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SERVICE MANUAL
Dynatron
150plus
®

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Summary of Contents for Dynatron 150plus

  • Page 1 SERVICE MANUAL Dynatron 150plus ®...
  • Page 2 IMPORTANT: Before treating a patient with the Dynatron 150plus, read the Contraindications, Warnings, and Precautions in this manual, and observe them whenever treating a patient with this device.
  • Page 3: Table Of Contents

    Dynatron ® 150plus Table of Contents Page Introduction to the Dynatron 150plus..................1 About Ultrasound........................1 Installation and Features.......................3 Unpacking ..........................3 Standard Accessories .........................3 Dynatron 150plus Physical Features..................4 Soundheads ..........................6 Treatment Instructions........................7 Soundhead Warming........................7 Turn Soundhead Warming OFF / ON..................8 Treatment Setup .........................8 Modify a Treatment in Progress ....................9...
  • Page 4 Warnings ..........................28 Usage Cautions - Combination Treatments ................28 Safety Features of the Dynatron 150plus.................28 Technical Specifications ......................29 Environmental Conditions .......................29 Dynatron 150plus Care and Cleaning Instructions ..............30 Suggested Maintenance Schedule....................30 Routine Calibration Inspections....................31 Authorized Service Center.......................31 Definition of Symbols......................32 Equipment Classification......................32 Disposal of Equipment and Accessories..................32...
  • Page 5 Dynatron ® 150plus Return Authorization .......................49 Why the Information is Necessary...................49 Packaging and Shipping of Replacement Parts ...............50 Medical Device Reporting Requirements ..................51 Schematics and QC Check Lists....................51 Table of Contents...
  • Page 6 Dynatron ® 150plus...
  • Page 7: Introduction To The Dynatron 150Plus

    150plus Introduction to the Dynatron 150plus Your new Dynatron 150plus gives you a wide range of treatment capabilities, yet it is compact, convenient and simple to use with its user-friendly touch panel for easy treatment setup. Here are some highlights of your Dynatron 150plus: •...
  • Page 8 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 150plus, be sure to read the operating instructions, contraindications, warnings, and precautions contained in this manual.
  • Page 9: Installation And Features

    Read the operating instructions and the contraindications, warnings and precautions in this manual before proceeding with a treatment. Standard Accessories Description Dynatron 150plus unit Power cord Operator’s manual Application manual Sample bottle Ultrasound gel...
  • Page 10: Dynatron 150Plus Physical Features

    Dynatron ® 150plus Dynatron 150plus Physical Features Before operating the Dynatron 150plus, 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. TIME POWER...
  • Page 11 Dynatron ® 150plus an optional battery power source. Only a Dynatronics-approved battery may be used. 4. TIME DISPLAY: Treatment time is displayed here. 5. 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.
  • Page 12: Soundheads

    ® 150plus 16. SOUNDHEAD HOLDER: The soundhead is placed in this holder when not in use. Soundheads Soundheads for the Dynatron 150plus are available in 2 cm , 5 cm , or 10 cm sizes. Each soundhead operates at 1, 2, and 3 MHz. The soundheads are waterproof allowing therapy to be administered in water, if desired.
  • Page 13: Treatment Instructions

    ON again. Press the power switch on the back of the device to turn on the Dynatron 150plus. 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.
  • Page 14: Turn Soundhead Warming Off / On

    Dynatron ® 150plus 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: •...
  • Page 15: Modify A Treatment In Progress

    Dynatron ® 150plus Ultrasound Usage Cautions in this manual). Do not hold the soundhead in the air, 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.
  • Page 16: Patient Coupling

    ® 150plus Patient Coupling The Dynatron 150plus 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).
  • Page 17: Head Temperature Bar Graph

    Dynatron ® 150plus To correct poor coupling make sure you are using an adequate amount of Ultrasound conductive gel 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.
  • Page 18: Head Temperature Hot

    Dynatron ® 150plus 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...
  • Page 19: Display Watts Or Watts/Cm

    POWER DISPLAY window. - A steadily-lighted decimal means the power is displayed in WATTS/cm - A blinking decimal means the power is displayed in WATTS. Restore Factory Defaults The Dynatron 150plus has the following default settings: • Soundhead Warming: ON •...
  • Page 20 Dynatron ® 150plus...
  • Page 21: Battery Operation

    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 150plus device. Turn the battery pack ON.
  • Page 22: Battery Requirements

    Battery Requirements • 12 volt and at least 5 amps peak current (1.5 ampere hours minimum). Do not substitute the Dynatron battery without first confirming with Dynatronics that the battery you are purchasing may be used with this device. •...
  • Page 23: Ultrasound With Electrical Stim Input

    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 150plus. NOTE: If you do not have a pin-to banana adapter, contact Dynatronics to order.
  • Page 24 Dynatron ® 150plus...
  • Page 25: Ultrasound General Information

    Dynatron ® 150plus 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.
  • Page 26: Penetration Of Ultrasound Waves

    Dynatron ® 150plus Head and Crystal Size Comparison 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.
  • Page 27: Types Of Delivery

    Dynatron ® 150plus • Select 1 MHz for deep lesions; provides a Half- Table 1 Value Distance (HVD) of about 5cm. • Select 2 MHz for moderate depth lesions; about 2.6cm HVD. • Select 3 MHz for superficial lesions; about 1.5cm HVD.
  • Page 28: Treatment Time

    Dynatron ® 150plus Treatment Time For Sub-Acute Conditions: area to be treated (cm ) = minutes of treatment 1.5 x ERA For Chronic Conditions: area to be treated (cm ) = minutes of treatment 1.0 x ERA For Maximal Thermal Effect:...
  • Page 29: Continuous Verses Pulsed Ultrasound

    3. Pulsed sound may have applications for wound management. Duty Cycle 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 10%, 20%, 50% or continuous. •...
  • Page 30: Output Power

    Dynatron ® 150plus • 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).
  • Page 31: Usage Cautions - Combination Treatments

    150plus Usage Cautions - Combination Treatments When using a Stim device in conjunction with the Dynatron 150plus 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.
  • Page 32 Dynatron ® 150plus...
  • Page 33: Contraindications, Warnings, Precautions

    Dynatron ® 150plus Contraindications, Warnings, Precautions Contraindications The Dynatron 150plus 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 •...
  • Page 34: Precautions

    POWER SHOULD BE REDUCED IF PATIENT COMPLAINS OF PERIOSTEAL BONE PAIN (BONE ACHE) Precautions The Dynatron 150plus must be used cautiously in the presence of any of the following conditions: • When there is a tendency to hemorrhage following acute trauma or fracture.
  • Page 35: Technical Specifications

    Dynatron ® 150plus 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, 2 MHz, 3 MHz 0-4 W;...
  • Page 36: Dynatron 150Plus Care And Cleaning Instructions

    150plus Dynatron 150plus Care and Cleaning Instructions Clean the outer surface of the Dynatron 150plus 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.
  • Page 37: Routine Calibration Inspections

    Dynatronics as repairable and which will not violate protection of Dynatronics’ proprietary information. Authorized Service Center All service of the Dynatron 150plus, except calibration, must be performed by Dynatronics’ Service Department. For service, contact the following: Dynatronics Customer Service Department...
  • Page 38: Definition Of Symbols

    Dynatron ® 150plus 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)
  • Page 39: Ultrasound Regulation

    10 minutes, and to within 1 minute of the preset duration of emission for settings greater than 10 minutes. NOTE: The Dynatron 150plus is accurate to within ±1% of any treatment time. Pursuant to FDA 21CFR 1050.10(f)(1), the uncertainties in magnitude, expressed in...
  • Page 40 Dynatron ® 150plus the temporal-maximum to temporal-average effective intensity, pulse duration, and pulse repetition rate for the Dynatron 150plus are as follows: Ultrasonic frequency .......±15% Effective Radiating Area ......±50% Ratio of the temporal-maximum to temporal-average effective intensity ..±20% Pulse duration ..........±10% Pulse repetition rate .........±10%...
  • Page 41: Beam Profile

    150plus Beam Profile The following diagrams show the typical spatial distribution of the radiated field for each size of Dynatron 150plusE 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.
  • Page 42 Dynatron ® 150plus 2 cm Head, Near Field: 1 MHz 3 MHz Beam Profile...
  • Page 43: Enter Soundhead Parameters

    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.
  • Page 44 ENTERED INTO YOUR DYNATRON DEVICE. USE ONLY THE ACTUAL NUMBERS PROVIDED WITH YOUR OWN SOUNDHEAD. 2. Plug in Soundhead. Turn the Dynatron 150plus 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%, 50%, Cont key) while turning the machine ON.
  • Page 45 Dynatron ® 150plus b. Select 50% Duty Cycle: With the 50% LED lighted, enter the value for Z – 2 MHz. c. Select 20% Duty Cycle: With the CONT LED lighted, enter the value for Temp – 2 MHz. d. Select 10% Duty Cycle: With the 10% LED lighted, enter “0” (zero) as the value for Coupling.
  • Page 46 Dynatron ® 150plus...
  • Page 47: Calibration Procedure

    ® 150plus Calibration Procedure With the exception of calibration, all service on the Dynatron 150plus device should be performed by a Dynatronics service technician. If your Dynatron 150plus 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.
  • Page 48 DUTY CYCLE toggle key (this is the key that selects 10%, 20%, 50% or Continuous). 6. The Dynatron 150plus performs the calculation internally for the “Z” (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).
  • Page 49 Dynatron ® 150plus 11. To calibrate the next soundhead, turn the machine off, and repeat steps 1 through 10 above. CAUTION: Avoid unnecessary Ultrasound exposure. Calibration Procedure...
  • Page 50 Dynatron ® 150plus...
  • Page 51: Problem Solving

    (see also “Head Temperature Hot,” page 12). The Dynatron 150plus uses several methods to inform the user of the temperature status throughout the treatment: •...
  • Page 52: Soundhead Temperature Too Cold

    Dynatron ® 150plus your whirlpool temperature is hot enough to cause the treatment to stop, you may need to adjust the temperature of the whirlpool. Soundhead Temperature 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.
  • Page 53 Dynatron ® 150plus 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.
  • Page 54 Dynatron ® 150plus...
  • Page 55: Sending A Unit In For Repair

    Dynatron ® 150plus 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.
  • Page 56: Packaging And Shipping Of Replacement Parts

    Dynatron ® 150plus 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 All defective or broken parts should be shipped back to Dynatronics in the original shipping container.
  • Page 57: Medical Device Reporting Requirements

    Reference: 21 CFR Part 803 Schematics and QC Check Lists The following pages provide the schematics and QC check lists for the Dynatron 125. Medical Device Reporting...
  • Page 58 Dynatron ® 150plus DYNATRON 125/150 plus FINAL QUALITY CHECK Unit S/N__________________ Software Ver._____ Date__/__/__ Repair____RS____Production____ Head SN: 5cm______________10cm______________2cm_______________1cm _______________ TECH/QC (initials) • Verify all keys work; all keys have good tactile feel • Verify all LED’s light up • Verify output turns off when STOP is pressed •...

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