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Operating instructions K-Laser Blue Derma Rev. ZE 

 

Page 69 of 70 

LABEL 

EXPLANATION 

 

Label_1: Warns of exposure to class 4 laser radiation hazards when 
using the laser unit. 

 

Label_2: Warns of potential laser radiation hazards when opening 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 clearance. 
(Only for Us market) 

Summary of Contents for Blue Derma

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 31...

Page 3: ...tions 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 f...

Page 4: ...ct 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...

Page 5: ...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 med...

Page 6: ...e 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...

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 eq...

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 o...

Page 9: ...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...

Page 10: ...er 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 Conne...

Page 11: ...ser 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 open...

Page 12: ...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...

Page 13: ...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 rechargea...

Page 14: ...ng 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 da...

Page 15: ...1 ENT handpiece 1 Endo handpiece 1 Optic fiber 400 m 3 m for Endo handpiece 1 Optic fiber 600 m 3 m for Endo handpiece 1 Interlock connector 1 Laser protective goggles 315 450 DIRM LB5 OD5 450 460 DI...

Page 16: ...hargeable 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 ca...

Page 17: ...e 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 E...

Page 18: ...n 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...

Page 19: ...tor 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...

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 steri...

Page 21: ...ten 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 makin...

Page 22: ...p 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 millime...

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...

Page 24: ...s 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...

Page 25: ...or 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 corre...

Page 26: ...ber 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 th...

Page 27: ...ved 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...

Page 28: ...rning 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 O...

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 disconnec...

Page 30: ...ng 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...

Page 31: ...vels 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 i...

Page 32: ...le 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 int...

Page 33: ...rectly 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 display...

Page 34: ...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 pres...

Page 35: ...ressing 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 k...

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...

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...

Page 38: ...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 va...

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 ene...

Page 40: ...le 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 goggl...

Page 41: ...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...

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 outc...

Page 43: ...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...

Page 44: ...ser 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 a...

Page 45: ...n 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 dev...

Page 46: ...d 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 warning...

Page 47: ...tting 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 rel...

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 Singl...

Page 49: ...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 opera...

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 opera...

Page 51: ...ress 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...

Page 52: ...sive 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...

Page 53: ...evice 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 ne...

Page 54: ...herapy 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 keep...

Page 55: ...ce 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 Pleas...

Page 56: ...rnal 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 be...

Page 57: ...y 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 disinfec...

Page 58: ...r 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...

Page 59: ...pes 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 wit...

Page 60: ...ect 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 wi...

Page 61: ...l 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...

Page 62: ...t 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 la...

Page 63: ...LECTROMAGNETIC 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 electron...

Page 64: ...y 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 comme...

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...

Page 66: ...atts 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...

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...

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: ...ng 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 Fibe...

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...

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