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COMPANION THERAPY COMPACT USER MANUAL CTC-12
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1. This switch is located on the rear panel of the COMPANION THERAPY COMPACT laser Laser Fiber Connection Port and Finger Switch Jack This port is located on the bottom of the device Laser can not emit without the fiber attached A metal emission port dust cap which is permanently attached to the unit can be secured on the emission port when fiber is not connected Fiber Connection Port Finger Switch Jack Page 6 COMPANION THERAPY LASER LiteCure LLC Remote Interlock This device is equipped with a remote interlock located at the rear of the device If the interlock is not inserted into the connector all electrical power to the controls and laser components is terminated The remote interlock MUST be inserted before the device can power on System Power On Off Visual Indicator Located on the front panel of the laser device this yellow indicator is illuminated continuously whenever the device is on Laser Emission Indicator The laser emission indicator is located on the front panel This yellow indicator is illuminuated whenever the laser emits The LCD display during the emission mode Internal Laser Energy Monitor There is an internal system that monitors the intensity of laser energy generated whenever laser emission occurs If the laser emission is not within the system tolerance laser emission will be aborted If the laser device is unable to maintain the preset laser power output s
2. THERAPY LASER LiteCure LLC 3 3 9 3 3 10 3 3 11 Finger Switch Jack Emission Port f s Remove the dust cap from the emission port DO NOT touch the fiber tip to any surface If the fiber tip or the emission port is contaminated then the device might be damaged during laser beam output emission Install the fiber optic into the emission port connector Securely tightened the screw nut to the emission port The fiber shall not be bent at a bend radius smaller than 5cm during the operation Improper inserting steeply bending and improper securing the fiber optic may lead to the damage to the fiber optic or delivery system and or harm to the users IMPORTANT Please DO NOT remove the fiber from the emission port once it has been secured for the first time unless the device is being packaged or transported to another location Repeated insertion and removal of the fiber before and after every procedure will increase the chance of emission port and fiber tip contamination If you must disconnect the fiber from the device then immediately attach the fiber tip cap Use Hand Piece Page 10 COMPANION THERAPY LASER LiteCure LLC WARNING DO NOT use Hand Piece without Hand Piece Head or inadequately secured Hand Piece Head on the Hand Piece Handle Doing so may cause serious and or irreversible injury 3 3 12 Exchange Hand Piece Head The Hand Piece Head is changeable WARNING ALWAYS P
3. Coat Length Skin Color and Coat Color of the animal you wish to treat smartcoat Select Patient Characteristics Body Type Coat Length Coat Color Skin Color Thin Short Light Light Average Medium Medium Medium Overweight Long Dark Dark After choosing the Body Type Coat Length Skin Color and Coat Color of the animal the button is red highlighted Click ca button to enter Select Condition to Treat Screen 4 2 3 Select Condition to Treat Choose the condition of the animal you wish to treat Q Select Condition to Treat o Acupuncture Wound E Arthritis Pain Trauma Edema Swelling Post Surgical Incision Lick Granuloma Additional Conditions Nex A3 After Te the condition of the animal the button is red highlighted Click button to enter Operation Screen 4 2 4 Operation Screen Protocols NOTE ONLY Power Setting can be selected by customer on Operation Screen Protocols Page 15 COMPANION THERAPY LASER LiteCure LLC O Operation uy 9 1 of 1 Treatment Areas E Eis S Z Time Time Remaining Sa 12W Pulsed Rate Hz STANDBY Power VV On the Operation ERR p button or press the scale on the scale meter Alb aA S 10 W D 12W to set laser output power you desired When button is pressed the unit sounds 6 beeps 6 seconds delay and the STANDBY button correspondingly
4. the area of the laser beam to alert those present ALWAYS place Laser in Use signs at location entrances where people will use the COMPANION laser device ALWAYS Turn the device OFF before relocating lifting or moving this equipment 3 3 1 Select a secure properly equipped and well ventilated location in which to install and operate the laser device 3 3 2 Ensure that the surface on which the device is placed will properly support the entire device 3 3 3 Place within 6 feet of an available 100 240Vac electrical outlet 3 3 4 Ensure adequate airflow around the device The laser device is air cooled and designed for use in a well ventilated environment 3 3 4 1 Select a flat hard surface not a surface that will inhibit airflow through the bottom of the device 3 3 4 2 There must be a minimum 4 clearance around the rear of the device 3 3 5 Locate and uncoil the AC power cord 3 3 6 Plug the Power Adaptor DC output connector to rear of the laser device Plug the power cord into the AC input on the Power Adapior 3 3 7 Plug the male end of the AC power cord into a grounded electrical outlet This should be only done last after all hardware has been attached 3 3 8 Connect the finger switch connector into finger switch jack on COMPANION THERAPY COMPACT bottom panel or connect the foot switch connector if you have into foot switch port on COMPANION THERAPY COMPACT laser rear panel Page 9 COMPANION
5. to evaporate before the laser equipment is used CAUTION Federal law USA restricts this device to sale by or on the order of a licensed practitioner NEVER allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual DO NOT leave the power switch on when not in use Prevent unauthorized and or unqualified use of the device as well as inadvertent laser emissions DO NOT allow any nonessential personnel into the treatment area during any laser procedure 4 1 Power On The initiation of the power on sequence shall be accompanied by audible alerts and then the PASSWORD screen will be displayed a g Type password 1234 Page 13 COMPANION THERAPY LASER LiteCure LLC Press the Enter Button to enter the HOME Screen as below COMPANION y smartecoat Companion Therapy COMPACT power meets convenience a P Protocols T Operation 2 Setup 4 2 Protocols Screen Press button to enter Protocols Screen as below O COMPANION Choose Animal you wish to Treat SE Feline lt 4 Previous 4 2 1 Choose Animal Choose the animal you wish to treat on the screen The animal you choose is red highlighted as below e g if Equine is chosen d COMPANION Y Choose Animal You Wish To Treat Page 14 COMPANION THERAPY LASER LiteCure LLC 4 2 2 Select Patient Characteristics Choose the Body Type
6. 00 Fax 301 847 8747 http www fda gov Laser Institute of America 12424 Research Parkway Suite 125 Orlando FL 32826 Tel 407 380 1553 Fax 407 380 5588 http www laserinstitute org 3 SYSTEM SET UP 3 1 Unpacking Using the COMPANION THERAPY COMPACT laser packing list unpack the device and its accessories from the shipping carton Check for missing parts and inspect the unit carefully for damage such as cracks dents or bent parts If items are missing or any physical damage is apparent please call LiteCure LLC at 302 709 0408 for assistance Notify the carrier if the damage appears to be the result of a shipping mishap 3 2 Usage Prerequisites RECOMMENDATION Individuals planning to use the laser system should attend laser orientation and education sessions to achieve operational proficiency Every facility or institution utilizing this device is encouraged to adopt an ongoing training and safety program Page 8 COMPANION THERAPY LASER LiteCure LLC 3 3 Setup USB Port and Ethernet Port 8 on the rear panel is for manufacturer use ONLY DO NOT use them unless without LiteCure s technician support WARNING DO NOT attempt to gain access to any internal device components THERE ARE NO USER SERVICEABLE COMPONENTS inside this laser device Doing so may cause serious and or irreversible injury CAUTION ALWAYS post Warning Signs for Class IV laser products ALWAYS post Warning Signs in
7. 12 Specifications Model Treatment Laser Wavelength Laser Power Spot Sizes Operating modes Aiming Laser Wavelength Aiming Laser Power Aiming Laser Frequency Audio Warning Signal Unit Volume Foot Finger Switch Operation Weight Dimensions Power requirement Operation temperature Storage temperature COMPANION 980 810 nm 12W Adjustable Continuous Wave CW 2Hz 10Hz 20Hz 100Hz 200Hz 500Hz 1000Hz 2500Hz 5000Hz and 10000Hz 650nm 3 54 1 0mW Off Steady Pulsed OFF CW Beep High Med Low ON OFF 7 Ibs 350mmx220mmx160mm 100 to 240VAC 50 60Hz 10 C to 35 C 20 C to 70 C Page 21 COMPAN THERAPY LASER LiteCure LLC ON Treatment Information The proper use of the Companion Therapy Compact laser requires appropriate laser safety practices and knowledge of laser tissue interaction In addition an understanding of laser wavelength frequency target tissue and anatomy are essential It is recommended that proper diagnosis and treatment plans are to be completed by or under the direct supervision of a licensed professional Veterinary Treatment Stored Protocols in the Laser Each protocol will begin with CW Continuous Wave and cycle through multiple frequencies for optimal treatment effect Depth of penetration is determined by spot size wattage and wavelength An understanding of veterinary anatomy and laser tissue interaction is imperative for safe optimal treatmen
8. COMPACT laser for out of warranty items Specially designed products damaged by the customer may not be returned Return Instructions Should you ever have to return a COMPANION THERAPY COMPACT laser product you must 1 First obtain an RMA number prior to returning goods Please contact the Company first to obtain a RMA number 2 Submit a written request or form via Mail or Fax After submitting the form a Returns Department representative will contact you within 24 hours You may be asked for additional information regarding your return 3 Attach all forms and any test results data you have to the items you are returning 4 Package the items according to the Packaging Instructions 5 Write the RMA Number on the outside of the box or include it on the shipping label IMPORTANT Without an RMA number on the outside of the box it my be returned to you without processing 6 Label and ship to LiteCure LLC 250 Corporate Blvd Suite B Newark DE 19702 Phone 302 709 0408 Fax 302 709 0409 Packaging Instructions 1 Pack the items you are returning in the original packaging material If the original packaging material is not available please follow these guidelines Insert or wrap and protect all ESD sensitive components separately in either static dissipative or static shielded packaging or materials 2 Wrap each item separately Fragile components need adequate cushioning from each other and the sides of the box 3 Use enou
9. COMPANION THERAPY LASER LiteCure LLC COMPANION THERAPY COMPACT USER MANUAL CTC 12 250 Corporate Blvd Suite B Newark DE 19702 USA Tel 302 709 0408 Fax 302 709 0409 w companiontherapylaser com LBLO00045A USER MANUAL CTC 12 DCN O COMPANION THERAPY LASER LiteCure LLC Table of Contents 1 INTRODUGTION nnn nnn enter teen one ree ren ee eee eee ee eee 2 1 1 R le DSS let Le 2 1 2 SAS Te EE 2 1 3 FP ROTOGHV GY CWC EE 3 1 4 PUP SOON E IGN EE 3 2 ARETY aticeteasanestacmeteneoeneseescateaaceotec aaseeseeranaceianataeteaseesadeseaaeeedaeteseqescanseceasescaeesears aceasaaeeenenateciuaeaeeaeuaedes 3 2 1 TS a E 3 2 2 Be Ee EE 3 2 3 AA d e EE 3 2 4 Beuren EE 4 2 5 Laser Salely Lab ls and SYMONS EE 5 2 6 Daley Device F Co WINGS asero er eree E E 6 2 7 LaSer EYS FOI CHO aces tricuisaecccenresenciavni nto E O 8 2 8 Sources for Additional Information and Assistance on Laser Safety cccceeceseeeeeeeeeeeeeeeeeeees 8 ON E TUP E 8 3 1 WED CICA Me T E A E E E N A A E E satg a eo taeh E EET 8 3 2 BE et 8 3 3 FS UD siete on re sens gente nei A T EEEE A AIEEE S E E E E E E anees 9 A OPERATION EE 13 4 1 POWO EE 13 4 2 POLCON SOFC E 14 Bhs KIO OSS ug a E sodea tenuate anehan shee uese aa oaschpacsseiaeesh cece tutte vausentdeaest 14 422 SOClCE Patent Ee e 15 A235 SCICCE CONGITION 10 THAN ees erae es r Er E Ea ESEN Ea E S ESTERE ER 15 4 24 Operation RR de ee EE 15 4 3 Operation Screen
10. F SYSTEM CONTROLS or performance of procedures other than those specified in this manual may result in hazardous radiation exposure e 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 e NEVER direct the laser beam at anything other than the area being treated Page 3 COMPANION THERAPY LASER LiteCure LLC NEVER allow the eyes of any living being to look directly into the distal end of a hand piece that is connected to an active laser device WITH or WITHOUT wearing appropriate laser emission protective eyewear DO NOT allow any reflective object to fall into or obstruct the path of the laser energy produced by this device Scattered or reflected laser energy can cause serious damage to eyes and skin The operator all assistants and the patient must remove all reflective objects Such as rings metal watchbands collars tags leashes and jewelry prior to treatment with this device THERE ARE NO USER SERVICEABLE COMPONENTS inside this laser device Therefore do not attempt to gain access to any internal device component Doing so may cause serious and or irreversible injury DO NOT remove protective eyewear until the operator returns the laser device to Standby mode To do this the operator release the foot finger switch touches the Ready screen button on the display panel and visually observes the las
11. No Protocol EE 17 4 4 EE 18 Bin MaM ee 20 5 1 Maintenance and Cali ANON cisrtetrcccsmnnsasrsersssinncanecitaiesininnea ENEE EEEa Eda AEA a CE SEEE 20 See eru el 21 Treatment Information 22 Laser Cleaning Guide Eoupment Care 25 Page 1 COMPANION THERAPY LASER LiteCure LLC 1 INTRODUCTION The COMPANION THEARPY COMPACT laser Model Number CTC 12 is classified as a Class IV laser device There are a variety of therapeutic applications The maximum output power is 12W This laser device is sold solely for VETERINARY INDUSTRIAL OR SCIENTIFIC purposes only Under NO circumstances should this laser system be employed as a medical device for human use LiECURE E ere Companion Therapy COMPACT COMPANIA 1 1 Device Description The laser source of this device is a solid state system It produces near infrared laser energy at 980nm and 810nm wavelengths The delivery system consists of a flexible optical fiber threaded through a lightweight hand piece Activation occurs when the operator enables the laser by pressing the foot finger switch Releasing the foot finger switch will deactivate the laser Depending on laser system configuration the foot finger switch can function as on off switch A convenient and easy to use touch screen display panel allows the operator to adjust or set laser output level with minimal effort The laser can operate in continuous wave mode or controlled pulse mode 1 2 Usage P
12. aser beam or its reflection operators should wear laser safety goggles provide by LiteCure Additional goggles can be purchased from LiteCure 302 709 0408 Page 24 COMPANION THERAPY LASER LiteCure LLC Laser Cleaning Guide Equipment Care Assembly and Disassembly lt is recommended that the laser remain assembled and ready for use If this is not appropriate make sure the laser aperture is never left open The fiber or protective plug should always be in place to ensure no dust dirt hair or dander enters the optical fiber socket General Cleaning A Warning Always turn off the system and unplug the power cord from the wall outlet before cleaning A Warning Always use protective eyewear and gloves when cleaning and disinfecting any equipment e Laser The outer casing can be wiped with dry soft cloth e Fiber Handling and Care The maximum permissible bending radius of optical fiber is 5 cm Short term during use Radius 5 cm Page 25 COMPANION THERAPY LASER LiteCure LLC COMPANION THERAPY COMPACT LASER Returns A Return Material Authorization number RMA is required for any returned goods Original purchase order number date of shipment and serial number must be provided before the RMA number can be issued All returns should be shipped with the original packaging materials with the assigned RMA number s clearly marked A cost estimate will be provided by COMPANION THERAPY
13. e User Manual 2 Use the device as required When done using the device power off in accordance with the User Manual and leave the hand piece connected Bending Limits of the Hand Piece Cable The radiation transferred within the hand piece cable goes through a very small diameter glass rod an optical fiber It can be damaged if bent too sharply The maximum permissible bending radius of optical fiber is 5 cm Laser Hand Piece Troubleshooting If the any part of the hand piece assembly is overheating or producing smoke then immediately power off device and discontinue operation And then call LiteCure LLC at 302 709 0408 immediately for assistance Page 12 COMPANION THERAPY LASER LiteCure LLC 4 OPERATION WARNING DO NOT use the System Controls or perform procedures other than those specified in this manual Failure to comply 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 AVOID THE USE of flammable solvents anesthetics oxidizing gases such as nitrous oxide N2O and oxygen or endogenous gases The high temperatures produced in normal use of the laser equipment may ignite some material for example cotton or wool when saturated with oxygen The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed
14. er device returning to Standby AVOID THE USE of flammable anesthetics or oxidizing gases such as nitrous oxide N2O and oxygen The high temperatures produced in normal use of the laser equipment may ignite some material for example cotton or wool when saturated with oxygen Solvents adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used 2 4 Precautions Please read and adhere to the following precautions Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual This laser device produces 980 and 810 nanometer near infrared laser energy that is invisible and can be an extreme hazard to the eyes of any living being Irreparable corneal and or retinal damage many occur if a person exposes one or both eyes to direct of indirect reflected laser energy The protective eyewear supplied with this device has an optical density rating gt 5 at 980nm and 810nm and meets ANSI 2136 1 and 2136 3 All personnel present during device operation must wear protective eyewear If needed Contact the LiteCure LLC at 302 709 0408 to purchase additional sets of protective eyewear DO NOT remove protective eyewear until the operator returns the laser device to Standby mode To do this the operator releases the foot finger switch touches the Ready screen button on the display panel and visually observes t
15. et by the user then the laser emission will be terminated The laser system will automatically shut off wnen the emission output is out of the range of 20 of set value The touch screen will display an error message To reset the device the user is required to press the EXIT B Sr P the touch screen when this error warning message is displayed Operation Errors 1 The device shall not leave STANDBY mode and enter READY mode and error message shall show if any of the following conditions occur e Optical fiber is not properly inserted e Safety interlock is not properly installed e Foot Finger Switch is depressed Page COMPANION THERAPY LASER LiteCure LLC 2 Also the device shall not keep in READY mode or EMISSION mode and error message shall show if any of the following conditions occur e Optical fiber is not properly inserted e Safety interlock is not properly installed 2 Laser Eye Protection The protective laser eyewear supplied with this device has an optical density rating gt 5 0 for 980 and 810nm laser emission All personnel present during device operation must wear this eyewear Contact LiteCure LLC at 302 709 0408 to purchase additional sets of protective eyewear 2 8 Sources for Additional Information and Assistance on Laser Safety Center for Devices and Radiological Health Office of Compliance 10903 New Hampshire Avenue Bldg 51 Rm 5271 Silver Spring MD 20993 0002 Phone 301 796 31
16. flashes to indicate that the laser is entering the Ready mode When the beeping stops and the READY button is solid yellow the laser is ready for emission Also when the beeping stops the aiming beam is activated if Aiming Beam setting is not Off in Setup Screen and allows the operator to aim the red light onto the treatment site in preparation for the treatment The device does not leave Standby mode to enter Ready mode and error message will show on the screen if any of the following conditions occur e Optical fiber is not properly inserted e Remote interlock is not properly installed e Foot finger switch is depressed The aiming beam can be shut off by pressing either the button or READY button to exit Ready mode In Ready mode when ON the foot finger switch the device enters Emission mode The laser emission indicator flashes during laser emission Page 16 COMPANION THERAPY LASER LiteCure LLC 4 3 Operation Screen No Protocol NOTE ONLY Power Setting Time Setting Pulsed Rate Setting and Reset Joules can be selected by customer on Operation Screen No Protocol cos Press Wiki button on the HOME SCREEN to enter Operation Screen as below Operation 6W ln aes ewer CLA ko gef n Za a ste Time Remaining Se A9 STANDBY Power VV On the Operation eect oo button or press the scale on the scale meter aw AUT BW zw LA D s IZ Nu set laser output power
17. gh cushioning material inside the box and around each item to ensure that the contents cannot move when you shake the box Note Fiber Cables Do not bend the fiber less than the minimum allowable fiber bend radius 4 Use adequate protection when covering sensitive fiber tips or optical components Page 26 COMPANION THERAPY LASER LiteCure LLC 5 Use a double box method for shipping all fragile electronic optical components and equipment Important The warranty may be considered void if the items received by the company are not packaged in a manner that complies with the Packaging Instructions Cancellation Fees Should it become necessary to cancel or modify orders prior to shipment a restocking fee of 15 to 50 of the total order amount will be charged by COMPANION THERAPY COMPACT laser for returns to stock Page 27
18. he laser device returning to Standby Select a secure properly equipped and well ventilated location in which to install and operate the laser Place Laser in Use signs at location entrances where people will use the laser device Always put the laser in Standby mode or switch the device off prior to connecting or disconnecting the hand piece Never leave this device in the READY mode unattended Turn the device off before moving lifting or relocating the laser device Never press the foot finger switch button without first verifying the safe orientation and proper positioning of the hand piece and ensuring compliance with all safety precautions During any laser procedure do not allow any nonessential personnel into the treatment area If the laser fails to operate properly contact the LiteCure LLC immediately at 302 709 0408 Page 4 COMPANION THERAPY LASER LiteCure LLC 2 5 Laser Safety Labels and Symbols The following labels appear on the laser device Manufacturer s General Identification Label See Figure Located on the bottom of the device The label displays the manufacturer model number serial number and date of manufacture This label also contains various regulatory compliance declarations SUP dyed a TS E AAA ALATE nD EE OA Bs DROS TO eT oe ECATIFHE D BAT A Gii Weng Va 08 teen jae deen Fuis ca CW CLASS IV LASER PRODUCT Manulactured Ery LiteGure LLG 290 Corporte B
19. lvd Surte B Newark DE 19702 Model Mic meral N Mig Dati Carpe Wain HOA P 10 General Safety Declaration Label See Figure Located on the rear of the device and warns of the radiation exposure hazard potential to eyes and skin N DANGER Laser radiation when open AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION Optical Fiber Applicator Symbol See Figure Located close to the emission port on the bottom of the device this symbol indicates that the laser energy emission occurs at the distal end of a properly connected hand piece Warranty Seal Symbol See Figure Located on the bottom of the laser device in such a way that any attempt to open the panels of this device will break this seal WARRANTY VOID IF SEAL IS BROKEN Remote Interlock Connector Symbol See Figure Located on the rear of the laser device this symbol indicates the place of remote interlock connector Page 5 COMPANION THERAPY LASER LiteCure LLC 2 6 Safety Device Features The device has specific safety related features All individuals who use this laser device should be familiar with the purpose and the operation of these features Emergency Power Off Switch This switch is located on the front panel of the COMPANION LASER Pushing the switch down terminates laser emission To reset the Emergency Power Off Switch the user must turn off the Power Switch on the rear panel and turn on again Power Switch
20. ments necessary to reduce swelling Page 23 COMPANION THERAPY LASER LiteCure LLC e Carcinomas Melanomas and Sarcoids Do not use laser over any known primary or secondary lesions Laser application to horses with Melanomas and Sarcoids should only occur under the supervision of a veterinarian e Pregnancy Laser therapy is contraindicated for use over the pregnant uterus Do not apply laser light to the pregnant animal e Treatment Over Sympathetic Ganglia the Vagus Nerves amp Cardiac Region In Animals With Heart Disease Laser therapy may significantly alter neural function and is therefore contraindicated over these regions in horses with heart disease Eye Protection Protective eyewear is necessary for both Class Ill and Class IV lasers The Companion Therapy Compact laser emits visible and Infrared which is invisible radiation and it is imperative that the supplied eye protect IS worn Safety Warnings It is safe to operate the laser only when the users follow all suggested safety measures Post clearly visible warnings in the area where the laser beam passes to alert those present Keep all unauthorized personnel out of the area where the laser is operated Maintain the laser in Standby mode or OFF when not in use Never look directly into the laser beam path or scattered laser light from any reflective surfaces Never look directly into the laser source As a precaution against accidental exposures to the l
21. ower Off in the device accordance with the User Manual before changing Hand Piece Head Remove Hand Piece Head from Hand Piece Handle and DO NOT touch the distal of the Hand Piece Handle Securely tighten the new Hand Piece Head to Hand Piece Handle Page 11 COMPAN THERAPY LASER LiteCure LLC ON WARNING DO NOT use Hand Piece without Hand Piece Head or inadequately secured Hand Piece Head on the Hand Piece Handle Doing so may cause serious and or irreversible injury WARNING Wear Laser Safety Eyewear provided with the laser before operating the laser device CAUTION Please do not remove the hand piece fiber from the emission port once it has been secured unless the device is being packaged or transported to another location Constant insertion and removal of the hand piece fiber before and after every procedure will increase the chance of emission port and fiber tip contamination If the emission port or the fiber tip is contaminated then the device might be damaged during laser beam output emission The dust cap is installed by the manufacturer as a means to prevent dust and debris from contaminating the emission port during shipping and before device installation and is not intended as the primary means to protect the emission port connector during normal use We recommend the following procedure 1 Before using the device for the first time install and secure the hand piece fiber in accordance with th
22. r penetration CW output followed by lower frequencies high fluence for pain CW output followed by lower frequencies moderate fluence for biostimulation CW output followed by higher frequencies inflammation and edema Laser Therapy Treatment Techniques Treat area from proximal to distal Treat biomechanical connected muscles and joints in the kinematics chain Post Operative or acute injuries use shorter times and or lower power Some injuries respond to a graduated treatment from deep to superficial Begin with Continuous Wave and move through appropriate frequency Page 22 COMPANION THERAPY LASER LiteCure LLC Contact Technique e Treatments can be done on contact or at a slight distance from the skin 1 2 inch Monitor for superficial thermal discomfort Change in tissue consistency can be felt during steady pressure Move probe in grid pattern 3 seconds per point perpendicular to joint capsule Treat 1 2 inches of surrounding healthy tissue Most patients will show at least a mild positive response in 1 2 treatments 4 20 joules at the surface per point Treatment Plans The effects of laser therapy are cumulative A suggested treatment would include initial treatment and ongoing maintenance treatments as needed Patients may show signs of improvement within the first 2 treatments but long term benefits result from a complete treatment protocol Treatment Schedule for Chronic Conditions 6 total treatmen
23. rerequisites RECOMMENDATION Every facility or institution utilizing this device is Individuals planning to use the COMPANION encouraged to adopt an ongoing Training and THERAPY COMPACT laser are actively Safety Program Such programs are outlined in the encouraged to attend laser orientation and latest revision of the ANSI Standard Z136 3 for the education sessions to achieve progressive Safe Use of the Lasers in Health Care facilities as levels of operational proficiency well as in standard training sections of Curriculum Guidelines Page 2 COMPANION THERAPY LASER LiteCure LLC 1 3 Protective Eyewear All Individuals present during the operation of this CAUTION device must wear protective eyewear with an optical density of 5 0 or greater at 980nm and 810nm wavelengths DO NOT remove protective eyewear until the operator returns the laser device to Standby mode To do this the operator must release Protective glasses are included with the original the foot finger switch touch the Ready purchase of this device screen button on the display panel and 8 visually observes the laser device returning For additional pairs of protective eyewear contact the to Standby LiteCure LLC at 302 709 0408 1 4 Air Cooled Design The laser device is air cooled and designed for use in indoor and outdoor environments CAUTION Place Laser Warning Sign at location entrance where people will use the COMPANION Therap
24. ts Week 1 Monday Wednesday amp Friday Week 2 Tuesday amp Friday Week 3 Single treatment 1 week after last treatment Week 5 or 6 Office Visit Re Check Treatment if needed Maintenance treatment when needed Treatment Schedule for Acute Injuries 6 total treatments Two treatments per week for 3 weeks or with injury re check or bandage change Treatment Conitraindications Contraindications for Laser Therapy are based upon prudence as opposed to experimental or clinical data The following contraindications are presented as a precaution for safe and effective treatment Laser Therapy should not be administered in the following situations e Hemorrhaging Do not apply laser light to any actively hemorrhaging lesion e Eyes Direct Irradiation of the Eyes Lasers are potentially harmful to the retina of the eye Never shine laser light into the eye at any time even while wearing safety goggles The technician administering laser therapy and all individuals including those holding the animal should wear safety goggles at all times e Testicles Do not apply laser light to the testicles of the animal e Corticosteroids Do not apply laser light to any area recently injected with corticosteroids e Photosensitive Medications Do not apply laser light to any animal currently receiving photosensitive medications e Epiphysitis When applying laser light to epiphysitis use a low dose initially and use only those treat
25. ts Small Animal preset wattage is set for patients ranging from 40 60 Ibs Larger patients may need the protocol repeated medial lateral or an increase in power to 10W for treatment of lager areas Once complete the operator may reactivate the laser and repeat a protocol by pressing the finger switch To maximize this feature consider bi lateral treatment of the target area before moving to different target area i e R amp L Hip before Back Preparation of Patient for Laser Therapy Treatment The area to be treated must be exposed The treatment area should be clean and free of surface dirt or oils Use rubbing alcohol to clean all instrument surfaces in contact with the patient CAUTION Assure alcohol on the instrument has fully evaporated before activating the laser Thermal effects vary with hair coat and pigmentation darker pigments absorb more If there is a withdrawal response increase distance and or move the handpiece more rapidly and or reduce power Spraying water on a dark hair coat is recommended You can also part the hair with your hands or clip Laser Therapy Treatment Considerations Treatments can be done in conjunction with stretching or Range Of Motion Monitor for superficial thermal discomfort Keep beam perpendicular to muscle fibers Keep beam parallel to joint surfaces Treat muscles connecting to a painful joint in addition to tendon attachments Higher energy densities are required for deepe
26. volume and finger switch override settings See Aiming Beam i Setup A Finger Switch REC Detault i English A Metric z Press Q button to exit the Setup Screen n Wem Aiming Beam SR Press button on Setup Screen to enter Aiming Beam Setup Screen as below Page 18 COMPANION THERAPY LASER LiteCure LLC See Aiming Beam Steady 5 nn nn nn Pylced Off button on Setup Screen to enter Unit Volume Setup Screen as below e Unit Volume l wem Tone High Med Low u n eee Beep Setup High Med Low Off etau Press Ss 8 button on Setup Screen to enter Foot Finger Switch Setup Screen as below Attention Finger Switch Override On should only be used by a qualified Off _ laser technician i Beam block should be used on the hand piece to avoid danger Page 19 COMPANION THERAPY LASER LiteCure LLC 5 Maintenance 5 1 Maintenance and Calibration This laser device is designed for maintenance free operation with normal use No maintenance and calibration operations are required by the end user The maintenance and calibration can only be made by the manufacturer The manufacturer recommends one calibration for each calendar year of use For detailed maintenance and calibration information contacts the manufacturer Page 20 COMPANION THERAPY LASER LiteCure LLC COMPANION THERAPY COMPACT LASER CTC
27. y Laser device 2 SAFETY This section provides a collection of safety guidelines and safety related statements relevant to the safe and effective operation of the laser Additional statements and protocols regarding safety appear elsewhere in this document Use this laser device according to all printed guidelines cautionary statements and protocols 2 1 Guidelines Operator s information is in compliance with section 1040 10 of Title 21 of the code of Federal Regulations Chapter1 Subchapter J of Health and Human Services Food and drug Administration and center for the devices and Radiological Health 2 2 Laser Safety Supervision Designate at least one person at each facility that utilizes this device as Laser Safety Supervisor responsible for providing training on all operating safety procedures 2 3 Warnings Please read and adhere to the following warnings Note If laser fails to operate properly contact the LiteCure LLC immediately at 302 709 0408 e This laser device is sold solely for VETERINARY INDUSTRIAL OR SCIENTIFIC purposes only Under NO circumstances should this laser system be employed as a medical device for human use e This laser device produces 980nm and 810nm laser energy that is invisible and can be an extreme hazard to the eyes of any living being Irreparable corneal and or retinal damage may occur if a person exposes one or both eyes to direct or indirect reflected laser energy e IMPROPER USE O
28. you desired 10 W Time On the Operation Screen press button to set laser treatment time you desired Pulsed Rate Hz On the Operation Screen press button to set laser treatment time you desired When button is pressed the unit sounds 6 beeps 6 seconds delay and the STANDBY button correspondingly flashes to indicate that the laser is entering the Ready mode When the beeping stops and the READY button is solid yellow the laser is ready for emission Also when the beeping stops the aiming beam is activated if Aiming Beam setting is not Off in Setup Screen and allows the operator to aim the red light onto the treatment site in preparation for the treatment Page 17 COMPANION THERAPY LASER LiteCure LLC The device does not leave Standby mode to enter Ready mode and error message will show on the screen if any of the following conditions occur e Optical fiber is not properly inserted e Remote interlock is not properly installed e Foot finger switch is depressed The aiming beam can be shut off by pressing either the button or READY button to exit Ready mode In Ready mode when ON the foot finger switch the device enters Emission mode The laser emission indicator flashes during laser emission 4 4 Setup C Setup Press KS button on the HOME SCREEN to enter Setup Screen as below which can be AN Unit Volume femme Wem Aiming Beam used to change aiming beam flash frequency 8 unit
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