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Dynatronics DYNATRON SmarTRAC, Operator'S Manual

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Dynatronics DYNATRON SmarTRAC Operator'S Manual Download Page 4

Table of ConTenTs

SMARTRAC  |  OPERATOR’S MANUAL REV. 0 | 4/06/2018

IV

General Specifications .......................................................................................................................... 22

Standard Components .............................................................................................................................................................22
Technical Specifications .............................................................................................................................................................. 
22
Environmental Conditions .....................................................................................................................................................23
SmarTRAC Labeling ................................................................................................................................................................23
Definition of Symbols and Labeling ......................................................................................................................................24

Maintenance and Troubleshooting ...................................................................................................... 25

Cleaning and Disinfection ......................................................................................................................................................25
Warning Messages, Error Messages, and Troubleshooting ................................................................................................25
Technical Maintenance ............................................................................................................................................................26
End of Life .................................................................................................................................................................................27

EMC Details .......................................................................................................................................... 28

Manufacturer Product Liability ........................................................................................................... 32

Warranty ............................................................................................................................................... 33

Warranty Registration .............................................................................................................................................................34

Summary of Contents for DYNATRON SmarTRAC

Page 1: ...Operator s Manual ...

Page 2: ...d Do not use in the presence of flammable anesthetics Do not use the Traction System near X ray or Diathermy devices These devices may emit high frequency noise that could affect the operation of the SmarTRAC Traction device IMPORTANT Before treating a patient with any Dynatron SmarTRAC device see the Contraindications Warnings and Precautions in this manual Read the operating instructions careful...

Page 3: ...andard Components 7 Connection to Power Supply 7 Disconnect From Power Supply 7 Attachment Carabiner Hook 8 Mounting on the Traction Frame 8 Cord Guidance 9 Cervical Traction Operating 9 Operating Instructions 10 Operator Controls 10 Basic Operation 10 Home 12 Protocols 12 Favorites 12 Manual Operation 13 Treatment Screen 14 Start Pause and Stop Treatments 15 Favorites 16 System Settings 17 Shutti...

Page 4: ...ns 22 Environmental Conditions 23 SmarTRAC Labeling 23 Definition of Symbols and Labeling 24 Maintenance and Troubleshooting 25 Cleaning and Disinfection 25 Warning Messages Error Messages and Troubleshooting 25 Technical Maintenance 26 End of Life 27 EMC Details 28 Manufacturer Product Liability 32 Warranty 33 Warranty Registration 34 ...

Page 5: ...and 45 lbs 200 Newtons cervical without unacceptable risk Operator s Profile All operators shall be properly trained and certified 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 attach electrodes and monitor pa...

Page 6: ...by the warranty policy Warranty registration should include the serial number for the device 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 The power cord must also be firmly plugged into the device itself When the...

Page 7: ...l time is 150 minutes As a safety measure if more than 150 minutes are set the device will not start Several safety measures are running and controlling the device during operation The patient stop is one of these measures It needs to be connected for the SmarTRAC to function When the user presses the patient stop or if it becomes disconnected the treatment will end and the force will be lowered b...

Page 8: ...igned and required for use in lumbar and cervical traction treatments see published literature for information and instructions Safety Features To protect the patient from potential hazards multiple mitigations are designed into the hardware and software There are electronic safeguards of force and mechanical safety for maximum force limitation Additional hardware mitigations are applied to protec...

Page 9: ...red towards zero with the configured Speed With the configured Speed the Traction Forces Ramp Up Time Ramp Down Time and number of repeats the total treatment time is calculated and shown in the treatment screen Single Progressive Traction The force is increased in a configured number of Steps Each Step increases the force partly in such a way that all Steps together result in the programmed Tract...

Page 10: ...gle therapy programs but most often in combination with other traction types to start and finish a combined traction treatment NOTE Starting a combined traction protocol with regressive traction is not possible It only lowers a previous programmed Traction Force towards zero in a configured number of Steps or towards the Traction Force value programmed ...

Page 11: ...D00310 SmarTRAC Operator s Manual Connection to Power Supply Insert the power cable into power socket on the back of the console and into a wall socket Turn on the device with push button located on the console above the power socket The device will initialize and perform a self test This may take a while At the end of the self test the device enters the Home Menu and is ready for use Disconnect F...

Page 12: ... arm CAUTION The cord must be attached to the carabiner hook by means of a knot capable of withstanding considerable traction without coming undone A suitable knot is shown in the figure below CAUTION Do not place the device in a location where the power cord could be tripped over or pulled out during treatment Do not attempt to use the device if it is not properly grounded Make certain that the d...

Page 13: ...tion Operating For cervical traction forces over 45 lbs 200 Newton are not allowed By selecting a traction force higher than 45 lbs 200 Newton a warning will be issued about exceeding this limit WARNING To ensure safe use during cervical traction when the limit warning appears do NOT press the Accept button in order to prevent traction forces over 45 lbs 200 Newton during the cervical traction tre...

Page 14: ...ed from power supply 1 Device connected to power supply touch screen 5 Power Input and Power Fuses 6 Type Number Plate Provides device information type and serial number as well as data on voltage and maximum current consumption 7 Patient Stop Switch Connection 8 Remote Control Connection Basic Operation Switch on the device ON using the Power Switch located on the back of the console 4 ...

Page 15: ...ters or a programmed sequential protocol as Favorite Delete Pause Interrupt Treatment Power will be reduced to zero Start Continue Treatment Accept selected option Stop Power reduces to zero Emergency Stop Power reduces to zero at maximum speed System Settings Remote Control is connected Static Traction type selection button Intermittent Traction type selection button Progressive Traction type sel...

Page 16: ... Protocols Selecting Protocols After selecting the Protocols menu in the main menu a list will appear with pre programmed protocols Scroll through this list using the arrows on the navigation bar Select the required protocol by pressing the relevant button Protocol Information For more information about a protocol press the info button on the left hand side of the protocol Favorites Retrieving Fav...

Page 17: ...meters Use the arrow keys on the screen to adjust the parameter Press ACCEPT on the navigation bar to confirm the set value The screen for setting the next parameter appears You can use the back key on the navigation bar to return to the previous parameter Setting with Body Weight You have the option to set the body weight and a percentage to determine the required power To do this press the Confi...

Page 18: ...hand side of the treatment screen you will be able to quickly view the main parameter settings In the middle of the screen the treatment setting will be depicted in a diagram On the left hand side of the screen you see a symbol for the therapy form setting In the case of a sequential program you will find the sequence of the programmed forms of therapy from top to bottom Adjusting Parameters You c...

Page 19: ...ters for this other form of therapy To remove part of a sequential program start by selecting the recycle bin on the navigation bar immediately followed by pressing the symbol of the relevant form of therapy in the left hand column Start Pause and Stop Treatments START Start the therapy with the Start button on the navigation bar PAUSE To interrupt the treatment press on the Pause button on the na...

Page 20: ... button is pressed the device acts the same as pressing the Patient Stop button and the force is lowered as fast as possible towards zero All buttons disappear until the force is back on zero lbs Newton again Favorites Storing Favorites When a treatment screen has been set completely as required the setting can be stored as a Favorite As long as the treatment has not been started a Store button is...

Page 21: ...ously stored treatment as a basis for a new program On the treatment screen any parameters can be adjusted before storing or starting the treatment System Settings Select the pictogram for system settings on the navigation bar of the Home menu On the configuration screens you can set the device on the basis of your personal preferences You can change or adjust various settings Configuration Screen...

Page 22: ...urn on or off a keyboard press sound End of Treatment Sound Button to select a number of sounds Screen 3 3 System Info Press this button to show current version and other system information This information can help your service engineer by providing important information Shutting Device Down Turn OFF the device with the Power Switch located on the back of the console 4 ...

Page 23: ...ng procedures for each mode of treatment available as well as the indications contraindications warnings and precautions Consult other resources for additional information regarding the application of Traction Therapy Warnings The patient must always hold the Patient Stop during treatment The patient must be within sight of the practitioner at all times Keep out of the reach of children Use the Sm...

Page 24: ... on maintenance page 26 The unit should be routinely checked before each use to determine all controls function normally Handle the unit with care Inappropriate handling of the unit may adversely affect its characteristics Do not operate the unit in the vicinity less than 6 2 meters distance of a short wave device such as X ray units or diathermy units These units may emit high frequency noise tha...

Page 25: ... Arthritis and other connective tissue disorders Midline Herniated Nucleus Pulposus Acute Torticollis Restrictive lung disease or other respiratory disorders Do not use traction on patients with structural disease e g osteomyelitis spinal caries and ankylosing spondylitis Do not use traction on patients with joint instability hypermobility or spinal fracture Do not use traction on patients with se...

Page 26: ...op Switch 7B0084 Fixing Knobs set of 4 7B0085 Nylon Cord 170 cm with Carabiner Hook 7B0086 Power Cord UL CSA 115V straight socket black or grey for USA 5D00310 SmarTRAC Operator s Manual Technical Specifications Voltage 100 240 V Frequency 50 60 Hz Maximum power max 70 VA Fuses 2 x T6 3AH250V Dimensions 8 7 x 13 4 x 11 8 inches H x L x W 22 x 34 x 30 cm H x L x W Weight 22 Lbs 10 kg ...

Page 27: ...lative humidity range of 10 to 90 non condensation c an atmospheric pressure range of 500 hPa to 1060 hPa Operation This equipment is designed to operate in normal use under the following environmental conditions a an ambient temperature range of 10 C 50 F b a relative humidity range of 10 to 90 non condensation c an atmospheric pressure range of 800 hPa to 1060 hPa Technical modifications reserve...

Page 28: ...he following symbols are included in the labeling for this device Definitions accompany each symbol Read the instructions TYPE B APPLIED PART According IEC60601 1 Fuse Warning Caution Non ionizing Electromagnetic Radiation End of Life Waste Electrical and Electronic Equipment WEEE Transport Values Temperatures Humidity Manufacturer Location ...

Page 29: ... small amount of the cleaning agent to a soft cotton cloth and then carefully clean the panel Do not spray cleaner directly on the panel Warning Messages Error Messages and Troubleshooting Self Test When the apparatus is turned on it will first execute a self test When an error is detected this being during the self test as well as during normal operation a pop up screen will appear on the display...

Page 30: ...this force will not be applied with cervical traction Technical Maintenance Electrical safety of the device relies on a properly grounded electrical connection via the power cord It is therefore necessary to have this connection checked annually To ensure continued compliance standard this unit should be adjusted and safety tested once each year This may be carried out by your supplier or by anoth...

Page 31: ...06 2018 27 End of Life TheSmarTRACcontainsmaterialsthatcannotberecycledand orarenoxioustotheenvironment Specialized companies can dismantle the unit and sort out these materials When you dispose of the unit follow local regulations and laws concerning waste management ...

Page 32: ...idance and Manufacturer s Declaration Electromagnetic Emissions The SmarTRAC and accessories is intended for use in the electromagnetic environment specified be low The customer or the user of the SmarTRAC and accessories should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The SmarTRAC uses RF energy only...

Page 33: ... or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Compliant Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 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 5 Ut 95 dip in Ut for 5 se...

Page 34: ...ers m Field strengths from fixed 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 af...

Page 35: ...rding to frequency of transmitter Rated maximum output power of transmitter W 150 kHz to 80 MHz d 1 17 x P 80 MHz to 800 MHz d 1 17 x P 800 MHz to 2 5 GHz d 2 33 x P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 33 For transmitters at a maximum output power listed above the recommended separation distance d in meters m can be estimated using the equat...

Page 36: ... or losses even if advised of the possibility thereof and regardless of the legal or equitable theory contract tort or otherwise upon which the claim is based In any case Enraf Nonius entire liability under any provision of this agreement shall not exceed in the aggregate the sum of the fees paid for this product and fees for support of the product received by Enraf Nonius under a separate support...

Page 37: ...e DYNATRONICS is not liable for any damage to the item 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 first 30 days of the warranty period DYNATRONICS will pay all necessary shipping costs associated with obtaining service under this warranty After the first 30 days o...

Page 38: ...d 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 the operation of this device IMPORTANT If there is anything about the operation or use of your Dynatronics product that you do not understand contact your dealer or Dynatronics for instruction As a trained medical practitioner you are solely resp...

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