Dentsply Sirona SiroLaser Blue Operating Instructions Manual Download Page 80

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11 Appendix
11.2 Appendix B -Label positions

Dentsply Sirona

Operating Instructions SiroLaser Blue

66 56 842 D3648

D3648.201.03.02.02 10.2018

Bottom side

CAUTION

CLASS 4 VISIBLE AND INVISIBLE LASER

RADIATION WHEN OPEN. AVOID EYE

OR SKIN EXPOSURE TO DIRECT

OR SCATTERED RADIATION

Radio module: nanoLOC AVR

FCC ID: SIFNANOLOCAVR0108

IC: 7654A-nanoLOCAVR

0682

SiroLaserBlue

REF6542273

SN00006

SironaDentalSystemsGmbH

Fabrikstr

.31,64625Bensheim

Germany

MFDA01

01/2015

0123

15VDC6.66

max100V

Use only with power supply

Sinpro MPU 101-106

USA ONLY

Complies with FDA performance
standards for laser products
except for deviations pursuant to
Laser Notice No. 50 dated
June 24, 2007

Under the battery cover

11.2.2

Wireless foot control – optional

Radio module: nanoLOC AVR

FCC ID: SIFNANOLOCAVR0108

IC: 7654A-nanoLOCAVR

0682

Wireless Footswitch

REF 6659556

SN 00006

Sirona Dental Systems GmbH

Fabrikstr. 31, 64625 Bensheim
Germany

MFD A01

04-2018

0123

15 V DC 6,66 A max 100 VA

AE68

Summary of Contents for SiroLaser Blue

Page 1: ...as of 10 2018 SiroLaser Blue Operating Instructions valid for USA English Rx only Federal law restricts this device to sale by or under the order of a dentist physician or licensed healthcare practiti...

Page 2: ...ns 8 2 3 Operating personnel 9 2 4 Physical working principle 9 2 5 Functional check 9 2 6 Laser radiation hazards 10 2 7 Nominal ocular hazard distance 10 2 8 Laser protective goggles 11 2 9 EasyTips...

Page 3: ...n off power 38 5 3 Enter pin code 40 5 4 Sleep Mode 40 5 5 Main home screen 40 5 5 1 Self Test 41 5 5 2 Favorites 43 5 5 2 1 Change a favorite 43 5 5 3 Submenu All applications 44 5 5 3 1 My Applicati...

Page 4: ...e rechargeable battery of the control unit 70 8 7 Replacing the batteries of the wireless foot control 71 8 8 Replacement of parts subject to wear and tear 72 9 Electromagnetic compatibility 73 9 1 El...

Page 5: ...Operating Instructions are designed to assist you prior to initial use and whenever you require information later on It is important to observe all safety information to prevent personal injury and ma...

Page 6: ...gingivectomy gingivoplasty gingival troughing crown lengthening hemostasis of donor site removal of granulation tissue laser assisted flap surgery debridement of diseased epithelial lining incisions a...

Page 7: ...d in the present manual have the following definitions Instructions for action Prerequisite 1 First action step 2 Second action step or Alternative action Result reaction of SiroLaser Blue Prompts you...

Page 8: ...situation which could lead to damage of the product or an object in its environment NOTE Information to make work easier For application information and other useful information 2 2 Standards and regu...

Page 9: ...persons against hazards ensure correct application of protective eyewear Unauthorized access In order to prevent false or improper use the SiroLaser Blue must not be used by unauthorized persons There...

Page 10: ...s exposure to radiation CAUTION Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure Dentsply Sirona cannot be held...

Page 11: ...instruments such as microscopes eye loupes or magnifiers together with the original protective goggles Use of these instruments with the protective goggles will no longer ensure sufficient eye protec...

Page 12: ...st not be sterilized again after usage They are disposable products and are not for re use Never reuse the single use fiber tips as they can also damage the handpiece optics if used more than one time...

Page 13: ...rona The user is responsible for any damage resulting from the use of non approved accessories It is not permitted to modify the design or construction of the unit Maintenance The unit must be checked...

Page 14: ...648 201 03 02 02 10 2018 3 System description 3 1 System overview SiroLaser Blue Control unit A B C D E F G I H A LED lights B Touch screen C Laser Stop key D Carry handle E Single use fiber tips Easy...

Page 15: ...tion 3 1 System overview 66 56 842 D3648 D3648 201 03 02 02 10 2018 15 A ON OFF switch B Power supply socket C Interlock connector including interlock connector D USB port Wireless foot control option...

Page 16: ...um power equals the average power In the adjacent example the laser is in CW mode with a power of 3 W Chopped mode In literature sometimes referred to as pulse mode The laser beam is interrupted at re...

Page 17: ...Laser Notice No 50 dated June 24 2007 USA ONLY This label stands for device compliance with FDA laser product performance standard This label stands for device compliance of the wireless foot pedal D...

Page 18: ...on socket for USB Interference is possible in the vicinity of the device 13 C 5 The disassembled handpiece sleeves may be sterilized only in autoclaves with saturated water vapor at minimum sterilizat...

Page 19: ...2018 19 Warns of laser radiation emission at the distal tip of the handpiece It also indicates the socket for the handpiece cable FINGER SWITCH Warns of laser radiation hazards when the fiber connect...

Page 20: ...p prox approximately mA Milliampere IR Infrared diode A m Ampere per meter g Gram mW Milliwatt kg Kilogram W Watt s Microseconds P Power ms Milliseconds Pmax Maximum power s Seconds J Joule m Micromet...

Page 21: ...rox 25 50 100 mW CW Laser system 445 970 nm Class IV 660 nm Class I according to IEC 60825 1 Device classification Class IIb according to Council Directive 93 42 EEC Emission modes CW continuous wave...

Page 22: ...ins of SiroLaser Blue is conducted by unplugging the plug of the power supply on the backside of the unit s housing Optical fibers specification Type of optical fiber EasyTip 320 EasyTip 200 EasyTip E...

Page 23: ...device must always be kept in the box supplied by Dentsply Sirona Thus stored the SiroLaser Blue can withstand the following ambient conditions Temperatures from 40 C to 70 C Relative humidity from 1...

Page 24: ...tips the following environmental factors have to be considered in terms of storage Protection from moisture Protection from pollution Mechanical stress Exposure to direct solar or UV radiation Exposur...

Page 25: ...Blue control unit including handpiece with integrated finger switch 1 x Additional handpiece sleeve for alternating oper ation 1 x Demo set of single use fiber tips non sterile demo fibers 2 x EasyTip...

Page 26: ...Bend Bending tool 2 pieces 66 18 180 Fibercutter 60 91 669 Laser protective goggles 65 41 515 Laser protective goggles for spectacle wearers 65 46 407 Laser protective goggles for patients 65 41 523 B...

Page 27: ...f the laser unit If any power supply other than the one recommended is used the approval of the entire unit automatically becomes void and the warranty granted by Dentsply Sirona expires The use of an...

Page 28: ...r tip EasyTip 200 sterile Single use optical fiber tip EasyTip Endo sterile For the specification of each type of EasyTip see chapter Technical Data 21 EasyTips are delivered sterile in a special pack...

Page 29: ...ptical fiber of the EasyTip may be damaged if it is seriously bent This may constitute a health hazard for patients dentists and dental assistants Remove the protection cap for treatment only Never to...

Page 30: ...s firmly seated on the handpiece and perform a visual check to make sure that it has not been damaged during shipment 7 Put the laser into operation by choosing any preset treatment A corresponding de...

Page 31: ...canal The endo stopper can be moved on the optical fiber 1 To guarantee the sterile conditions of the fiber tip please use the sterilized bending tool to adjust the position of the endo stopper 2 Plac...

Page 32: ...iber It is only necessary to create small notch to produce a clean break when breaking the fiber at the notch WARNING If the optical fiber of the EasyTip does not protrude at least 5 mm out of its met...

Page 33: ...rers are used physical properties such as load carrying capacity and transmission behavior may vary Dentsply Sirona therefore assumes no liability in such cases Therefore use only Dentsply Sirona ligh...

Page 34: ...ip after treatment make sure to protect the optical fiber socket with the protective cap provided for this purpose Make sure that no dust or dirt can enter the optical system Otherwise the unit may be...

Page 35: ...e connected to a switch that is located near the door of the treatment room in order to ensure automatic interruption of the laser emission NOTE The installation must be performed by a qualified elect...

Page 36: ...er goes back one screen Home User goes directly back to home screen OK User agrees to settings confirms and activates action Save Settings of application will be saved in My Applications Delete Settin...

Page 37: ...screen The duty cycle is displayed in 1 steps from 1 to 100 without unit 100 is displayed as CW The frequency can be entered by typing in the numbers or by moving higher or lower by using plus or minu...

Page 38: ...iroLaser Blue for the very first time you will automatically be asked to set up the unit Please proceed as requested 1 Language and country setting For all users except US users Change the pre set cou...

Page 39: ...e to immediately restart the unit due to the shutdown process of the unit Please wait a few seconds until the shutdown is completed WARNING The laser main switch does not disconnect the battery loadin...

Page 40: ...hing the display the unit will immediately wake up and jumps into the password screen 5 5 Main home screen Gingivectomy Perio Germ reduction Endo Germ redaction Gangrene germ reduct Favorite 5 Favorit...

Page 41: ...please perform the registry of the wireless foot control and or check the battery see chapter Install wireless foot control optional 34 If the wireless foot control remains not selectable please conta...

Page 42: ...t or log in in month For the last 30 days it is displayed continuously on the home screen After excess of the service interval the days are displayed with a minus and red coloured The laser remains fu...

Page 43: ...applications from My Applications can be defined as favorite applications directly accessible from the home screen Four favorites are already pre selected at delivery but can be changed 5 5 2 1 Change...

Page 44: ...eous Aphthous Ulcers Periodontology Sulcular debridement Gingival incisions of granulation tissue Surgery Soft tissue surgery For surgical indications the unit offers one general preset program soft t...

Page 45: ...soon as the laser unit s notification to wear laser protective goggles appears and whenever the green LEDs are lit Any actuation of the finger or wireless foot control activates the laser unit Incorr...

Page 46: ...nt efficacy 3 Time In our example the output duration time is set to continuous 00 s In this mode the laser is activated as long as the finger or wireless foot control is pressed By pushing on the tim...

Page 47: ...0 Hz is entered the chopped mode set Selecting OK returns you to the treatment submenu in which you can further adjust the power time and duty cycle NOTE The chopped mode is not available with an aver...

Page 48: ...e keyboard field is hidden 4 Enter your desired parameters 5 The new input will be confirmed by pressing the OK button Applications can be deleted from My Applications by pressing the delete button WA...

Page 49: ...OK 5 5 3 2 4 User management When entering the user parameters menu the key user is already configured similar to a computer administrator This administrator has the possibility to enter five additio...

Page 50: ...o use NOTE Non usable applications due to direct selection or power limit restriction appear shaded and are disabled Load save user profiles It is possible to either upload user profiles including the...

Page 51: ...en CAUTION Leave the USB stick and the power cable plugged in until the completion of software update The software update may take up to five minutes 4 Enter the pin code The software update was succe...

Page 52: ...d 5 5 3 2 8 Laser calibration check WARNING You must wear the supplied laser protective goggles during the entire laser calibration check The following section describes the procedure to check the las...

Page 53: ...f the tolerance the test is stopped If the calibration check is passed successfully the message Calibration Test passed will appear Acknowledge with OK If the laser shows an error message please conta...

Page 54: ...ttings Language Language is only available if Country Settings are set for NON US English is preset and fixed for the US the button is grayed out You have the choice of different languages The current...

Page 55: ...splayed OK for confirmation ar row to go back to the cur rent screen No action oc curs Warns the user that USB is missing Please plug a suitable USB device Ver sion 2 0 into the slot Confirmation via...

Page 56: ...mple de fects 68 Displayed when the diode current differs by more than the 20 tolerance compared to the calibrated current Please contact Dentsply Sirona your local dental dealer or your authorized se...

Page 57: ...ent screen No action oc curs The device asks to use the protective goggles OK for confirmation ar row to come back to the current screen No action occurs Displayed in case of over heating of the laser...

Page 58: ...ress the fin ger switch for three sec onds This screen is dis played during laser cali bration for the calibration process with power me ter The operator presses Yes or No if the mea sured value in in...

Page 59: ...al of hyperplastic tissues treatment of aphthous ulcers leukoplakia laser removal of diseased infected inflamed and necrosed soft tissue within the periodontal pocket sulcular debridement removal of d...

Page 60: ...Anesthetics not needed Apply laser 1 3 mm away from lesion for a few seconds semicon tact wave the laser fiber over the entire lesion Interrupt treat ment briefly if pain sensations occurs Periodontol...

Page 61: ...ograms for 660 nm To create a 445nm or a 660 nm program please create a new program in my applications as described in chapter My Applications 48 and choose the 445nm or 660 nm wavelength 6 5 Examples...

Page 62: ...erstand the patient s medical history prior to treatment Exercise caution for general medical conditions that might contraindicate a local procedure Such conditions may include allergy to local or top...

Page 63: ...sher disinfector The parts may be seriously damaged For the number of sterilization cycles see chapter Replacement of parts subject to wear and tear 72 7 1 Cleaning NOTE Manual cleaning must always be...

Page 64: ...e of MinuteWipes from Alpro In the USA Caviwipes are recommended Observe the instructions provided by the manufacturer of these disinfectants 7 3 Sterilization WARNING Therapy light guide MultiTip han...

Page 65: ...protected against contamination Sterilize again once the storage period has elapsed This is not valid for sterile delivered single use EasyTips 7 4 Cleaning the control unit Use a dry soft cloth to r...

Page 66: ...W and 3 W 8 2 Cleaning the handpiece optics CAUTION From time to time the cleaning of the handpiece optics can be required because of soiled optics for example due to a missing optic protection cap Th...

Page 67: ...of therapy light guide 33 Before each treatment session System owner Calibration check of the laser see Laser calibra tion check 52 Weekly System owner Recommended check of the optical power at the en...

Page 68: ...If the foot control is not working Check if the foot control is chosen in the settings submenu Check the battery of the wireless foot control Register the wireless foot control again Single use fiber...

Page 69: ...accustic signal when activating the laser and or pushing the buttons Check the settings for the accustic signals in the settings submenu If you cannot solve the malfunction switch off the laser and c...

Page 70: ...may be damaged 7 Switch on the laser use power supply if necessary 8 Choose Battery calibration in the settings menu The following message will appear Unplug the laser and press OK for battery calibr...

Page 71: ...ch the SiroLaser Blue off at the main switch This prevents accidental triggering Removing and replacing the batteries 1 Remove the screws from the bottom of the foot control 2 Remove the cover and ope...

Page 72: ...e Therapy light guides change after 2 000 sterilization cycles or every two years Silicone key pad of the handpiece change after 400 treatments sterilizations Fiber cutter change after 400 treatments...

Page 73: ...with a certain level of performance 9 1 Electromagnetic emission The UNIT is intended for operation in the electromagnetic environment specified below The customer or user of the UNIT should make sur...

Page 74: ...rential mode 2 kV common mode voltage The quality of the line power supply should be that of a typical commer cial or hospital environment Voltage dips short interruptions and variations of the power...

Page 75: ...n the compliance level 3 in each frequency range Interference is possible in the vicinity of equipment bearing the following graphic symbol 1 The higher frequency range applies at 80 MHz and 800 MHz 2...

Page 76: ...he transmitter W Working clearance according to transmission frequency m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 P 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...

Page 77: ...To initiate return of the electrical device please send a disposal request to enretec GmbH You have the following options here Use the Returning an electrical device button under the eom menu item on...

Page 78: ...our country Prior to disposal remove the following batteries Batteries in the wireless foot control Lithium battery in the SiroLaser Blue 10 2 Accessories MultiTips handpiece sleeve incl keypad for fi...

Page 79: ...Council Directive 93 42 EEC concerning medical devices 11 2 Appendix B Label positions 11 2 1 Control unit The following figures show the positions of the labels on the SiroLaser Blue Front side SiroL...

Page 80: ...Sirona Dental Systems GmbH Fabrikstr 31 64625 Bensheim Germany MFD A01 01 2015 0123 15V DC 6 66 A max 100VA Use only with power supply Sinpro MPU 101 106 USA ONLY Complies with FDA performance standar...

Page 81: ...se the interlock circuit when the treatment room door is closed Lp1 Optional low level lamp used as an optical warning while the laser is in operation T1 Power transformer S2 Main switch for power sup...

Page 82: ...be required due to technical improvements Sirona Dental Systems GmbH Sprache englisch Printed in Germany D3648 201 03 02 02 10 2018 Nr 126 299 Sirona Dental Systems GmbH Fabrikstr 31 64625 Bensheim G...

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