Summus Medical Laser KP Platinmum Laser System User Manual

K-Laser USA LLC Platinmum Laser System User Manual

Contents

User_Manual

page 1of 50Platinum Laser SystemUser ManualK-laser USA, LLCVersion: V1.0All rights reserved.Revision Date: May 04, 2018
page 2of 50Instructions Before UseThank you for using the Platinum Laser System！When receiving this product, please check the integrity of the packaging. Refer to thepacking list and check the product components and their quantity. If there are anypacking damage, equipment damage or component missing, please contact our salespersonnel or dealer for replacement.In order to serve you better, please confirm the packaging in good condition andcheck the product set, fill out the product receipt, the user file form and trainingrecords, and return to the company promptly.It is recommended that users receive train before use, and read the instructions,and have the relevant security measures to avoid the damage on the human bodyand equipment that caused by the possible harmful laser radiation in the courseof use.The company will not be liable for any personal injury or damage to equipmentcaused by the failure to follow instructions in the course of use.
page 3of 50Table of Contents1 Introductions................................................................................................................42 Indications................................................................................................................... 53 Contraindications........................................................................................................ 64 People with caution..................................................................................................... 75 Adverse Reactions....................................................................................................... 86 Specifications.............................................................................................................. 97 Safety Warnings.........................................................................................................108 Installation.................................................................................................................169 The appearance of the medical device...................................................................... 2010 Operation Guide...................................................................................................... 2111 Reminding Function Description............................................................................ 3712 Maintenance............................................................................................................ 4013 The Waste Dispose.................................................................................................. 4214 Product Identification And Packing Instructions.................................................... 4315 Electromagnetic Compatibility............................................................................... 4616 FCC Statement........................................................................................................ 4717 Services................................................................................................................... 4818 Contact information.................................................................................................49
page 4of 501 IntroductionsThe Platinum Laser System is a therapeutic laser product for relieving mild musclepain and joint pain.The product uses intelligent human-computer interaction system,which is committed to clinicians and patients to bring a safe and effective treatmentexperience.1.1 Model / Specifications and Divide InstructionsP41.2 Device DescriptionThe Platinum Laser System is a Class IV laser product that uses GaAlAssemiconductor lasers as energy sources to deliver laser energy to the treatment area byan optical path transmission system. The optical transmission system is composed of aflexible fiber connected to the laser source and handle switch, SAM905 coupler.Clinicians set reasonable treatment parameters according to the patient's condition andtreatment, click the hand-held switch to start treatment.Platinum Laser System has the following characteristics in the alleviation andtreatment of pain:To provide a non-invasive treatment for patients with tissue pain, muscle strainusing laser irradiation.With a stronger tissue penetration, 980nm diode laser can be more in-depthrole in the patient's tissue, significantly alleviate and improve local pain,muscle strain and other symptoms.There are continuous output mode and pulse output mode. With continuousmode, the maximum output power is 24W which can provide doctors a varietyof effective treatment options.With intelligent human-computer interaction system and the internal tutorialvideo screen, the interface is more clear and the operation is more simple tofacilitate medical operations.Provide a variety of security reminding function, to facilitate the safe andeffective use of this product.
page 5of 502 IndicationsThe Platinum Laser System as laser devices for medical application intended toalleviate musculoskeletal pain, osteoarticular diseases and laser acupuncture.
page 6of 503 ContraindicationsPeople with the following symptoms are disabled:Melanoma, precancerous lesionsPregnancy response of the crowdPatients with acute hemorrhagic diseaseThyroid diseaseCutaneous tuberculosisActive bleedingCardiopulmonary and renal failurePre - stroke symptomsAcute inflammation associated with sepsis symptoms
page 7of 504 People with cautionLight sensitive populationsPatients with local or major anesthesia, heart disease, pulmonary disease,hemorrhagic disorder, sleep apnea, immunocompromised patientsDo not accept laser treatment psychologically, do not meet the doctor'streatment
page 8of 505 Adverse ReactionsIn the course of treatment, doctors should pay attention to the treatment of patientswith the treatment site and treatment of skin conditions, adjust the correspondingparameters or move the handpiece to adjust the energy convergence according totreatment.In the course of treatment, due to laser irradiation tissue, the treatment site ofthe blood circulation will accelerate, there may be skin redness phenomenon.In conventional treatment, reddening of the skin is normal reaction.In the course of treatment, when laser irradiation site appears hot phenomenon,appropriately move the laser treatment handpiece away from the treatment siteto reduce the energy convergence; or by setting the treatment parameters toreduce the laser output power.In the course of treatment, treatment should be immediately stopped andthermal burns treatment must be done when the treatment site of skin burns,blisters ,etc.WARNING: The treatment parameters should be set according to the patient'scondition and clinical diagnosis. And in the course of use, make the appropriateprotective measures, operating the device safely and effectively in strictaccordance with the contents of the instructions. Otherwise, injury or damageto persons or device may be caused.
page 9of 506 SpecificationsModelP4Laser ClassificationClass 4Laser typeGaAlAsOperation modeCW/PulsedWavelength(Working)650±20nm,810±10nm,915±10nm,980±10 nmMax Output power200mW,8W,8W,8WWavelength(Indication)650±20 nmMax Indication power＜2mWUncertainty for output power≤±10%Magnitudes of the cumulativemeasurement uncertainty≤±20%Expected increase in the measuredquantities≤±10%Positive pulse width0ms– 999 msNegative pulse width0ms–999 msTransmission system200um,400um,600umTimer0-3600sAdapter input parameters100-240VAC,50/60HzMain Unit input parameters19VDC，5.8ABattery capacity3350mAhCooling MethodAir coolingWeight≤3KG NWDimensions300 220 200 mmDate of manufactureSee product nameplateValidity Period5 yearsDivergence Angle25°
page 10 of 507 Safety WarningsPlatinum Laser System is a Class 4 laser product. During use and maintenance, do notlook into the laser or direct beam to avoid irreversible damage to the eyes. For thisreason, some safety precautions must be observed when using this product as follows.Otherwise, it may cause personal injury or damage to equipment.7.1 Requirements to the Room7.1.1Requirements to the entrancePlatinum Laser System is a Class 4 laser product. Each entrance door has to bemarked clearly with a laser warning logo.A laser warning logo with laser wavelength information must be put up on allentrance doors, preventing anyone from entering the room when the laser isemitted and being exposed to laser radiation.Each entrance door has to be equipped with a warning light. Every time the laseris switched on the warning light has to come on and be illuminated to the outside.Interlock shall be installed at each entrance and connected to the remoteinterlocking connector on the rear panel of the device. When the door is opened,the device can not emit laser.7.1.2 Laser radiation protection at windowsAll openings to the exterior of the laser room including windows must be properlysecured to prohibit the escape of laser beams, resulting in danger.7.1.3 Protection against high reflective SurfaceTo avoid any direct or indirect scattered radiation from the laser beam, no highlyreflective material should be found in the treatment room. This includes mirrors,picture frames, polished chromium surfaces and windows. All such surfaces have tobe removed or protected by non-reflective material.7.1.4 Warning Labels of the EntranceA laser warning label must be put up on all openings to the exterior of the laser roomincluding windows.7.1.5 Fire HazardsDo not work with the device and the laser beam close to flammable, anesthetic or anyother solvents which are easily flammable. Remove the paper and plastics from thelaser working area. Within a certain distance, these materials absorb considerableenergy can be ignited.When the laser is not in use or patients are changed or a break in the treatment occursplease turn the device into “Standby” status or just switch off the device.
page 11 of 507.2 Warnings for patients, operators and other personnelIt is strongly recommended that users receive related training and carefully read theinstructions to be familiar with the basic operation and safety regulations before use.Nominal Ocular Hazard Distance (NOHD) ：NOHD identifies the beamirradiance or the amount of irradiation is equal to the distance of the maximumpermissible exposure (MPE) of the cornea. The product has a NOHD of3.43Km. In other words, in the absence of any defensive situation, the distancebetween the human eye and the laser emission point must exceed 3.43Km.Laser direct radiation or scattered radiation can cause irreversible damage tothe cornea, retina, and skin tissue. All Individuals present during the operationof this device must wear protective goggle with an optical density of 5.0 orgreater at 980nm wavelength.Never attempt to view the laser beam or the indicator light along an opticalpath with eyes or with optical device, which may cause irreparable damage tothe eyes.Do not remove the protective goggles until the operator returns to the standbymode.In the course of use, do not move the laser irradiation area to an unspecifiedtreatment site.In the course of treatment, a minimum distance of 3cm should be maintainedbetween the laser output handpiece window and the patient's skin. And thetreatment time is generally 3-5 minutes. In the course of treatment, the doctorsmust always pay attention to the treatment of patients to avoid skin redness,burning and other adverse reactions.When connecting or removing the handpiece, make sure that the device is instandby mode or switched off.Do not place the laser in READY mode to avoid unnecessary hazards instandby mode.Do not allow non-personnel to enter the treatment area during laser treatmentto avoid any laser radiation.Do not wear any reflex jewelry or items during treatment. Avoid scattering orreflecting laser energy that may cause damage to eyes or skin.The handpiece must be placed in the working area of the medical personnelwho is responsible for the treatment and only can be operated by full-timepersonnel.Users should wear medical plastic gloves, use alcohol (or lens paper) to cleanthe probe end and handpiece until the alcohol is completely evaporated beforeusing the device.When the laser device is not being used, please turn off the power switch andremove the key to prevent non-designated personnel or unauthorized personsfrom operating the device.When the device is working, if there is any abnormality (such as crash, nodisplay, light abnormality, etc.), press the emergency stop switch immediately
page 12 of 50and turn off the device. To identify the reasons before deciding whether tooperate. If necessary, please contact the designated dealer or K-Laser for help.If the device does not work properly, please contact the company or dealer forconsultation immediately. Do not disassemble the device without guidance orpermission by unauthorized persons to avoid the serious, irreversible harm onhuman body and device that caused by the possible electric shock.No strong pull, extreme bending fiber in the course of the use. Failure to do somay cause a loss of laser transmission efficiency, which may result in adecrease in the therapeutic effect. In severe cases, fiber breakage may damagethe optical transmission system or cause unknowable damage to the user (orpatient).It is strongly recommended that the device be inspected and maintainedregularly.To avoid risk of electric shock, this equipment must only be connected to asupply main with protective earth.7.3 Safety warnings pertaining to the operation of the equipment7.3.1 WarningsPlease choose a well-ventilated location for device installation. A minimumdistance of 20 cm should be maintained between the ventilation slots and thewalls to avoid the temperature rise. Otherwise, the treatment instrument couldnot work, or even damage to the laser would be caused.Strong electromagnetic environment may affect the normal operation ofdevice. It should also be avoided that the device is together used with othereasily interfered devices.Unauthorized accessories (e.g handpiece, protective goggles, key switches,interlock, etc.) may cause laser radiation hazards and damage to device. Pleaseuse the related accessories specified by our company.Before moving or lifting the laser device, please turn off the device and protectthe handpiece, fiber and the laser window with a dust cap from dust.Check the integrity of the beam transmission system before use：A good wayto check the integrity of the transmission system is to have the aiming beampass through the same transmission system as the working beam. If the lightspot of the aiming beam is not at the end of the transmission system, or itsintensity is reduced or does not appear to converge, this may indicate that thetransmission system is damaged or not working properly.The use of flammable anesthetics or oxidizing gases must be avoided, such asnitrous oxide (N2O) and oxygen. Certain materials, such as cotton wool, areoxygen-rich and will be ignited by the high temperature generated by the laserdevice being use. Solvents and flammable solutions used for cleaning anddisinfection should be volatilized before using the device. It should be notedthat there is a risk that the internal gas may be ignited.
page 13 of 507.3.2 Storage and use of the environmentThe followings are the environmental conditions for the storage and use of thedevice.Storage Temperature: 0~35℃ (With packaging)Operating Temperature: 10~30℃Storage humidity: ＜80% (With packaging)Use ambient humidity: 30%~75%Operating environment：86~106kPaAltitude：≤2000mAvoid direct sunlight, rain is strictly prohibitedWell ventilatedAvoid storing in strong electromagnetic environmentAvoid severe vibrationAvoid storing in explosive, corrosive gases, excessive dust or salt of theenvironment7.4 Safety SignsThe device has the following label affixed at the relevant location informing the userof the safety-related information of the device and to warn the user that the laser has aradiation hazard to avoid direct exposure or scattering of laser light to the eyes andskin.See 14 parts of product identification and packaging instructions.
page 14 of 507.5 Safety functionsThe Platinum Laser System provides some special safety function devices such as keyswitch, emergency stop switch and remote interlock. These devices are used foridentification or emergency interruption, etc. All users of this product should befamiliar with the purpose of these safety devices and methods of operation.Caution - Use of controls or adjustments or performance of procedures otherthan those specified herein may result in hazardous radiation exposure.7.5.1 Emergency StopON OFFAs shown, the switch is located on the front panel of the SAT-G30 for emergencyinterruption of the laser output. When the device is working, if there is abnormalworking (such as crash, no display, light abnormal, etc.), immediately press theemergency stop switch to stop the laser output. Reset the emergency stop switch torestore power to the system, at which point the laser can not emit the laser. Pleasereset the parameter and press the handpiece to emit the laser.Follow the direction of the arrow on the emergency stop switch, turn the emergencystop switch or pull up the emergency stop switch to reset the emergency stop switch.7.5.2 Remote InterlockAs shown, the remote interlock is located below the rear panel of the device. Theremote interlock should normally be connected to an interlock (normally closedswitch) on the entrance door of the room. And its head should be connected to theremote control interlock interface. When the door is opened, the device can not emitlaser, preventing anyone from entering the room when the laser is emitted and beingexposed to laser radiation.Note: There is a red dot on the connector. Insert the interlock with the red dot facingupward as the picture shows above.
page 15 of 507.5.3 Indicator lightsThe indicator lights are located on the right of the LCD panel for power, remingding,laser output prompts.1) When the device is turned on, the power indicator light is green;2) When the laser is emitting, the corresponding indicator light is yellow；3) When the warning state occurs, the corresponding indicator light is red.
page 16 of 508 Installation8.1 Check the appearance and packing itemsPlatinum Laser System is packed and inspected at the factory. After you receive theproduct, please check the box whether damage. After unpacking, please check thepacking items whether complete.#ItemsNumber1Platinum Laser System12HandPiece13Protection Goggles24Remote Interlock15Adapter16Lithium battery17User Manual18Product Inspection Certificate19Packing List1Note: Please check the contents of the packing list whether complete, missing ordamaged. Please contact the designated dealer or the company for replacement ifthe above items are found missing or damaged, or the packaging has obviousdamage, crashes and so on.WARNING: Use of non-specified accessories may cause laser radiation hazardsand device damage. If the Handpiece, Fiber, Adapter, Lithium battery and otheraccessories are damaged or lost during use, and if you need to purchase theaccessories again, please contact your designated dealer or K-Laser to purchase.
page 17 of 508.2 Preservation of packaging materialsCarefully save all packaging material. It is your best choice to pack these materialswhen you store or return them to our company for repair.8.3 Device InstallationNote: Please install the equipment under the guidance of our authorizedtechnician or the designated dealer.8.3.1 Installation site and platform selectionPlatinum Laser System adopts air cooling design. Please choose a well-ventilatedlocation for equipment installation; placement platform requires a hard texture, shallnot impede the air flow of the bottom of the equipment. Keep the device at least 20cmaway from the wall to facilitate the operation of the power switch.8.3.2 Remote interlock installationThe interlock (normally closed switch) shall be installed at each entrance andconnected to the remote interlock connector on the rear panel of the device while thedevice is in operation.When the door is opened, the device can not emit laser,preventing anyone from entering the room when the laser is emitting and beingexposed To laser radiation.Remote interlock interface located above the device, the port has anti-plugdesign. Align the red part of the remote interlock connector with the red part ofthe device connector and insert the connector horizontally into the device.Note: We recommend that the door should be closed entirely and can’t be openedfrom outside when the unit is in use, or it’ll terminate the therapy at once.
page 18 of 508.3.3 Handpiece ConnectionThe handpiece connection is divided into the connection of signal side and theconnection of laser side:1) The handpiece signal port is located on the front panel of the device, which has ananti-mis-insertion design. Please align the red port of the connector to the red port ofthe device connector and insert the connector horizontally into the device.2) The handpiece laser port is located on the front panel of the device, when installingthe handpiece, first turn the dust cap on the laser port and the dust cap on thehandpiece counterclockwise, remove it and place it in the accessory bag; Gently insertthe laser port and tighten the fastening nut clockwise. The port is a laser window,when connecting the laser handpiece, please turn off the device to prevent exposure toClass 4 laser radiation.After the laser handpiece is connected with the device, try not to separate thehandpiece and the laser port to prevent equipment from being damaged by dust. Ifseparation is necessary, protect it with a dust cap as soon as possible after theseparation, and do not bend the fiber tail cover during separation to prevent damage orbreakage of the fiber.WARNING: In order to avoid dust contamination, do not touch the laser portand the handpiece port by hand when connecting the handpiece, otherwise it willlead to decreased output power, burned fiber head or coupler and other issues;When connecting the handpiece or fiber into the laser port, try not to bend orimproper fixation to prevent the fiber break, burn fiber and coupler. Failure tofollow these procedures will lead to optical fiber and optical transmission systemdamage, resulting in laser radiation hazards.8.3.4 The use of handpieceAfter setting the treatment, open the indicator light and click the "STANDBY" buttonin the interface to enter the "READY" state. In the "READY" state, align thehandpiece head with the treatment site and press the handpiece button switch to firethe laser.In the course of treatment, the laser output handpiece window and the patient's skinshould maintain a minimum distance of 3cm, and the treatment time is generally 3-5minutes. At the same time, the treatment staff should always pay attention totreatment to avoid the patient's skin redness, burning and other adverse reactions.
page 19 of 50During the course of treatment, please wear protective goggles. Do not look into thelaser beam or reflected or scattered light of the laser beam, otherwise irreversibledamage to the eyes could occur. In the course of treatment, do not remove thehandpiece head to prevents the laser energy from over-irradiating the skin; Do not usethe handpiece to illuminate the non-treated area.Note: If the accessories(such as handpiece) are damaged, lost, or need to be purchased,please contact the designated dealer or K-Laser. The use of non-designatedaccessories will result in device not working, or damage and injury to personnel.
page 20 of 509 The appearance of the medical device#ITEMDESCRIPTION1DisplayDisplay all the operation information2HandpieceTreatment Handpiece3IndicatorPower(Green)/Reminding(red)/Laser(Yellow)4Fiber SpoolStores Fiber5HolderHandpiece holder6HandleFor Transporting the Unit7Foot switch ConnectorPortConnects Wired Foot switch to the Unit8Remote Interlock PortConnects Interlock to the Unit9Circuit BreakerMaster ON/OFF Switch10DC Power ConnectorConnects Power Supply to the Unit11Lithium ion batteryBack-up power12Fiber PortSMA 90513USB PortSoftware Update14Emergency StopButtonDisables the device In the Event of anEmergency15Safety GogglesLaser protective glasses
page 21 of 5010 Operation GuideThere are continuous and pulse output modes in Platinum Laser System, the operatorshould select a reasonable treatment based on the patient's condition and treatmentoptions.1) When using continuous mode for treatment, it is recommended that the powersetting does not exceed 3W. In the course of treatment, we recommend the use of scantreatment methods and observe the treatment at any time to prevent a long timeexposure to a site, causing skin and soft tissue burns.2) When using pulse mode, it is recommended that the operator limit the averagepower to within 3W with positive and negative pulse width settings.WARNING: If the control device, regulating device or operation does not followthe prescribed method, the hazardous radiation exposure may result in injury ordamage to personnel and equipment. And the control device, regulating devicesinclude: LCD, emergency stop, key switch, remote interlock, handpiece switch,etc.10.1 PreparationsBefore starting the systems, make sure to complete the following:The protective goggles are available for the people in the room;The device has already been plugged into electricity, and the socket has a goodgrounding;The handpiece has already been connected to the laser aperture;The remote interlock connector has been used.10.2 Starting of the device1) Turn on the system main power, power indicator will be green with the system fansworking. At the same time, the LCD screen lights up.2) The system will perform a self-check.3) After the self-test, the system enters the standby main interface.Note: After the system is powered on, it will enter the self-test program, and thewelcome interface will be showed after the completion of self-test, please be patient.10.3 Custom treatments operation instructions1）After the self-test completed, enter Figure 1: standby interface.
page 22 of 50Figure 1: Standby interface
page 23 of 502）Click on the standby interface, enter to the power-on password input interface(Figure 2), enter the power-on PIN code.Figure 2: PIN code input interface3）After entering the PIN code, enter the user selection interface (Figure 3), click on"CUSTOM TREATMENT" to enter the custom treatments interface.
page 24 of 50Figure 3: User Selection Interface4）Click "CREATE CUSTOM TREATMENT" in the Custom treatments Interface(Figure 4) , create a new treatment plan.
page 25 of 50Figure 4: Custom Treatments Interface5）Into the treatment parameter selection interface (Figure 5), the treatment is dividedinto six phases (PHASE 1 ~ PHASE 6), the user can change the treatment time,treatment power, pulse frequency, wavelength selection and other parametersaccording to the actual needs of each stage. When setting completed, click "SAVEAS", select the category, enter the name of the treatment plan, such as "hh", click
page 26 of 50"SAVE" to save.Figure 5: Treatment parameter setting interface6）Go back to the "Custom Treatments" interface (Figure 6) and select the treatmentplan you just created. If you want to edit it again, click "EDIT"; if you want to deleteit, click "DELETE"; if you want to copy the treatment, click "DUPLICATE" , Enterthe new program name; if you want to directly treat, click on "USE TREATMENT" to
page 27 of 50enter the start treatment interface, it shows the parameters of the treatment plan, youcan increase or decrease the time and energy by 25%, after the confirmation, click"START TREATMENT".Figure 6: Custom Treatments Interface7）Enter the protective goggles warning interface (figure 7). Please make sure theuser has put on protective goggles to avoid the laser radiation.
page 28 of 50Figure 7: Protective Goggles Warning Interface8）After confirming that the protective goggles are worn, press the finger switch toenter the start treatment interface, and “LASER ON” (Figure 8) is displayed in thelower right corner. The device starts the treatment with accompanying sounds andindicators.
page 29 of 50Figure 8: Treatment interface9.4 Administrative settings instructions1）Click “ADMINISTRATIVE SETTINGS” in the interface of Figure 1 to enter theadministrative setting interface, see Figure 9.
page 30 of 50Figure 9: Administrative Settings interface2）Click "WIFI" and click "ON" to connect to the wireless network.
page 31 of 50Figure 10: WIFI connection interface3）Click “CUSTOMIZATIONS” to enter the customizations parameter settingsinterface (Figure 11). You can set the device's sound size, brightness, date, time, unitof measure and other parameter settings.
page 32 of 50Figure 11: Customizations Parameter Settings interface4）Click on "LANGUAGE" to enter the language settings interface (Figure 12) toset the user's language.
page 33 of 50Figure 12: Language Settings interface5）Click "DEVICE INFO" to enter the device parameter information interface, youcan view the device information.
page 34 of 50Figure 13: Device Parameter Information Interface6）Click "DASHBOARD REGISTRATION" to enter the user registration interface(Figure 14), you can fill in user-related information and change the password andother operations.
page 35 of 50Figure 14: User Registration infterface7）Click "USERS" to enter the user management interface (Figure 16), you canchange the administrator name, password, add users and other operations.
page 36 of 50Figure 15: User Management Interface
page 37 of 5011 Reminding Function Description11.1 Reminding TypesThe system provides five reminding prompts, namely:High temperature remindingRemote interlock remindingHandpiece switch remindingLaser remindingFiber remindingAll of the above remindings are technical remindings. When the reminding occurs, theuser must do the appropriate treatment according to the priority of the reminding toprevent the harm to personnel or device.11.2 Reminding ModeThe Platinum Laser System provide three kinds of reminding modes. They are sound,graphical reminding signs, reminding indicator. Abnormal system state will lead toreminding and interrupt the laser outputting to ensure the safety of personnel anddevice. Moreover, the reminding delay is less than 1s.11.3 Reminding FunctionThe Platinum Laser System monitors the operating status of the system in real time.Sounds, indicator lights, and graphical reminding signs alert the system to abnormalevents while interrupting the laser laser outputting.The following table details the reminding types, reminding priority, reason andreminding fix methods for this device:Reminding TypesReasonExclusion MethodsHigh Temperaturereminding1.Laser temperature exceeds 45℃;2. Fiber coupler temperatureexceeds 60 ℃;3. Temperature sensor failure;1. Turn off the power, if the temperature remindingcaused by the high temperature, air cooling device for10 minutes and it will return to normal after the boot;2. Please contact the company for after-salesmaintenance.Remote InterlockremindingThe remote interlock is not properlyinserted or is not inserted into thedevice;Check the rear panel of the device and whether theremote interlock is correctly inserted into the device; Ifthe remote interlock is inserted into the device and thereminding condition is still unresolved, please contactthe company for after-sales maintenance.Handpiece SwitchremindingThe handpiece switch is notproperly inserted or is not insertedinto the device;Press the handpiece switch buttonwhen it’s not into the "Ready" state;1,Check the front panel and whether the handpieceswitch is correctly inserted into the device;2, If the handpiece is properly inserted into the device,the reminding status is still unresolved, please checkthe handpiece switch button is pressed or not;3, Check the above operation, if there is still remindingstatus, please contact the company for after-salesmaintenance.
page 38 of 50Laser remindingEmergency interlock failuresPlease contact the company for after-salesmaintenance.Fiber remindingFiber connector is not inserted intothe laser window;Micro - switch of laser windowfails;Insert the fiber connector into the laser window of thedevice;If there is still an reminding, please contact thecompany for after-sales maintenance.Based on the above, the user can perform general troubleshooting. If the fault can notbe solved, please do not disassemble inspection and contact the company forafter-sales maintenance.11.4 Reminding System TestThe user can determine whether the reminding system is functional by self-test: Forexample, if the user unplug the remote interlock, the system will appears sound,reminding indicator, graphical reminding signs and other reminding messages. Afterverifying the reminding system is functional, please restore the remote interlock.11.5 Fault Diagnosis and AnalysisDo not use the device for treatment when the device is malfunctioning or in otherabnormal conditions. Please promptly in accordance with the instructions for thetroubleshooting and contact the company for customer service advice.FailurePhenomenonCause AnalysisExclusion MethodsTurn on the powerswitch, the systemindicator does notlight and the systemdoes not start1, Emergency stop is not turnedon;2, The power switch is not turnedon;3, Fuse blown.1, Release of emergency stop switch;2, Turn on the power switch;3, Remove the fuse holder and check the internalfuse with professional tools. If the fuse is damaged,replace the two 1A 250V quick-blow fuses andinsert the fuse holder into the filter switch.The screen displaysan reminding1, Remote interlock is notconnected;2, The handpiece switch is notconnected;3, The handpiece fiber is notconnected;4, Laser failure.1,Check whether the remote interlock is connectedproperly;2,Check the handpiece switch is connectedproperly;3, Check whether the fiber is connected properly;4, Check whether the handpiece switch is pressed instandby mode;5,Contact the company for after-sales maintenance;There is no soundindication when thelaser is outputtingBuzzer malfunctionContact the company for after-sales maintenance;Laser powerattenuation1, The glass lens of handpiece iswith dust or other dirt;2, Laser attenuation;1, Clean the glass lens with a paper towel;2,Calibrate the laser power according to theinstructions;3,Contact the company for after-sales maintenance;No laser emission1, The coupler is damaged;Contact the company for after-sales maintenance
page 39 of 502, Optical fiber is damaged;3, Laser is damaged;4, System failure.Note: Users can perform general troubleshooting according to the above. If you cannot solve the problem, do not disassemble to check, please contact the companyafter-sales staff for maintenance.
page 40 of 5012 Maintenance12.1 Daily maintenance1) Protect the fiber of handpiece from rigid bending, so as not to break the fiber.2) After removing the handpiece, immediately cover the dust cap to prevent dustpollution, dust cap must be cleaned with alcohol before use.3) Do not use a hard or sharp things scratch the touch screen, can not use chemicalreagents rub the touch screen. Please wipe carefully with lens paper.4) Before using the device, please wear medical plastic gloves and check whether theend of the handpiece probe is clean. Otherwise, use alcohol (or lens paper) to cleanthe probe end and handpiece until the alcohol is completely evaporated before usingthe device.5) Clean the surface of the device regularly to prevent the accumulation of dust. Werecommend the use of alcohol, but should avoid splashing liquid into the interior ofthe device.6) The vibration or collision should be tried to avoid in the process of moving thedevice.7) Please contact the company or the designated dealer to repair and maintain thedevice when the power is reduced. Do not disassemble the device without guidance toavoid the damage on the human body and device that caused by the possible harmfullaser radiation.8) It is advisable to carry out a routine inspection and maintenance and powercalibration every year under the guidance and operation of our authorized personnelor designated dealers to avoid possible damage to the device and harmful laserradiation on personnel.12.2 The maintenance for long-term storagePlease pack the device in accordance with the factory packaging for long-term storageand then place it in a well-ventilated, dry, cool environment.1) Turn the power switch to the "OFF" position and unplug the power adapter;2) Turn the power switch to the "O" position and unplug the power cord;3) Rotate the fastening nut at the laser port of the handpiece counterclockwise andgently unplug the handpiece fiber. Then protect the handpiece with the dust cap andoptical fiber laser port;4) Gently unplug the handpiece signal connector and the remote interlock connector,then place them into the accessory bag with the key switch.5) Place the main device, accessory bag, handpiece, power cord, protective gogglesin the packing box.6) After being packed, place the device in a well-ventilated, dry, cool environment.12.3 Power CalibrationNote: When the outputting power is found to be more than ± 10% of the setting power,please contact our company or a designated dealer for power calibration.
page 41 of 50The suggested frequency for calibriation is once per year.When it expires and needs tobe calibrated, the user can send it to our company for calibration or our companyengineer to go to the scene for calibration. Users are not allowed to calibratethemselves in order to avoid the risk of laser radiation.WARNING: Please carry out the calibration of the device under the guidance of theauthorized personnel of the company or the designated dealer. During the calibrationprocess, please wear eye protection to avoid possible harmful laser radiation damageto personnel and device.CALIBRATION SCHEDULEAuthorized by:Purchase Date ____//____// ____________ ______________________________Calibration 1 ____//____// ____________ _______________________________(12 months after purchase date)Calibration 2 ____//____// ____________ ________________________________(24months after purchase date)Calibration 3 ____//____// ____________ _______________________________(36 months after purchase date)Calibration 4____//____// ____________ ________________________________(48months after purchase date)Calibration 5 ____//____// ____________ _______________________________(60 months after purchase date)Calibration 6 ____//____// ____________ _______________________________(72 months after purchase date)Contact PIOOM to be connected to the repair center closest to the laser location. Repair andmaintenance centers are located worldwide.
page 42 of 5013 The Waste DisposeScrapped device and loss parts (such as Battery，etc.)should be strictly in accordancewith the local laws and regulations for processing rather than could be discardedoptionally.
page 43 of 5014 Product Identification And Packing InstructionsProduct identification and packaging instruction are in line with EN ISO 15223-1:2012 and other related requirements. Product identification and packaging used ingraphics, symbols are as follows:Graphics / symbolsMeaningPositionLaser Danger &Optical FiberThe window of thefiber connection onthe top of the deviceClass 4 laser productexplanatoryLaser output andstandard informationThe position of theback panel near thetop of the deviceremoteinterlockThe position of theback panel near thetop of the deviceLaser apertureLaser outputwindow on the toppanel of the devicePanelThe position of theback panel near thetop of the deviceLaser output andstandard informatioinThe position of theback panel near thetop of the device
page 44 of 50Emergency Power OffThe position of theemergency stopswitch at the sidepanel of the deviceProduct nameplateThe position of therear base of thedeviceFCC NoteThe position of therear base of thedeviceSerials numberThe position is onthe nameplateInstruction manualThe position is onthe nameplateManufacture dateThe position is onthe nameplateManufacturerThe position is onthe nameplateNon-recyclableThe position is onthe nameplateBF TypeThe position is onthe nameplateIPX1Water proof levelThe position is onthe outer packageFragile, be carefulThe position is onthe outer packageKeep DryThe position is onthe outer package
page 45 of 50Transport should beuprightThe position is onthe outer packageTemperatureLimitationThe position is onthe nameplateFCC IDThe position is onthe nameplate
page 46 of 5015 Electromagnetic CompatibilityPlatinum Laser System conforms to the EMC requirements of IEC 60601-1-2: 2015and has been tested in accordance with IEC 60601-1-2: 2015.Warning: Keep away from strong radiation sources and electromagneticinterference environment. External RFI and electromagnetic interference willaffect the normal operation! Such as cardiac pacemakers and other devicesensitive to electromagnetic environment, please try to avoid using together.
page 47 of 5016 FCC StatementThis equipment has been tested and found to comply with the limits for a Class B digitaldevice, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonableprotection against harmful interference in a residential installation. This equipment generatesuses and can radiate radio frequency energy and, if not installed and used in accordance withthe instructions, may cause harmful interference to radio communications. However, there isno guarantee that interference will not occur in a particular installation. If this equipment doescause harmful interference to radio or television reception, which can be determined byturning the equipment off and on, the user is encouraged to try to correct the interference byone or more of the following measures:-- Reorient or relocate the receiving antenna.-- Increase the separation between the equipment and receiver.-- Connect the equipment into an outlet on a circuit different from that to which the receiver isconnected.-- Consult the dealer or an experienced radio/TV technician for help.§ 15.21 Information to user.Any Changes or modifications not expressly approved by the party responsible forcompliance could void the user's authority to operate the equipment.The antenna must be installed complying with the requirements of manufacturer or supplier,and it must be at least 20cm from human body.
page 48 of 5017 Services17.1 Quality commitmentThe company guarantees the factory technical parameters of Platinum Laser System is in linewith the product standard requirements of the EU medical device regulatory approved, andpromises the sale of products for free maintenance within 12 months.1) Provide laser training and clinical guidance;2) Provide parts or machine spare parts;3) Product maintenance and technical advice.When it expires and needs to be calibrated, the user can send it to our company for calibrationor our company engineer to go to the scene for calibration. Users are not allowed to calibratethemselves in order to avoid the risk of laser radiation.17.2 Disclaimer ClauseDamage to the product caused by the following will not be covered by the warranty:1) The customer is incorrect, improper use.2) operate and store in an environment other than those specified in the product specification;3) Unauthorized removal of the shell, modified device.4) Use accessories that do not match the device.5) Incorrect maintenance.6) Turn on the chassis of the laser system.
page 49 of 5018 Contact informationIf there’s any difficulty in using the medical laser systems, or any questions andsuggestions, please visit our website, call or write to the company.We will provideyou and the company's products for a comprehensive long-term service!K-laser USA, LLCAdd: 1185 West Main Street Franklin,Tennessee 37064 U.S.A.Tel:866-595-7749Email:info@k-laser.com
page 50 of 50EU Authorised Representative Information:EU Authorised Representative: EmergoEU Representative Address: Prinsessegracht 20, 2514 AP, The Hague, TheNetherlands

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