DYNATRON ® 125 | OPERATOR’S MANUAL REV.
CAUTION Federal law restricts this device for 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. Risk of burns and fire: Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. DANGER - Explosion Hazard: Do not use in the presence of flammable anesthetics.
Table of Contents Table of Contents Section I: Introduction Introduction to the Dynatron® 125™ Ultrasound................................................................................... 1 About Ultrasound.......................................................................................................................................................................1 Simplified Setup.......................................................................................................................
Table of Contents Ultrasound Modality Information........................................................................................................ 16 Selecting the Appropriate Soundhead....................................................................................................................................16 Penetration of Ultrasound Waves...........................................................................................................................................
Table of Contents General Specifications........................................................................................................................... 34 Dynatron 125 Specifications....................................................................................................................................................34 Ultrasound Specifications / Power Output............................................................................................................................
Introduction to the Dynatron® 125™ Ultrasound Introduction to the Dynatron® 125™ Ultrasound The Dynatron 125 Ultrasound device is compact, convenient, and portable. Simple to use and intuitive to operate, the touchscreen control panel allows changes to intensity, frequency, and time while a treatment is in progress, providing maximum treatment flexibility. With the Dynatron 125, there is no longer a need to manually enter soundhead parameters.
Introduction to the Dynatron® 125™ Ultrasound Language Selection The default language on the Dynatron 125 is English; however, both French and Spanish are also available. To change the default language: 1) Begin at the OPERATIONS SCREEN. 2) Press the SETTINGS key symbol. 3) In the upper right-hand corner, the current language selection will appear. 4) Pressing the LANGUAGE key, toggle to the desired language. 5) Press the symbol in the lower left-hand corner to return to the OPERATIONS SCREEN.
Installation and Features Installation and Features Unpacking When you receive the unit, immediately unpack it and all accessories. Check for possible damage, obvious or concealed. In case of damage, immediately notify the freight 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, including calibration.
Installation and Features Standard Components REF The following accessories are included with the Dynatron 125 units: Qty Part No. Description: One of the following devices plus accessories as listed: 1 D125B Dynatron 125 Ultrasound 1 7B0241 Power Cord (black) 1 5D00270 Operator’s Manual 1 7B0217 DynaGel Ultrasound Gel 100ml Sample Soundheads Applicator soundheads are available in the following sizes: Part No.
Dynatron® 125™ Physical Features Dynatron® 125™ Physical Features Before operating the Dynatron 125 device, acquaint yourself with the control panel by reviewing the illustrations and descriptions on the following pages. The numbered features in the diagrams correspond to the numbered descriptions.
Dynatron® 125™ Physical Features Dynatron 125 Physical Features Before operating the Dynatron 125, acquaint yourself with the control panel by reviewing the illustrations. Each of the features is numbered in the diagram, and a description for each feature follows: 1. CUSTOMIZABLE DUTY CYCLE The DUTY CYCLE key is a toggle key located at the bottom center of the Operations Screen. Options include 10, 20, 50, and 100% (Continuous) Duty Cycle. 2.
Dynatron® 125™ Physical Features 9. BRIGHTNESS / CONTRAST As contrast and clarity of the screen graphics can be affected by the lighting in the area where the Dynatron 125 is used, this key allows for the manual adjustment of the brightness/contrast of the displays. 10. POWER DISPLAY - W/cm2 to WATTS This key shows the POWER selected for the current treatment. The Default Power is displayed in WATTS per square centimeter (WATT/cm2).
Dynatron® 125™ Physical Features Dynatron 125 Console Jacks Front Panel - Ultrasound Jack Illustrated below is the Ultrasound Input Jack located on the Front Panel of the Dynatron 125.
Dynatron® 125™ Physical Features c. Battery. This jack may be used to supply power to the device using an optional battery pack. More information about the optional battery operation is provided later in this manual. Ultrasound Error Messages If an error occurs during any active treatment, the Dynatron 125 will sound a tone/beep. An Error Message will appear on the Operations Screen. Below are samples of the error messages that may occur.
Ultrasound Instructions Ultrasound Instructions Ultrasound therapy channels soundwaves through muscle, nerve, bone, and connective tissue to aid in reducing pain, muscle spasms, and joint contractures. The physiological effect of Ultrasound therapy depends upon the frequency of the Ultrasound signal. The lower frequency (1 MHz) penetrates deeper than a higher frequency (such as 2 MHz or 3 MHz), thus the practitioner can decide which frequency to use according to the condition and depth to be treated.
Ultrasound Instructions Make sure a soundhead is firmly plugged into the device before turning the device ON. 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. Please acquaint yourself with the following terms and device features prior to delivering an Ultrasound treatment.
Ultrasound Instructions Head Temperature - Over Heating If coupling (the effective degree to which the Ultrasound energy is delivered from the soundhead to the patient’s body) is not adequate during treatment, the temperature of the soundhead rises and the patient does not receive the full intended dosage. If the SOUNDHEAD reaches approximately 108 degrees, ULTRASOUND will be disabled and the Operations Screen will read: “SOUNDHEAD IS TOO HOT! OUTPUT HAS BEEN DISABLED TO ALLOW COOLING.
Ultrasound Instructions Ultrasound Quick Setup 1. Turn ON the main power switch at the back of the unit. 2. FREQUENCY. Using the FREQUENCY toggle key, select 1 MHz, 2 MHz, or 3 MHz. 3. DUTY CYCLE. Using the DUTY toggle key, select 10%, 20%, 50%, or 100% (Continuous). 4. TIME. Change the treatment TIME, if desired, by pressing the time display. Use the up and down arrow keys to select the desired time. Press return after the time has been modified. 5. INTENSITY.
Ultrasound Instructions If you wish to use the default settings, increase the Intensity to desired treatment level and press START. If you wish to customize settings, follow steps outlined below. 2. Choose the FREQUENCY. Press the FREQUENCY display toggle key on the Operations Screen to select 1, 2, or 3 MHz. Any one of the three Frequencies may be used with the 2 cm2, 5 cm2 or 10 cm2 soundheads. 3.
Ultrasound Instructions 8. Press START. Press the green START key, the treatment timer begins to count down and output is delivered to the soundhead. If Intensity is not set before pressing START, an error message will appear: “NO HEAD INTENSITY. TREATMENT WILL NOT START. PLEASE INCREASE INTENSITY.” 9. PAUSE. Temporarily PAUSE a treatment, if necessary, while the treatment is in progress. To temporarily PAUSE an Ultrasound treatment, press the green START/PAUSE key.
Ultrasound Modality Information Ultrasound Modality Information 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.
Ultrasound Modality Information The selection of the appropriate soundhead is key to the success of the treatment and 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. For example: • A 2 cm2 soundhead can deliver up to 4 Watts and is appropriate for small areas (i.e. hands, fingers, feet).
Ultrasound Modality Information 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 Contact 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.
Ultrasound Modality Information 4. Use a little lower intensity for the first treatment to gauge response. 5. Patient feedback is key. A treatment should feel warm, but the patient should never feel heat, pain, stabbing, pricking or dull ache. Acute Conditions:......................................... 0.1 – 0.5 W/cm2 (no appreciable thermal effect). Sub-Acute Conditions:............................0.5 – 1.0 W/cm2 (Mild to Moderate thermal effect). Chronic Conditions:.............................1.0 – 2.
Ultrasound Modality Information • 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.
Ultrasound Problem Solving Ultrasound Problem Solving Whirlpool Treatments If you are treating in a whirlpool, you may find that the temperature in the whirlpool approaching 103˚F, causing the overheated soundhead caution to appear on the Operations Screen. This is a cautionary warning only to let you know that you are approaching the temperature limit. You may, however, continue with the treatment at this level.
Ultrasound Problem Solving If this error occurs, check to be sure the soundhead is firmly plugged into its connector. If you are unable to clear the message by reconnecting the soundhead, contact Dynatronics’ Customer Service Department at 1-800-874-6251 for assistance. Miscellaneous 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.
Ultrasound Beam Profiles Ultrasound Beam Profiles The following diagrams show the typical spatial distribution of the radiated field for each size of Dynatron 125 soundheads. 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 cm2 Head. Near Field 1MHz 2 MHz 3 MHz DYNATRON ® 125 | OPERATOR’S MANUAL REV.
Ultrasound Beam Profiles 5 cm2 Head. Near Field 1MHz 2 MHz 3 MHz 2 cm2 Head. Near Field 1MHz 2 MHz 3 MHz DYNATRON ® 125 | OPERATOR’S MANUAL REV.
Combination Therapy - Using the Combo Jack Combination Therapy Using the Combo Jack The Combo Jack provides the ability to combine electrical stimulation from an existing electrotherapy device with the Dynatron 125 Ultrasound. The existing stimulator device must comply with IEC 601-1 and IEC 601-2-10 (general and particular standards) requirements. The banana jack accommodates a Combination Lead Wire or requires the use of a pin-to-banana adapter in order to provide Stim output through the Ultrasound head.
Combination Therapy - Using the Combo Jack Stim Through the Soundhead With combination therapy, the soundhead is used in place of one electrode for a Stim treatment; and electrotherapy current is delivered through the soundhead. This means that for a normal 2-electrode Stim treatment therapy, one electrode would be placed on the patient with the soundhead acting as the second electrode site to complete the setup. During the treatment, the stim current passes between the soundhead and the other electrode.
Contraindications, Warnings, & Precautions for Ultrasound Treatment Contraindications, Warnings, & Precautions for Ultrasound Treatment Contraindications The Dynatron 125 Ultrasound should not be applied in the following CONDITIONS: • Pregnancy • Acute and sub-acute thrombosis and thrombophlebitis • Potentially malignant lesions, tumors malignant or benign • Areas or lumps that may be suspected as cancerous or precancerous • Third degree musculo-tendonous lesions • Cardiac pacemaker or other imp
Contraindications, Warnings, & Precautions for Ultrasound Treatment • Hemophilia • Where sensory nerve damage is present with a loss of normal skin sensation.
Contraindications, Warnings, & Precautions for Ultrasound Treatment Warnings • Do not use in general area where high-powered, high-frequency transmitting surgical units are being operated. Short wave diathermy should not be turned on or used at the same time as this Dynatron device. • Do not use the same power outlet or line with a whirlpool and certain traction machines.
Technical Information Technical Information CAUTION There are no serviceable parts in the Dynatron 125 devices. Setting Defaults The Dynatron 125 Ultrasound has default settings that are automatically selected when the device is turned on. The default settings feature allows previously used treatment parameters to be set up in just seconds. For guidance in selecting the appropriate treatment settings consult published medical literature.
Technical Information Restore Factory Defaults If you have saved your own defaults, but would like to return ALL the default settings to those that were set at the factory, follow the steps below: 4. Touch the SETTINGS icon in the lower right-hand corner of the Operations Screen. 5. Touch “RESTORE FACTORY DEFAULTS.” All of the factory defaults are no restored for all future treatments.
Battery Operation Battery Operation Use ONLY a Battery Meeting Specifications Before purchasing or using an existing battery with the Dynatron 125 device, refer to the section titled “Battery Requirements” in this manual. 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.
Battery Operation treatment has ended. The yellow BATTERY ICON will appear in the lower left-hand corner of the Operations Screen, indicating the battery level. 5. When the available battery power becomes too low to continue operating the device, the following message will appear: “ERROR: BATTERY LEVEL TOO LOW FOR TREATMENT OPERATION. CHARGE IMMEDIATELY!” The treatment intensity will ramp down, any treatments that were running at the time will stop, and the device will shut down.
General Specifications General Specifications Dynatron 125 Specifications Power Requirements.................................................................................. 100-240 V~, 50/60 Hz Power Consumption........................................................................................................... 65 Watts Fuse:.....................................................................................................120V~ - 0.8A; 240 V~-1.6A Dimensions.......................................
General Specifications • 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 21CFR 1050.10(c)(2). The treatment timer must be accurate to within 0.
General Specifications Ultrasound Head • Ultrasound heads should be cleaned with warm water. Always keep the head free from gel buildup. Alcohol may be used to sterilize the soundhead. • Do not use ice water for cooling soundheads. • Do not allow soundheads to overheat repeatedly. This could result in thermal shock to the crystal. Damage of this type is not covered by the warranty. • Do not drop the unit or the soundheads as severe damage will occur.
General Specifications CAUTION For continued protection against risk of fire, replace fuses only with type IEC 60127. For 120/240VAC supply, use 250V, 1.6A slow-blow. Routine Ultrasound Inspections for the Dynatron 125 Government agencies regulate the frequency at which Ultrasound units must have their calibration checked. The device must still be examined at the periodic intervals specified by the governing agency for the country in which the device is used.
General Specifications Definition of Symbols and Labeling Some or all of the following symbols are included in the labeling for this device. Definitions accompany each symbol.
General Specifications The following labels appear on the Dynatron 125 console, and Ultrasound Heads.
Electromagnetic Emissions and Immunity Electromagnetic Emissions and Immunity Tables 1 through 4 below list the Dynatron 125 declarations of electromagnetic emissions and immunity, and give user guidance on the Dynatron 125 in an electromagnetic environment per IEC 60601-1-2 guidelines. Table 1 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Dynatron 125 (and accessories) is intended for use in the electromagnetic environment specified below.
Electromagnetic Emissions and Immunity Table 2 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Dynatron 125 (and accessories) is intended for use in the electromagnetic environment specified below. The customer or the user of the Dynatron 125 (and accessories) should assure that it is used in such an environment.
Electromagnetic Emissions and Immunity Table 3 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The Dynatron 125 (and accessories) is intended for use in the electromagnetic environment specified below. The customer or the user of the Dynatron 125 (and accessories) should assure that it is used in such an environment.
Electromagnetic Emissions and Immunity Table 4 Recommended separation distance between portable and mobile RF communications equipment and the Dynatron 125 (and accessories) The Dynatron 125 (and accessories) is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Medical Device Reporting Requirements Medical Device Reporting Requirements Under the Safe Medical Devices Act (SMDA), 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.
Medical Device Reporting Requirements Reporting any Incident of Patient Discomfort Dynatronics recommends that if discomfort of any level is reported by the patient, the treatment be stopped immediately. The device and all accessories in use during that treatment should be isolated and held for inspection. Make a note of treatment parameters that were in use during the treatment including intensity settings.
Dynatron® 125™Limited Warranty Dynatron® 125™ Limited Warranty DYNATRONICS CORPORATION warrants the Dynatron 125 products and the applicator soundheads (excluding other accessories) that are purchased with the unit to be free from factory defects in materials and workmanship under normal use for TWO YEARS from the date of purchase by the original owner. Accessories that accompany this product (which are listed as “accessories” on a list included with each unit) are warranted for 90 DAYS.
Dynatron® 125™Limited Warranty Dynatron® 125™ Warranty Registration To register the warranty for your Dynatronics unit, complete all information requested, and MAI, FAX , or EMAIL to: Dynatronics, 7030 Park Centre Drive, Salt Lake City, Utah 84121, Fax: 801-568-7711, Email: info@dynatron.com.
