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BALANCE SYSTEM™ SD (version 4.x)

INSTRUCTIONS FOR USE

950-440

System, Balance SD, 115 VAC 15.6” display

950-441

System, Balance SD, 230 VAC 15.6” display

950-444

System, Balance SD, 100 VAC 15.6” display

950-450

Optional FreeSway Handles

FN: 19-092-CLR Rev B 6/19

Содержание 950-440

Страница 1: ...n 4 x INSTRUCTIONS FOR USE 950 440 System Balance SD 115 VAC 15 6 display 950 441 System Balance SD 230 VAC 15 6 display 950 444 System Balance SD 100 VAC 15 6 display 950 450 Optional FreeSway Handles FN 19 092 CLR Rev B 6 19 ...

Страница 2: ... balance Here the user can find information from compliance to clinical support and if the desired information is not found Biodex can be contacted directly at supportservices biodex com Thank you Biodex Medical Systems Inc Contact information Manufactured by Biodex Medical Systems Inc 20 Ramsey Road Shirley New York 11967 4704 Tel 800 224 6339 Int l 631 924 9000 Fax 631 924 8355 email supportserv...

Страница 3: ...g the Printer Stand with Optional FreeSway Hooks 13 Turning On the System 14 Turning Off the System 15 Configuring the System 16 Common Icons and Buttons 19 3 Planning a Session 20 Evaluating a Patient 20 Setting Up a Session 20 4 Getting Started 22 Starting a Session 22 Adjusting the Support Handles 22 FreeSway Handles 23 Adjusting the Display 24 Positioning the Patient s Feet 25 Common Actions 2...

Страница 4: ...egration Defaults 48 Changing Fall Risk Defaults 50 Managing Custom Protocols 50 Creating a New Protocol 50 Managing Custom Sensory Tests 52 Patient Management 54 8 VibroTactile System 59 Getting Started 60 Attach the Link Box 60 Connect to the Display 61 Charging the tactile belt receivers 63 Configuring Equipment in Facilities with One VibroTactile System 67 Configuring Equipment in Facilities w...

Страница 5: ...5 Definition of Symbols The following symbols and their associated definitions are used and implied throughout this manual ...

Страница 6: ...ant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occ...

Страница 7: ...n Note Complete information on the Electromagnetic Compatibility for the Biodex Balance System can be located in the Compliance Supplement located on the Biodex website www biodex com or can be obtained by contacting Biodex Customer Service see Contact information Note Normative Data for the Balance System is located in the Normative Data Supplement located on the Biodex website www biodex com or ...

Страница 8: ...manual might result in user error or inaccurate data Save all documents for reference WARNING Allow only qualified trained personnel to operate or service this system Do not use this system in a manner other than specified in this manual If the equipment is used in a non specified manner the protection provided by the equipment might be impaired and results could be compromised WARNING Never leave...

Страница 9: ...iple socket outlet MSO effectively leads to creating an ME SYSTEM and can result in a reduced level of safety Patient Weight 60 lb 27 kg 400 lb 181 kg Operating Conditions Temperature 15 C to 30 C 60 F to 86 F Humidity Range 30 to 75 non condensing Atmospheric Pressure 70kpa 10psi to 106kpa 15psi Storage Conditions Temperature 20 C to 60 C 4 F to 140 F Humidity Range 10 to 100 Atmospheric Pressure...

Страница 10: ...ditioned fall risk concussion management and other general conditions Contraindications for Use Contraindications include severe osteoporosis non union fractures Bariatric patients weighing greater than 400 pounds patients under 60 pounds patients with poor safety awareness cognition acute conditions such as pulmonary embolus thrombus acute MI acute fractures BP over 180 110 Hg patients with sever...

Страница 11: ...s to be closed Figure 1 2 VibroTactile System The CTSIB Indexed Pad is a foam pad that is placed over the platform for sensory integration testing Figure 1 3 CTSIB Indexed Pad The optional FreeSway Handles are free floating yet contained within a controlled opening They allow patients to experience unimpeded postural sway while holding onto handles that are available for support The FreeSway Handl...

Страница 12: ...ecial precautions regarding EMC and must be installed and used according to EMC information 2 To move the Balance System SD tip the system and use the wheels to roll the system into position When the system is upright the wheels are not in contact with the floor and the system is in a fixed position 3 Position the printer stand next to the Balance System SD 4 Set the printer on its stand Leveling ...

Страница 13: ...lied with the Biodex product may not be compatible for customers outside of the North America South America Australia and some Pacific countries Do not install the supplied printer cartridges before reading the enclosed information included with the printer Installing Optional Accessories Locate the necessary cable and power cords for the optional external monitor keyboard or mouse 1 Connect the m...

Страница 14: ... On the System The Balance System SD turns on when the power cord is plugged into an AC power supply The software starts automatically 1 Plug the power cord of the Balance System SD into an AC power supply The Home screen is displayed see Figure 2 1 The Balance System platform is active and in the locked position Figure 2 1 Home Screen 2 Turn on the printer 3 If an external monitor is used turn on...

Страница 15: ...sequence to turn off the system 1 Shut down the software as illustrated in Figure 2 2 2 Unplug the system from the power supply Figure 2 2 Shut Down Icon The software can be restarted while the system is plugged in Touch the rocker switch on the bottom of the display to restart the software see Figure 2 3 Figure 2 3 Power Switch on Display 1 2 ...

Страница 16: ...itted each time the patient makes the cursor hit a target On Touch any section of the bar to set the volume level from 1 to 10 Screen Configuration The Screen Saver setting sets the number of minutes the display remains on when the system is not in use After the inactivity timer expires the screen fades Inactive 1 Touch the or keys to set the number of minutes of inactivity 2 To activate touch the...

Страница 17: ...tricts access to certain sections of the system configuration such as default system settings and patient data 159 1 To change the access ID code touch the keypad icon and enter the new code 2 Touch OK to save the New Access ID Code and return to the Default Settings screen 6 After changes have been made touch Back to exit and return to the Utilities menu 7 Touch Back a second time to return to th...

Страница 18: ...quires Age Height Range Touch the check box to require Date of Birth Height Require Patient ID for Patient Record Patient Setup does not use a patient ID number or medical record number Touch the check box to require a Patient ID Enable Additional Information on Patient Setup Patient Setup has an inactive Additional Info icon Touch the check box to enable the Additional Info icon This allows users...

Страница 19: ...ch the Clear Tracing icon Magnifying Glass Enlarges the screen for easier viewing After enlarging the view the setting for the platform cannot be changed until the original view is restored Keypad Displays a window to enter numbers Keyboard Displays a window to enter text Start Begins the session and the timer starts The current score is displayed Stop Stops the session No more data is recorded an...

Страница 20: ...r of gravity COG when the platform is in a level static mode The height or weight cannot be entered or changed after a test is complete Setting Up a Current Session Setting Up a Future Session Touch either Testing or Training to display the Patient Setup screen see Figure 3 1 Touch Utilities Patient Management At the Access ID Code screen enter the ID code 159 or the site s code and touch OK Touch...

Страница 21: ... 4 enter a name or ID number to search or scroll through the list of patients After a search touch the Refresh icon to return to the list of patients Figure 3 4 Select a Patient Screen 2 Touch the patient record to highlight it and touch OK The display is refreshed with the patient s information 3 If the patient s height or weight has changed since the last session touch Edit and enter the new val...

Страница 22: ...fety of the available support from the FreeSway Handles while improving postural stability They can then progress to performing balance training without using any handles Adjust the display height so that the patient looks straight ahead at the screen This encourages good posture and data collection Position the patient s feet for center of gravity Make sure the patient continues to stand in the c...

Страница 23: ...Insert and spin black connectors to the right to attach the FreeSway Handles Figure 4 3 Adjusting the FreeSway Handles The FreeSway Handles when secured on the BioSway become a stable platform This assists users with balance impairments to cope with their fear of falling while safely and independently performing exercises to improve their function NOTE This unit can be used with therapist assistan...

Страница 24: ...aining To adjust the Challenge Level or degree of the opening Pull out the knobs and slide to adjust the opening position for the desired amount of float Push the knobs back in to lock Adjusting the Display Figure 4 4 Adjusting the Display Turn the knob on the back of the support post to the left to loosen Pull the knob out towards you Adjust the display height up or down until you have reached th...

Страница 25: ...e points Figure 4 5 Position Patient Screen 4 Use Table 4 1 to estimate the foot placement based on the patient s height Table 4 1 Estimates for Foot Placement Height Default Foot Angle Heel Position 53 in 1 34 m 10 10 F7 F15 53 59 in 1 34 1 49 m 10 10 E7 E15 59 65 in 1 49 1 65 m 10 10 D67 D16 65 73 in 1 65 1 85 m 73 in 1 85 m 10 10 C5 C17 Common Actions Choose Training or Test mode from the Home ...

Страница 26: ...ssion the settings for platform stability skill level time and target or movement orientation can be adjusted Setting Up a Test Session The settings for a test session are more constrained than for a training session because the results are compared to normative data sets Touch Testing test name Next OR Touch Test Options The Test Options screen for the specified test is displayed 1 Touch or to se...

Страница 27: ...Save Results Completed If this test result is not saved the system prompts to confirm Touch Print to generate the report for the test To save a PDF file of the test report insert a flash drive into one of the USB ports on the display Touch Export PDF The PDF file is copied to a new folder named BioReports on the flash drive If more files are saved to this flash drive the files are named uniquely ...

Страница 28: ... anterior posterior medial and lateral movements In this mode the platform is static The patient sees the axes in green when weight bearing is within targets The score is the percentage of time the patient was within the target range 1 Touch one of the three Axis icons to select the orientation for training The display changes to show only that axis Figure 5 1 displays both axes Anterior Posterior...

Страница 29: ...nter of gravity indicated by the cursor within the target box see Figure 5 2 Scoring is a percentage of the net good hits divided by the total target hits All hits outside the boundary are subtracted from the total target hits This value equals the net good hits If the cursor crosses a red boundary a hit is subtracted from the good hit total For example if a patient achieved ten target hits but al...

Страница 30: ...vel Postural Stability Training In the Postural Stability Training mode patients practice specific movement patterns or strategies Select one of the following approaches Place targets anywhere on the screen grid The patient leans and shifts to make the cursor touch each target The score is the total of touched targets Set a ring or boundary The patient balances to keep the cursor within the bounda...

Страница 31: ...egrees back for a total of 12 degrees of sway A pattern of targets is displayed One target blinks The patient must move the cursor from the center target to the blinking target and back to the center target see Figure 5 4 Scoring is a percentage of movement outside the sway envelope and measures the precision of the movement The straighter the movement the better the stability For example if the s...

Страница 32: ...subtracted from the total target hits This value is the net good hits For example if all the targets are cleared on the easiest maze but the maze wall is hit 6 times the score is 20 26 or 77 1 Set the length of time for the training session 2 Set the resistance level of the platform Static or 1 through 12 3 Touch Skill Level until the desired configuration is displayed a Easiest maze has 26 target...

Страница 33: ... speed of its movement The patient moves the cursor to keep it within the target see Figure 5 6 1 Set the length of time for the training session 2 Set the resistance level of the platform Static or 1 through 12 3 Touch Skill Level repeatedly to increase or decrease the size of the target 4 Touch Circle Speed to rotate through three speeds The single green circle is the slowest speed and requires ...

Страница 34: ...Each test can be run with a static or a dynamic platform For a static test the device measures the angular excursion of the patient s center of gravity COG which is calculated from the patient s height COG is approximately 55 of height In a dynamic test the variance of the platform angle from the platform s level position is measured as well as degrees of deflection over time This data illustrates...

Страница 35: ...r the mCTSIB or BESS test Use the indexed foam pad on the platform for the dynamic surface test conditions To test visual conflict conditions provide the patient with eyeglasses that create a distorted yet transparent image For example modify clear safety glasses to mar the lenses or cover them with clear adhesive tape Clinical Test of Sensory Integration of Balance CTSIB The Clinical Test of Sens...

Страница 36: ...s Conflict Some visual input but it conflicts with vestibular input Condition relies on vestibular and somatosensory inputs Dynamic Eyes open Evaluates somatosensory interaction with visual input Eyes closed Evaluates somatosensory interaction with vestibular input Conflict Evaluates the mediation of visual with vestibular and somatosensory inputs Figure 6 2 Testing Options for mCTSIB ...

Страница 37: ...ced with a measure of sway Errors can be noted but they do not affect the score A test consists of three positions on two types of platforms for a total of six conditions Some conditions can be excluded see Table 6 1 1 Touch the check boxes next to the conditions to include the condition in the test 2 To note errors e g the patient grabs the support handle touch the check box next to Error Scoring...

Страница 38: ...mity strength proprioception and vestibular or visual deficiencies see Figure 6 4 Figure 6 4 Limits of Stability Test 1 During each trial patients must shift their weight to move the cursor from the center along a target path and back to center as quickly and with as little deviation as possible After completing a target path the patient returns the cursor to center and holds for three seconds bef...

Страница 39: ...dent when viewing the tracing if it enabled A patient could have a score of 6 5 yet the standard deviation could be only 0 8 The tracing displays the patient did not sway very much However if the patient swayed a lot the standard deviation is higher Thus the standard deviation is indicative of sway Figure 6 5 Postural Stability Test During each trial patients must hold their position to keep the c...

Страница 40: ...r dynamic see Figure 6 6 This test is a good indicator of dynamic control within a sway envelope Poor control and inconsistent or increased times suggest assessment for lower extremity strength proprioception vestibular or visual deficiencies Figure 6 6 Motor Control Test 1 Touch Test Options to set the Motor Control Hold Time 2 Touch or to select a time ranging from 0 25 to 5 seconds 3 At the Mot...

Страница 41: ...ial consists of two tests left leg and right leg During each trial patients must hold their position to keep the cursor in the center Figure 6 7 Bilateral Comparison Test Left 1 Touch Test Options 2 Touch or to select a time ranging from 0 25 to 5 seconds 3 Set the resistance level of the platform Static or 1 through 12 4 Touch Collect Data to begin the next trial Note After each trial the screen ...

Страница 42: ...trol and assessment for lower extremity strength proprioception and vestibular or visual deficiencies NOTE One condition of the Fall Risk test is conducted with the patient s eyes closed and another condition is conducted with the patient in a narrow stance Never leave the patient unattended For tests in a narrow stance see Figure 6 8 position the patient so that the space between their feet is 2 ...

Страница 43: ...ny time Touch Lock Platform to make the platform level and firm It is always level and firm in static mode and returns to this mode after three minutes of inactivity The platform remains locked until a new trial or test is started Touch Utilities on the Main screen 1 At the Access ID Code screen enter the ID code 159 or the site s code and touch OK Reports Patient Management Configuration System M...

Страница 44: ... Test Used to return to the Test Menu to start a new testing session New Training Used to return to the Training Menu to start a new training session Repeat Used to repeat the selected test training Print Used to print the report Creating a Report for Results 1 Touch Reports select the patient record and touch Next see Figure 7 2 Figure 7 2 Selecting a Patient for a Report Screen 2 The list of ses...

Страница 45: ...d new session using the default settings Three Report Types are available Test Results Progress Report All or Progress Report by Selection If a test result is viewed the system displays the Stored Test Results screen see Figure 7 4 The results can be printed a progress report of results from all sessions can be created or a new session that repeats the test can be started see Printing a Report and...

Страница 46: ...ges 4 The default printer is the printer attached to the Balance System If a network printer is available it can be selected Multiple copies can be printed 5 Touch Advanced to display a Windows screen Select options to refine the report Creating a Progress Report Progress Report creates a graph of the data points of CTSIB tests over time against normative data or not see Figure 7 6 Figure 7 6 View...

Страница 47: ...report see Figure 7 7 Figure 7 7 Selecting Conditions for a Progress Report 5 Set the type of Comparative Data The default is normative data If a baseline test is available a percentage over the patient s baseline score can be selected see Figure 7 8 Figure 7 8 Selecting Data for a Progress Report 6 For Normative Data select a specific data set and then touch Next see Figure 7 9 ...

Страница 48: ...ctions Refer to Configuring the System Balance System SD Configuration Use Balance System SD Configuration to configure the system in detail Refer to Configuring the System for general information about this screen This section describes how to edit clinical codes and facility information and create custom protocols Change Sensory Integration Defaults The normative data in both sensory integration...

Страница 49: ...ets for Sensory Integration Tests For each type of test touch the Group and Age Range drop down menus to make changes or add a new group see Figure 7 11 Select the keypad icons beside each row to edit the normative data for that group Touch Restore Defaults to reset the normative data to the factory setting ...

Страница 50: ... Protocols Use Custom Protocol List to add edit or delete customized testing or training protocols see Figure 7 13 Managing Custom Protocols Training and testing protocols can be created for a specific purpose After a protocol is created it can be accessed from the main Training and Testing menus Creating a New Protocol 1 At the Main screen touch Utilities 2 At the System Utilities screen touch Co...

Страница 51: ...cify the new protocol An example is illustrated in Figure 7 14 Figure 7 14 Specifying Options for a Custom Protocol 7 When finished touch Save Protocol 8 Enter a name for the protocol to be displayed in the Custom Protocol List NOTE Use Edit to change only Custom Sensory Tests Selecting a Custom Protocol 1 To select a custom protocol touch Custom Protocol from either the Training or Testing menu s...

Страница 52: ... adequately to meet requirements a custom protocol specifically for sensory testing can be created Custom Sensory Tests are not accessed using the Custom Protocols icon on the Testing screen Instead each Custom Sensory Test has a separate icon on the Sensory Testing submenu after the mCTSIB and BESS icons Creating a Custom Sensory Integration Test 1 At the main screen touch Utilities 2 At the Syst...

Страница 53: ...eck box to connect this protocol with a data set The square changes color to green when active One of the provided normative data sets can be selected or a new data set can be added 14 For a custom BESS test touch Error Scoring to enable error reporting 15 Touch Next to access the Custom Protocol Overview screen This screen has options specific to the type of test and to enable tracing during the ...

Страница 54: ...Used to filter the files to export to a flash drive for a patient Import Used to import a patient file from a flash drive Patient Management Test Results Delete Used to delete test results for a specific patient Edit Used to change the test results for a specific patient Export CSV Used to export a patient s test information to a flash drive New Test Used to return to the Test Menu to start a new ...

Страница 55: ...n an existing patient s profile touch the patient s name to highlight the row and then touch Edit To view a patient s test results touch the patient s name and touch Next The Patient Management Test Results screen is displayed as illustrated in Figure 7 18 Touch a test and then touch Edit The results for that specific test are displayed Figure 7 18 Selecting a Patient s Test Results Deleting Patie...

Страница 56: ...fic date Prior To a specific date between two dates From To Enter the date 3 Touch OK to confirm 4 The selected files are deleted and the system returns to the Patient Management screen Exporting Patient Data Use Export Patient Data to copy a stored test to a file in the Biodex file format bio or a CSV file format A program such as Microsoft Excel can be used to open and edit the CSV file For more...

Страница 57: ...igure 7 19 filter the files to export Set the Type whole patient records or specify a test type Set the Time Frame From a specific date Prior To a specific date between two dates From To Enter the date 3 Select the format to export CSV or the Biodex proprietary format biodata 4 Touch Export USB to copy the filtered data to the folder named BioCsv or BioData To Export a Multi Record Data Use the Ti...

Страница 58: ...gure 7 21 Import Patient Data Screen 5 Depending on how the files were exported options such as importing whole patient files or importing specific types of tests may be available Editing Stored Results 1 CPT ICD G Code codes and comments for a patient s test results can be selected 2 Touch the patient s name to highlight the row and then touch Edit 3 From the Patient Management Test Results scree...

Страница 59: ...ng can be used as an indicator of positive reinforcement to affirm positional control It can also indicate negative outcomes in instances where positional control is not achieved 1 2 3 4 5 6 7 9 10 Figure 8 1 Vibrotactile Kit which includes 1 Two Belts 71 91 cm and 91 122 cm 2 Link Box 3 Two Tactile Belt Receivers 4 Short USB to micro USB Cable 5 Long USB to micro USB Cable 6 AC USB Charger 7 Two ...

Страница 60: ...e Feedback Option on the Balance System SD Configuration Screen Attach the Link Box The link box provides a wireless link between the tactile belt on the patient s waist and the biofeedback displayed on the screen To install the link box peel off the protective coverings on both parts of the fastener strip and position it on back of the display as illustrated in Figure 1 3 ...

Страница 61: ...tile belt receiver boxes for each are identical and can be interchanged if needed Use the RJ Connector cable see Figure 1 4 to connect the tactile belt receiver box to the connector on the tactile belt Figure 8 4 Connecting the Tactile Receiver Box to the Belt Clip the tactile belt receiver box to the belt fabric see Figure 1 4 Select the belt that best fits the patient Place the belt around the p...

Страница 62: ...tor lights on the tactile belt receiver boxes The light on the left is for the battery status The light on the right is for USB power Table 8 1 Receiver Box Status Indicator Status Color Status Battery Indicator Solid Green Battery charged half capacity or greater trickle or not charging Solid Orange Battery charge less than half but not critical Solid Red Battery charge is critically low not char...

Страница 63: ...lection If the belt has been idle for some time it is sleeping and will not immediately connect By touching the RESET button the belt receiver wakes up and connects correctly There are two icons on the upper right corner of the display that indicate tactile belt link box communication and tactile belt receiver box battery status the first for wireless reception and the second for battery Figure 8 ...

Страница 64: ...screen see Figure 1 2 When enabled during a training session the tractors will vibrate as explained in the following table Training Display Description Postural Stability The tactile belt tractors will vibrate 1 When the target is hit Location of target will determine what tactor vibrates e g a target at 2 00 on the screen will activate a tactor on the patient s right hip 2 When the therapist touc...

Страница 65: ...thin the boundary graphic will be bright green Random Control As the patient moves to maintain the cursor within the randomly roaming circle tactors will vibrate if the cursor falls outside of circle The vibration will stop when the patient is able to move the cursor back inside the circle Maze Control The objective is for a patient to move the cursor through the maze hitting targets If the maze w...

Страница 66: ...66 When vibrotactile feedback is being employed during a training session it will be denoted at the top of the training report page ...

Страница 67: ...ver boxes will be labeled A1 and A2 A0 A1 A2 Figure 8 9 VibroTactile System Equipment Labeling On the screen displayed below a line through the wireless connection battery symbol denotes that no tactile belt is communicating with the link box Touch the wireless battery symbol once to configure tactile belt A1 or A2 In this example A1 is configured Figure 8 10 The Wireless Connection Battery Symbol...

Страница 68: ...xperience what the vibrotactile sensation is like For a tactor test select Fast or Slow In the Fast test each tactor will vibrate for a second In the Slow test tactors will vibrate for 1 second When finished a screen will display stating that test is complete There is no error message if a tactor did not vibrate If a tactor is not vibrating during this test something is not working correctly Try p...

Страница 69: ...e System is purchased some steps are required to ensure that the various link boxes and tactile belt boxes do not interfere with each other Please contact Biodex Customer Support for assistance Patients with Pacemakers At the time of writing there is no information regarding use of the VibroTactile System with patients having pacemakers Although the VibroTactile System uses considerably less power...

Страница 70: ...splay 2 Touch Backup to USB 3 The system displays the message System Backup Successful Touch OK 4 Remove the flash drive When the drive is viewed the backup is in the BioBackup folder Restoring Data from USB The Restore operation overwrites all settings selections and patient database The system can only restore the data from backed up data on the flash drive 1 Insert the flash drive with the back...

Страница 71: ...flash drive in the root directory of the drive 2 Go to the Home screen 3 Insert the flash drive into one of the USB ports on the display 4 The Software Update screen illustrated in Figure 9 2 is displayed Follow the directions to complete the update Figure 9 2 Software Update Screen Cleaning the Balance System It is a good practice to wipe the support handles with disinfectant or cleaner after eac...

Страница 72: ... observing or working on the system 1 Spread the lubricant 2 Turn on the system If the parts need more grease use white lithium grease For questions or assistance contact the Biodex Customer Service Department Maintaining the Printer Follow the instructions in the printer manual If replacement ink cartridges cannot be found contact either Biodex Support or a Biodex distributor Disposal An appropri...

Страница 73: ...om 26 to 36 above platform 66 to 91 cm Handles can be removed from the system when not in use or interchanged with the optional FreeSway Handles User Weight Capacity Maximum 400 lb 181 kg Minimum 60 lb 27 kg Printer HP DeskJet Printer Stand 24 x 24 61 x 61 cm Power 115 VAC 50 60 Hz 15 amp line or 230 VAC 50 60 Hz 15 amp line Power Rating 520 watts Certification Certification ETL listed to UL 60601...

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