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VCA sound SMART RLT Sport, User Manual

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VCA sound SMART RLT Sport User Manual Download Page 20

 

UM0000001 Rev_0 (2019/11/25)                   

Page 

20

 of 

36

         Copyright 2019 Sound Technologies

 

 

5810 Van Allen Way, Carlsbad CA 92008 

800.268.5354  |  soundvet.com 

6.9 Sources for Additional Information and Assistance on Laser Safety 

 
 

 

 

Office of Communication and Education 
 

 

 

Center for Devices and Radiological Health 
Food and Drug Administration 
10903 New Hampshire Avenue WO32-5245 
Silver Spring, MD 20993 USA 
Tel:  1-301-796-5660 

https://www.fda.gov/about-fda/office-medical-products-and-tobacco/center-devices-and-radiological-
health

 

 
 
Laser Institute of America 
13501 Ingenuity Drive, Suite 128 
Orlando, FL 32826 USA 
Toll Free: 1-800-345-2737 
Tel: 1-407-380-1553   

https://www.loa.org

 

  
 
 

Summary of Contents for sound SMART RLT Sport

Page 1: ...of 36 Copyright 2019 Sound Technologies 5810 Van Allen Way Carlsbad CA 92008 800 268 5354 soundvet com USER MANUAL Regenerative Laser Therapy SMART RLT Sport is a BWF 5 Series laser manufactured by B W TEK Inc for Sound Technologies Inc ...

Page 2: ... Way Carlsbad CA 92008 800 268 5354 soundvet com Sound Technologies Inc 5810 Van Allen Way Carlsbad CA 92008 Contact Technical Support 800 268 5354 http www Soundvet com Email Techsupport soundvet com B W TEK Inc 18 Shea Way Suite 103 Newark DE 19713 Tel 302 368 7788 http www bwtekmed com ...

Page 3: ... SAFETY 7 6 1 Guidelines 10 6 2 Laser Safety Supervision 11 6 3 Laser Safety 11 6 4 Labels and Symbols 11 6 5 Safety Devices 14 6 6 Laser Eye Protection 16 6 7 Electrical Safety 17 6 8 Electromagnetic Compatibility 17 6 9 Sources for Additional Information and Assistance on Laser Safety 20 7 SYSTEM SET UP 21 7 1 Receipt and Unpacking 21 7 2 Setup 21 8 OPERATION 22 8 1 Main Menu Display 22 8 2 Sear...

Page 4: ... subject matter presented 2 PRECAUTIONS Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual The protective eyewear supplied with this device has an optical density rating 5 in the 1064 nm region All personnel present during device operation must wear this eyewear Contact Sound Technologies Inc at 800 268 5354 Option 1 t...

Page 5: ...nce of procedures other than those specified in this manual may result in hazardous radiation exposure FAILURE TO COMPLY with all safety instructions and warnings may expose all participants to harmful levels of laser radiation and or dangerous levels of electrical current NEVER direct the laser beam at anything other than the area to be treated NEVER allow the eyes of any living being to look dir...

Page 6: ...class 4 laser device 5 1 Device Description The SMART RLT Sport system is designed for therapeutic treatment of the equine species and more specifically tissue regeneration The laser reaches deep into the body through intact skin to stimulate the body to achieve a highly beneficial result The laser therapy increases circulation reduces pain and inflammation and promotes cellular metabolism in tiss...

Page 7: ...ar contact Sound Technologies Inc at 800 268 5354 Option 1 5 3 Environmental Safety The laser system must be stored transported and operated in accordance with the environmental conditions provided in this manual The laser device is air cooled and designed for use in a well ventilated area that maintains relative humidity and temperature conditions conducive to conventional human productivity This...

Page 8: ...Safety Officer LSO Eye Protection Class 4 Therapy Lasers can emit both visible and invisible radiation Protective eyewear is necessary for both Class 3 and Class 4 lasers where irradiation of the eye is possible Required Users Administrator of the laser therapy treatment Patient If treating near the head area of the horse using a towel or blinkers to block any potential laser exposure is recommend...

Page 9: ...mage irreparable corneal and or retinal damage and possible blindness to one or both eyes Do not allow any reflective object to fall into or obstruct the path of the laser beam Always wear protective eyewear Any person present during the laser operation must wear protective eyewear Never look directly into the end of any laser hand piece Never direct the laser light directly into the eyes or direc...

Page 10: ...atment protocol established for patient Laser injury management protocol in place for accidental injury Document laser treatment and post treatment outcome Contraindications Do not apply over an implanted device i e a pacemaker pet microchip OK Do not apply over the thyroid gland ovaries or testicles Do not treat over any cancer malignancy Do not treat over an actively hemorrhaging area Safety Fam...

Page 11: ...utions Please refer to Section 2 PRECAUTIONS Warnings Please refer to Section 3 WARNINGS 6 4 Labels and Symbols The following labels appear on the SMART RLT Sport laser Manufacturer Factory Identification Label Located on the lower side of the deck The label indicates the manufacturer model number serial number S N i e 191006 004 and date of manufacture DOM Month Year i e October 2019 of the SMART...

Page 12: ... 800 268 5354 soundvet com Aperture label and Aperture Icon Located on the hand piece This label indicates the laser aperture The laser emission can only be emitted from the laser aperture on the hand piece International Laser Hazard Symbol This icon denotes a laser product located on the lower side of the deck ...

Page 13: ...rning when the panel is open Warranty Seal Label Located on the lower side of the deck Any attempt to open the top plate of this device will break this seal voiding the system warranty Certification Label Located on the lower side of the deck this label denotes Compliance with CDRH requirements Sound Label Located on the outside of the system adjacent to the power entry module this label indicates...

Page 14: ...restores power To reset the Emergency Power Off Switch the user must press twist and rotate in the direction indicated by the arrows then release it as the switch pops out returning it to its normal position SMART RLT Sport software must be stopped and restarted Model SmartRLT Sport Input Power 100 240V 2 5A 50 60Hz Contact Information 5810 Van Allen Way Carlsbad CA 92008 760 918 9626 SOUNDVET COM...

Page 15: ...n the laser emission is ON Laser Emission Audio Indicator The laser will have an audio beeping sound when the laser is emitting This audio comes from the tablet speakers so sound should never be muted on turned below an audible range on the tablet Remote Interlock The purpose of the remote interlock connector is to permit the user to connect a remote barrier interlock emergency stop switch or simi...

Page 16: ...og Timer The laser firmware will automatically halt laser emission if the tablet software does not message the firmware once every half second during laser operation This is to prevent a loss of communication to the firmware preventing a hazardous situation 6 6 Laser Eye Protection The protective laser eyewear supplied with this device has an optical density rating 5 0 for 1064nm laser emission Al...

Page 17: ...ctly onto the equipment surfaces Gently dry dust the inner deck and tablet with a tissue to remove visible dust and contamination When electrical components must be replaced use only components that are appropriately rated for the application Replace fuse switches or connectors only with components of the same type and rating as the original equipment Refer to Section 8 8 1 for replacement parts a...

Page 18: ...ixed 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 Conducted Immunity AC Power I O Lines IEC EN 61000 4 6 3Vrms 6Vrms in ISM Amatuer Radio Band 0 15 80 MHz AC Mains 3Vrms 6Vrms in ISM Amatuer Radio Band 0 15 80 MHz I O Ports Electri...

Page 19: ...EN 61000 3 2 Limit None Voltage Fluctuation IEC EN 61000 3 3 Limit None WARNING Use of accessories and cables other than those specified or provided by the manufacturer of Smart RLT Sport device could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation WARNING Portable RF communications equipment including periphera...

Page 20: ...unication and Education Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue WO32 5245 Silver Spring MD 20993 USA Tel 1 301 796 5660 https www fda gov about fda office medical products and tobacco center devices and radiological health Laser Institute of America 13501 Ingenuity Drive Suite 128 Orlando FL 32826 USA Toll Free 1 800 345 2737 Tel 1 407 380...

Page 21: ...9 feet of an available 110 VAC 50 60Hz electrical outlet c Ensure adequate airflow around the system Be cautious not to block air vents on the side of the case There must be a minimum 4 clearance around the sides of the system 2 Open the case and verify components are placed neatly inside Uncoil the fiber optic cable and inspect hand piece Make sure that the emergency stop button is disengaged and...

Page 22: ...gency Patient control by tapping the icon There is a help icon that will bring the user context sensitive help including documentation and videos detailing operation for the current screen The cog icon will bring up a menu with the options to close or update the application Also there is a new AIS cloud button This launches a full page browser window that defaults to https antechimagingservices co...

Page 23: ...treatment icon Existing treatments for this patient will be represented here as treatment tiles which display information specific to the treatment a begin resume treatment icon and a display notes icon to view notes that were entered after the treatment 8 3 Creating a Patient For non urgent situations you will tap the add patient icon This will open the Add Patient form where you will enter both ...

Page 24: ...ain Patient Screen by tapping the left arrow 2 save the information and 3 add another patient by tapping the Save and Add control or save the information and move to the treatment plan screen by tapping the right arrow For emergency situations you will tap the Add Emergency Patient icon This will take you directly to the treatment plan screen 8 4 Treatment Calendar We have included a treatment cal...

Page 25: ...8 5354 soundvet com 8 5 Patient Reporting Patient reporting can be performed by tapping the report icon on the patient tile This icon appears as follows The report will show patient data all treatments performed on the patient as well as any scheduled appointments The report may be printed or saved to word pdf or excel ...

Page 26: ...These selections do not alter the treatment protocol but rather are included as reference notes for review or future use For existing patients whom have already been treated and the resume treatment icon has been selected these items will already be selected The displayed images show the standard anatomical area to which the laser treatment will be applied There is basic patient information displa...

Page 27: ...r system Typically this status will read StandBy prior to operation If the tablet is not communicating with the laser firmware you will see a status that reads Communication Error Additionally in the section below you will see a fault indicator that says Comm with a red background The software has several alarms for error conditions as follows FD Fiber disconnected Interlock Interlock is open HR H...

Page 28: ...nt Treatment Calendar The calendar icon will bring up a calendar in scheduling mode In this mode the operator will be able to create an appointment for treatment by tapping into a day in the calendar or can schedule periodic treatments by selecting the day s of the week and the total number of treatments at the top of the screen You can select individual days to add and for your convenience there ...

Page 29: ... Pulse and dose Tapping this button will prompt the use with an alert window with some text explanations of each option There is also a another video icon that launches a video explanation of the modifications in more detail The workflow is 1 User selects a protocol 2 User presses the Manual Settings Button 3 Alert window pops up with full text explanation of what to change when and how 4 If user ...

Page 30: ...e Do not press the hand switch until you see Status Ready on the Treatment control as this safety measure will cause an error this is to ensure a user is in positive control of the hand switch Release the hand switch at the end of each phase and do not press again until you see Status Ready on the treatment control again To get started ensure that the Begin Treatment button shows Status Standby If...

Page 31: ...mounts automatically When the time remaining reaches 0 the application will move to the next phase or stop the treatment automatically Pressing the same button used to start the treatment will cancel the treatment at any point A quick sequence of four audible beeps signals the end of the treatment WARNING VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE AND SKIN EXPOSURE TO DIRECT OR SCATTERED RADI...

Page 32: ...in as an administrator then the operator management option selection will be available by tapping on the icon and selecting the operator icon The administrator may add users edit users and delete users from this screen The administrator will give the operator a four digit key code to function the laser The patient report will show who performed the treatment based on this information ...

Page 33: ...ing a water moistened tissue take care to use minimum water the towel should not be dripping wet never store with residual gel Disinfection of the aperture lens is possible by wiping with a sterile alcohol prep pad as sold by Medline and others it is important that no residual moisture or fibers remain after the cleaning Be sure to always inspect the lens after any cleaning before use Using the Ro...

Page 34: ...ten with a Philips screw driver careful not too tight a quarter turn past snug is sufficient Visually inspect the case externals making sure the latches and handles are not lose from attachment or damaged If so contact service Check functionality of the Emergency Switch and Remote Interlock Annually Factory Recertification these systems require factory test and inspection on an annual basis Contac...

Page 35: ... PN RLT Hand piece mounting pin 30 921 RLT Sport Fan Filter Frame In 30 922 RLT Sport Fan Filter In 60ppi 30 923 RLT Aperture Lens Cloth 30 924 RLT Rough Surface Lens Cap 70 129 RLT Aperture Lens 30 926 RLT Sport Vent Frame Out 30 966 RLT Sport Vent Filter Out 30ppi 30 963 RLT Sport Fiber Locating Handle 30 967 RLT Sport Fiber Locating Pin 30 964 RLT Sport Remote Interlock Plug 30 965 ...

Page 36: ...g Power 20W Grouped Pulse Energy 1000 mJ in 50 ms Grouped Pulse Frequency 20 Hz typical 1 30 Hz adjustable Aiming Beam 650 nm Spot Size 9 mm Contact 13 mm 1 distance 17 mm 2 distance Optical Cable 800 micron 0 37 NA 6Ft Operating Temperature 10 30 C Storage Temperature 10 50 C Cooling Forced Air Weight 45 lbs Voltage Input 110 220 VAC Nominal Ocular Hazard Distance NOHD 250m ...

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