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BTE ECCENTRON Operator's Manual

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OPERATOR'S MANUAL

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  • Page 1 OPERATOR’S MANUAL...
  • Page 2 40060004...
  • Page 3 The furnishing of this document does not give you license to these patents, trademarks, copyrights, or other intellectual property except as expressly provided in any written license agreement from BTE Technologies. Printed in the U.S.A.

  • Page 4: Warranty

    This limited warranty is in lieu of all warranties, expressed or implied, and all other obligations or liabilities on the part of BTE Technologies. We neither assume nor authorize any person to assume any other obligation or liability in connection with the sale of this product.

  • Page 5: Table Of Contents

    Table of Contents Safety Important Notes Assembly and Maintenance General Operation System Startup General Hardware Operation General Software Operation System Shutdown Dosing and Exercise Eccentron Training Paradigm Client Training Client Positioning Practice Session Clinician Management Clinician Menu Administration Resources Utilities Client Management...
  • Page 6 40060004...

  • Page 7: Safety

    Safety Before Operating the Eccentron 1. Remove the transport casters 2. Attach the front cover 3. Attach the rear side covers 4. Adhere to all usage and positioning instructions 5. View the Clinician Usage Video prior to setting up clients for exercise...
  • Page 8 Be sure the front cover and both rear side covers are securely attached prior to operating the system. For instructions on removing or replacing covers, see the Assembly and Maintenance section. Network Connection The Eccentron is not intended to be connected to a network, do not do so unless instructed by BTE. Equipment Modification •...
  • Page 9 Instruct clients on proper positioning and exercise motion for safety and efficacy. It is very important that all Clients and Clinicians are aware of correct and incorrect positioning before and during exercise. • The Eccentron is not recommended for use by people under the age of 16. • Follow instructions for use •...
  • Page 10 40060004...

  • Page 11: Important Notes

    Even if you have a dedicated outlet for your Eccentron, have a technician check the outlet with a voltmeter to ensure that the wall voltage does not exceed the specified voltage + 10 percent. If your wall voltage exceeds these voltage specifications, call BTE immediately.
  • Page 12 Definitions of Symbols and Certification Marking Manufacturer General Warning Sign Catalogue Number Medical Device (Product and Model Number) Serial Number Type B Applied Part Where applicable: Authorized Representative In CE Marking with the Notified The European Community Body number SGS Product Certification Follow Instructions for Use Mark Alternating Current...
  • Page 13 It also measures strength and dynamic workload through its control mudle interface. General Description The Eccentron is a closed-chain exercise device that provides eccentric (negative) resistance to patient motion. The equipment includes bilateral, adjustable motorized pedals, an interactive display, a control system and a control module for user interface, user data storage and reporting.
  • Page 14 The system is intended to be used to increase muscle strength of the lower extremities. Detailed The Eccentron is intended for use in physical rehabilitation of patients with injuries and conditions that affect lower extremity strength. It is used in functional and sport rehabilitation where the patient performs compound motions to strengthen muscles used in real life tasks, for example transitioning between standing and sitting, descending stairs, jumping, and stopping forward motion (braking motion).
  • Page 15 Operating Principles The Eccentron is a device that supplies a constant force to a user’s lower extremities at varying speeds. The user is meant to resist the force using their legs and feet in order to create an eccentric exercise for the lower extremities.

  • Page 16: Eu Declaration Of Conformity

    If a serious incident occurs while using this device, the user needs to report the incident to BTE Technologies. For users in the European Union, the user needs to report the incident to BTE Technologies and to the competent authority of the Member State in which the user and/or patient is established (per EU Medical Device Regulation (EU 2017/745), Annex 1.23.4(z)).

  • Page 17: Assembly And Maintenance

    Assembly & Maintenance This chapter will guide you through the steps necessary to get your Eccentron ready to use, and includes recommended maintenance. The Eccentron is shipped with transport casters. These are designed to provide maximum protection in transit and ease of installation.

  • Page 18: Installation

    Do not plug into an extension cord. • You may position the Eccentron with the front or side, or back against the wall. There must be a minimum of 36” (91 cm) distance between the wall and the equipment front or back. This space is required for on-site assembly and servicing.
  • Page 19 2. Use a ¾” wrench to remove the screw from frame tube on the side of the frame. Then, pull the caster out of the frame tube. Figure 3 – Unscrew Tube Screw Figure 4 - Remove Caster 3. Repeat this for the remaining 3 casters. 4.
  • Page 20 Figure 7 - M4 x 10 screws 4. Plug the Power cable, DVI cable, and USB cable into the back of the monitor. Figure 8 - Monitor Cables 40060004...
  • Page 21 Attach the Rear Side Covers 1. Using a Phillips screwdriver, remove the washer and screw in the frame. Repeat on the opposite side. Figure 9 - Frame Screws 2. The side housing assemblies are not interchangeable; the truncated apex faces forward on both the right and left sides.
  • Page 22 3. Align the right side housing and secure it using the screw and washer previously removed from the frame. Repeat for the left side housing. Figure 11 - Side Housing Attachment Attach the Front Console 1. Remove the 2 screws and washers on each side of the frame. Figure 12 - Console Frame Screws 2.
  • Page 23 3. Remove the bolts and washers from the horizontal plate of the Monitor Arm. 4. Install the Front Closeout Cover and secure it with the washers and bolts. Figure 18 - Console Screw Attachments Figure 17 - Console Screw Attachments 40060004...
  • Page 24 3. Plug the power cord into the rear cover, and plug into the dedicated outlet. 4. Turn on the power switch on the back panel. Figure 21 - Power Cord Figure 22 - Power Switch Your Eccentron is now ready to use! 40060004...
  • Page 25 Figure 24 – Fully Assembled Eccentron 40060004...
  • Page 26 Relocation This section describes how to move the Eccentron to another location in the facility. 1. Shut down the software, turn of the power switch, and unplug the power cable from the wall outlet. 2. Have the transport casters and hardware ready.
  • Page 27 Figure 28 - Lift Console off Frame 40060004...
  • Page 28 Repeat for the other 3 casters. Figure 29 - Attach Caster to Frame 4. Use a ¾” wrench to raise the casters and lift the Eccentron off the floor. Figure 30 - Raise Casters to Lift Frame 5. Carefully move the device to the desired location, and remove the casters. Follow the “Installation”...
  • Page 29 Recommended Enhancements In addition to the equipment shipped to you from BTE, the purchase of the following items from a local supplier is recommended for additional protection of your clients, equipment, and data: • Disinfectant wipes to clean the commonly used surfaces •...
  • Page 30 For optimal performance, shut down the software and turn of the power switch the every night. • Do not install any additional software onto the control module. The BTE Eccentron system is in constant communication with the control module, so a “clean,” dedicated control module is crucial to the integrity of the system.

  • Page 31: Software Maintenance

    Creating a log file • You may be instructed by a representative of BTE to supply a log file from the system during a service event. To retrieve the log file from the system follow the procedure below. 1. Plug a USB flash drive into the USB port on the back of the monitor.
  • Page 32 To export the database you will require a USB flash drive 1. Plug a USB flash drive into the USB port on the back of the monitor 2. Log into the Eccentron as a clinician 3. From the clinician drop down menu select Utilities.
  • Page 33 1. Plug a USB flash drive into the USB port on the back of the monitor with the database 2. Log into the Eccentron as a clinician 3. From the clinician drop down menu select Utilities. 4. From the utilities screen select Database 5.
  • Page 34 Moisten a soft towel with a manufacturer recommended cleaner and wipe off the screen. • Do not spray any liquid onto the back of the touch screen display. Eccentron Frame • Wipe down the system with an alcohol-based or approved disinfectant solution.
  • Page 35 Preventive Inspections • Prior to each use, be sure the pendant is stored correctly and the cable attachment is free of cracks or other damage. • Periodically inspect the seat adjustment mechanism for any unusual wear or damage. • Periodically inspect the cables for unusual wear or damage. Environmental Protection At the end of the system’s useful life, please remove the hard drive and have it professionally cleaned to remove all data;...

  • Page 36: General Operation

    1. Connect the Pendant cable (2) on the rear base of the Eccentron, and place the pendant in its holder. 2. Verify that the power cord (3) is plugged into the rear base of the Eccentron frame and then plug into a dedicated wall outlet.

  • Page 37: General Hardware Operation

    For ease of client access to the seat, the armrests are moveable. Manually raise the armrests as needed for clients to get in and out of the seat. Keep the arms down (parallel to the floor) while the Eccentron is in use.
  • Page 38 Seat Position CAUTION: Do not allow knee extension beyond 30° Proper client positioning in relation to the pedals is critical for safe and effective use of the Eccentron. Follow the on-screen instructions carefully for seat set up. 1. While the Client is seated with feet on pedals and heels touching the bottom pedal rim, position the seat so that the knee of the most extended leg has at least 30°...
  • Page 39 Machine Settings Match Once a client is set up into the system, the software will require the same seat settings to be used each time for that client. As a reminder for seat positioning, the seat setting saved will show on screen. Pendant Pendant Actions The pendant offers four simple functions for client convenience: Start and Pause exercise;...

  • Page 40: General Software Operation

    The first screen that appears in the software is the Welcome, or Log In, screen. A Username and PIN are required to access the software, so BTE has provided a default log in for first time access to the system.
  • Page 41 • Provide Demo exercise sessions Details on these features and more are found in the Clinician Management section. Client Functions Within the Eccentron software program Client users can: • Learn correct positioning and motion for exercise • Practice resistance prior to first recorded exercise session •...

  • Page 42: Shut Down The System

    Shut Down the System The control module is sensitive to improper shutdown. Shutting down the Eccentron system improperly can cause damage to the control module and/or the database utilized by the Eccentron software that can render the Eccentron system inoperable.

  • Page 43: Dosing And Exercise

    For best results, clients should be regularly evaluated against their baseline to be sure treatment is sufficient and effective. The Eccentron Testing and Training Paradigm were developed to provide objective measurement and gradual acclimation to exercise while accommodating exercise progression—and regression—needs.
  • Page 44 Dosing Test The Dosing Test begins with a warm-up, consisting of 6 repetitions (12 strides total) performed at a submaximal effort. The purpose of the warm-up is to ease the client into their dosing test so that maximum effort is not applied from a cold start. The Dosing Test itself consists of 6 repetitions (12 strides total), performed at the Client’s safe maximum effort.

  • Page 45: Client Training

    Clinicians should supervise Client training. Clients are first informed of important safety and use guidelines, and then are required to agree to the Eccentron usage terms. The Client will not have access on the Pendant to progress through the training screens, so the Clinician must provide navigation and acceptance of terms at the touch screen display.
  • Page 46 The training introduction screens provide basic instruction and safety guidelines to follow. Figure 3 - Training Introduction Screen “The Eccentron is an easy and highly effective way to strength train without lifting weights. When exercising, the pedals will move automatically. Use your legs to resist against the pedals as they come toward you.
  • Page 47 Figure 4 - Safety Guidelines Screen Always Never • • Follow the usage Exercise with straight, instructions and locked, or warnings. hyperextended knees. • Exercise only under • your own Log In. Resist the pedals when you are out of •...
  • Page 48 Client record. Select Proceed to proceed under the usage terms. Figure 5 - Acceptance of Terms Screen “I understand and agree to follow all safety, positioning, and usage guidelines for the Eccentron. If further information is desired, please contact a facility Clinician, or BTE.”...

  • Page 49: Client Positioning

    Client Positioning The key to safe and successful outcomes on the Eccentron is proper Client positioning. It is very important to follow the positioning recommendations provided here and in the Clinician and Client Training materials. Ingress and Egress The Eccentron is designed to facilitate Client seating regardless of level of assistance they may need.
  • Page 50 Knee Bar Eccentron includes a knee bar, installed to aid in ensuring correct patient leg positioning. The ideal position for the knee bar is for the top of the cushion to be directly under the knee however it can be adjusted for comfort.
  • Page 51 Foot Position Instruct clients to keep their feet flat on the foot pedal beds with heels against the heel cup at all times during exercise, and to never remove feet from the moving pedals. If foot movement is needed for any reason like repositioning, Pause the exercise first.

  • Page 52: Practice Session

    Practice Session The software allows first-time users an opportunity to practice the exercise prior to performing the Dosing Test. During the Practice Session, encourage the Client to resist against the pedals as they come toward the Client. Effective cues, depending on the advised effort, include, “Try to slow down the pedal motion,” and, “Try to stop the pedal from coming toward you.”...
  • Page 53 Figure 12 - Activate Pedals Screen Figure 13 - Speed Adjustment Screen “If the motor is not moving, please start it. Press the “Press the center button to start the pedals moving. down arrow button to slow down the pedals.” Press it again to pause the pedals.
  • Page 54 Figure 16 - Resistance Motion Screen Figure 17 - Resistance Motion Screen “Now we’ll try the other leg. “Now let’s try both legs. Using just your left leg, resist—or brake—against the Practice resisting on both legs until you see the pedal as it comes toward you as shown.
  • Page 55 Dosing Test Screens The Dosing Test consists of a warm-up of 6 reps (full strides on each leg), and then a recorded test of 6 reps. During the warm-up, instruct the Client to resist at a comfortable submaximal level. Figure 18 - Dosing Warm-up Figure 19 - Dosing Warm-up During the Dosing Test, instruct the Client to resist at their safe maximum level for each stride.
  • Page 56 Once the Dosing Test is finished, there are 3 options for proceeding. Figure 22 - Dosing Test Completion Screen 1. Manually override the set exercise parameters for the Client by modifying the Session Settings. To do this, select the Override icon, which takes you to the Session Settings screen. Manually enter the desired values and proceed to exercise.
  • Page 57 Exercise Screen Controls There are various screen controls that the Clinician and Client should be aware of during exercise. See General Hardware Operation/Pendant. Pendant Buttons The pendant allows the client to start, pause, resume, and stop the exercise program. The clinician can use the corresponding buttons on screen for the same functions.
  • Page 58 Pause/Resume Exercise The Client can pause the exercise (pedal and screen activity) by pressing the center button once. To resume exercise, press it again. To exit the exercise session from the Pause screen, hit the down arrow button. Session data will be saved.
  • Page 59 Exercise Program The Eccentron exercise program provides a “ramp-up” of gradually increasing duration, with intermittent Dosing Tests to properly set the Target Range. Additionally, the exercise session itself includes a short warm-up, active exercise, and brief cool-down stages. Exercise Preparation Clients should perform a general warm up for 5–10 minutes, or as Clinician recommends, prior to using...
  • Page 60 Pre-set Exercise Manually-set Exercise Sample Exercise Session Stages Warm Up In addition to the general therapy warm up, the pre-set exercise session provides a short period of time at the beginning of the session for the Client to become adjusted to the exercise resistance. This lasts for 1 minute, or 10% of the duration, whichever is greater.
  • Page 61 Interactive Game The Eccentron software displays a fun, animated game screen to teach, entertain, and motivate the client while exercising. The game screen portrays the Client as a hiker going downhill. Select Start to begin the pedal and screen activity. Force bars below the hiker show real-time force effort exerted on the pedals.
  • Page 62 Performance Motivation The interactive game trains clients to stay in a particular force range, for neuromuscular performance gains. The goal for the “hiker” is to have all the force bars land inside the Target Range band. The “% on Target” area displays the accuracy of each leg individually in hitting the target, as well as an average for both legs.
  • Page 63 • If a diamond is earned, the diamond accrual at the top of the screen increases. • If a diamond is missed, there is no “penalty”. A new diamond will start forming with the next on- target stride. Excessive Effort Control Force exceeding the Target Range is discouraged and will not earn diamonds.
  • Page 64 Demo Exercise There is a “demo” session pre-programmed on the Eccentron. This is available to test out the device and get a feel for the eccentric resistance motion as well as the software and game features. Demo data results are not saved.

  • Page 65: Clinician Management

    Clinician Management The Eccentron software provides helpful administrative and treatment features in order to get the most out of your equipment. In addition to the ability to add and search for client records, more options and features are available via the Clinician Menu. Clinicians should execute the Administration and Resource sections prior to treating Clients on the Eccentron.

  • Page 66: Administration

    Session Reports Progress Reports 2. Administration The Administration section contains the Eccentron setup information. This section allows the modification of software, exercise, and data collection defaults. For details on these features, see the System Configuration section below. For details see the Administration section below.

  • Page 67: Resources

    3. Resources The Resources section contains usage and training materials. • Operator’s Manual • Clinician Usage Video 4. Utilities • Software Update Export Log Files • Database Export Restore Administration Use the Administration section to set up the clinic, clinical users, and system preferences. Action buttons at the top right of the screen allow for Demo exercise, and Log Out of the system.
  • Page 68 From the Administration screen, select Clinic Setup to enter your clinic information. This step is optional, however, if it is filled out your clinic information will print on the client reports. Figure 3 - Clinic Setup Screen 1. Enter the following Clinic information from the keypad: a.
  • Page 69 Figure 4 - Administration Screen: Clinician Setup Add Clinician Each Clinician should have an individual Login, and each user must have a unique Username. Clinician name and credentials (if entered) will print on Reports. When the Add Clinician icon is clicked, the following screen appears.
  • Page 70 3. Create a Username of < 25 alphanumeric characters (required) 4. Create a 4-digit PIN using the numeric keypad (required) 5. Enter Clinician credentials of < 50 characters (optional) 6. Save the entry when finished by choosing OK Search/Select Clinician Use the Search feature to locate an existing Clinician record.
  • Page 71 Figure 7 - Edit Clinician Screen 1. To edit Client info, touch inside the field you wish to edit. All information can be edited except Username. 2. Save the entry to keep your changes, or select Cancel to keep the current information. Delete Clinician Press the Delete (trash can) icon to permanently delete a clinician record.
  • Page 72 NOTE: Deleted records cannot be recovered. System Configuration The Eccentron software is pre-programmed with default settings allowing a clinician to safely use the system while becoming familiar with all its functionality. Once the clinician is knowledgeable with all the parameters, the default settings can be modified. Be aware that these are global settings that apply to every client.
  • Page 73 Figure 10 - Compilation of System Configuration Options NOTE: It is recommended that no changes be made to the formula default settings until the Clinician has a thorough understanding of the Eccentron usage guidelines and pre-set treatment plan. Before making changes to these parameters, it is critical that you have an understanding of functions and calculations.
  • Page 74 Metric. System Language The default language displayed on the Eccentron is English. The system language can be changed by selecting from the drop down menu in System Configuration, or by selecting the appropriate language icon on the Log In screen. A software restart will occur after language has been changed.
  • Page 75 3. Save the value change by selecting OK, or Cancel to keep the default value. Logging Level The Eccentron software logs a baseline level of information during its use to aid diagnostic purposes in case any troubleshooting by technical support is necessary. Increasing this setting may result in a degradation of software performance, as additional information is stored in the log file.
  • Page 76 1. Click the box to remove the ‘X’. The RPE box will no longer appear at the end of an exercise session. 2. Click the box again to restore the default setting of “On”. Resources The Resources section contains all usage information related to operation and performance of the Eccentron. 40060004...
  • Page 77 The training materials provided include a brief Usage Video on the use and performance of the Eccentron. This video demonstrates proper Client positioning and use of the hardware features. It is strongly recommended that all Clinicians view the video prior to putting Clients on the Eccentron.
  • Page 78 Figure 14 - Video Warning Message Figure 15 - Video Reminder Message The Usage Video can be accessed 2 ways: Immediately after a new Clinician is added to the database, and via the Resources tab under Administration. Clinicians will be able to conveniently review any of the training materials as needed.
  • Page 79 Figure 16 - Video Player Screen The training video covers: • Client access on and off the device • Proper client positioning for exercise • Pendant use • Eccentric resistance motion • Dosing Tests Utilities (Database & Software) Occasionally system maintenance may be necessary for database operations and software updates, which are accessed via the Utilities section.
  • Page 80 Figure 17 - Utilities Screen Software Management The Software screen provides two options: Update and Export Log Files. Software Update Software updates may periodically be provided via an external device. Press the Update button and follow the simple on-screen instructions. Once the update file is located, simply press “OK” to start the install.
  • Page 81 Database Restore will automatically generate a system restart. Back Ups The data created by using the Eccentron (i.e. dosing, treatment, or exercise) is automatically backed up daily. When a backup file is created, the previous day’s file is overwritten. A new file is created with the most recent data.

  • Page 82: Client Management

    Client Management This Chapter addresses client record management, which includes adding, viewing, modifying, and deleting Client records. Additional options in this section allow for individual machine and session settings for each Client, including pre-set and manual exercise options. Client Add/Search To access the Client Add/Search screen, select Clients from the Clinician Menu.
  • Page 83 Figure 2 - Add Client Screen 1. Enter the new Client name of up to 40 alphanumeric characters into the First and Last Name text fields. 2. Create a Username of up to 24 alpha characters. 3. Create a 4-digit PIN using the numeric keypad. 4.
  • Page 84 Figure 3 - The Client Detail Screen From the Client Record screen, a Clinician can: 1. Edit or Delete a Client 2. Modify seat settings 3. Set or modify exercise parameters 4. View Client Reports 5. Administer a Dosing Test 6.
  • Page 85 Edit Client Client information can be modified as needed or permanently deleted from the system. Also, if a client forgets their PIN, a new PIN may be entered here. To access the Edit screen, click the Client icon on the Client Record screen.
  • Page 86 Delete Client The Delete option is available from the Edit screen. Press the Delete (trash can) icon to permanently delete a client record. Figure 5 - Delete Client 1. Select the Delete icon, which prompts a warning asking for confirmation. 2.

  • Page 87: Machine Settings

    Machine Settings Machine Settings are physical adjustments to be made on the Eccentron so that the Client is comfortably and safely positioned for exercise. The seat position setting is determined during the Client’s first session. There may be instances when range of motion increases as the Client’s rehab progresses, so seat settings may be adjusted if necessary.
  • Page 88 Session Settings Session Settings refer to the parameters set for the current Exercise Session. Target Force, Session Duration, and Pedal Speed are pre-set in the software, or they can be manually set by the Clinician. Overriding the pre-set Session Settings is considered to be a Manual Session. Once the Client has performed a Manual session, the Session Settings will stay as entered until the Clinician changes them again.

  • Page 89: Reports

    Reports This chapter highlights the reporting functions of the Eccentron software. For each Client, reports can be generated, saved, exported, and printed. There are two types of reports available: session reports and progress reports. Session Report Screen After the completion of an exercise session, the performance data collected is displayed as a Session Report.
  • Page 90 If a client is logged in, selecting “Done” will log them out and return to the Login screen. The same happens if Exit is pressed. If a clinician is logged in, selecting “Done” will revert to the Client Add/Search screen. Progress Report Screen To switch from the Session Report to the Progress Report, select the Progress button.

  • Page 91: Export Reports

    Export Reports The Export function on the Report screens allows for saving and printing reports. The exported Session Report contains charts for force and work performed over the duration of the exercise. The force chart does not include data from the warm-up and cool down periods, however, the work chart does.
  • Page 92 When you select Export, the software provides a filename, which CANNOT be modified. Use the following steps to export either a Session or Progress Report. Figure 4 - Export File Naming 1. Insert a flash drive into the USB port. 2.
  • Page 93 Session Report Sample 40060004...
  • Page 94 Progress Report Sample 40060004...
  • Page 95 40060004...
  • Page 96 40060004...

  • Page 97: References

    References Albert, M. (1995) Eccentric Muscle training in Sports and Orthopaedics (2 Ed.). Churchill Livingstone, London, UK, pp. 174. Friedmann, B., Kinscherf, R., Vorwald, S., Muller, H., Kucera, K. Borisch, S., Richter, G., Bartsch, P., Billeter, R. (2004). Muscular adaptations to computer-guided strength training with eccentric overload. Acta-Physiol.
  • Page 98 40060004...

  • Page 99: Appendix

    Appendix EMC Guide Guidance and manufacturer’s declaration – electromagnetic emissions Eccentron is intended for use in the electromagnetic environment specified below. The customer or the user of Eccentron should assure that it is used in such an environment Emissions test...
  • Page 100 Guidance and manufacturer’s declaration – electromagnetic immunity Eccentron is intended for use in the electromagnetic environment specified below. The customer or the user of Eccentron should assure that it is used in such an environment. IEC 60601 test Immunity test...
  • Page 101 Guidance and manufacturer’s declaration – electromagnetic immunity Eccentron is intended for use in the electromagnetic environment specified below. The customer or the user of Eccentron should assure that it is used in such an environment. IEC 60601 test Immunity test...
  • Page 102 Recommended distance between portable/mobile RF communication equipment and Eccentron Eccentron does not need to be used in a radiated RF controlled environment. Customers or users of Eccentron shall maintain the minimum safe distance between portable/mobile RF communication equipment (transmitter) and Eccentron to prevent electromagnetic interference. The minimum distance shall be accordance with the maximum output of the communication equipment as recommended below.

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