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Fona Aquamarine, Operating Instructions Manual

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74

Aquamarine

11 Appendix

11.1

Appendix A – Certification

The unit is manufactured in compliance with the provisions of 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 Aquamarine:

Rear side

Bottom side

Summary of Contents for Aquamarine

Page 1: ...l f b Operating Instructions...

Page 2: ......

Page 3: ...hazards 10 2 6 Nominal ocular hazard distance 11 2 7 Laser protective goggles 12 2 8 UniTip EndoTip and ActiveTip 13 2 9 Contamination 13 2 10 Installation 14 2 11 Modifications 15 2 12 Radiotelephone...

Page 4: ...Self Test 44 5 4 2 Preset programs 45 5 5 Error messages warnings and instructions 49 5 6 Own programs 51 5 7 Settings 52 5 7 1 User management 52 5 7 2 Language 53 5 7 3 Audio Video 53 5 7 4 Service...

Page 5: ...8 Replacement of parts subject to wear and tear 66 9 Electromagnetic compatibility 67 9 1 Electromagnetic emission 68 9 2 Interference immunity 69 9 3 Working clearances 71 10 Disposal 72 10 1 Batter...

Page 6: ...initial use and whenever you require information later on It is important to observe all safety information to prevent personal injury and material damage Please perform maintenance and cleaning based...

Page 7: ...elf with its functioning and the specified warning and safety information The technical documents are a component of the product Help If you reach an impasse despite having thoroughly studied the Oper...

Page 8: ...s for action References Lists Designations Prerequisite 1 First action step 2 Second action step or Alternative action Result reaction of Aquamarine Prompts you to do something See General information...

Page 9: ...equirements may include special safety regulations concerning protection against laser radiation These requirements must be fulfilled The Aquamarine is manufactured in compliance with the provisions o...

Page 10: ...ized persons Therefore the Aquamarine equipment must be protected against unauthorized access when not in use This can be achieved for example by switching the Aquamarine off after usage so that the e...

Page 11: ...de Oxygen saturated materials such as cotton wool can catch fire due to high temperature that the unit reaches during operation Label removers and flammable solutions used for cleaning and disinfectin...

Page 12: ...s in the case Make sure that the laser protective goggles are not damaged conform to standard EN 207 with the following protection levels LB5 435 465 nm are suitable for the correct wavelengths labele...

Page 13: ...oken Otherwise the tips may become hot UniTip 320 m EndoTip 200 m and ActiveTip must be checked for sure seating prior to each use 2 9 Contamination Accessories Danger of cross contamination Pay atten...

Page 14: ...ion see chapter Installation Functional Check The system owner is obliged to use only technically faultless products Please check the unit for proper functioning before putting it into operation In ca...

Page 15: ...se of non approved accessories It is not permitted to modify the design or construction of the unit Maintenance The unit must be checked and maintained at regular intervals as described in chapter Mai...

Page 16: ...B Touch screen C Laser Stop key D Carry handle E Handpiece including laser diode F Single use fiber tips UniTip 320 m EndoTip 200 m G Finger switch with exchangeable keypad H Removable handpiece slee...

Page 17: ...0 OFF which can be adjusted via the duty cycle The average power is the product of power and duty cycle The result is better thermal control due to the fact that the OFF periods are used for thermal r...

Page 18: ...omatic control is integrated If the handpiece back is getting closer to the temperature limit the unit indicates that If the handpiece reaches the limit the unit will automatically interrupt the laser...

Page 19: ...p to 4 packages maximum Please refer to manual first IEC 60601 1 3rd ed Power flip switch indicator on the control unit s backside I indicates on O indicates off position of the flip switch Class II u...

Page 20: ...f hot surfaces The back part of the handpiece can get warmer during operation as is serves as a cooling element for the laser source Warning of a magnetic field in the holder of the handpiece Specific...

Page 21: ...ere per meter g Gram mW Milliwatt kg Kilogram W Watt s Microseconds P Power ms Milliseconds Pmax Maximum power s Seconds J Joule m Micrometer RF Radiofrequency nm Nanometer Hz Hertz mm Millimeter kHz...

Page 22: ...ass IV according to IEC 60825 1 Device classification Class IIb according to Council Directive 93 42 EEC Emission modes CW continuous wave chopped 10 Hz to 150 Hz Pulse Repeated pulse Pulse duration C...

Page 23: ...the plug of the power supply on the backside of the unit s housing Type of optical fiber UniTip 320 m EndoTip 200 m Core diameter 320 m 200 m Cladding diameter 385 m 240 m Coating diameter 408 m 270 m...

Page 24: ...onmental conditions Temperatures from 10 C to 33 C Relative humidity from 10 to 95 Atmospheric pressure from 80 kPa to 106 kPa The Aquamarine may be operated in the following environmental conditions...

Page 25: ...to direct solar or UV radiation Exposure to temperature fluxuations In a closed storage system e g cupboard drawer or in shelves or rooms of the room class II according to DIN 1946 4 2008 12 From 15 C...

Page 26: ...below 1 x Aquamarine control unit 1 x Handpiece including laser source with integrated finger switch 1 x Fiber cutter 2 x FiberBend bending tool 1 x Rechargeable battery already mounted 2 x Laser pro...

Page 27: ...sleeve with keypad 66 05 484 Keypad finger switch 66 03 604 UniTip 320 m 25 pieces 66 10 740 EndoTip 200 m 25 pieces 66 10 773 ActiveTip 8mm 66 10 971 Optic protection cap for handpiece 5 pieces 65 79...

Page 28: ...power cable is actually connected will be always displayed on the touch screen IMPORTANT Please keep the original packaging of the Aquamarine control unit as well as of the handpiece It is required f...

Page 29: ...lock Therefore it is necessary to wake up activate the battery by connecting the power supply to the unit during the initial start up NOTICE There will be a warning if the rechargeable battery reaches...

Page 30: ...r finger switch IMPORTANT Please keep in mind during attaching the handpiece sleeve on the handpiece body that the handpiece sleeve has a notch at the back which fits into the plunger pin on the body...

Page 31: ...ent dental procedures and indications UniTip 320 sterile EndoTip 200 sterile For the specification of each type of tip see chapter Technical Data 22 UniTip and EndoTip are delivered sterile in a speci...

Page 32: ...le use fiber tips again after usage Sterilization effects strongly the characteristics of the single use fiber tips laser power output form accuracy WARNING Never use the laser without optical fiber c...

Page 33: ...he Aquamarine is ready you can check to make sure that the aiming beam illuminates evenly i e projects a circular light pattern see adjacent picture To do this aim the single use fiber tip vertically...

Page 34: ...oot 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...

Page 35: ...obe projects no pattern at all or only an uneven pattern cut off another one to two millimeters After treatment The easiest and safest way to dismount the UniTip 320 m or EndoTip 200 m from the handpi...

Page 36: ...tion cycles or 2 years which marks the end of the service period the ActiveTip will have reached their wear limit Please check the usage period based on the LOT number definition of LOT week year e g...

Page 37: ...infecting and sterilizing the ActiveTip please refer to chapter Cleaning disinfection and sterilization 57 WARNING Use of the laser unit when the aiming beam is not functioning properly may cause inju...

Page 38: ...et by gently pulling back the other sleeve of the bridge plug to open the quick release 3 The plugs and sockets are color coded Please connect your interlock cable plug to the socket coded with a red...

Page 39: ...ceptibly clicks in 5 To remove the interlock cable from the operation unit gently pull back the outer sleeve at the cable s plug to open the quick release Please find the technical data sheet with cir...

Page 40: ...kwards Minus and Plus User is able to count up and down e g parameters Switch between different pages User is able to switch between different pages if there is more than one page of this screen No an...

Page 41: ...ayed in 10 steps from 10 to 100 without unit 100 is displayed as CW The frequency can be entered by moving higher or lower by using plus or minus When using plus or minus the frequency will be set in...

Page 42: ...e laser device To switch off the laser device press the flip switch into the off position on the backside of the control unit Laser stop In case of emergency press the laser stop button Note that the...

Page 43: ...opening the submenu you will be able to select among your self defined programs or to define a new program It is possible to create 12 different own programs Settings Within this submenu you will be a...

Page 44: ...ckaging for sending it to the calibration check Time to service The safety test is a mandatory test for all medical devices The Aquamarine needs to be tested once every two years The information for t...

Page 45: ...ication Putting the laser in ready mode Putting the laser in ready mode is described by means of the example SURGERY 1 Select the desired indication in our example SURGERY The pre set parameters will...

Page 46: ...eady for operation CAUTION Please do not press the finger switch during the 2 seconds of laser activation before being in ready mode to avoid an error message WARNING All persons present in the room o...

Page 47: ...adjust the time between continuous unlimited 0 seconds or 1 to 9999 seconds Frequency C In our example CW continuous wave mode This is the modulation frequency of the laser unit By pushing on the Minu...

Page 48: ...pushing on the Minus or Plus button left respectively right to the parameter value you will be able to adjust the duty cycle between 10 and 90 in 10 increments 5 Average power E In our example 1 2 W w...

Page 49: ...exists Please choose another program name 400 NO CONNECTION TO THE HAND DEVICE The connection between control unit and handpiece is disrupted or missing Check the handpiece connection at the control u...

Page 50: ...according to the calibration characteristic curve 1 step Software update If error message remains Exchange the handpiece 490 BASE DEVICE TIMEOUT The communication monitoring on the side of the handpi...

Page 51: ...reen opens 4 Enter your desired parameters via the Plus and Minus buttons left and right to the parameter values 5 The new input will be confirmed by pressing the Save button The new created own progr...

Page 52: ...average power W possiblity to change presets as well as selectable programs Pin code After pressing on the pin code field the admin is able to define a four digit numeric pin code of the new user via...

Page 53: ...nd push button sound as well as the display brightness will immediately be applied 5 7 4 Service Menu NOTICE If No is entered the user is not able to define own programs as well as not able to change...

Page 54: ...erative edema Treatment with the laser is low pain and not pain free We recommend using anesthetics if necessary The Aquamarine may be operated only by trained and qualified personnel NOTICE In terms...

Page 55: ...tissue surgery 445 1 2 CW 320 Stretch the tissue and use laser tip like an scalpel to excise the tissue Caution Avoid contact to implant and bone Perio germ reduction 445 0 6 CW 320 Irradiate the who...

Page 56: ...tics area Risk Minor necrosis or scarring of the radicular area Countermeasure When working in periodontal pockets always aim the laser parallel to i e never perpendicular to the roots Run the distal...

Page 57: ...ently pulling the sleeve off the handpiece body after disposing the single use fiber tip or the light guide 2 Clean the handpiece sleeve with a suitable brush under running water Light guide ActiveTip...

Page 58: ...the use of MinuteWipes from Alpro In the USA Caviwipes Observe the instructions provided by the manufacturers of these disinfectants WARNING Light guide ActiveTip handpiece sleeve fibercutter and ben...

Page 59: ...and storage to prevent scratching or chipping the light guides inthe autoclave Do not exceed a temperature of 140 C 284 F during the drying cycle Do not abort the drying cycle before it has ended Do...

Page 60: ...e handpiece optics Please proceed as follows for cleaning the optics at the handpiece 1 Switch off the control unit and unplug the handpiece from the control unit 2 Dismount the optical fiber glass ro...

Page 61: ...ng the following actions at regular intervals Action Frequency Conducting personnel Check of the single use fiber tips or light guide see Assembly of sterile single use optical fiber tips 31 and Assem...

Page 62: ...SB stick with the software update and starts the update process Leave the USB stick and the power cable plugged in until the completion of software update The Software update may take several minutes...

Page 63: ...no aiming beam Check to see if the single use fiber tip or light guide or its connector is damaged If the single use fiber tip or light guide is damaged replace it with a new one Check the connection...

Page 64: ...for their technical personnel Please contact your local dental depot or an authorized Customer Service Department for technical support The Aquamarine may be sent in for repair or for safety inspecti...

Page 65: ...ng ridge C of the new battery pack inside the guide groove D of the control unit s battery slot 5 Push the battery pack B inside the slot until the quick release fastener A perceptibly clicks in 6 Swi...

Page 66: ...or every two years Silicone key pad of the handpiece change after 400 treatments sterilizations Fiber cutter change after 400 treatments sterilizations or every two years Rechargeable battery change a...

Page 67: ...uch use is necessary this equipment and the other equipment should be observed to verify that they are operating normally WARNING Use of accessories transducers and cables other than those specified o...

Page 68: ...The UNIT uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions according to CI...

Page 69: ...power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and variations of the power supply according to IEC 61000 4 11 5 UT for period 95 dip of UT...

Page 70: ...tional measures such as reorientation or repositioning of the UNIT 3 Over the frequency range 150kHz to 80MHz field strengths should be less than 3V m Conducted RF interference IEC 61000 4 6 3 Veff 15...

Page 71: ...tance d in meters m can be determined for transmitters whose maximum power rating is not specified in the above table using the equation that belongs to the corresponding column wherein P is the maxim...

Page 72: ...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 the enretec GmbH homepage www enretec de Alternativ...

Page 73: ...following battery Lithium battery in the Aquamarine 10 2 Accessories ActiveTip glass rod handpiece sleeve incl keypad for finger switch bending tool for UniTip and EndoTip and fiber cutter may be disp...

Page 74: ...unit is manufactured in compliance with the provisions of Council Directive 93 42 EEC concerning medical devices 11 2 Appendix B Label positions 11 2 1 Control unit The following figures show the posi...

Page 75: ...ection supplied with the Aquamarine Insulate the jumper between pins 1 and 2 connect both of these pins to relay K1 with a two core cable K1 Low level relay AC Door switch S1 Must close the interlock...

Page 76: ...76 Aquamarine...

Page 77: ......

Page 78: ...FONA Dental s r o Stefanikova 7 SK 811 06 Bratislava Slovakia K K MTKOMNT 66 24 436 D3575 201 07 01 j W p a p d e c PNI a J SQSOR _ I d K K...

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