CTX-15. User Manual. Companion Therapy Laser. with Empower Delivery System, Perfect Protocol Smart Coat Plus Technology & Patient Tracker

Transcription

1 User Manual CTX-15 Companion Therapy Laser with Empower Delivery System, Perfect Protocol Smart Coat Plus Technology & Patient Tracker Companion Animal Health 250 Corporate Blvd, Suite B Newark, DE Phone Toll Free Fax

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3 >> Table of Contents 1 >> Conventions Used PAGE Warning Caution Recommendation Note 5 2 >> Introduction PAGE Device Description Usage Prerequisites Protective Eyewear Air Cooled Design 7 3 >> Safety PAGE Laser Safety Supervision Warnings and Cautions Safety Device Features Laser Eye Protection Sources for Additional Information and 13 Assistance on Laser Safety 4 >> Glossary and Abbreviations PAGE 14 5 >> Features PAGE 15 6 >> System Set-Up PAGE Receipt and Unpacking Laser Safety Training Set-Up/ Location Optical Fiber Connections 18 7 >> Empower Delivery System PAGE Preparation of Patient for Laser Therapy Treatment Empower Delivery System Descriptions 20 8 >> Operation PAGE Fiber Installation Laser Safety Eyewear Power On Set Up Protocol Selection, SmartCoat Plus Technology Unit Operation (Protocols) Unit Operation (Manual) Standby Mode 28 page >> 3

4 8.9 Ready Mode Emission Mode Perfect Protocol Resources Max TX Patient Tracker 32 9 >> Accessories PAGE Finger Switch Foot Switch Medical Grade Power Cord Laser Safety Eyewear >> Specifications PAGE >> Cleaning PAGE >> Maintenance and Calibration PAGE >> Treatment Information PAGE >> Sources for Additional Information PAGE 39 and Assistance on Laser Safety 15 >> Warranty Information PAGE Return Procedure Packaging Instructions Cancellation Fees Standard Warranty Plan Extended Warranty Plan >> Appendix, Labels PAGE Warning Label Manufacturer s Label Non Interlocked Protective Housing Label Warranty Seal Optical Fiber Applicator Label Laser Emission Label Emergency Laser Off Label Finger/ Foot Switch Label Remote Interlock Connector Label Fuse Label ETL Mark Label AC Power Input Label Protective Earth (Ground) Label (Inside Device) Power Switch Label 45 page >> 4

5 1>> Conventions Used Various Warnings, Cautions, Recommendations and Notes are presented throughout this document. Explanations and examples of each follow. 1.1 Warning Calls the reader s attention to a specific or potential danger in advance. If ignored or compromised, the situation could result in the possibility of injury, death or other serious adverse reaction associated with the use or misuse of the device. WARNING! DO NOT direct the laser beam at anything other than the area to be treated. 1.2 Caution Alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property. CAUTION DO NOT allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual. 1.3 Recommendation Offers guidance that may be worthy of acceptance or trial within a specific area of CTX-15 application and may serve to optimize overall utilization. RECOMMENDATION Designate at least one person at each facility that utilizes this device as laser safety supervisor, responsible for providing training on all operating and safety procedures. 1.4 Note Describes the conditions or exceptions that may apply to the subject matter presented. NOTE The optical fiber must be properly inserted and secured into the laser emission port before the device s operational mode can change from standby to ready. page >> 5

6 2>> Introduction The Companion Therapy Laser, CTX-15, is classified as a Class IV laser device. There are a variety of therapeutic applications. The maximum output power is 15W. This laser device is sold solely for VETERINARY, INDUSTRIAL, OR SCIENTIFIC purposes! Under NO circumstances should this laser system be employed as a medical device for human use. 2.1 Device Description The laser source of this device is a solid-state diode. 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. 2.2 Usage Prerequisites Every facility or institution utilizing this device is encouraged to adopt an ongoing Training and Safety Program. Such programs are outlined in the latest revision of the ANSI Standard Z136.3 for the Safe Use of the Lasers in Health Care facilities, as well as in standard training sections of Curriculum Guidelines. RECOMMENDATION Individuals planning to use the Companion Therapy Laser are actively encouraged to attend laser orientation and education sessions to achieve progressive levels of operational proficiency. 2.3 Protective Eyewear All Individuals present during the operation of this device must wear protective eyewear with an optical density of 5.0 or greater at 980nm and 810nm wavelengths. Protective glasses are included with the original purchase of this device. For additional pairs of protective eyewear, contact LiteCure at or for US and Canada. Caution DO NOT remove protective eyewear until the operator returns the laser device to Standby mode. To do this, the operator must release the foot/finger switch, touch the Ready screen button on the display panel, and visually observes the laser device returning to Standby. page >> 6

7 2.4 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 Therapy Laser device. page >> 7

8 3>> 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. 3.1 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. 3.2 Warnings and Cautions Please read and adhere to the following warnings. Note: If laser fails to operate properly, contact LiteCure immediately at or for US and Canada Warning Use carefully. Never allow untrained personnel to operate this device unless directly supervised by a properly trained and experienced individual. Warning NEVER look directly into the distal end of the optical fiber connected to an active laser device, NEVER aim the laser light directly into the eyes, and NEVER direct the laser beam at anything other than the area to be treated WITH or WITHOUT the appropriate laser-emission protective eyewear. Indirect or direct eye contact with the output beam or scattered laser light from any reflective surfaces will cause serious damage, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. Warning DO NOT allow any reflective objects to fall into or obstruct the path of the laser energy produced by this device. The operator, all assistants, and the patient must remove all reflective objects (such as rings, metal watchbands, and jewelry) prior to treatment with this device. Indirect or direct eye contact with the output beam or scattered laser light from any reflective surface will cause serious, irreparable corneal and/or retinal damage, and possible blindness to one or both eyes. Warning DO NOT remove protective eyewear until the operator returns the laser device to Standby mode. To do this, the operator should press and release the foot/finger switch, touch the Ready screen button on the display panel, and will visually observe the laser device returning to Standby. page >> 8

9 Warning DO NOT use the system controls or performance of procedures other than those specified in this manual. Doing so may result in hazardous radiation exposure. Warning DO NOT attempt to gain access to any internal component. THERE ARE NO USER-SERVICEABLE COMPONENTS inside this laser device. Doing so may cause serious and/or irreversible injury. Warning AVOID THE USE of flammable solvents, anesthetics, oxidizing gases such as nitrous oxide (N 2 O) and oxygen (O 2 ), or endogenous gases. The high temperatures produced during normal use of the laser equipment may ignite some material, such as cotton or wool, when saturated with oxygen. The solvents of adhesives and flammable solutions used for cleaning and disinfecting should be allowed to evaporate before the laser equipment is used. Warning 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. Warning This laser device is sold solely for VETERINARY, INDUSTRIAL, OR SCIENTIFIC purposes! Under NO circumstances should this laser system be employed as a medical device for human use! Warning Treatment head should not be held in place on patient without movement during laser emission. Warning The flat lens on non-contact treatment heads should not be allowed to come in direct contact with the hair coat, feathers, whiskers, etc., and should be held 1-2 inches from skin of patient. page >> 9

10 Caution The protective eyewear supplied with this device has an optical density rating >5 at 980nm and 810nm and meets ANSI Z136.1 and Z136.3 (see specification sheet) standards. All personnel and patients present during device operation must wear this eyewear. Contact LiteCure at or for US and Canada to purchase additional sets of protective eyewear for this device. Caution Select a secure, properly equipped, and well-ventilated location in which to install and operate the laser. Caution ALWAYS place Laser In Use signs at location entrances where people will use the laser. Caution ALWAYS Turn the device off before lifting, moving or relocating the device. Caution DO NOT press the finger/foot switch without first verifying the safe orientation and proper positioning of the hand piece and distal end of the optical fiber and ensuring compliance to all safety precautions. Caution DO NOT allow any nonessential personnel into the treatment area during any laser procedure. Caution ALWAYS put the laser in Standby mode or turn the device OFF prior to adjusting or connecting/ disconnecting the hand piece or fiber optic. Caution NEVER leave this device in the Ready mode unattended. See pages 28 and 29. If the laser fails to operate properly, contact LiteCure at or for US and Canada. page >> 10

11 3.3 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 of the CTX-15. Pushing the switch down terminates all electrical power to the laser device s microprocessor and laser-emitting components. To reset the Emergency Power Off Switch, the user must re-start the laser device. Power Switch This switch is located on the bottom, right front panel of the CTX-15. A password is required to activate the laser system. The operator enters the password when the password entry screen appears. To power the CTX off slide the button on the home screen to the right, for off. Laser Emission Port This port is located on the bottom of the device. The laser can not emit without the fiber attached. A metal emission port cap which is permanently attached to the unit can be secured on the emission port when fiber is not connected. Optical Port Finger Switch Port page >> 11

12 Remote Interlock This device is equipped with a remote interlock located on the back 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. See section 8.2. System Power On/Off Visual Indicator Located on the front bottom of the laser device, the LCD panel is illuminated continuously whenever the user activates the laser device and the emergency power off switch is disabled. A green LED located below the LCD panel will illuminate when system power is on. Laser-Emission Indicator The laser emission indicator is located on the LCD display during the emission mode. EMISSION 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 set by the user then the laser emission will be terminated. The laser device will automatically shut off when 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 button on 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: Optical fiber is not properly inserted Remote interlock is not properly installed Foot/finger switch is depressed 2. Also, the device shall not remain in READY mode or EMISSION mode and error message shall show if any of the following conditions occur: Optical fiber is not properly inserted Remote interlock is not properly installed page >> 12

13 3.4 Laser Eye Protection The protective laser eyewear supplied with this device has an optical density rating > 5.0 for 980nm and 810nm laser emission. All personnel and patients present during device operation must wear this eyewear. Contact LiteCure at or for US and Canada to purchase additional sets of protective eyewear. 3.5 Sources for Additional Information and Assistance on Laser Safety Center for Devices and Radiological Health Office of Compliance 2098 Gaither Rd. Rockville, MD Tel: Fax: Laser Institute of America Research Parkway, Suite 125 Orlando, FL Tel: Fax: page >> 13

14 4>> Glossary and Abbreviations Term CW, Continuous Emission, or Continuous Mode Pulse, Pulse Emission or Pulsed Mode Duty Cycle Frequency Hertz Remote Interlock Joule Watt Stop Definition Continuous laser emission Pulsed laser emission (pulsed mode) Pulse ON Time/ (Pulse ON Time + Pulse OFF Time) Laser pulse repitition rate Measuring unit for frequency (pulses per second) Safety device that stops laser radiation when the Remote Interlock Circuit is opened Unit of measure for emitted energy Unit of measure for power End of treatment or treatment break Abbreviation cm 2 Hz S W J nm V IR NOHD Definition Square Centimeter Hertz Second Watt Joule Nanometer Volt Infrared Nominal Ocular Hazard Distance According to EN page >> 14

15 5>> Features >> Front View Touch Screen Interface Emergency Power Off Switch Display LED Indicator >> Bottom View Warranty Seal Label Optical Port Finger Switch Port page >> 15

16 >> Back View USB Port Remote Interlock Receptacle Laser Emission Label Foot Switch Receptacle DC Power Cord Receptacle page >> 16

17 6>> System Set-Up 6.1 Receipt and Unpacking WARRANTY VOID IF SEAL IS BROKEN Using the CTX-15 packing list, unpack the CTX-15 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 contact LiteCure at or for US and Canada for assistance. Notify the carrier if the damage appears to be the result of a shipping mishap. If Warranty Seal Label is not found on device or is broken, please do not operate this device and contact LiteCure at or for US and Canada immediately for assistance. 6.2 Laser Safety Training 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. Undergoing installation training by a manufacturer s representative. 6.3 Set-Up/ Location 1. Select a secure, properly equipped, and well-ventilated location in which to install and operate the laser device. 2. Ensure that the surface will properly support the entire device. 3. Place the device within 6 feet of an available V electrical outlet. 4. Ensure adequate airflow around the device. The laser device is air-cooled and designed for use in a well-ventilated environment. a. Select a flat hard surface (not a surface that will inhibit airflow through the bottom of the device). b. There must be a minimum 4 clearance around the rear of the device. 5. Locate and uncoil the AC power cord. 6. Plug the power cord into the DC input on the rear of the laser device. Plugging the device in should only be done last, after all hardware has been attached. 7. Plug the male end of the AC power cord into a grounded electrical outlet. 8. Connect the finger/foot switch to the rear of the CTX-15 laser device. page >> 17

18 6.4 Optical Fiber Connection Caution If the optical port or the fiber tip is contaminated, then the device might be damaged during laser beam emission. 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. Repeated insertion and removal of the hand piece fiber before and after every procedure will increase the chance of emission port and fiber tip contamination. Your fiber may ship already connected. 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. Fiber Connection Procedure 1. Remove protective cap from optical port on rear of unit 2. Remove the hand piece and optical fiber from the protective foam packaging 3. Remove protective cap from the end of the fiber optic cable 4. Carefully insert end of fiber optic cable into optical port 5. Thread connector onto optical port until tight page >> 18

19 CAUTION 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. Repeated 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 beam 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 the User Manual. 2. Use the device as required. 3. When done using the device, power off in accordance with the User Manual and leave the hand piece connected. page >> 19

20 7>> Empower Delivery System 7.1 Preparation of Patient for Laser Therapy Treatment 1. The area to be treated must be exposed. (Do not treat through bandage material) 2. The treatment area should be clean and free of surface dirt or oils. Any topical sprays, ointments, or lotions should be shampooed and rinsed off completely prior to treatment. 3. If cleaning treatment head prior to administering laser therapy to patient, make sure to use only isopropyl alcohol of 70% alcohol or less, Ensure all alcohol is completely evaporated and treatment head completely dry prior to use on patient (see section 11). 4. Examine treatment head surface (ball surface, cone lens) to ensure free of cracks, burn marks, blemishes, or residue prior to use. Warning This laser device is not intended for operation in areas subject to explosion hazards such as flammable materials, gases or substances. A fire or explosion could occur. Caution DO NOT use hand piece head until alcohol solution used in cleaning procedure completely evaporates. Doing so may cause the laser to ignite alcohol solutions or vapors. 7.2 Empower Delivery System Descriptions 1. The Empower DS is composed of a double sheathed optic fiber and a hand piece with interchangeable treatment heads. Hand Piece Handle and Finger Switch Do NOT use without a treatment head attached Do NOT use without treatment head fully attached Warning DO NOT use hand piece without treatment head or inadequately secured treatment head on the hand piece handle. Doing so may cause serious and/or irreversible injury. page >> 20

21 2. Exchange treatment head, securely tighten the new treatment head to hand piece handle. Small Cone Small Ball Large Ball Large Cone (small, non-contact treatment head) (small, contact treatment head) (deep tissue applicator, large contact treatment head) (large, non-contact treatment head) Table 7.1 Laser Hand Piece Style NOHD (meters) Beam Divergence Small Cone 3.0 m Full Angle (degrees) 47 Large Cone 3.6 m Full Angle (degrees) 47 Small Ball 6.0 m Full Angle (degrees) 12 Large Ball 29.0 m Full Angle (degrees) 3 page >> 21

22 Hand Piece with Finger Switch and Large Deep Tissue Applicator Contact Treatment Head (Large Ball) This treatment head is for use in applications where contact and soft tissue manipulation during treatment are desired. Indications for use for the large ball are muscular or deep soft tissue injuries, arthritis, edema/swelling and other deep tissue conditions. The large ball is not recommended for use over open wounds, non-intact skin, or areas that would be sensitive to contact. This head should be held perpendicular to the skin and not approaching at an angle. The area to be treated and a significant surrounding margin should be covered evenly in a painting or serpentine motion. The Large Ball can be used at power settings up to 15W. Hand Piece with Finger Switch and Large Non-Contact Treatment Head (Large Cone) Recommendation Not to be used in a non-contact mode. This treatment head is for general use and applications where no contact or soft tissue manipulation during treatment is desired. Indications for use for the large cone are wounds, otitis externa, pyotraumatic dermatitis, postsurgical incisions and other superficial tissue conditions. It may also be used in place of either of the contact treatment heads for therapy over areas that are hypersensitive to direct contact, such as over bony prominences or in patients with thin skin or hyperesthesia. The Large Cone Head can be used at power settings up to 15W, 1-2 inches from the skin of the patient. Hand Piece with Finger Switch and Small Deep Tissue Applicator Contact Treatment Head (Small Ball) This treatment head is for use in applications where contact and soft tissue manipulation during treatment are desired. Indications for use for the small ball are muscular or tissue injuries in tight spaces or near sensitive areas. The small ball is not recommended for use over open wounds, non-intact skin or areas that would be sensitive to contact. This head should be held perpendicular to the skin and not approaching at an angle. The area to be treated and a significant surrounding margin should be covered evenly in a painting or serpentine motion. The Small Ball is recommended for use only at power settings of 3W or below for optimal patient comfort, however it can be used at power settings up to 6W safely if proper technique is used. Recommendation Not to be used in a non-contact mode. Hand Piece with Finger Switch and Small Non-Contact Treatment Head (Small Cone) This treatment head is for general use and applications where fine control with no contact or soft tissue manipulation during treatment is desired. Indications for use for the small cone are very small wounds in tight spaces or near sensitive areas (such as the mouth). The area to be treated and a significant surrounding margin should be covered evenly in a painting or serpentine motion. The Small Cone is recommended for use only at power settings of 3W or below for optimal patient comfort and should NOT be held in place without movement during treatment. The small cone lens should NOT be allowed to come in direct contact with the hair coat and should be held 1-2 inches from the skin of the patient. page >> 22

23 Warning Wear laser safety eyewear provided with the laser before operating the laser device. Caution Do not remove the Empower Delivery System fiber from the emission port once it has been secured unless required. Repeated insertion and removal of the fiber will increase the chance of emission port and fiber tip contamination. If the emission port or the fiber tip is contaminated, 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 into the laser emission port in accordance with section Use the device as required. 3. When done using the device, power off and leave the hand piece connected. Bending Limits of the Hand Piece Cable: The light 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 any part of the hand piece assembly is overheating or producing smoke, then immediately power off device, discontinue operation, and contact LiteCure at or for US and Canada for immediate assistance. Laser Treatment Head Cleaning: For information on cleaning refer to section 11. page >> 23

24 8>> Operation 8.1 Fiber Installation Take off the fiber cap. Make sure the fiber tip is clean prior to inserting into the optical port; secure by screwing the fiber locking collar onto the optical port. See section Laser Safety Eyewear ALWAYS wear the protective eyewear supplied with this device. All personnel present during device operation must wear this eyewear. Laser safety eyewear must also be resistant to physical damage or photo-bleaching resulting from laser exposure. All personnel who are within the nominal ocular hazard distance (NOHD) are considered to be within the controlled area and must wear laser safety eyewear. See table 7.1 In addition to providing the required laser safety eyewear, take the following steps to secure the treatment room: 1. To alert personnel before they enter the controlled area, post the included laser safety sign on the outside of the treatment room door when the laser is in use. 2. Close the treatment room door during operation of the laser. Or, optionally, the Remote Interlock Receptacle can be connected to the treatment room door through an interlock circuit so that laser emission is automatically disabled when the treatment room door is opened. A blocking barrier, screen, or curtain capable of blocking or filtering the laser beam could be placed to create a controlled area inside a large treatment room. The barrier should be made of material that can withstand the power of the treatment beam for the maximum exposure time. Caution The protective laser eyewear has an optical density rating > 5.0 for 980nm (see specification sheet) laser emission. All personnel present during device operation must wear this eyewear. Contact LiteCure at or for US and Canada to purchase additional sets of protective eyewear for this device. page >> 24

25 8.3 Power On Press and hold the button on the bottom of the screen for several seconds to turn the laser on. The initiation of the power-on sequence shall be accompanied by audible alerts, and then the HOME Screen (as below) will be displayed. Press protocols to initiate SmartCoat Plus technology Press the Operation button to enter the Manual Operation screen, and to access Perfect Protocol Press Patient Tracker to view patient treatment records Press Resources button to view animations, the user manual and video resources Press Setup button to enter Setup Screen Slide the power off button to the right to turn off the display 8.4 Setup In Setup Screen, the software allows operator to change the Aiming Beam, Unit Volume and finger/ foot switch Override settings. Press cancel button to cancel the selected settings Aiming Beam: Steady, Pulsed, Off a. 3.5+/-1.0mW Unit Volume: Tone (High, Med and Low) a dB at High Unit Volume: Beep (High, Med and Low) Unit Volume: Off Finger (Foot) Switch Override: On/ Off If overrided is switched on both aiming beam and volume must be on. Press save changes button to save the selected settings Press reset to default button to reset the settings to the default settings. Press Metric for metric units to be displayed throughout the software Press 3W Warning Message Off to not recieve the 3W Warning prompt when utilizing protocols over 3 Watts. page >> 25

26 8.5 Protocol Selection, SmartCoat Plus Technology Animal Selection After selecting Protocols on the home screen, select the animal you wish to treat. The icon turns red when selected and progresses to the next screen. SmartCoat Plus Technology The next screen requests SmartCoat Plus Technology selections to be input. The screen to the left will prompt the user to enter specific patient characteristics that may affect the absorption or penetration of the light to the target tissue. Please note for Canine and Feline patients a weight selection must also be made. Choose the body type, coat length, coat color and skin color of the animal you wish to treat. After choosing the patient s characteritistics, the button is red highlighted as shown on the left. Press next to continue to condition selection. Condition Selection Click the box of the condition to be treated. A red box appears next to the selected condition. Press next to select either the size of the area to be treated (e.g. for a Wound treatments), or to select the anatomical location you wish to treat (e.g. for Arthritis treatments). Choose Treatment Area(s) or Size of Area to Treat Click the treatment area(s) you desire to treat. The chosen area(s) appear highlighted in red as seen in the image to the left. page >> 26

27 Some protocols request that a size selection is made - see the image on the next page. Press the size of the area you wish to treat and select next to progress to the operation screen. When you press next after the treatment area(s) are selected you enter the unit operation screen in Standby mode. The selected settings are listed in the current treatment box on the right side of the screen (see below). 8.6 Unit Operation (Protocols) On the unit operation screen, press the - and + buttons next to the power box to increase or decrease power, in increments of 0.5 watts. You may also press on the dial to increase or decrease power. When the standby button is pressed the unit will beep 6 times (6 second delay) and/or the standby button will flash to indicate that the laser is entering ready mode. When the beeping stops and the ready button appears, the laser is ready for emission. (see image below). When the beeping/ flashing stops, also at this time the aiming beam is activated (if Aiming Beam setting is not Off in Setup Screen) to allow the operator to aim the red light onto the treatment site in preparation for the treatment. (See section 8.9) 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. (See section 8.10) Optical fiber is not properly inserted Remote interlock is not properly installed Foot/finger switch is depressed The aiming beam can be turned off by pressing either the home button or the ready button to exit Ready mode. Ready In Ready mode, when the foot/finger switch is depressed, the device enters emission mode. The laser emission indicator flashes between yellow and grey during emission. (See section 8.11) EMISSION EMISSION page >> 27

28 8.7 Unit Operation (Manual) Press the operation button on the home screen to enter the operation screen shown below. The screen will appear in Standby Mode. 8.8 Standby Mode In Standby Mode, the software allows operator to change the laser power, laser modulation frequency, laser emission timer and energy reset. Standby button is active Modulation frequency display shows the selected modulation frequency Aiming beam is inactive Unit does not enter Ready Mode if finger / foot switch is closed - creating error message: a. Operation Error, Optic Fiber is not inserted. b. Audible beep - 3 times Press exit button to return to Standby Mode Unit does not enter Ready Mode if safety interlock is not inserted - creating error message: a. Operation Error, Remote Interlock is not inserted. b. Produce audible beep - 3 times Press exit button to return to Standby Mode Press the Power Setting Scale, roate the power wheel, or press the + / - button to set the laser power. The selected laser power will be shown at the Power Setting Window. To scroll to the desired power value, maintain pressure on the desired button. The laser power can be set from 0.5W to 15W. Press the Pulsed Rate + / - button to set the laser modulation frequency. The selected laser frequency will be shown at the Pulsed Rate Window. To scroll to the desired frequency value, maintain pressure on the desired button. The laser frequency can be set from CW to 10,000Hz NOTE: The duty cycle in the Pulsed mode is 50%. Press the Time + / - button to set the laser treatment time. The selected laser treatment time will be shown at the Time Window. To scroll to the desired time value, maintain pressure on the desired button. Press Energy Reset button to reset the energy monitor value to zero. Press the Home Icon in the upper-left corner to return to the Main Menu. page >> 28

29 8.9 Ready Mode When in Ready Mode the laser will emit when the finger/ foot switch is activated. The purpose of Ready Mode is to wait for the user to press the finger/ foot switch and start laser emission. The software has a 6 second delay (6 beeps) to warn the user during the transition from Standby to Ready Mode. During the transition, the Standby button changes to Ready and flashes. After 6 beeps, the aiming beam emits from the hand piece if the aiming setting is on. Ready In Ready Mode, the software allows operators to change the laser power level and laser emission time. Energy counter can be reset and modulation frequency can be changed in Standby Mode. Ready button is active Modulation frequency display shows the selected modulation frequency Aiming beam emits from the hand piece if the aiming setting is on. The device will leave Ready Mode if fiber is not inserted correctly - creating error message: a. Operation Error, fiber is not inserted. b. Audible beep - 3 times Press exit button to return to Standby Mode The device will leave Ready Mode if the safety interlock is not inserted/ attached to the back of the unit - creating error message: a. Operation Error, Remote Interlock is not inserted. b. Audible beep - 3 times Press exit button to return to Standby Mode Press the Power Setting Scale or the + / - button to set the laser power. The selected laser power will be shown at the Power Setting Window. To scroll to the desired power value, maintain pressure on the desired button. The laser power can be set from 0.5W to 15W. Press the Pulsed Rate + / - button to set the laser modulation frequency. The selected laser frequency will be shown at the Pulsed Rate Window. To scroll to the desired frequency value, maintain pressure on the desired button. The laser frequency can be set from CW to 10,000Hz (See table in section 10). NOTE: The duty cycle in the Pulsed mode is fixed at 50%. Press the Time + / - button to set the laser treatment time. The selected laser treatment time will be shown in the Time Window. To scroll to the desired time value, maintain pressure on the desired button. Press Energy Reset button to reset the energy monitor value to zero. The device will return to Standby Mode from Ready Mode if it is inactive for more than 3 minutes. Press the Ready button to return to Standby Mode. page >> 29

30 8.10 Emission Mode The software monitors the laser output power in accordance with the parameter settings on the display to ensure the power is within operating tolerance. During emission, the software does not allow users to change any settings on the display. The software displays the word EMISSION at the bottom of the screen. The device produces beeps, or a steady tone, or no audible tone during emission according to the audio settings specified in the Setup Menu. During emission, the software does not allow users to change any settings on the display. The laser output power is the same as the power setting on the display within operating tolerance when the laser modulation frequency is CW. When the laser modulation frequency is not CW, the average power is 50% of the power setting on the display within operating tolerance. The device will exit from Emission Mode if the fiber is not inserted - creating error message: a. Operation Error, Optic Fiber is not inserted b. Audible beep - 3 times c. Laser beam is disabled Press exit button to return to Standby Mode The device will exit from Emission Mode if the safety interlock is not inserted - creating error message: a. Operation Error, Remote Interlock is open b. Audible beep - 3 times c. Laser beam is disabled Press exit button to return to Standby Mode The device will exit from Emission Mode if the laser power is outside of tolerance - creating error message: a. Laser power is out of range b. Produce audible beep - 3 times c. Laser beam is disabled Press exit button to return to Standby Mode The device will exit from Emission Mode if the laser diode malfunctions - creating error message: a. Laser temperature is out of range b. Produce audible beep - 3 times c. Laser beam is disabled Press exit button to return to Standby Mode Laser emission is disabled when the timer counts down to zero if timer setting is not CW. Laser emission continues until emission is stopped using the finger/foot switch if timer setting is CW. If laser emission is interrupted using the finger/foot switch, the laser emission can be resumed by activating the finger/foot switch until the remaining time is over. page >> 30

31 8.11 Perfect Protocol In Perfect Protocol, the software allows the operator to enter a target treatment area in cm 2, a target power in watts, a target energy density in J/cm 2, and the patient s skin and coat color to generate custom protocols. Watts may be entered in tenths, while treatment area and target energy density must be entered as whole numbers. The small i icons show additional information about each treatment parameter when selected Resources Press the Resources button on the home screen to access the user manual, videos, or 3D Anatomy. The 3D Anatomy screen, shows 3D animations of feline, canine or equine patiens with different anatomical structures including muscles, bones and nerves. You may select any combination of structures that you wish to be visible on the animation. page >> 31

32 8.13 MaxTX At the top of each treatment screen, there is a MaxTX button. When selected, this function removes the use of any frequencies which may be part of a treatment protocol and delivers the entire total dose of energy (total joules) in continuous wave (CW) emission. You will note, that when selected, the treatment time is slightly shorter, due to the fact that CW delivers more energy within a given amount of time than using pulsed frequencies (due to the 50% duty cycle during these phases of energy delivery) Patient Tracker Select the Patient Tracker button on the home screen to access Patient Tracker. Customers will receive a software revision update when Patient Tracker is released. page >> 32

33 9>> Accessories 9.1 Finger Switch A finger switch comes with the hand piece. The laser device treats the finger switch as a simple on/ off device. When Override function is off, pressing down the finger switch produces 100% of the laser energy set by the operator. Fully releasing the pressed finger switch stops laser emission. When Override function is on (not for normal operation), pressing down the finger switch one time produces 100% of the laser energy set, and pressing again stops the laser emission. 9.2 Foot Switch An optional foot switch can be purchased for this laser device. The laser device treats the foot switch as a simple on/ off device. Releasing the pressed foot switch stops laser emission. When closed, the cover of the foot switch is designed to prevent inadvertent foot pedal control surface depression. Always turn the laser off when not in use. When foot switch operation is desired, press down on the cover then release. The cover is springloaded and will open automatically. 9.3 Medical Grade Power Cord 9.4 Laser Safety Eyewear Caution ALWAYS wear the protective eyewear supplied with this device. Eyewear is rated at the wavelength of operation (see specification sheet). All personnel and patients present during device operation must wear this eyewear. Contact LiteCure at or for US and Canada to purchase additional sets of protective eyewear for this device. ALWAYS wear the protective eyewear supplied with this device. All personnel present during device operation must wear this eyewear. page >> 33

34 10>> Specifications Model Laser Type Laser Wavelength Aiming Beam Wavelength Aiming Beam Power Maximum Output Power Output port Operating Modes Audio warning signal level Cooling Dimensions Weight Power Requirement Operation Temperature Storage Temperature Companion Therapy Laser, CTX-15 Class 4, Solid State 810 ± 10nm, 980 ± 10nm 650 nm ± 15nm 3.5mW ± 1.0mW 15 aperture of hand piece Empower Delivery System Continuous Wave (CW) Pulse Wave (50% duty cycle) 2, 10, 20, 100, 200, 500, 1000, 2500, 5000, 10000Hz 40 to 65 db Thermal Electrically Cooled with Forced Air 14 x 10 x 7 in 36 x 25.5 x 18 cm 8.5 lb 3.8 kg V~ 50/60Hz 400VA 10 o C to 35 o C -20 o C to 70 o C page >> 34

35 11>> Cleaning Warning Always turn off the system and unplug the power cord from the wall outlet before cleaning. Warning Always use protective eyewear and gloves when cleaning and disinfecting any equipment. Caution DO NOT use Treatment Head until alcohol solution used in cleaning procedure is completely dry. Doing so may cause the laser to ignite alcohol solution or vapors. The CTX laser device uses solid-state laser technology. It is important to keep the unit and accessories free from dust. To clean the exterior surface of the unit itself: Wipe with a soft cloth moistened with isopropyl alcohol solution. Ensure the solution is only 70% alcohol or less. Solutions of more than 70% alcohol can cause product damage. It is NOT recommended to use a paper towel to clean the unit itself as small fibers from the paper towel may become adhered to uneven surface(s); If this occurs, we recommend using masking tape to remove any adhered paper fiber from the surface. Recommendation DO NOT use anything to clean the lens on hand piece. Doing so may damage the lens during laser emission. See section 7.2 for photo of handpeice. Handpiece lens, do not clean Attachment lens, clean carefully page >> 35

36 To clean accessories and treatment heads: 1. To clean the exterior and interior surfaces on treatment heads: Wipe with a soft non-fiberous cloth moistened with isopropyl alcohol solution. Ensure the solution is only 70% alcohol or less (30% or more water), as solutions of more than 70% alcohol can cause product damage. Before cleaning, turn off the system and unplug the power cord from the wall outlet Avoid using soiled or gritty cloths Avoid using compressed air to remove dirt or hair from either interior or exterior surface of treatment heads as this may leave a film behind. Always dampen the cloth before cleaning If other disinfectants must be used to clean treatment heads in the case of infectious disease, after cleaning, ensure that all cleansers have been removed by wiping again with 70% (or less) isopropyl alcohol as described above, and then dry as described below. After cleaning, ensure that all cleansers have been removed and the parts are dry 2. After cleaning the treatment head, wipe it dry with a soft cloth. Then leave it on a clean surface to dry. To expedite drying time of the treatment head, you may wipe treatment head with a solution 70% (or less) isopropyl alcohol. 12>> Maintenance and Calibration Calibration Procedure 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. For detailed maintenance and calibration information contact the manufacturer. Disclaimer Warning Calibration is a service procedure to be done only by LiteCure-certified Service Personnel. Adjustment by anyone other than a certified LiteCure Service Personnel voids any existing manufacturer s warranty on the instrument. page >> 36

37 13>> Treatment Information The proper use of the Companion Therapy 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 Preset protocol will begin with CW (Continuous Wave) and cycle through multiple frequencies. Depth of penetration is determined by spot size, tissue type being treated, wattage, and wavelength. An understanding of veterinary anatomy and laser tissue interaction is imperative for safe, optimal treatments. Once complete, the operator may reactivate the laser and repeat a protocol by pressing the finger switch. 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. Any topical sprays, ointments, or lotions should be shampooed and rinsed off completely prior to treatment. Use isopropyl alcohol solution (70% or less with water) to clean all instrument surfaces in contact with the patient. Thermal effects vary with hair coat and pigmentation darker pigments absorb more. If patient appears uncomfortable and/or haircoat feels excessively warm, 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. Caution CAUTION! Assure alcohol on the instrument has fully evaporated/dried before activating the laser. Laser Therapy Treatment Considerations Treatments can be done in conjunction with stretching or gentle Range Of Motion exercises. Monitor for superficial thermal discomfort. Keep beam perpendicular to skin surface at all times. Treat muscles connecting to a painful joint in addition to tendon attachments. page >> 37

38 Laser Therapy Treatment Techniques For edema/swelling, treat area from proximal to distal to facilitate lympatic drainage. Treat biomechanical connected muscles and joints in the kinematics chain. Post-Operative or acute injuries use shorter times and/or lower power. Contact Technique Treatments can be done on contact or at a slight distance from the skin, 1/2 inch. Monitor for superficial thermal discomfort. Continuously move probe in grid pattern Treat 1-2 inches of surrounding healthy tissue. Treatment Contraindications 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: Hemorrhaging: Do not apply laser light to any actively hemorrhaging lesion. 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. Testicles: Do not apply laser light to the testicles of the animal. Injectable Medications: Do not apply laser light directly over any area recently injected with any medication, vaccines, etc. Photosensitive Medications: Do not apply laser light to any animal currently receiving photosensitive medications. Epiphysitis: When applying laser light to epiphysitis, use a low dose initially and use only those treatments necessary to reduce swelling. Cancer or Malignancy: 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. Pregnancy: Laser therapy is contraindicated for use over the pregnant uterus. Do not apply laser light to the pregnant animal Treatment Over Sympathetic Ganglia, the Vagus Nerves & 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. page >> 38

39 14>> Sources for Additional Information and Assistance on Laser Safety Center for Devices and Radiological Health Office of Compliance New Hampshire Avenue Bldg. 51, Room 5271 Silver Spring, MD Phone Fax American Institute of Medical Laser Applications Raymond Road Marysville, Ohio Phone Fax Laser Institute of America Research Parkway, Suite 125 Orlando, FL Phone Fax page >> 39

40 15>> Warranty Information 15.1 Return Procedure Please review terms of purchase and date of shipment to determine validity of warranty claim. Warranty claim should only be made for products within the terms of the warranty policy. 1. Contact LiteCure at or for US and Canada and obtain a Return Material Authorization number (RMA) and detailed return instructions. A form will be faxed and must be completed, signed and returned to LiteCure for customers where distributorship and/ or a representative is not available, all claims should be addressed to: Service LiteCure 250 Corporate Blvd, Suite B Newark, DE Be prepared to furnish: Product Model and Serial Number Purchase and Shipment Date Reason for Return Name of person and phone number at your organization for further communication. 3. Adhere to LiteCure s complete return instructions for transportation and packaging and ship the product (freight and insurance prepaid) with proper documentation containing the RMA number and the information specified above. 4. LiteCure will advise the purchaser of its determination of warranty at the earliest possible time. Providing complete information as requested will expedite the procedure 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 enough 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 (4 inch diameter) allowable fiber bend radius. 4. Use adequate protection when covering sensitive fiber tips or optical components. 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. page >> 40

41 15.3 Cancellation Fees Should it become necessary to cancel or modify orders, a restocking fee of 10% of the total order amount will be charged by Companion Therapy Laser for returns to stock Standard Warranty Plan Companion Therapy Laser products and components are warranted to be free from defects in materials and workmanship for a period of 36 months from the date of initial shipment. Companion Therapy Laser s liability under this 36 month warranty is limited to: Laser Internal and External Components 36 months. Laser Diodes, Laser Hand piece Cable and Laser Hand piece Probe 36 months. Companion Therapy Laser shall replace any part during the original warranty period Extended Warranty Plan Companion Therapy Laser will provide an extended warranty for additional years beyond the Standard Warranty Plan. Please contact LiteCure at or for US and Canadafor details. Notice: The Standard and the Extended Warranty Plans will not apply to those products which have been: (i) Repaired or altered other than in accordance with the terms of this Agreement, or (ii) Abused, misused, improper handling in use, or storage, or used in an unauthorized or improper manner or without following written procedures supplied by Companion Therapy Laser, or (iii) Original identification markings, labels have been removed, defaced or altered, or (iv) Any other claims not arising directly from material defects in material or workmanship. page >> 41

42 Special contracts or contracts for non-standard products may have modified terms of warranty and, in such cases; the terms as stated in the individual contract must be signed by the duly authorized officer of Companion Therapy Laser and will supersede the standard terms. Companion Therapy Laser will make final determination as to cause or existence of defect and, at its option, repair or replace the products which prove to be defective during the warranty period. Products replaced under warranty will be warranted only for the balance of the warranty period from the original supplied equipment. This warranty extends only to the original purchaser of the equipment from Companion Therapy Laser. The purchaser must notify Companion Therapy Laser within 15 days of first noticing the defect and promptly return the defective product upon receipt of RMA number(s) before expiration of the warranty period. Products believed by purchaser to be defective shall be returned to Companion Therapy Laser with the transportation and insurance prepaid by purchaser. Repaired or replaced products will be returned to purchaser by Companion Therapy Laser, FOB city destination within the Continental United States. Transportation beyond these limits will be charged to purchaser. The warranty set out in above paragraph is the exclusive warranty made by Companion Therapy Laser and is in lieu of all other warranties (except for specific product performance warranties), whether written, oral, or implied, including any warranty of merchantability or fitness for a particular purpose, and shall be customer s sole remedy and Companion Therapy Laser s sole liability on contract or warranty of otherwise for the products. This warranty shall not be modified or amended without the written approval of an officer of Companion Therapy Laser. IN NO EVENT SHALL COMPANION THERAPY LASER BE LIABLE FOR ANY INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FAILURE TO PERFORM UNDER THIS AGREEMENT OR THE FURNISHING, PERFORMANCE OR USE OF ANY GOODS OR SERVICES SOLD PURSUANT HERETO, WHETHER DUE TO BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE OR OTHERWISE. page >> 42

43 16>> Appendix/Labels 16.1 Warning Label This label indicates the laser classification. It warns of the radiation exposure hazard potential to eyes and skin. Class 3R Laser Product 650nm 4.5mW CW Class 4 Laser Product 980nm 15W 9W CW or 2Hz-1kHz, 50% duty cycle IEC : 2007 CAUTION ATTENTION CAUTION WARNING VISIBLE AND INVISIBLE LASER RADIATION AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION RAYONNEMENT LASER VISIBLE ET INVISIBLE ÈVITER L EXPOSITION DE L OEIL OU DE LA PEAU AU RAYONNEMENT DIRECT OU DIFFUS FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN USE CAREFULLY. MAY CAUSE SERIOUS BURNS. DO NOT USE OVER SENSITIVE SKIN AREAS OR IN THE PRESENCE OF POOR CIRCULATION. THE UNATTACHED USE OF THIS DEVICE BY CHILDREN OR INCAPACITATED PERSONS MAY BE DANGEROUS Manufacturer s Label The label displays the manufacturer, model number, serial number, and regulatory compliance declarations Non Interlocked Protective Housing Label Located on the bottom of the device and warns of the radiation exposure hazard potential to eyes and skin. page >> 43

44 16.4 Warranty Seal Labels are on the underside of the laser device to indicate any attempt to open the housing. WARRANTY VOID IF SEAL IS BROKEN 16.5 Optical Fiber Applicator Label Located close to the emission port on the top of the device, the laser emission label indicates that the laser energy emission occurs at the distal end of a properly connected hand piece Laser Emission Label 16.7 Emergency Laser Off Label 16.8 Finger/Foot Switch Label 16.9 Remote Interlock Connector Label Fuse Label F1AL250V page >> 44

45 16.11 ETL Mark Label EC REP EMERGO EUROPE Molenstratt BH, The Hague The Netherlands Phone: Fax: CONFORMS TO UL STD CERTIFIED TO CAN/CSA STD C22.2 No This laser product complies with 21 CFR and except for deviations pursuant to Laser Notice No. 50, dated June 24, AC Power Input Label Protective Earth (Ground) Label (Inside Device) Power Switch Label page >> 45