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Dynatron

®

150

plus

Contraindication, Warnings, Precautions

27

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
•  Third degree musculo-tendonous lesions
• Cardiac

pacemaker

•  Implants of any electrical nature
•  Skin diseases
•  Multiple sclerosis
•  Osteomyelitis
•  Disturbances in cardiac rhythm
•  Tissue or bone with acute sepsis
•  Arteriosclerosis or weakened blood vessels
• Hemophilia
•  Where sensory nerve damage is present with a loss of normal skin sensation.

The Dynatron 150plus Ultrasound should not be applied to the following areas:

•  Transcerebrally
•  To the eye
•  To the ear
•  Over a carotid sinus
•  To the heart
•  To major subcutaneous nerves and blood vessels
•  To the spinal cord
•  Around the bulbar area of the spinal cord
•  To reproductive organs
•  Over viscera (stomach, spleen, liver)
•  Over epiphyseal areas of the bones in growing children
•  Over stellate ganglion and subcutaneous major nerves
•  To tissues previously treated by deep x-ray or other radiation
•  Over the joint capsule in acute or sub-acute arthritic conditions
•  Over ischemic tissue in patients with vascular disease
•  Over a laminectomy site
•  Over total joint replacements (the effect of Ultrasound on the new plastics is

unknown)

• Over healing fractures

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Содержание 150plus

Страница 1: ...SERVICE MANUAL Dynatron 150plus ...

Страница 2: ...utions in this manual and observe them whenever treating a patient with this device INDICATIONS FOR ULTRASOUND USE Ultrasound therapy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain muscle spasms and joint contractures but not for the treatment of malignancies 21 CFR 890 5300 Dynatron 150plus Service Manual Revised June ...

Страница 3: ...dify a Treatment in Progress 9 Patient Coupling 10 Ultrasound Coupling Bar Graph 10 Head Temperature Bar Graph 11 Head Temperature Hot 12 No Soundhead 12 Display Watts or Watts cm2 13 Restore Factory Defaults 13 Battery Operation 15 Battery Requirements 16 Battery Life 16 Ultrasound With Electrical Stim Input 17 Ultrasound General Information 19 and Usage Cautions 19 Selecting the Appropriate Soun...

Страница 4: ...nvironmental 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 Ultrasound Regulation 33 Beam Profile 35 Enter Soundhead Parameters 37 New Smart Heads 37 Using Older Model Soundheads 37 Calibrat...

Страница 5: ... 150plus Table of Contents v 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 ...

Страница 6: ...Dynatron 150plus vi ...

Страница 7: ...upling should be corrected If your device is version 1 04 or above a bar graph will appear Modify Treatments In Progress You can modify treatment time power frequency or duty cycle while a treatment is in progress It is not necessary to stop the treatment Portable The Dynatron 150plus is small and light weight making it readily portable An optional carry case is available from your Dynatronics dea...

Страница 8: ...tment 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 ...

Страница 9: ...sential to insure you are not billed for services that are covered by the warranty policy Connect the AC power cord which is equipped with a hospital grade UL listed plug to a properly grounded 110 120V 60 Hz AC outlet The device will automatically switch to 220 240V 50 Hz when connected to a power source with that voltage Do not place the cord or the device in a place where the cord could be trip...

Страница 10: ...1 7 6 8 13 14 16 2 e 2 MHz Dynatron 150plus Control Panel 1 POWER OFF ON SWITCH Located on the back of the unit This switch is labeled 1 and 0 Set the switch to 1 for ON set the switch to 0 for OFF 2 ELECTRICAL STIM INPUT JACK This jack is used for combining Ultrasound with electrical stimulation The output end of a lead connected to a Dynatron electrotherapy device may be plugged into this jack T...

Страница 11: ...ed treatment starts The timer begins counting down and output from the soundhead is started 11 STOP This key is pressed to stop the output to the applicator head resets the timer to zero and ends the treatment 12 PAUSE This key is pressed to pause an Ultrasound treatment in progress When the treatment is paused the treatment timer is stopped an LED on the PAUSE key is lighted and the output power ...

Страница 12: ...t in use Soundheads Soundheads for the Dynatron 150plus are available in 2 cm2 5 cm2 or 10 cm2 sizes Each soundhead operates at 1 2 and 3 MHz The soundheads are waterproof allowing therapy to be administered in water if desired Information regarding calibration of soundheads is provided later in this manual ...

Страница 13: ... the unit remain ON throughout the day if it is used regularly If the device is being powered by the optional battery unplug the battery or turn the battery OFF after treatment has ended to save battery power When the unit is first powered ON it goes through an automatic self test and head check procedure After the calibration procedure is completed the device is available for treatment To set up ...

Страница 14: ...etting up a treatment 1 Set Time Press the UP DOWN ARROW keys to set the time for the treatment When treatment starts a countdown timer displays the time remaining in the treatment 2 Set Duty Cycle Press the DUTY CYCLE TOGGLE key one or more times to select the desired duty cycle Continuous 50 20 or 10 percent Your selection is indicated by a green light next to the selected option 3 Choose Freque...

Страница 15: ...eatment the output stops and the timer stops counting down but the treatment may be resumed by pressing PAUSE again or START IMPORTANT For patient safety and comfort it is recommended that you start with 0 1 W cm2 then increase power to the desired level after the treatment begins Modify a Treatment in Progress The following parameters may be modified during a treatment Frequency Press the FREQUEN...

Страница 16: ... area approximately twice the size of the soundhead in area The full surface of the soundhead should maintain contact with the patient s skin except with underwater treatments If all or part of the soundhead is not touching the patient coupling may not be adequate and the patient will not receive the intended dosage of the ultrasonic wave and or the soundhead may warm up very quickly Ultrasound Co...

Страница 17: ...l also change the display from bar graph to the treatment time display however pressing these keys will change the treatment time as well Changes to the treatment settings including frequency duty cycle and size of soundhead will cause some variance in the graph Head Temperature Bar Graph During an Ultrasound treatment you can view a graph showing the relative soundhead temperature by pressing STA...

Страница 18: ... temperature water to cool the head more quickly NEVER USE ICE OR ICE PACKS TO COOL THE SOUNDHEADS as this is likely to cause thermal shock to the electronic components of the soundhead and may necessitate 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 For direct coupling you may...

Страница 19: ... Restore Factory Defaults The Dynatron 150plus has the following default settings Soundhead Warming ON Coupling Sensing OFF Power Display Watts cm2 Each of these settings may be changed by the user instructions are provided earlier in this section If you have changed the settings for this device but would like to return ALL the default settings to those that were set at the factory do the followin...

Страница 20: ...Dynatron 150plus 14 ...

Страница 21: ...Plug the battery adapter into the jack labeled BATT on the back of the Dynatron 150plus device Turn the battery pack ON 3 Set up and deliver treatments as you normally do 4 When available battery power is reduced to a certain level the device will flash a message BATT LO to indicate low battery power The treatment can continue but you will probably be unable to set up and deliver another treatment...

Страница 22: ...ommended Cat No 270 1534D This cord comes with a 2 amp fuse which must be replaced with a 5 amp fast blow fuse Note If a low quality gauge cord is used you can get the BATT LO error when the battery is not low Battery Life The length of time that a unit can be used with a battery pack is dependent on several factors The amperage of the battery pack A larger amperage will provide longer use The mod...

Страница 23: ... jack on the back of the Dynatron 150plus NOTE If you do not have a pin to banana adapter contact Dynatronics to order Attach the other lead output to an electrode use an electrode that you normally use with your Dynatron electrotherapy device and place the electrode in the desired location on the patient s body The electrode should be placed slightly outside the area where the Ultrasound will be ...

Страница 24: ...Dynatron 150plus 18 ...

Страница 25: ...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 cm 2 soundhead can deliver up to 20 Watts and is appropriate for large areas i e torso and back Ultrasound is a directed beam of energy Therefore not only will the average spatial intensity be a factor in the dosage the patient receives but the time delivered...

Страница 26: ...o high or the treatment time is too long Penetration of Ultrasound Waves The correct frequency should be selected for the depth of penetration desired The amount of penetration needed is determined by the density of tissue and the depth of the site to be treated Care should be taken to select a penetration level that does not cause periosteal bone pain The frequency determines the depth of penetra...

Страница 27: ...cator moves across the skin is very important in determining how much Ultrasonic output is delivered If the rate is too slow the patient may feel periosteal pain bone ache pain It the rate is too fast or if the applicator head becomes uncoupled with the skin the amount of treatment is reduced Uncoupling can also cause the soundhead to overheat 2 Immersion Method Here the area to be treated is plac...

Страница 28: ...cking or dull ache Acute Conditions 0 1 0 5 W cm2 no appreciable thermal effect Sub Acute Conditions 0 5 1 0 W cm 2 Mild to Moderate thermal effect Chronic Conditions 1 0 2 0 W cm 2 Moderate to Strong thermal effect NOTE It is very common that intensity is always 1 5 W cm 2 This is incorrect in many cases A more specific intensity should be used based on patient response and stage of injury Freque...

Страница 29: ...agement 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 Continuous is 100 50 Duty Cycle means that during every second of treatment there is as much OFF time as ON time usually microsecond pulses 20 means there is four times as much OFF time as ON time...

Страница 30: ... patient discomfort Output power may be reduced by simply choosing a lower watt setting Output power is also effectively reduced by selecting a pulsed duty cycle Coupling The term coupling refers to the ability to deliver ultrasonic waves from the soundhead to the skin surface with as little impedance or dissipation of power as possible The best coupling is achieved when the soundhead has full dir...

Страница 31: ...onjunction 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 ...

Страница 32: ...Dynatron 150plus 26 ...

Страница 33: ...s Hemophilia Where sensory nerve damage is present with a loss of normal skin sensation The Dynatron 150plus Ultrasound should not be applied to the following areas Transcerebrally To the eye To the ear Over a carotid sinus To the heart To major subcutaneous nerves and blood vessels To the spinal cord Around the bulbar area of the spinal cord To reproductive organs Over viscera stomach spleen live...

Страница 34: ...ctive mat to remove any static charge from the operator Use a surge suppresser if power problems are encountered Avoid unnecessary exposure to Ultrasound patient and therapist NOTE For further technical information on therapeutic Ultrasound and its physiological effects please consult published medical literature Usage Cautions Combination Treatments When using a Stim device in conjunction with th...

Страница 35: ... Environmental Conditions Transport and Storage This equipment is capable while packed for transport or storage of being exposed for a period not exceeding 15 weeks to environmental conditions not outside the following ranges a an ambient temperature range of 40 C to 70 C b a relative humidity range of 10 to 100 including condensation c an atmospheric pressure range of 500 hPa to 1060 hPa Operatio...

Страница 36: ...ered by the warranty Suggested Maintenance Schedule SERVICE TO BE PERFORMED BY A TECHNICIAN Annually Annual Ultrasound calibration should be performed by a qualified technician Inspect soundhead connectors on unit and on soundhead MAINTENANCE PERFORMED BY USER 1 Inspect accessories daily for wear and damage Examine cables and connectors on the cables for any visible sign of wear or damage Replace ...

Страница 37: ...tronics for the inspection As an alternative these periodic checks may be performed in your own office by a local independent contractor who is expert in checking the calibration of Ultrasound equipment The calibration procedure MUST be performed by a qualified Ultrasound technician using the proper equipment Detailed calibration procedures may be obtained from Dynatronics Customer Service at the ...

Страница 38: ...tion against electric shock Class I According to the type of protection against electric shock Type BF According to the degree of protection against harmful ingress of water ordinary According to the degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Equipment not suitable for use in the presence of a flammable anesthetic mixt...

Страница 39: ...of the temporal average ultrasonic power shall not exceed 20 percent for all emissions greater than 10 percent of the maximum emission FDA 21CFR 1050 c 1 ii The sum of the errors in the indications of temporal maximum ultrasonic power and the ratio of the temporal maximum effective intensity to the temporal average effective intensity shall not exceed 20 percent for all emissions greater than 10 p...

Страница 40: ...ge effective intensity pulse duration and pulse repetition rate for the Dynatron 150plus are as follows 1 Ultrasonic frequency 15 2 Effective Radiating Area 50 3 Ratio of the temporal maximum to temporal average effective intensity 20 4 Pulse duration 10 5 Pulse repetition rate 10 ...

Страница 41: ...ated 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 10 cm2 Head Near Field 1 MHz 3 MHz 5 cm2 Head Near Field 1 MHz 3 MHz ...

Страница 42: ...Dynatron 150plus Beam Profile 36 2 cm2 Head Near Field 1 MHz 3 MHz ...

Страница 43: ...r that soundhead into the Dynatron 150plus before using the soundhead The following instructions are provided only in the event you need to enter soundhead parameters Be sure to follow these steps carefully to ensure you have entered all parameters correctly The procedure utilizes keys and displays on the key pad that are normally used for other purposes but which have specialized applications in ...

Страница 44: ... for F1 Z and TEMP Enter the numbers as follows a Select CONT Duty Cycle The CONT and 1 MHz LEDs are lighted Enter the value for F1 1 MHz by pressing the time selection keys until the desired value is displayed in the time display Use the Time Selection up down keys to enter the desired number The value you enter is displayed in the TIME display Press and hold the up or down key to move more quick...

Страница 45: ...d Enter the value for F1 3 MHz by pressing the time selection keys until the desired value is displayed in the time display b Select 50 Duty Cycle With the 50 LED lighted enter the value for Z 3 MHz c Select 20 Duty Cycle With the CONT LED lighted enter the value for Temp 3 MHz d Select 10 Duty Cycle With the 10 LED lighted enter 0 zero as the value for Coupling The coupling feature is not availab...

Страница 46: ...Dynatron 150plus 40 ...

Страница 47: ...onfirm your power meter meets this qualification Ohmic Instrument UPM DT1 or UPM DT 10 are recommended for use Water Quality Water used in the testing procedure must be degassed water with an oxygen content of four parts per million 4ppm or less The following steps are provided to assist the technician with the calibration procedure A calibration program is built into the software for the device T...

Страница 48: ...When the watts reading on the meter is at 1 0 W cm2 for the soundhead and the reading is stable press the 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 automa...

Страница 49: ...Dynatron 150plus Calibration Procedure 43 11 To calibrate the next soundhead turn the machine off and repeat steps 1 through 10 above CAUTION Avoid unnecessary Ultrasound exposure ...

Страница 50: ...Dynatron 150plus 44 ...

Страница 51: ...ts on the soundhead will cease flashing You can then press PAUSE or START to resume the treatment Cooling the Soundhead The temperature alert not only ensures good coupling throughout the treatment it helps avoid damage to the soundhead crystal If the soundhead becomes too hot it must be allowed to cool down before resuming the treatment The head will cool slowly if allowed to sit at room temperat...

Страница 52: ...ions can cause an error in operation When this occurs the machine will not allow a treatment to be set up or delivered and will display an error message in the LED displays An error message can consist of any combination of alpha numeric characters which are not normally expected at any given point in treatment setup or delivery Some errors are easily resolved by the following methods Press STOP t...

Страница 53: ... once the condensation is gone If you have tried all of these suggestions and the error is still displayed on the LEDs the device may require service by the manufacturer In this case contact Dynatronics Customer Service at 1 800 874 6251 for further assistance Do not send the device to Dynatronics without first contacting the Customer Service Department ...

Страница 54: ...Dynatron 150plus 48 ...

Страница 55: ...RA number When the unit is received at Dynatronics it is unpacked and inspected for shipping damage An inventory of the parts that were sent with the unit is taken at that time and recorded on the RA sheet Any observed damage is also noted on the sheet The unit is then examined by a repair technician who evaluates the problems with the unit and writes observations on the RA form The technician com...

Страница 56: ...and Shipping of Replacement Parts All defective or broken parts should be shipped back to Dynatronics in the original shipping container These containers are designed to withstand the punishment of shipping If the original containers are not usable find containers that are similar in protection so damage in shipping will be prevented The person or company sending the unit to Dynatronics is respons...

Страница 57: ...d 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 Definition of serious injury A serious injury is an injury that 1 is life threatening 2 results in permanent impairment of a body function or permanent damage to body structure or 3 necessitates medical ...

Страница 58: ... MHz 4 9 5 1 9 8 10 2 19 0 20 4 2 mhZ 4 9 5 1 9 8 10 2 19 0 20 4 3 MHz 4 0 5 1 9 8 10 2 XXXXXXXX 2cm 1 0 Watt 0 5 2 0 Watts 1 0 4 0 Watts 2 0 1 MHz 0 9 1 1 1 9 2 1 3 9 4 1 2 MHz 0 9 1 1 1 9 2 1 3 9 4 1 3 MHz 0 9 1 1 1 9 2 1 3 0 4 1 1cm 1 0 Watt 1 0 1 5 Watts 1 5 2 0 Watts 2 0 2 MHz 0 9 1 1 1 4 1 6 1 9 2 1 3 MHz 0 9 1 1 1 4 1 6 XXXXXXXX Ground Fault Chassis leakage not to be greater than 75uA and o...

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