K-LASER Blue Derma, Operating Instruction

Page 1: ...Operating instructions K Laser Blue Derma Rev ZE Page 1 of 70 Blue Derma Operating instruction English ...

Page 2: ... without written consent from Eltech K Laser s r l Via Castagnole 20 H Treviso Title Operating Instruction K Laser Blue Derma English language Date 24 10 2019 Rev ZE Manufacturer Via Castagnole 20 H 31100 Treviso Italy Tel 39 0422 21 04 30 Fax 39 0422 29 71 37 e mail service klaser it web site www klaser eu The device is manufactured in compliance with the provisions of Council Directive 93 42 EEC...

Page 3: ...itions 13 4 Installation 14 4 1 Standard equipment 14 4 2 Spare parts and optional 15 4 3 Power supply 16 4 3 1 Replacing the rechargeable battery 17 4 4 Optic fiber with connector 18 4 4 1 Handpiece for therapy 19 4 4 2 Contact surgical handpiece 20 4 4 3 No contact surgical handpiece 23 4 4 4 ENT handpiece 25 4 5 Care of handpiece s fiber 26 4 6 Interlock 27 4 7 Wireless footswitch 27 5 Operatio...

Page 4: ...act surgical handpiece 59 7 5 Cleaning of the ENT handpiece 60 8 Maintenance and service 61 8 1 Maintenance 61 8 2 Troubleshooting of simple defects 61 8 3 Safety check 62 8 4 Technical support repair and testing 62 9 Manufacturer s declaration on electromagnetic compatibility 63 9 1 Definitions 63 9 1 1 Emission electromagnetic 63 9 1 2 Interference immunity 63 9 1 3 Immunity level 63 10 Appendix...

Page 5: ...n be used in medical practice in physical therapy centers and in sport facilities The device can be used in an ambulatory for surgical and medical practice Notice The device may be operated only by medical qualified personnel The applicable occupational safety regulations and accident prevention measures and the current operating instructions must be complied with Notice Users are obliged to use o...

Page 6: ...ce included the power cable provided by the manufacturer Otherwise performance degradation of the device could happen Caution Not use the laser unit with surgical high frequency devices 1 5 Disposal of main unit and parts Notice TO ALL OPERATORS pursuant to the Legislative Decree of the 14th of June 2014 n 49 actuation of directive 2012 19 EU on the waste of the electrical and electronic equipment...

Page 7: ... side of the control unit Warning Observe all labels on the device Warning Operation of this laser unit by unauthorized persons must be prohibited in order to prevent incorrect or improper use Laser equipment not in use must be protected against unauthorized access This can be achieved for example by switching off the laser unit after use so that the electronic access key must be entered prior to ...

Page 8: ... on the rating plate of the adapter or in the technical specifications Warning Do not use the device if a visual inspection shows that it has been damaged Warning If you accidentally spill any liquid on the unit immediately stop treatment disconnect the power cable and contact your local depot or your authorized service center for assistance Caution Never under any circumstances try to disassemble...

Page 9: ...f you are using CW continuous emissions in order to check the sensibility of the patient and the energy density especially if the patient s skin is particularly brown Warning In case of the use of the handpiece for therapy it is recommended to verify that the part to treatment not present neo of great dimension or dark zones that could absorb excessive amounts of energy In this case protect with d...

Page 10: ...fer to manual first Do not dispose with domestic waste Connection socket for DC input from the power supply Connection socket for scanner handpiece not implemented Connection socket for interlock Connection socket for USB Laser radiation warning Specification of laser output power and wavelength of IR and aiming beam see also Chapter Technical data Verifies the compliance of the device with IEC 60...

Page 11: ...aser emission Chopped Mode Frequency Number of laser pulses per second Hertz Unit of measure for frequency Interlock Safety device that stops laser radiation when the door of the treatment room is opened Joule Unit of measure for emitted energy Watt Unit of measure for laser power 2 3 Abbreviations cm2 Square centimeter Hz Hertz s Seconds W Watt mW Milliwatt one thousandth of a watt J Joule nm Nan...

Page 12: ...e classification Class IIb according to Council Directive 93 42 EEC Wavelength nm 445 nm 5 nm 660 nm 10 nm 970 nm 15 nm 445nm 970nm total power W 20 13 445 nm CW power W 20 8 445 nm in pulsed mode W 20 10 970 nm CW power W 20 3 Max power 660 nm mW 100 Emission mode CW continuous wave pulsed modulated 1 Hz to 10 kHz IP degree of protection Laser unit IP20 footswitch cover not waterproof IPX5 accord...

Page 13: ...o 1060 hPa Caution Do not leave the device in a vehicle parked in the sun The inside temperature of the car could thus heat up to a point where individual components may be damaged Notice The rechargeable battery must be fully charged regularly After six months of no charging storage the rechargeable battery might lose its loading capacity and might not be rechargeable anymore 3 5 Operating condit...

Page 14: ...ing tool 1 Interlock connector 1 Laser protective goggles 315 450 DIRM LB5 OD5 450 460 DIRM LB3 OD3 808 1070 D LB6 I LB8 R LB7 OD8 650 680 650 680 0 01W 2x10E 6J RB1 OD1 2 1 Laser protective goggles darker 315 450 DIR LB5 OD5 450 460 DIR LB3 OD3 620 650 DIR LB1 OD1 650 680 DIR LB2 OD2 755 1090 D LB6 IR LB7 OD7 620 635 0 01W 2x10E 6J RB1 OD1 2 650 665 0 1W 2x10E 5J RB2 OD2 3 1 Ocular protector for ...

Page 15: ... 1 ENT handpiece 1 Endo handpiece 1 Optic fiber 400 µm 3 m for Endo handpiece 1 Optic fiber 600 µm 3 m for Endo handpiece 1 Interlock connector 1 Laser protective goggles 315 450 DIRM LB5 OD5 450 460 DIRM LB3 OD3 808 1070 D LB6 I LB8 R LB7 OD8 650 680 0 01W 2x10E 6J RB1 OD1 2 1 Laser protective goggles darker 315 450 DIR LB5 OD5 450 460 DIR LB3 OD3 620 650 DIR LB1 OD1 650 680 DIR LB2 OD2 755 1090 ...

Page 16: ...chargeable battery and whether the power cable is actually connected will be always displayed on the touch screen Notice There will be a warning if the rechargeable battery will reach a low level of capacity Notice While operating should the charge level of the battery be below 5 the green led will flash at 5 intervals to remind the user to plug in the unit The device is fully functional and can b...

Page 17: ...he new battery Replace the battery cover taking care the fiber lock will be in the proper position and screw gently Do not screw too firmly Plug in the power supply connector and switch on the device Enter in Setup menu select battery calibration A message screens asks to confirm the battery calibration process Press OK to confirm Unplug the power supply connector and wait until the device switche...

Page 18: ...on Always cover the connector with the special protective cap Make also sure that no dust or dirt enter the connector Otherwise the unit may be permanently damaged Use a soft cloth to clean it Caution Always cover the connector and the optic fiber with the special protection caps if the fiber is dismounted to make sure that no dust or dirt can enter inside Otherwise the unit may be permanently dam...

Page 19: ...ctor B Handpiece for therapy Initial check Caution Prevent dust dirt and foreign particles from entering the handpiece Make sure that it is always cleaned before during and after the use Caution Always cover the connectors with the special protective caps provided for this purpose after the removal of the handpiece The operator can attach the handpiece for therapy B to the connector A When attachi...

Page 20: ... been disinfected and sterilized in autoclave Notice The optic fiber tip the disposable tip the bending tool and the sleeve can be sterilized in an autoclave with saturated water vapor at minimum sterilization values of 134 C 273 2 F 3 min holding time and 2 04 bar 29 59 psi overpressure without damage Contact surgical handpiece body assembly The operator can attach the handpiece body B to the con...

Page 21: ...hten the optic fiber tip so that it can be easily loosened Make sure not to overwind Caution Never use the laser without fiber check for correct fixation Insert the handpiece body into the sleeve making sure that the optic fiber tip easily slides Slide the sleeve to regulate the optic fiber tip The optic fiber tip must protrude at least 1 cm out of the disposable tip Warning If the optic fiber tip...

Page 22: ...ip vertically at a white background located approx 5 cm away If the aiming beam projects no pattern at all adjust the aiming beam brightness or only an uneven pattern cut off another one to two millimeters Warning The aiming beam must not be aimed toward a person s eye It comprises an intensive light source even when set to a low power level Always wear protective goggles Now you can bend the disp...

Page 23: ... entering the optic fiber connections and the optic system Make sure that the optic system is always cleaned before during and after the use Otherwise the unit may be permanently damaged Warning After each use make sure to clean and disinfect the handpiece parts Disinfect and sterilize the optic fiber and the sleeve 4 4 3 No contact surgical handpiece This handpiece is made of the following parts ...

Page 24: ...ts The rotation of the two parts makes the operation easier The user must hear a sound click locking the parts This guarantees a correct connection No contact surgical tip assembly Screw the no contact surgical tip on the handpiece body Caution Check whether the surgical tip is damaged before attaching it Replace it if necessary Caution Please check that the surgical tip is firmly attached prior t...

Page 25: ...tor A When attaching or detaching the parts we recommend to slightly rotate the two parts This guarantees an easier connection The user must hear a sound click locking the parts This guarantees a correct connection Caution Check whether the ENT handpiece is damaged before attaching it Replace it if necessary Caution Please check that the ENT handpiece is firmly attached prior to each use Warning T...

Page 26: ...iber irreparably Marker of optic fiber s end Warning The fiber must be wound around the device counter clockwise Should it be wound differently will damage the fiber irreparably Warning The arrow of the label shows the correct winding of the fiber Warning The optic fiber may be damaged if it is seriously bent pitched or improperly routed Warning Bear in mind the maximum bending radius of the optic...

Page 27: ...rved 4 7 Wireless footswitch The wireless footswitch must be assigned to the device via a registration To register the footswitch proceed as follows In Set up select the item Set touch Press the key to start the procedure Follow the on screen instructions Caution Touch a grounded metal part before opening the housing to prevent damage to the PC board due to electrostatic discharge Caution Prior to...

Page 28: ...erning the battery status Press the icon to check the battery percentage Connected charging battery Battery is connected to power supply and charging Information Press it to see device information OK Operator confirms and activates action Back Operator goes back one screen Clear Press it to delete in case of wrong typing Save Operator saves an application OK Laser Laser is being activated Delete A...

Page 29: ... the on off button on the backside of the unit In case of the device is switched off the laser diode is permanently disconnected from power supply Notice The laser main switch on off does not disconnect the battery loading circuit i e the batteries are loaded even if the laser is off Notice In case of emergency press the laser stop button Note that the laser is interrupted and restarted in a safe ...

Page 30: ...ing Press it to confirm the pin code Press it to see device information Warning The device may be operated only by qualified personnel Do not give the access to unauthorized third parties Do not write down the electronic access key somewhere else to reduce the risk of misuse of the laser by unqualified persons Please turn off the unit after the use 5 4 Main menu screen After entering the pin code ...

Page 31: ...evels of the red aiming beam can be defined Graphic of the laser impulse Wavelength selector Press it to select needed wavelengths in individual or combined way Treatment phases if available Press to increase or decrease the value ISB modality It is on if the green bar is present DISB modality It is on if the green bar is present Press it to save a treatment Press it to go back one screen Press it...

Page 32: ...gle or combined modality 445nm selected the impulse is light blue 970nm selected the impulse is yellow 445nm 970nm selected the impulse is violet The explanation of the following icons is described into more details The following phases can be selected Deep Surface Finish Haemostasis or CW The selected phase has a green background If the keys are pressed the peak power can decrease or increase var...

Page 33: ...irectly enter into a manual area The device will automatically define the following parameters The explanation of the impulse profile on the screen is described into more details The impulse is displayed in light blue Horizontal line and numerical value on the right represent the average power that the device automatically calculates If ISB modality is on a bar with red profile 970nm emission is p...

Page 34: ...r vein s treatment of the Vascular area the device asks to select the patient skin type based on the Fitzpatrick tone scale These treatments can be applied only for light skin Notice If the key is pressed the device warns the operator that is entering in manual area and asks confirmation before proceeding After confirmation you will enter in the following area In some areas the device will directl...

Page 35: ...pressing numeric keyboard or by key to increase or decrease the number of impulses Frequency modality Sets the emission time expressed in seconds It can be defined by the user by pressing the numeric keyboard or by key to increase or decrease the number of seconds The 0 value on numeric keyboard corresponds to a laser emission in an infinite sequence This is shown as CW modality Where predicted Se...

Page 36: ... which the laser is emitting Toff is the time of the impulse during which the laser is off The height of the impulse is the peak power of emission The yellow line and the numerical value represent the average power that the device automatically calculates on the base of Ton Toff and power set by the operator This line gets on and off based on the average power Warning In order to increase the ener...

Page 37: ... screen Laser armed After a delay of 2 seconds by this button pressure the aiming beam is switched on and the laser is ready to be used Press it to save a treatment Notice In all the no contact tip the CW modality is not available The device will automatically define the following parameters The device calculates the energy delivered according to selected power and time The device shows the energy...

Page 38: ...f impulses Frequency modality Sets the emission time expressed in seconds It can be defined by the user by pressing the numeric keyboard or by key to increase or decrease the number of seconds The 0 value on numeric keyboard corresponds to a laser emission in an infinite sequence This is shown as CW modality Where predicted Sets the emission time expressed in seconds in continuous wave CW In this ...

Page 39: ... on the average power Warning In order to increase the energy and thus the tissue cutting strength it is recommended to decrease the T OFF time rather than to increase the T ON time In this way the energy of each impulse remains the same but the impulses frequency increases So the thermal damage around the treated tissue is limited Notice Press the key to save treatment The saved treatment is stor...

Page 40: ...ble the sound pressing the sound icon present on the laser activation screen The sound is disabled for the current treatment Warning All persons present in the room must wear the laser protective goggles as soon as it is advised during use Notice Before starting a laser treatment in battery operation please reconfirm the battery status When you actuate the foot switch the laser starts emitting At ...

Page 41: ...r represents the IR emission during the T OFF to perform bio stimulation of the tissue that is being surgically treated The images below represent the outcome of the histological test on lingual tissue after an incision made in ISB modality The ISB modality executes an incision with characteristics superior to those of an IR laser inasmuch as there is no presence of interstitial edema or other dam...

Page 42: ... going past below the top layer of the skin Regarding protrusions below 2 mm with respect to the top layer of the skin it is recommended to use only the ISB modality The images below represent the outcome of the histological test on lingual tissue after vaporizing the tissue in DISB modality The DISB modality has a vaporizing property for faster removal and stripping away tissue that must be compl...

Page 43: ...s modality is ideal for the removal of protruding tissue masses above 2mm from the skin s outer layer The incision made in ISB modality is superior to that of a IR laser with the edges of the incision perfectly defined and surrounding tissue perfectly healthy DISB ISB Deep Intelligent Surgical Blue combined with Intelligent Surgical Blue When both these modalities are activated deep surgery may be...

Page 44: ...aser treatment in battery operation please reconfirm the battery status Notice From the list of the treatments press to remove the treatment press to rename it The user can manage parameters pressing and the following screen will appear Select the field to be modified and then press Green selected field Grey not selected field Press it to count up and down numerical value Press it to go back previ...

Page 45: ...en field On the event the operator needs to modify and adjust the power the selected wavelength is highlighted in a red field Each wavelength can be singularly selected For each treatment phase the device keeps trace of the performed modifications The followings images show the colors used for the status identification In this screen The operator is working in this phase No modifications have been...

Page 46: ...nd it is adjustable between 0 1 W and max value of the model In 0 01 W increments by numeric keyboard or by touching Notice For the use of optics please read carefully specific instructions and warnings The device calculates the average power from the power values and duty cycle Frequency can be set in an infinite modality by selecting CW or may be adjusted from 1 10000 Hz by numeric keyboard or t...

Page 47: ...itting At the same time two yellow LEDs at the upper right and left end of the device control unit light up as well as the laser active bar on the touch screen and the audible alarm sounds When you release the switch to interrupt treatment the laser is deactivated but remains ready for operation Notice The user can disable the sound pressing the sound icon present on the laser activation screen Th...

Page 48: ... warning sound and press button sound by using the arrows Press OK for confirmation Battery calibration process Follow the instruction displayed on screen Configure the switch emission modalities Single touch laser active if fingerswitch is kept pressed Double touch laser is active at the first pressure of the fingerswitch Second pressure disables the emission RRT Remote Restart Control Software u...

Page 49: ...e device Digit the new pin code Confirm by pressing OK The numeric pad always displays the used key code Press it to confirm the new P I N Press it to go back one screen Warning The device may be operated only by qualified personnel Do not give the access to unauthorized third parties Do not write down the electronic access key somewhere else in order to minimize the risk of misuse of the laser by...

Page 50: ... pressed the message LASER ON appears and at the same time yellow LEDs light up audible alarm sounds and laser starts emitting At the switch release the laser is deactivated but remains ready for operation Notice Double touch At the first pressure of the switch the message LASER ON appears at the same time yellow LEDs light up audible alarm sounds and laser starts emitting At the switch release th...

Page 51: ...Press it to go back one screen Press View history to visualize the screen to set year and month to be consulted Use the arrows to scroll the date Confirming the choice with OK the device will show the treatment s parameters as in the following screen Press it to go back one screen Press it to export performed treatments into the USB stick Laser armed to perform the screened treatment After a delay...

Page 52: ...ssive modality modulated 1 10000 Hz or continuous CW Average power Total emitted energy even in case the operator performs more than 12 phases the device calculates the total emitted energy Arrows used to scroll treatments and number of pages to be scrolled The device allows the user to choose the following different file formats TXT Format available on any text program CSV Format used to exchange...

Page 53: ...device was not accepted Please plug it in again or try another USB device Connect plug to the DC IN Connect the DC IN connector to the device Battery low Please recharge The battery level is low and needs to be charged Battery very low Estimated power for 180 s The battery level is very low remaining power for 180 seconds and needs to be charged Wait laser source cooling To avoid damage of the las...

Page 54: ...therapy in direct contact to skin of the patient but to keep distance from the skin and always move it Warning Before therapeutical treatment with the handpiece for therapy please treat fix points keeping a distance of two centimetres from the skin of the patient in particular if you are using continuous emissions in order to check the sensibility of the patient and the energy density especially i...

Page 55: ...ice Use only disinfectants that comply with the requirements of your national authorities and whose bactericidal fungicidal and virucidal properties have been tested and properly certified Notice Please proceed carefully not to scratch and damage the foil on the touchscreen Notice The device may be disinfected only by wiping it Do not use spray disinfectant on the device Notice Optic fiber can be ...

Page 56: ...ernal lens use a cotton bud to clean it taking care not to extremely press the optic part More stubborn spots can be removed with a proper lens cleaner Wait the complete evaporation of the detergent before using the handpiece You can disinfect it using any of the products that are commonly used to disinfect medical electrical equipment e g MinutenWipes from Alpro and Caviwipes TM Observe the instr...

Page 57: ...ny of the products that are commonly used to disinfect medical electrical equipment e g MinutenWipes from Alpro and Caviwipes TM Observe the instructions provided by the manufacturers of these disinfectants Notice All debris must be removed from the optical fiber tip before it is detached from the handpiece Notice Use only not spray disinfectants that comply with the requirements of your national ...

Page 58: ...er running water Disinfect the optic fiber tip Remove the handpiece body Insert the protective caps of the handpiece body and handpiece socket Clean and disinfect the handpiece body Clean and disinfect the optic fiber with connector After use clean and disinfect the tool Caution Always cover the connectors with the special protective caps provided for this purpose after each removal of the handpie...

Page 59: ...ipes from Alpro and Caviwipes TM Observe the instructions provided by the manufacturers of these disinfectants Notice Do not use spray disinfectant on the handpiece optics Notice Use a gauze soaked with no alcohol detergent to clean the handpiece optics Clean and disinfect the no contact surgical tips Notice Use only disinfectants that comply with the requirements of your national authorities and ...

Page 60: ...fect medical electrical equipment e g MinutenWipes from Alpro and Caviwipes TM Observe the instructions provided by the manufacturers of these disinfectants Notice Use only disinfectants that comply with the requirements of your national authorities and whose bactericidal fungicidal and virucidal properties have been tested and properly certified Notice Clean the optic of the handpiece with a dry ...

Page 61: ...al safety checks for your laser unit these regulations must be complied with and the corresponding checks must be performed The manufacturer accepts responsibility for the safety of the laser unit only if the following requirements are fulfilled Modifications of the laser unit or repair work may be performed only by authorized personnel The electrical installations in the rooms where the device is...

Page 62: ...it and its accessories for mechanical damage that might impair operation General function check Check of the visual and audible indicators Check the electrical safety Check the power emission of the laser Check the cleaning of the optics 8 4 Technical support repair and testing In case technical support contact the following address ELTECH K LASER s r l Via Castagnole 20 H 31100 Treviso Italy Phon...

Page 63: ...ELECTROMAGNETIC ENVIRONMENT GUIDANCE RF emissions CISPR 11 Group 1 The unit uses RF energy only for its internal function The RF emission is therefore very low and it is improbable that nearby electronic devices might be disturbed RF Emission CISPR 11 Class A The unit is suitable for use in all establishments except for those destined to domestic use and those directly connected to the public low ...

Page 64: ...ly should be that of a typical commercial or hospital environment Surge EN 61000 4 5 2 kV differential mode 2 kV differential mode The quality of the line power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines EN 61000 4 11 Ut 0 0 5 cycle 0 15 90 135 180 225 270 and 315 Ut 0 1 cycle Ut 70 25 30...

Page 65: ... the unit including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter d 1 2 P from 150 kHz to 80 MHz d 1 2 P from 80 MHz to 800 MHz d 2 3 P from 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter manufacturer and d is the recommended separation distance in meters Radiated HF EN 61000 4 3 3 Vrms ...

Page 66: ...watts Separation distance according to frequency of transmitter in meters From 150 kHz a 80 MHz D 1 2 P From 80 MHz a 800 MHz D 1 2 P From 800 MHz a 2 GHz D 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters can be determined using the equation appli...

Page 67: ... Page 67 of 70 10 Appendix 10 1Appendix A Label positions The following figures show the positions of the labels on the device Picture 1 front side Picture 2 rear side Label 11 Label 5 Label 1 Label 4 Label 7 Label 8 Label 9 Label 14 Label 13 Label 5 ...

Page 68: ...Operating instructions K Laser Blue Derma Rev ZE Page 68 of 70 Picture 3 inner side Picture 4 bottom Label 2 Label 3 Label 10 Label 12 Label 6 ...

Page 69: ...ing the laser unit Label_3 Use only with power supply Sinpro MPU 101 106 Label_4 Specification of laser output power and wavelength of diode and aiming beam Label_5 Laser radiation warning Label_6 Fiber connection Label_7 DC in for power supply Label_8 Socket for Interlock Label_9 Socket for USB Label_10 K Laser Blue Derma Identification serial number of the device Label_11 Laser stop Label_12 FDA...

Page 70: ...Operating instructions K Laser Blue Derma Rev ZE Page 70 of 70 Label_13 Correct fiber winding Label_14 On off the device ...