K-LASER Blue Dental, Operating Instruction

Page 1: ...Operating instructions K Laser Blue Dental Rev ZE Page 1 of 72 Blue Dental 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 Dental English language Date 24 10 2019 Rev ZE Manufacturer Via Castagnole 20 H 3...

Page 3: ...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 16 4 4 Optic fiber with connector 17 4 4 1 Contact surgical han...

Page 4: ...or therapy 61 7 5 Cleaning of no contact surgical handpiece 62 8 Maintenance and service 63 8 1 Maintenance 63 8 2 Troubleshooting of simple defects 63 8 3 Safety check 64 8 4 Technical support repair...

Page 5: ...t with his specific requirements The device can be used in medical practice in medical and dentist ambulatories The device can be used in ambulatories for medical and dental practice Notice The device...

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: ...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...

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 Conn...

Page 11: ...d laser 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...

Page 12: ...to IEC 60825 1 Device 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 7 445 nm CW power W 20 4 970 n...

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: ...er 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...

Page 15: ...dy 1 No contact surgical tip 1 Skin spot tip 1 Minor telangiectasia tip 1 ENT handpiece 1 Interlock connector 1 Laser protective goggles 315 450 DIRM LB5 OD5 450 460 DIRM LB3 OD3 808 1070 D LB6 I LB8...

Page 16: ...ing 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 t...

Page 17: ...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 18: ...nter 4 4 1 Contact surgical handpiece This handpiece is made of the following parts A Optic fiber with connector B Contact surgical handpiece body C Sleeve for contact surgical handpiece body D Dispos...

Page 19: ...Caution Check whether the disposable tip is damaged before attaching it Replace it if necessary Caution Please check that the disposable tip is firmly attached prior to each use Warning Always use the...

Page 20: ...f the part Adjustment of the optic fiber Notch the optic fiber tip with the blade of the tool Bend the optic fiber tip at the notched location It breaks at the notched location with a smooth perpendic...

Page 21: ...lid in a bent disposable tip the optic fiber tip surface may be destroyed danger of optic fiber tip breakage As soon as you disassemble the optic fiber tip after treatment make sure to protect the con...

Page 22: ...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 23: ...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...

Page 24: ...zation values of 134 C 273 2 F 3 min holding time and 2 04 bar 29 59 psi overpressure without damage No contact surgical handpiece body assembly The operator can attach the handpiece body B to the con...

Page 25: ...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 t...

Page 26: ...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 27: ...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 28: ...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 29: ...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...

Page 30: ...creen is displayed Ten different levels 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 ISB m...

Page 31: ...ncy 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 k...

Page 32: ...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 33: ...one screen Press it to enter a manual screen User confirmation is needed 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...

Page 34: ...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...

Page 35: ...ases Speed frequency of impulses emitted in a second If the keys are pressed frequency number of impulses in a second decreases or increases Warning Follow carefully the indications written in the man...

Page 36: ...y 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 Where predicted Press it to save a treatment directly from this scr...

Page 37: ...yboard 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...

Page 38: ...ice 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 energy and thus the tissue cutt...

Page 39: ...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 40: ...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 41: ...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 en...

Page 42: ...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 gogg...

Page 43: ...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 tissu...

Page 44: ...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 45: ...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 46: ...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 47: ...y green 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 t...

Page 48: ...d it is adjustable between 0 1 W and max value of the model In 0 01 W increments numeric keyboard or by touching Notice For the use of optics please read carefully specific instructions and warnings T...

Page 49: ...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 re...

Page 50: ...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 51: ...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 52: ...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 oper...

Page 53: ...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 54: ...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 use...

Page 55: ...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 56: ...mended not to use the handpiece for 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...

Page 57: ...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 58: ...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 disinfe...

Page 59: ...th under 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 di...

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: ...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 62: ...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 63: ...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 64: ...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 65: ...ION TEST COMPLIANCE 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...

Page 66: ...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 comm...

Page 67: ...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 80...

Page 68: ...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 69: ...69 of 72 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 15 Label 1 Lab...

Page 70: ...Operating instructions K Laser Blue Dental Rev ZE Page 70 of 72 Picture 3 inner side Picture 4 bottom Label 2 Label 3 Label 10 Label 12 Label 6...

Page 71: ...on 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...

Page 72: ...Operating instructions K Laser Blue Dental Rev ZE Page 72 of 72 Label_12 FDA clearance Only for Us market Label_13 Correct fiber winding Label_14 On off the device Label_15 K Laser Dental logo...