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 re: 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 ammable anesthetics.
IMPORTANT: Before treating a patient with any Dynatron®125 device, see the “Contraindications, Warnings, and
Precautions” in this manual. Read the operating instructions carefully.
COMPLIANCE: e contents of this “Instructions For Use” manual are exactly the same in both the printed and electronic forms.
INDICATIONS FOR USE
ULTRASOUND:
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.
Introduction to the Dynatron® 125™ Ultrasound .................................................................................. 1
About Ultrasound ......................................................................................................................................................................1
Language Selection ....................................................................................................................................................................2
Before You Treat a Patient ......................................................................................................................................................... 2
Installation and Features ........................................................................................................................ 3
Standard Components ............................................................................................................................................................... 4
Head Temperature - Over Heating ........................................................................................................................................12
Display Watts or W/cm2 ..........................................................................................................................................................12
Ultrasound Modality Information ....................................................................................................... 16
Selecting the Appropriate Soundhead ...................................................................................................................................16
Penetration of Ultrasound Waves ..........................................................................................................................................17
Types of Delivery......................................................................................................................................................................18
Treatment Time ........................................................................................................................................................................18
Frequency of Treatment ..........................................................................................................................................................19
Poential for Burns or Periosteal Pain ....................................................................................................................................19
Ultrasound Problem Solving ............................................................................................................... 21
Soundhead Temperature Too Cold ........................................................................................................................................21
No Soundhead ..........................................................................................................................................................................21
Replacing the Soundhead .......................................................................................................................................................22
Combination erapy - Using the Combo Jack ................................................................................... 25
Stim rough the Soundhead ................................................................................................................................................26
Section III: Contraindications, Warnings, and Precautions
Contraindications, Warnings, & Precautions for Ultrasound Treatment .......................................... 27
Save New Defaults .................................................................................................................................................................... 30
Safety Features of the Dynatron 125 ......................................................................................................................................31
Battery Life ................................................................................................................................................................................33
Ultrasound Specications / Power Output ...........................................................................................................................34
Ultrasound Regulation and Compliance ..............................................................................................................................34
Care and Cleaning Instructions .............................................................................................................................................35
Routine Ultrasound Inspections for the Dynatron 125 ......................................................................................................37
Returning a Unit for Repair ....................................................................................................................................................37
Denition of Symbols and Labeling ......................................................................................................................................38
Disposal of Equipment and Accessories .............................................................................................................................39
Electromagnetic Emissions and Immunity ......................................................................................... 40
Medical Device Reporting Requirements ............................................................................................ 44
Denition of serious injury ....................................................................................................................................................44
Reporting any Incident of Patient Discomfort .....................................................................................................................45
e 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 exibility. With the Dynatron 125, there is no longer a need to manually enter soundhead parameters.
Soundheads are engineered with SmartHead technology that places calibration parameters directly inside each soundhead.
Ultrasound
All of the Dynatronics’ devices featuring ultrasound technology, including the 125, are the only devices in the industry
oering 1, 2, and 3 MHz frequencies for the greatest range in depth of treatment. Choose 1 MHz for deep treatments, 2 MHz
for moderate depth, or 3 MHz for supercial depth. Flexibility doesn’t end there, the Dynatron 125 has a Combo Jack for
setting up Stim and Ultrasound Combination treatments.
About Ultrasound
Ultrasound therapy is supported by a wealth of scientic literature. Channeling soundwaves through muscle, nerve, bone,
and connective tissue has been documented to aid in reducing pain muscle, spasms, and joint contractures. e “Ultrasound
Usage Cautions” in this manual provide some general guidelines for Ultrasound treatments to help ensure you deliver safe
and eective treatments to your patients. Further information about Ultrasound may be obtained from published medical
literature.
Simplied Setup
e unique design of the Dynatron 125 display screen means treatment setup has never been easier. A few simple key presses
are all you need to set up a treatment. e User Interface intuitively groups and displays all the options on the well lit LCD
screen to ensure that treatment parameters can easily be selected and adjusted.
A routine treatment setting can easily be set and saved as the default treatment—saving time in the treatment setup.
e 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 le-hand corner to return to the OPERATIONS SCREEN.
Operator’s Prole
All operators shall be properly trained and certied medical practitioners or those working under the direction of a licensed
medical practitioner, capable of reading and comprehending instructions for use as described in this manual. Operators will
have reasonable mobility and dexterity to apply ultrasound and monitor patient response to treatments. e operator should
be able to hear an audible signal indicating completion of treatments. ere should be no other limitations for operating
this device.
Before You Treat a Patient
Before administering a treatment to a patient with the Dynatron 125, familiarize yourself with all the operating instructions
for the ultrasound modality, as well as the contraindications, warnings, and precautions. In addition to this information,
consult other published sources for additional application and safety instructions regarding use of each type of therapy.
CAUTION
Device should be at room temperature prior to treatment.
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 le a claim for the damage sustained.
Do not destroy or discard the shipping carton. e carton should be reused if the device must be shipped for any reason,
including calibration. e 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 located at the back of this manual and return it to Dynatronics within 30 days
of purchase. is is essential to insure you are not billed for services that are covered by the warranty policy. Warranty
registration should include serial numbers for both the device and soundheads.
Connect the AC power cord, which is provided as 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).
e power cord must also be rmly plugged into the device itself. When the cord is properly connected, it cannot be easily
pulled out. Do 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 in this manual before proceeding with a treatment.
Before operating the Dynatron 125 device, acquaint yourself with the control panel by reviewing the illustrations and
descriptions on the following pages. e numbered features in the diagrams correspond to the numbered descriptions.
Before administering treatment to a patient, read the sections later in this manual that provide specic instructions for
performing treatments along with contraindications, warnings, and precautions for all modalities.
Note: e User Interface on Dynatron 125 device is engineered with “CapSense Touch Technology” requiring that the user
make direct contact with the keys on the faceplate using dry, bare ngers or a glove with a conductive ngertip.
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
e 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. FREQUENCY
Located in the lower le-hand corner of the Operations Screen, the FREQUENCY key allows the practitioner to
toggle between 1, 2, and 3 MHz frequencies. is value is not saved as a default when changed. e system will
default back to 1 MHz when the device is turned o and on again.
3. INTENSITY
INTENSITY is controlled by using the UP and DOWN INTENSITY ARROWS located in the center of the Operations
Screen. As the arrows are pressed, modications are immediately displayed in between the arrows.
4. TIME / TIME SCREEN
When the window is pressed, the TIME SCREEN appears. TIME defaults to 5:00 min. but can be adjusted by using
the UP and DOWN ARROW KEYS located on the TIME SCREEN.
5. SAVING TREATMENT TIME AS A DEFAULT
From the TIME screen, pressing the image in the lower le-hand corner aer setting the TIME will save the TIME
setting as the new default. Once saved, the saved TIME selection becomes the default TIME for all future treatments.
6. RETURN KEYS
Wherever shown, these keys, located on both the TIME screen and the SETTINGS screen, return the display to the
Operations Screen.
7. SETTINGS KEY / SETTINGS SCREEN
Pressing the SETTINGS KEY opens the SETTINGS SCREEN. Inside the SETTINGS SCREEN the practitioner can
control BRIGHTNESS, VOLUME, LANGUAGE, turn HEAD WARMING ON and OFF, and change the INTENSITY
display to either to W/cm2 or WATTS. Once changes are made to Language, Head Warming, or Intensity; these
changes become the Default Settings and will remain in place until additional changes are made.
8. VOLUME
e volume of the sound can be changed from low, to medium, to high.
As contrast and clarity of the screen graphics can be aected 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 WAT TS
is key shows the POWER selected for the current treatment. e Default Power is displayed in WATTS per square
centimeter (WATT/cm2). WATT/cm2 is the intensity of the Ultrasound at the head surface; it is the total Watts
divided by the eective radiating area of the head. e display may be changed to WATTS, if desired, by pressing the
POWER toggle key located on the Settings Screen.
11. LANGUAGE
e default language for the Dynatron 125 is English; however, both French and Spanish are also available. To change
the language, press the LANGUAGE toggle key until the desired language appears in the display.
12. HEAD WARMING
e HEAD WARMING feature defaults to OFF. When HEAD WARMING is ON but idle, the soundhead is warmed
automatically. Head warming may be turned OFF or ON by pressing the WARMING key located on the Settings
Screen.
13. HEAD CALIBRATION
Manually entering parameters for the Dynatron 125 SmartHeads is not necessary. is key provides the capability to
enter parameters manually in the event that parameters are lost or the user wishes to enter the parameters manually.
is key is also used to access user calibration mode for soundheads.
14. RESTORE DEFAULTS
e Dynatron 125 has the following default settings: Soundhead Warming OFF, Time 5:00 min., and Power Display
set to Watts/cm2. Each of these settings may be changed by the user along with other setting (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, press the RESTORE DEFAULT KEY.
15. START
e green key in the upper right corner of the Operations Screen is the START key. Press the START key and the
treatment timer will begin to count down. During treatment, this same key will act as the PAUSE key.
16. STOP
Pressing the RED STOP key during a treatment immediately stops the output and sets the treatment intensity to zero.
Illustrated below is the Ultrasound Input Jack located on the Front Panel of the Dynatron 125.
Le-Side Panel - Combo Jack
Located on the le-side of the Dynatron 125 is a banana jack designed to accommodate a Combination Lead Wire,
connecting the Dynatron 125 to an existing Stim source, making it possible to set up a combination treatment and
provide Stim output through the Ultrasound Head.
Front Panel Ultrasound Jack
Back Panel Jacks
a. POWER CORD ENTRY MODULE. is entry module is designed to accommodate a hospital-grade
power cord.
b. Power 1/0 (ON/OFF) Switch. Located on the back of the unit this switch is labeled “1” and “0.” Set the switch
c. B att e ry. is 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 ERROR MESSAGESCAUSE
ERR 200
ERR 201
ERR 202SOUNDHEAD CURRENT TOO HIGH!Soundhead over current
ERR 203SOUNDHEAD CURRENT TOO LOW!Soundhead under current
ERR 204
ERR 205
ERR 206
SOUNDHEAD DISCONNECTED! TREATMENT PAUSED.
CORRECT PROBLEM WITH SOUNDHEAD TO RESUME
THERMISTOR ON SOUNDHEAD IS MALFUNCTIONING!
PLEASE REPLACE SOUNDHEAD.
SOUNDHEAD IS TOO HOT!
OUTPUT HAS BEEN DISABLED TO ALLOW COOLING.
SOUNDHEAD WAS JUST DISCONNECTED,
DISABLING POWER OUTPUT!
PATIENT COUPLING.
PLEASE REAPPLY SOUNDHEAD TO PATIENT. Inadequate patient coupling.
NO HEAD INTENSITY.
TREATMENT WILL NOT START.
PLEASE INCREASE INTENSITY.
SOUNDHEAD NOT DETECTED!
CORRECT PROBLEM WITH SOUNDHEAD TO RESUME.
ENTERED CALIBRATION DATA RANGE ERROR.
CORRECT PROBLEM BY RE-ENTERING DATA.
Soundhead parameters manually
US Probe calibration
data is corrupted
Intensity not set - or -
Head disconnected.
Bad soundhead cord.
Head disconnected.
Bad soundhead cord.
entered incorrectly.
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.
e physiological eect of Ultrasound therapy depends upon the frequency of the Ultrasound signal. e 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.
A section in this manual entitled “Ultrasound Usage Cautions” provides some general guidelines for Ultrasound treatment
and selection of the appropriate soundhead to help ensure safe and eective treatments are delivered to your patients. Further
information about Ultrasound application may be obtained from published medical literature.
WARNING
• ALWAYS keep the applicator soundhead in constant motion.
• ALWAYS keep the soundhead properly coupled to the patient’s skin or submerged underwater when intensity
is turned ON.
• Use ample conductive gel to ensure good coupling throughout the treatment. If needed, apply additional gel
during the treatment.
• See the section of this manual entitled “Contraindications, Warnings, and Precautions” for Ultrasound treatments.
• Be alert for any sign of periosteal (bone) pain.
• Be sure to read all instructions for operation before treating a patient.
• Use of controls or adjustments or performance of procedures other than those specied herein may result in
hazardous exposure to ultrasonic energy.
Make sure a soundhead is rmly plugged into the device before turning the device ON. When changing to a dierent size
soundhead, turn the machine o rst, 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.
Soundhead Warming
Soundhead Warming is an optional feature used to maintain a comfortable soundhead temperature for the patient. When
Soundhead Warming is ON, the soundhead should remain in its holder as a small amount of Ultrasound output is emitted
from the soundhead (0.1 W/cm2). e soundhead warming mode is automatically stopped during a treatment, and resumes
automatically as needed aer a treatment has ended. Although the Soundhead Warming feature defaults to OFF, it can be
turned ON at any time by going to the Setting Screen and pressing the WARMING key.
CAUTION
• Do not drop the soundhead on hard surfaces.
• Do not cool the soundhead with ice water or ice packs.
• Do not allow the soundhead to overheat repeatedly.
• Do not hold the soundhead in the air while a treatment is running.
All of these conditions are likely to damage the soundhead crystal and/or to stress electronic components in the
device. Damage caused by these conditions is not covered by warranty.
Coupling
e 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. Coupling (contact between the soundhead and the treatment site) may be
provided by a coupling agent such as a gel or lotion. Any material used as a coupling agent must be highly conductive of
ultrasonic waves. Air is a very poor conductor of ultrasonic waves. Holding the soundhead in the air while a treatment is
running may also damage the soundhead crystal and/or stress electronic components in the device.
If any part of the soundhead is exposed to air during the treatment, coupling is decreased. e air bubbles in a whirlpool, for
example, can decrease the eective Ultrasound therapy to the patient. Avoid allowing any air between the soundhead and
the treatment area. Water is an excellent conductor of ultrasonic waves; therefore, underwater treatments provide excellent
coupling.
During any Ultrasound treatment the soundhead should be moved continuously, covering an area approximately 2-4 times
larger than the size of the soundhead. e full surface of the soundhead should maintain contact with the patient’s skin
(except with underwater treatments).
If coupling (the eective 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.”
e soundhead must be cooled before the treatment can resume. When the soundhead cools suciently, press START
to resume the treatment. e output power resumes, the display returns to its normal state, and the timer resumes. e
soundhead should cool quickly if placed in the soundhead holder or if held exposed to the air. Larger soundheads take longer
to cool than smaller heads. If the soundhead is not cooling as quickly as needed to resume the treatment, it can be placed in
room temperature water to quicken the cooling process. Sometimes just applying more conductive gel will adequately cool
the head.
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 a 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 by applying ample conductive
gel or lotion. Reducing the power when treating an area where it is dicult to obtain good coupling will also keep the
soundhead from overheating.
Display Watts or W/cm
2
Power for the Dynatron 125 may be displayed as WATTS or W/cm2. To choose the desired option, select the Settings Key on
the Operation’s Screen. On the Settings Screen, press the POWER toggle key to select the desired power display. e default
setting for power is W/cm2; however, the display you prefer may be selected at any time before or during a treatment.
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 aer the time has been modied.
5. INTENSITY. Use the Up/Down arrow keys within the INTENSITY button to raise or lower the INTENSITY
to the desired level.
6. Press START.
7. MODIFY a treatment in progress, if desired. While the treatment is in progress, the following parameters
can be modied: FREQUENCY, DUTY CYCLE, TIME, and INTENSITY.
8. PAU SE . e PAUSE key may be pressed at any time aer a treatment has been started. e output will stop
and the timer will PAUSE.
9. STOP. Press the STOP key to stop the treatment.
Detailed Ultrasound Setup
1. Turn the main power switch at the back of the unit to the ON position.
e following Default Parameters will automatically appear in the Operation’s Screen:
Frequency ........................................1 MHz
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. Select the DUTY CYCLE
Press the DUTY CYCLE toggle key located on the Operations Screen to select one of the four available options: 10%, 20%,
50%, or 100% (Continuous) duty cycles.
4. MODIFY TREATMENT PARAMETERS
e following parameters can be modied at the time of set-up or while the treatment is in progress. : FREQUENCY,
DUTY CYCLE, TIME, INTENSITY, HEAD WARMING, and POWER DISPLAY of WATTS or W/cm2.
• HEAD WARMING
Access the Settings Screen by pressing the Settings Key in the lower right hand corner of the Operations Screen.
On the Settings Screen, press the WARMING key to toggle between Head Warming ON and OFF. When the
image turns “BLUE,” Head Warming is ON. When the display returns to black and white, Head Warming is OFF.
• POWER DISPLAY
Press the Setting Key on the Operations Screen. From the Settings Screen, select the appropriate toggle key to
change the POWER DISPLAY from WATTS to W/cm2.
5. TIME.
Touch the TIME display on the Operations Screen to access the TIME SCREEN. e default time is set for a
5:00 min. treatment. Time can be changed by using the TIME Up/Down arrow keys located to the right of the
TIME display. Aer selecting the treatment time, press the Return Key located in the lower right-hand corner
to return to the Operation’s Screen.
6. SAVE SELECTED PARAMETERS AS THE DEFAULT TREATMENT PARAMETERS.
To save the treatment TIME that has been selected for a current treatment as the Default TIME, touch the TIME
window on the Operations Screen. Press the image in the lower le-hand corner. e selected treatment TIME
is now saved as the Default for future treatments. Any changes made to Language, Head Warming, and Intensity
Display Units are automatically saved as Defaults.
7. RAISE THE INTENSITY.
On the Operations Screen, use the INTENSITY Up/Down arrow keys located on either side of the Power Display to
increase the power to the desired treatment setting. For patient safety and comfort, it is recommended that treatment
begins with .1 W/cm2, before increasing power to the desired level aer the treatment begins. Valid ranges are from
0.1 to 2.0 W/cm2 (exceptions: valid ranges when using a 10 cm2 head are from 0.1 to 1.0 W/cm2).
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. A tone will sound indicating
that the treatment has been paused. e Ultrasound output from the soundhead stops and the treatment timer is
paused without ending the treatment. Press the green START/PAUSE key again to restart the treatment. A tone will
sound indicating that the treatment is again in progress. Output resumes and the treatment timer starts from where
it was paused.
NOTE: During a COMBO treatment, THE STIM OUTPUT OF THE TREATMENT IS NOT PAUSED when the
PAUSE key is pressed, although the Ultrasound output is stopped and the treatment timer is paused.
10. S T O P.
When the treatment time has elapsed, the ultrasound to the patient stops and a tone sounds signaling the end of a
treatment. Treatments in progress may be stopped at any time by pressing the red STOP key.
Ultrasound, by its very nature, has the ability to irritate the patient’s skin. While the benets 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.
e 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 specic 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, ngers, feet).
• A 5 cm2 soundhead can deliver up to 10 Watts and is appropriate for medium sized areas (i.e. extremities such as
arms, legs, and cervical areas).
• A 10 cm2 soundhead can deliver up to 10 Watts and is appropriate for large areas, i.e. torso and back).
Ultrasound is a directed beam of energy. erefore, 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 cm2 is treated for 5
minutes. en an area of 200 cm2 is treated for 5 minutes. Both receive the same intensity. e 200 cm2 area however does
not receive the same dosage (only ¼ ) because as the soundhead is moved around the area it has to cover represents 4 times
as much tissue.
e Soundhead area measurement is the ERA (eective radiating area). Each soundhead has an eective radiating area. It is
not necessarily the outside diameter of the soundhead, but the area 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.
NOTE: If a patient experiences pain during a treatment, the size of the soundhead maybe inappropriate for the area
being treated, the intensity maybe too high, the treatment time maybe too long, or coupling maybe poor.
Penetration of Ultrasound Waves
e correct frequency should be selected for the depth of penetration desired. e 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.
e frequency determines the depth of penetration of
the Ultrasonic wave.
• Select 1 MHz for deep lesions; provides a
Half-Value Distance (HVD) of about 5cm.
• Select 2 MHz for moderate depth lesions; about
2.6cm HVD.
• Select 3 MHz for supercial lesions; about
1.5cm HVD.
HVD is the approximate point at which the Ultrasound
energy is reduced to half in the average human tissue.
Ultrasound can be delivered in four dierent 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. e soundhead is moved slowly, but continuously. is is the method of
choice.
e 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). If 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. e soundhead is rated IPX7, so it can be
immersed with the area to be treated. e water becomes the coupling agent. e 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. is allows direct wound sonation without bringing the soundhead in direct contact with the wound.
4. Stationary Soundhead. is method is dangerous. Hot spots can develop. Do not use.
Treatment Time
For Sub-Acute Conditions:
For Chronic Conditions:
For Maximal ermal Eect:
area to be treated (cm2)
= minutes of treatment
1.5 x ERA
area to be treated (cm2)
= minutes of treatment
1.0 x ERA
area to be treated (cm2)
= minutes of treatment
.8 x ERA
Treatment Intensity
Several factors come into play as one decides the level of intensity for the treatment.
1. Supercial lesions require less intensity.
2. Less intensity should be used if bone is supercial to the treatment eld.
3. Less intensity should be used when the stage of the injury makes heating questionable.
NOTE: It is very common that intensity is always 1.5 W/cm2. is is incorrect in many cases. A more specic
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 eectively given every other day.
3. Ultrasound should give some positive benets by the 3rd or 4th application. If not, discontinue the treatment and
consider other options.
4. A maximum of 12 to 15 Ultrasound treatments should 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.
Usage Cautions – Combination Treatments
When using a Stim device in conjunction with a Dynatron 125 device to output Stim through the soundhead, observe
all contraindication, warnings, precautions, and usage cautions provided by the manufacturer for all modalities involved.
Dynatronics’ stim devices ae recommended. Any other stim device used must not exceed the voltage levels of a Dynatronics’
stim device to ensure safety for the patient.
Poential for Burns or Periosteal Pain
Some patients’ skin is more sensitive to Ultrasound output. is can cause a reaction similar to a heat rash. It is also possible
for a patient to suer a burn from Ultrasound therapy if the therapy is not administered properly. is can occur for the
following reasons:
• 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 reect 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 sucient coupling agent and make sure there are no bubbles in the gel. When treating in water, clear the
bubbles o the soundhead and the patient’s skin.
An un-calibrated soundhead can also cause tingling, excess heat, aching, or a burning sensation.
Read Ultrasound Contraindication, Warning, & Precaution in this manual for more information.
If you are treating in a whirlpool, you may nd that the temperature in the whirlpool approaching 103˚F, causing the
overheated soundhead caution to appear on the Operations Screen. is 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. If your whirlpool
temperature is hot enough to cause the treatment to stop, you will need to adjust the temperature of the whirlpool.
Soundhead Temperature Too Cold
If the soundhead has been sitting in a very cold room or vehicle, it could be too cold to operate when plugged into the console.
e keypad may not respond to key presses and the device will not function until the soundhead is suciently 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 at face of the soundhead against the palm of your hand for 30 to 60 seconds to warm it slightly. is
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. You can 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.
No Soundhead
If the device cannot detect a soundhead during setup or during an ultrasound treatment, the error message “SOUNDHEAD
DISCONNECTED! CORRECT PROBLEM WITH SOUNDHEAD TO RESUME!” will appear on the Operations Screen.
If this error occurs, check to be sure the soundhead is rmly 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. Some errors are easily resolved by the following methods.
• Press STOP to stop the treatment, and turn the machine OFF then ON again. Always wait 5-10 seconds before
restarting the device.
• Check to be sure the soundhead has not become disconnected from the machine. e soundhead should be rmly
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.
• Make sure the soundhead is not too hot. In this case a Soundhead error will appear in the Operations Screen.
• Check to see if conditions may have caused extreme moisture/condensation in the device. is could occur when
the machine has become very cold and is brought indoors to a warm, humid environment. Condensation is a not
a serious condition. Allow the machine to sit in a dry environment until the condensation dries. e machine will
operate normally once the condensation is gone.
• Should the touch screen become unresponsive but the treatment timer continues to count down, you may continue
delivering the treatment until it ends. If the touch screen remains unresponsive, cycle the power o/on the device.
When the condition persists, contact the Customer Service Department.
If you have tried all of these suggestions, the device may require service by the manufacturer. In this case, make a note of the
error message and the sequence of events that caused the error, and contact Dynatronics Customer Service at 1-800-874-6251
for further assistance. Do not send the device to Dynatronics without rst contacting the Customer Service Department.
Replacing the Soundhead
e Ultrasound probe is a “smart” probe. e treatment head contains a microcontroller to store calibration data and
communicate that data to the console when the probe is plugged into the device. is feature allows the user to change
soundheads on the console without entering the calibration data associated with each soundhead.
In addition, the Dynatron 125 provides a “Head Calibration” key that gives the user the capability to enter parameters
manually in the event that parameters are lost or the user wishes to enter the parameters manually. is key, located on the
Settings Screen, is also used to access user calibration mode for soundheads. Soundheads should still be calibrated on an
annual basis.
e following diagrams show the typical spatial distribution of the radiated eld for each size of Dynatron 125 soundheads.
is applies to the radiation emitted into the equivalent of an innite medium of distilled, degassed water at 30˚C and with
line voltage variations in the range of ±10 percent of the rated value.
e Combo Jack provides the ability to combine electrical stimulation from an existing electrotherapy device with the
Dynatron 125 Ultrasound. e existing stimulator device must comply with IEC 601-1 and IEC 601-2-10 (general and particular standards) requirements. e 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. e choice of electrotherapy modalities
that can be combined with an Ultrasound treatment depends on the stimulation device being used. Refer to the stimulation
device’s instruction manual for instructions regarding delivering electrotherapy. Dynatronics’ stim devices ae recommended.
Any other stim device used must not exceed the voltage levels of a Dynatronics’ stim device to ensure safety for the patient.
WARNING
• DO NOT use combination therapy for underwater treatment. Placing active electrodes underwater poses a
serious hazard to the patient!
• Use VERY LOW STIM INTENSITY for COMBO treatments.
• Remember to observe all contraindications, warnings, precautions, and usage cautions for BOTH Ultrasound
and Electrical Stimulation therapy when performing combination therapy.
• Since electrical current travels between the electrode and the soundhead during a COMBO treatment, the
electrode should be placed in proximity with the treatment area. Do not place the electrode and soundhead in
positions that will cause current to pass through contraindicated areas.
• Avoid removing the soundhead from the skin surface during “Stim rough Soundhead” treatments as
this may cause a momentary interruption of Stim current which may be uncomfortable to the patient. e
soundhead should remain in full contact of the skin until current output is stopped.
• Be alert for any sign of periosteal (bone) pain.
With combination therapy, the soundhead is used in place of one electrode for a Stim treatment; and electrotherapy current
is delivered through the soundhead. is 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. At the same time ultrasonic
waves are introduced into patient tissue through the soundhead. Avoid touching the electrode with the soundhead during the
treatment. Keep the soundhead in contact with the patient’s skin at all times, and keep the intensity low for the Stim current.
WARNING
• When setting up a combination treatment, observe all Contraindications, Warnings, and Precautions for both
therapies to be used.
• Use VERY LOW STIM INTENSITY for COMBO treatments.
• Carefully comply with all instructions for the use of the existing electrotherapy device when it is used in
combination with the Dynatron 125.
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.
• 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 suppressor if power problems are encountered.
• Avoid unnecessary exposure to Ultrasound (patient and therapist).
ere are no serviceable parts in the Dynatron 125 devices.
Setting Defaults
e Dynatron 125 Ultrasound has default settings that are automatically selected when the device is turned on. e 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.
Save New Defaults
If your most common treatment settings are dierent than the ones already set for this device, you can change the defaults
to suit your own preferences. Setting new defaults is simple and defaults may be changed again and again whenever needed.
1. Set up a treatment using your preferred settings. Intensity, Frequency, and Duty Cycle cannot be saved as default
settings.
2. Touch the TIME window on the Operations Screen. e Time Screen will appear.
3. Press the image in the lower le-hand corner. Treatment Parameters are now saved as the Default Parameters for
future treatments.
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.
Environmental Conditions
Transport and Storage
is equipment, while packed for transport or storage, should not be exposed to environmental conditions outside the
following ranges:
+70°C
a. an ambient temperature range of -40°C
b. a relative humidity range of 10% to 100% including condensation
c. an atmospheric pressure range of 500 hPa to 1060 hPa
Operation
is equipment is designed to operate in normal use under the following environmental conditions:
+30°C
a. an ambient temperature range of +10°C
b. a relative humidity range of 30% to 75% including condensation
c. an atmospheric pressure range of 700 hPa to 1060 hPa
Safety Features of the Dynatron 125
• All intensity levels are automatically set to zero at the end of treatment (ensures proper setting of intensity levels for
the next patient).
• Internal surge protection protects against line noise, machine switching operation and any other type of interference
that could cause patient discomfort.
• e Power Cord is considered the ‘disconnect device’ when it is necessary to ensure that the device is disconnected
from a power source (for service or otherwise). Do not position the device such that it would be dicult to disconnect
the power cord from the device.
• Soundhead temperature monitoring prevents the soundhead from becoming too hot, both to protect the soundhead
crystal from damage and to ensure patient comfort.
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.
All Dynatron 125 devices are manufactured with battery capabilities allowing deliver of treatments wherever power may be
unavailable or unreliable. To use the optional battery, do the following:
1. It is recommended that a battery be charged for 24 hours prior to
operating the Dynatron 125 device. DISCONNECT the battery
charging cable from the battery while it is in use for treatment.
2. Plug the battery adapter into the jack labeled “BAT-INPUT 12V-DC”
on the back of the Dynatron 125 console. e green BATTERY ICON
will appear in the lower le-hand corner of the Operations Screen.
Battery Available
Caution, Low Battery
Battery Level Too Low.
Charge Immediately!
3. Set up and deliver treatments.
4. When battery power is reduced to approximately 11 volts, a low battery warning will be displayed in the lower
right-hand corner of the Treatment Display Screen “CAUTION: BATTERY LEVEL GETTING LOW!” e treatment
can continue; however, there will not be enough power to set up and deliver another treatment when the current
treatment has ended. e yellow BATTERY ICON will appear in the lower le-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!”
e treatment intensity will ramp down, any treatments that were running at the time will stop, and the device will
shut down. Before battery operation can continue, the battery must be recharged.
Note: If using a smaller gauge wire (20 AWG and up) the BATT LOW error is possible when the battery is not low.
Battery Requirements
• 12 volt and at least 5 amps hours.
• Battery adaptor cord must match the plug end of the battery pack. e barrel plug end must match the 0.325” barrel
jack adaptor plug on the Dynatron 125.
• e cord needs to be a minimum of 18 AWG gauge wire. 14-16 AWG gauge wire will work as well with a 5 amp fast
blow fuse.
Battery Life
e length of time that a unit can be used with a battery pack is dependent on several factors:
• e amperage of the battery pack. Larger amperage will provide longer use.
• e 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.
CAUTION
Follow battery manufacturer’s instructions for usage and care. When disposing of a used battery, comply with the
laws and procedures required in your area.
• FDA 21CFR 1050(c)(1)(i). e 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). e sum of the errors in the indications of temporal-maximum ultrasonic power and the
ratio of the temporal-maximum eective intensity to the temporal-average eective intensity shall not exceed ±20
percent for all emissions greater than 10 percent of the maximum emission.
• FDA 21CFR 1050.10(c)(2). e 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 1 minute of the preset duration of emission for settings greater than 10
minutes.
NOTE: e 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, eective radiating area, and the ratio of the temporal-maximum to temporal-average eective intensity, pulse
duration, and pulse repetition rate for the Dynatron 125 is as follows:
(1) Ultrasonic frequency ....................................................................................................... ±15%
(2) Eective Radiating Area ................................................................................................. ±20%
(3) Ratio of the temporal-maximum to temporal-average eective intensity ............... ±20%
• Clean the outer surface of the Dynatron 125 devices with a slightly damp or lightly moistened cloth. Mild household
cleaners work well on the frame, but do not use cleaners on the display windows. Do not spray the solution directly on the unit. Solvents, caustic solutions and harsh or abrasive cleaners must never be used.
• Do not attempt to sterilize the device or the soundheads using any type of sterilization equipment including
autoclaves.
• Avoid stretching cords to full length, bending cords sharply or wrapping cords tightly. Undue stress on cords can
damage connections.
• Keep all food and 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.
• Do not place hot packs or any items with moisture content on top of the console.
• 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. is 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.
Suggested Maintenance Schedule
Service To Be Performed Annually By A Technician:
• Annual Ultrasound calibration should be performed by a qualied 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 uid.
3. If a machine or soundhead is dropped, or if it sustains damage due to lightning, severe power surge, 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. 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. Inspect device air vents periodically to ensure air ow is not blocked. An ordinary household vacuum hose may be
used to clean dust from air vents externally.
6. ere are no serviceable parts in the Dynatron 125. DO NOT attempt to unscrew or tighten the Ultrasound probe
heads. Immediately report any device malfunction to Dynatronics Customer Service Department.
WARNING
Hazardous electrical output. To reduce the risk of electrical shock, do not remove cover. Refer servicing to
qualied service personnel.
For continued protection against risk of re, 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. e device must
still be examined at the periodic intervals specied by the governing agency for the country in which the device is used. To
have the inspection performed by Dynatronics, contact Dynatronics’ Customer Service Department. e device will need to be
shipped to Dynatronics for the inspection. As an alternative, these periodic checks may be performed in your own locale by an
independent contractor, who is expert in checking the calibration of Ultrasound equipment. e calibration procedure MUST
be performed by a qualied Ultrasound technician using the proper equipment, and is recommended every 6 to 12 months.
Returning a Unit for Repair
BEFORE sending a device to Dynatronics for service, you must FIRST obtain a return authorization number. Call
Dynatronics’ Customer Service Department at (800) 874-6251 and discuss any problems or required service to save time
and ensure the machine is returned to you as quickly as possible.
Autorización de Retorno
e following information will need to be supplied when calling Dynatronics’ Customer Service to obtain a return Service
Order Number (SVO):
1. User name and address
2. User phone number
3. Serial number of the unit
4. A description of the problem with the unit
Aer receiving the Service Order Number (SVO), the number should be clearly written on the outside of the shipping container.
Packaging and Shipping of Replacement Parts
All defective or broken parts should be shipped back to Dynatronics in the original shipping container. ese containers are
designed to withstand the punishment of shipping. If the original containers are not usable, nd containers that are similar
in protection so damage in shipping will be prevented. e person or company sending the unit to Dynatronics is responsible
for any shipping damage resulting from a poorly packaged part or unit.
e following labels appear on the Dynatron 125 console, and Ultrasound Heads.
Manufacturer’s Label
Electrical Ratings Label
Ultrasound
Equipment Classication
is device is classied as follows:
• Protection against electric shock: Class I (protectively earthed enclosure)
• Protection against electric shock: Type BF (oating patient-applied part)
• Protection against harmful ingress of water: none
• Equipment not suitable for use in the presence of a ammable anesthetic mixture with air or with oxygen or nitrous oxide.
• Mode of operation: Continuous operation
Disposal of Equipment and Accessories
ere is no risk posed in disposal of this equipment or its accessories. ese items contain no hazardous materials. Follow
the WEEE or the applicable guidelines for your country of residence with respect to the disposal of electrical or electronic
equipment. For disposal of accessory batteries, see manufacturer’s instructions and follow applicable laws and regulations in
your area.
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 specied below. The customer or the user of the Dynatron 125 (and accessories) should assure that it is used in such
an environment.
The Dynatron 125 (and accessories) uses RF energy only
for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment
The Dynatron 125 (and accessories) is suitable for use in
all establishments other than domestic and those directly
connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Dynatron 125 (and accessories) is intended for use in the electromagnetic environment specied
below. The customer or the user of the Dynatron 125 (and accessories) should assure that it is used in
such an environment.
Emissions Test
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
IEC 60601
Test Level
+/- 8 kV contact
+/- 15 kV air
+/- 2 kV for power
supplyline
+/- 1 kV input/output lines
+/- 1 kV differential mode
+/- 2 kV common mode
<5 % Ut
(>95 % dip in Ut)
for 0,5 cycle
40 % Ut
(60 % dip in Ut)
for 5 cycles
70 % Ut
(30 % dip in Ut)
for 25 cycles
Compliance
Level
Compliant
Compliant
Compliant
Compliant
Electromagnetic Environment
Guidance
Floors should be wood, concrete or
ceramic tile. If oors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital environment. If the user of
the equipment requires continued
operation during power mains interruptions, it is recommended that the
equipment be powered from an uninterruptible power supply or a battery.
<5 % Ut
(>95 % dip in Ut)
for 5 seconds
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
should be at levels characteristic of
a typical location in a typical commercial or hospital 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 specied below. The customer or the user of the Dynatron 125 (and accessories) should assure that it is used in such
an environment.
Emissions
Test
Conducted
RF
IEC 61000-4-6
Radiated RF
IEC 610000-
4-3
IEC 60601
Test Level
3 Vrms
150 KHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
Compliance
Level
3V
3V/m
Electromagnetic Environment Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Dynatron 125
(and accessories), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.17 x P 80 MHz to 800 MHz
d = 1.17 x P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in
meters (m).
Field strengths from xed RF transmitters, as determined
by an electromagnetic site survey, should be less than
the compliance level in each frequency range
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be pre-
dicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location
in which the Dynatron 125 (and accessories) is used exceeds the applicable
RF compliance level above, the Dynatron 125 (and accessories) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dynatron 125 (and accessories).
b. Over the frequency range 150 KHz to 80 MHz, eld strengths should be less than 3 V/m.
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. The customer or the user of the Dynatron 125 (and accessories)
can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the Dynatron 125 (and accessories) as recommended below, according to the maximum power of the communications equipment.
Separation distance (meters) according to frequency of transmitter
Rated maximum output
power of transmitter
W
0.010.120.120.23
0.10.370.370.74
11.21.22.3
103.73.77.4
100121223
For transmitters at a maximum output power listed above, the recommended separation distance (d) in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P
is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects and people.
Under the Safe Medical Devices Act (SMDA), the manufacturer and distributor are required to report specic 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 2 working days based on the following criteria:
• If you receive information that reasonably suggests a probability that a device caused or contributed to a:
• death
• serious injury, or
• serious illness
• If you receive information that reasonably suggests a device malfunction and a recurrence will probably cause:
• death
• serious injury, or
• serious illness
Denition 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 (i) 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).
Dynatronics recommends that if discomfort of any level is reported by the patient, the treatment be stopped immediately.
e 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. Also note environmental factors
that were observed during the treatment (oce lights ickering, static electricity discharge, other devices in use on the same
power source or in the same room, etc.)
e incident should be reported immediately to Dynatronics Customer Service at 1-800-874-6251. e customer service
representative will inform you if it is necessary to send the device and/or accessories to Dynatronics for inspection.
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. If this
product is defective within the warranty period, DYNATRONICS will, subject to the conditions set forth below:
(1) repair or replace defective parts at no charge within a reasonable period of time with new or remanufactured parts, at DYNATRONICS’ option; and
(2) provide labor for the repair or replacement of defective parts under this warranty without charge.
Parts used for replacement under this warranty are warranted for the remainder of the original warranty period. THE REPAIR OR REPLACEMENT OF
DEFECTIVE PARTS SHALL CONSTITUTE THE SOLE AND EXCLUSIVE REMEDY IN THE EVENT OF A BREACH OF WARRANTY.
REGISTRATION REQUIRED. In order for this warranty to be valid, the warranty registration card (included with the product) must be lled out and
returned to DYNATRONICS within 30 days of purchase by the original owner. A copy of an invoice or receipt may be requested to verify purchase date.
REPAIRS. All repairs must be performed by an authorized service facility. Any modications or repairs by unauthorized parties will void this warranty.
OBTAINING WARRANTY SERVICE. Authorization by DYNATRONICS is required before obtaining service under this warranty. erefore, before
shipping or delivering this product to an authorized service facility for warranty service, call DYNATRONICS and obtain a return authorization number.
PACKAGING AND SHIPPING. Any unit shipped to an authorized service facility for service under this warranty must be in the original shipping
carton, freight prepaid, fully insured, and properly packed to prevent damage. DYNATRONICS is not liable for any damage to the unit while in transit.
Include a summary of the problem with the product. Write the return authorization number obtained from DYNATRONICS on the shipping label.
SHIPPING COSTS. Within the rst 30 days of the warranty period, DYNATRONICS will pay all necessary shipping costs associated with obtaining
service under this warranty. Aer the rst 30 days of the warranty period, the owner is responsible for all costs associated with shipping the product to
an authorized service facility. DYNATRONICS will pay all costs associated with shipping the product back to the owner aer service is completed, and
will ship the product using the same carrier or type of carrier and service that was used by the owner for the incoming shipment.
EXCLUSIONS. Any defect, malfunction or failure caused by or resulting from improper installation, service, maintenance or repair, or from abuse,
neglect, transportation, accident, act of God, or other cause beyond the control of DYNATRONICS will not be covered by this limited warranty. ANY
IMPLIED WARRANTIES COVERING THIS PRODUCT, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO ONE YEAR FROM THE DATE OF PURCHASE BY THE ORIGINAL
OWNER. DYNATRONICS SHALL NOT IN ANY CASE BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT, OR OTHER
SIMILAR DAMAGES ARISING FROM BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, OR ANY OTHER LEGAL THEORY
EVEN IF DYNATRONICS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SOME STATES DO NOT ALLOW LIMITATIONS
ON HOW LONG AN IMPLIED WARRANTY L ASTS OR THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES,
SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND
YOU MAY ALSO HAVE OTHER RIGHTS WHICH VARY FROM STATE TO STATE.
For more information concerning repairs, operation, or technical assistance, please contact the DYNATRONICS dealer nearest you, or contact
DYNATRONICS directly at: the address below.
Dynatronics Corporation
7030 Park Centre Drive • Salt Lake City, Utah 84121 • (801) 568-7000 (800) 874-6251
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.
PLEASE TYPE OR PRINT PLAINLY
Purchase Information:
Purchase Date:Model Number:Serial Number:
Practitioner / Contact Name:
Clinic or Institution:
Address:
City:State:Zip:
Dynatronics’ Sales Representative:
☐ I have read and understand the information contained in the operator’s manual for this device.
☐ I have received in-service training from my dealer and/or Dynatronics for this device.
IMPORTANT: If there is anything about the operation or use of your Dynatron device that you do not understand,
contact your dealer or Dynatronics for instruction. As a trained medical practitioner, you are solely responsible for
determining appropriate application of this device for your patients.
BEFORE RETURNING A UNIT TO DYNATRONICS FOR SERVICE, YOU MUST OBTAIN A RETURN
AUTHORIZATION NUMBER. CALL 1-800-874-6251.
Failure to register the warranty may result in a delay in completion of services, and service will be billable.
How did you hear about the Dynatronics product you just purchased? (Check all that apply)
☐ Advertising
☐ Mail
Decision to purchase your equipment was based on? (Check all that apply)
☐ Advertising
☐ Product Literature
☐ Company Reputation
How do you nd information about therapy products you want to purchase? (Check all that apply)
☐ Magazines
☐ Mail
For information about therapy products, what magazines do you read? (Please list all that you read) _____________
_________________________________________________________________________________________________
What features are you most interested in when purchasing equipment? (Check all that apply)
☐ User Friendliness
☐ Portability
☐ Price
☐ Unique Features
☐ Presets
Safety
☐
☐ Referral
☐ Dealer
☐ Price
☐ Features
☐ Demo
☐ Other Practitioners
☐ Dealer
☐ Warranty
☐ Accessory Package
☐ User Programmable
☐ ERA
☐ BNR
☐ Soundhead Frequencies
☐ Trade Show
☐ Catalog
☐ Peer Recommendation
☐ Dealer
☐ Trade Show
☐ Product Reference
☐ UL Listing
☐ Educational Materials
☐ Design
☐ Number of Modalities
☐ User Modiable
☐ Quality
☐ Magazine Article
☐ Other _______________
☐ Other (Specify) _______
______________________
______________________
☐ Other (Specify) _______
______________________
☐ Number of Channels
☐ Company/Dealer Support
☐ Other _______________
______________________
______________________
______________________