressing both the UP and DOWN power keys at the same time the decimal in the display will flash continuously when displaying WATTS decimal remains solid when displaying WATT cm Installation amp Features Dynatron 125 14 POWER SELECTION KEYS These UP DOWN ARROW keys are used to set or change the power setting for a treatment Press the UP ARROW key to increase power and press the DOWN ARROW key to decrease power 15 ULTRASOUND OUTPUT JACK The soundhead plugs into this jack for Ultrasound therapy 16 SOUNDHEAD HOLDER The soundhead is placed in this holder when not in use Soundheads Soundheads for the Dynatron 125
54. sly treated by deep x ray or other radiation e Over the joint capsule in acute or sub acute arthritic conditions e Over ischemic tissue in patients with vascular disease e Over a laminectomy site e Over total joint replacements the effect of Ultrasound on the new plastics is unknown e Over healing fractures Contraindications Warnings Precautions 22 Dynatron 125 POWER SHOULD BE REDUCED IF PATIENT COMPLAINS OF PERIOSTEAL BONE PAIN BONE ACHE Precautions The Dynatron 125 must be used cautiously in the presence of any of the following conditions Warnings When there is a tendency to hemorrhage following acute trauma or fracture Acute Bursitis Do not use in continuous duty cycle mode Do not use in general area where high powered high frequency transmitting units are being operated Short wave diathermy should not be turned on or used at the same time as the Dynatron 125 Do not use the same power outlet or line with a whirlpool and certain traction machines In areas which are carpeted and static electricity is present it may be necessary to use a conductive mat to remove any static charge from the operator Use a surge suppresser if power problems are encountered Avoid unnecessary exposure to Ultrasound patient and therapist NOTE For further technical information on therapeutic Ultrasound and its physiological effects please consult published medical literature Usage Cautions Combination Treatments
55. the Customer Service Department Problem Solving 38 Dynatron 125 Sending a Unit in for Repair Return Authorization To send a unit to Dynatronics for repair you MUST first receive authorization from Dynatronics This authorization is represented by a Return Authorization RA number An RA form is used internally at Dynatronics to help identify who is sending the unit in for repair and why It shows customer complaint or problem information and has the address where the unit should be shipped after repair When a service call is received by Dynatronics the following information must be supplied before an RA number can be issued User name and address 2 User phone number 3 Serial number of the unit 4 A description of the problem with the unit This information is important so we may identify the problem before the unit is shipped and ensure proper handling of the repair or disposition of the unit The user or dealer name and address and the serial number of the unit are required before Dynatronics will issue an RA number When the unit is received at Dynatronics it is unpacked and inspected for shipping damage An inventory of the parts that were sent with the unit is taken at that time and recorded on the RA sheet Any observed damage is also noted on the sheet The unit is then examined by a repair technician who evaluates the problems with the unit and writes observations on the RA form The technician completes the
56. tment 0 8 x ERA Treatment Intensity Several factors come into play as one decides the level of intensity for the treatment 1 Superficial lesions require less intensity Less intensity should be used if bone is superficial to the treatment field 3 Less intensity should be used when the stage of the injury makes heating questionable 4 Usealittle lower intensity for the first treatment to gauge response Ultrasound Usage Cautions 18 Dynatron 125 5 Patient feedback is key treatment should feel warm but the patient should never feel heat pain stabbing pricking or dull ache Acute Conditions 0 1 0 5 W cm no appreciable thermal effect Sub Acute Conditions 0 5 1 0 W cm Mild to Moderate thermal effect Chronic Conditions 1 0 2 0 W cm Moderate to Strong thermal effect NOTE It is very common that intensity is always 1 5 W cm This is incorrect in many cases A more specific intensity should be used based on patient response and stage of injury Frequency of Treatment Treatment can be given daily It is not uncommon to give Ultrasound twice daily but this may be excessive Some guidelines may be helpful 1 Daily may be the best maximum frequency 2 Ultrasound can be effectively given every other day 3 Ultrasound should give some positive benefits by the 3 or 4 application If not discontinue the treatment and consider other options 4 A maximum of 12 to 15 Ultrasound treatments should
57. topped the timer is paused and the Pause light is lighted When the soundhead cools sufficiently the power display and the lights on the soundhead will cease flashing You can then press PAUSE or START to resume the treatment Cooling the Soundhead The temperature alert not only ensures good coupling throughout the treatment it helps avoid damage to the soundhead crystal If the soundhead becomes too hot it must be allowed to cool down before resuming the treatment The head will cool slowly if allowed to sit at room temperature To cool the soundhead quickly you can place it in room temperature water Sometimes just applying more conductive gel will adequately cool the head Larger soundheads will take longer to cool down DO NOT USE ICE to cool the soundhead as this can cause thermal shock to the crystal and may necessitate a costly repair Damage caused by thermal shock is not covered under the warranty Whirlpool Treatments If you are treating in a whirlpool you may find the temperature reaches a high enough temperature to cause the display to flash 105 see also Head Temperature Bar Graph page 11 This is a warning only to let you know you are approaching the temperature limit You may however continue with the treatment at this level If your whirlpool temperature is hot enough to cause the treatment to stop you may need to adjust the temperature of the whirlpool Problem Solving 37 Dynatron 125 Soundhead T
58. u as quickly as possible Routine Calibration Inspections Government agencies regulate the frequency at which Ultrasound units must have their calibration checked Even though the Dynatron 125 does an internal diagnostic procedure at startup the device must still be examined at the periodic intervals specified by the governing agency To have the inspection performed by Dynatronics contact Dynatronics Customer Service Department the device will need to be shipped to Dynatronics for the inspection As an alternative these periodic checks may be performed in your own office by a local independent contractor who is expert in checking the calibration of Ultrasound equipment The calibration procedure MUST be performed by a qualified Ultrasound technician using the proper equipment Detailed calibration procedures may be obtained from Dynatronics Customer Service at the number provided below Dynatronics will make available on request circuit block diagrams component part lists descriptions calibration instructions or other information which will assist the user s appropriately qualified technical personnel to repair those parts of the equipment which are designated by Dynatronics as repairable and which will not violate protection of Dynatronics proprietary information Authorized Service Center service of the Dynatron 125 except calibration must be performed by Dynatronics Service Department For service contact the follow
59. upling Higher output levels have a greater potential for patient discomfort Output power may be reduced by simply choosing a lower watt setting Output power is also effectively reduced by selecting a pulsed duty cycle The term coupling refers to the ability to deliver ultrasonic waves from the soundhead to the skin surface with as little impedance or dissipation of power as possible The best coupling is achieved when the soundhead has full direct contact over the treatment site or when the treatment site and soundhead are separated only by a substance that provides excellent conductance For example water is an excellent conductor of ultrasonic waves Therefore Ultrasound treatment in water provides excellent coupling Air is a poor conductor of ultrasonic waves If any part of the soundhead is exposed to air during the treatment coupling is decreased The air bubbles in a whirlpool for example can decrease the effective Ultrasound therapy to the patient When treating a patient outside of water the soundhead must maintain good contact with the patient s skin at all times In addition a good conductive gel or lotion should be used to ensure the best possible coupling Many such products are commercially available specifically for Ultrasound therapy Usage Cautions Combination Treatments When using a Stim device in conjunction with the Dynatron 125 to output Stim through the soundhead observe all contraindications warning
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