Dror Orthodesign Ltd.
Contents
1. Check that the system is not damaged visually prior to use 1 Brush your teeth and rinse the mouthpiece with lukewarm water before insertion 2 Place the mouthpiece on your teeth and make sure that it fits securely 3 Make sure that the flexible tubing end is 15 connected to the Electrical Air Pump Unit and make sure that it is locked in place NOTE If the tubing is loose or disconnected insert the tube into the connector and it will lock automatically For tube disconnection press the connecior tip and pull the tube gently 4 Connect the tube from the end of the mouthpiece to the quick disconnect coupling on the end of the spiral tube 3 Turn on the PTC unit by pressing power button 6 To start Pulsating inflation press pulsating treatment button see once 7 The PTC will start working to inflate and deflate the balloon in the programmed parameters during the pulsating mode you should see progress bar blink with dots according to your progress 8 Once the treatment is completed the PTC will turn off automatically 9 Disconnect the tube from the Mouthpiece 10 Take the mouthpiece off your teeth 11 Rinse the mouthpiece in water NOTE li The Mouthpiece must remain on the teeth throughout each treatment period 10 14 hours CAUTION AN While the mouthpiece is in use do not drink smoke or eat Place the personal dental device on your teeth Check that it is firmly in place Tu2. Aerodentis Orthodontic System Model PTC4 L GA cl O Z Lu Dror Orthodesign Ltd Aerodentis Dental Practioner Instructions for Use Revised Oct 2012 Software Version 1 2 3 Cat Num 4 1 2008 Dror Orthodesign Ltd All Rights Reserved This manual contains information that is proprietary to Dror Orthodesign Ltd Dror Orthodesign No part of this publication may be reproduced in any form without prior written approval by Dror Orthodesign All information intellectual property or other proprietary rights relating to this manual and to the Dror Orthodesign Aerodentis System and any software components contained therein are proprietary products of Dror Orthodesign protected under international copyright and patent law PATENTS Several patent applications have been filed covering the technology embedded in the Dror Orthodesign Aerodentis System DISCLAIMER The Aerodentis System should only be used in the manner prescribed in this Instructions for Use Changes or modifications not expressly approved by Dror Orthodesign Ltd or use of the device in any other manner than indicated in this manual could affect the safety or effectiveness of the Aerodentis System and void the system s warranty Neither Dror Orthodesign Ltd nor any of its shareholders directors employees or affiliates shall be held responsible in any manner for any bodily injury and or property damage arising from operation or use of this d
3. materials and workmanship for a period of x year from the date of delivery of the System to you If the System contains a defect in design materials or workmanship and such System is returned to Dror Orthodesign within 1 one year of delivery of the System to you Dror Orthodesign will repair or replace the System or issue a credit for the purchase price of the System with the choice to repair replace or credit being within the sole discretion of Dror Orthodesign The foregoing repair replacement or credit remedy will be your sole remedy for breach of the warranty set forth in this Section b Limitation of Warranties The warranties contained in Section a above do not cover damage to the System caused by accident misuse abuse negligence failure to install in accordance with Dror Orthodesign Ltd s installation instructions failure to operate under conditions of normal use and in accordance with the terms of the documentation accompanying the System failure to maintain in accordance with applicable documentation 33 accompanying the System alteration or any defects not related to System design materials or workmanship This warranty does not cover damage which may occur in shipment This warranty does not apply to Systems not purchased new This warranty does not apply to any System or any individual parts of a System which have been repaired or altered by anyone other than Dror Orthodesign Ltd or a person or entity authorized by
4. St order of a physician eier Ge Tel Aviv 69359 ISRAEL li Consult accompanying document LLASY AVI1LOL Mandibular Mouthpiece SN Po Maxillary Mouthpiece SN Po Obelis s a EC Boulevard G n ral Wahis 53 1030 Brussels BELGIUM 0482 90 8V 1Scl 4 System Description Introduction The Aerodentis System applies force on selected teeth requiring realignment The amount of force is determined by the dental practitioner and is applied to the teeth by means of a pressure element inflatable balloon contained within the individually fitted mouthpiece The mouthpiece attaches to the electrical air pump unit via a polyurethane hose until the inflation of the balloon contained in the mouthpiece reaches the desired pressure pre set according to the dental practitioner Through repeated use of the device 14 hours daily applied force repositions each tooth from its original state to the predetermined final tooth position via a track per tooth mechanism Pneumatic pressure force may be applied on the buccal or lingual surfaces of each individual tooth undergoing treatment The device is designed to be used for 10 14 hours per day for a period of approximately 1 5 years system Components The system consists of the following components Front Select Menu Display Control buttons Stop treatment On Off SN Start treatment 10 Air tube connection 7 Year Personal data card slot Charging indicator Cha
5. done after consulting your doctor What happens if I wear the Aerodentis device less than 10 hours a day Applying Aerodentis treatment for less than 10 hours a day or the number of hours your doctor prescribes will slow down the progress of your treatment Each individual has a minimum cut off point Treatment hours below this point will render the treatment ineffective Why is the pulsated air pressure so important The concept behind using pulsating orthodontic force has been clinically proven Studies have shown that a device with pulsating force moved the teeth faster than continuous force Studies using animal models have further demonstrated the benefits of pulsating force compared to continuous force The Aerodentis device features programmable pulsating force This enables your doctorto prescribe each patient an accurate force level and pulsating cycles according to the initial progress of teeth movement Based on previous clinical and research data applying pulsating force does not cause hyalinization and necrosis This may potentially decrease the risk of root resorption a common problem with conventional braces Is Aerodentis treatment painful 26 No The gentle pulsating action mimics our body s natural rhythm and physiology Sometime patients feel slight pressure when first applied Initially the force is set to be minimal and is gradually increased These small gradual changes make it more comfortable and do no
6. expose to direct sunlight Do not use a damaged System Use of damaged components might result in malfunctioning of the System The Aerodentis System should be installed and serviced only by qualified service personnel authorized by Dror Orthodesign Ltd Do not open the system covers 3 system Labels The following provides a description of the graphical symbols that appear on the Aerodentis System components and packaging Warning Caution Consult Accompanying document Type BF applied part Fragile handle with care ra gt DS E Keep dry Indoor operation only Sorted disposal Class Il has been designed in such a way that it does not require a safety connection to electrical earth T a PR o The following labels are affixed to the system Personal Treatment controller Label PERSONAL TREATMENT CONTROLER Caution Federal Law restricts this wd Dror Ortho Design LTD device to sale by or on the 7 Hartom St Jerusalem order of a physician 9777507 ISRAEL T 972 0 74 700 6700 Warning To be used only with F 972 0 74 700 6767 Orthodesign Mouthpiece Warning Only use the charger provided with your system or Consult accompanying document E a X C 9VDC Aerodentis AG e aerodentis ee nes Wollerauerstrasse 41b d GC 048 Mouthpiece Label JerOdENLIS Moutrpiecs Pursating set Caution Federal Law restricts this Dror Ortho Design LTD device to sale by or on the 4B M Gilat
7. Dror Orthodesign Ltd to repair Systems DROR ORTHODESIGN LIMITED HEREBY DISCLAIMS WITH RESPECT TO THE PRODUCTS ALL OTHER WARRANTIES AND CONDITIONS WHETHER EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OR CONDITIONS OF OR RELATED TO MERCHANTABILITY FITNESS FORA PARTICULAR PURPOSE ACCURACY OR COMPLETENESS OF INFORMATION LACK OF NEGLIGENCE AND CORRESPONDENCE TO DESCRIPTION LIMITATION OF LIABILITY A TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW EXCEPT FOR DAMAGES ARISING UNDER SECTION a ABOVE IN NO EVENT SHALL DROR ORTHODESIGN LIMITED BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE PRICE YOU PAID FOR THE PRODUCT THE FOREGOING LIMITATION SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE B IN NO EVENT SHALL DROR ORTHODESIGN LIMITED BE LIABLE FOR ANY SPECIAL INCIDENTAL INDIRECT OR CONSEQUENTIAL DAMAGES WHATSOEVER ARISING OUT OF OR IN ANY WAY RELATED TO THE USE OF OR INABILITY TO USE THE SOFTWARE AND OR THE PRODUCT OR THE PROVISION OF OR FAILURE TO PROVIDE SUPPORT SERVICES BY DROR ORTHODESIGN LTD EVEN IF DROR ORTHODESIGN LIMITED HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH CONSEQUENTIAL DAMAGES THE FOREGOING DISCLAIMER OF CONSEQUENTIAL DAMAGES SHALL BE APPLICABLE REGARDLESS OF WHETHER THE ACTION GIVING RISE TO SUCH DAMAGES IS IN TORT CONTRACT STRICT PRODUCTS LIABILITY OR OTHERWISE 34
8. atment and in rare instances require additional dental treatment such as endodontic and or additional restorative work and or tooth loss As with all orthodontic treatments the health of the bone and gums which support the teeth may be impaired or aggravated and the length of the roots of the teeth may be Shortened a threat to the longevity of the teeth In rare instances problems in the temporo mandibular joint jaw joint may result in joint pain headaches or ear problems The bite may change during the course of the treatment and may result in temporary patient discomfort If a bite change occurred the bite may require adjustment by the doctor at the end of the treatment Electrical Classification The Aerodentis System complies with IEC 60601 1 and IEC 60601 1 2 The unit is classified as Class Il continuously operated ordinary equipment with BF applied parts and with Signal input output parts The device is not intended for use in the presence of flammable mixtures The Device is classified as Portable equipment WARNING The Electrical Air Pump needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the accompanying documents WARNING Portable and mobile RF communications equipment can affect the Electrical Air Pump Unit About this Manual This manual provides the information necessary to operate the Aerodentis System in a safe and
9. cal Air Pump Unit with care Do not drop knock or shake the Electrical Pump Unit Rough handling can break internal circuit boards e pp The Electrical Air Pump Unit is not water proof Keep the Control Unit dry A e The System is intended for indoor operation only Damaged System should not be disposed as unsorted municipal waste Please contact your local distributor for unit disposal e The Aerodentis System should be serviced only by qualified service personnel authorized by Dror Orthodesign Ltd e Inthe event that the Aerodentis System does not operate properly contact Dror Orthodesign Ltd customer support e Do not use water or any other liquids to clean the Electrical Air Pump Unit e Do not operate the charger with a damaged cord or plug If damaged have the charger replaced immediately by a qualified service technician Following this rule will reduce the risk of electric shock fire or serious personal injury e The Electrical Air Pump Unit should be used only with the Aerodentis mouthpiece e Do not attempt to replace the batteries Battery replacement should be performed by Dror Orthodesign Ltd personnel only and not by the user Changes or modifications not expressly approved by Dror Orthodesign Ltd could affect the safety or effectiveness of the System and void the system s warranty Do not disassemble the charger Only a Dror Orthodesign technician is authorized to service the device Do not
10. console for each new personal dental device After the personal dental device has been placed on your teeth begin the calibration process Make certain the calibration is completed and indicated on the display 10 Frequently Asked Questions How does Aerodentis work The Aerodentis system relies on the same biomechanical principles of traditional orthodontics applying force to move your teeth to the desired position Instead of applying constant uniform force through metal braces or aligners that must be periodically tightened or readjusted Aerodentis works by using air pressure to move your teeth gradually while you sleep Because this pulsed air pressure works more effectively than constant force only approximately 10 hours per day of active treatment is needed The rest of the time you are completely free from any orthodontic devices What if I sleep for less than the hours need to wear the device ES The Aerodentis system is designed for primary use while at rest It is the most comfortable and easiest way to perform treatment Of course if more time is needed to complete the minimum hours your doctor determined just pick the time and place that is best for you watching television working on the computer or studying What happens if I wear the Aerodentis device more than 10 hours a day Applying Aerodentis treatment for more than 10 hours a day will accelerate treatment progress Of course this should only be
11. efficient manner Please read and thoroughly understand the manual before operating the system If any part of this manual is not clear contact Dror Orthodesign Customer Support for clarifications The manual is intended to serve as an accompanying document to the Aerodentis System This manual should always accompany the unit and Should be read and understood in its entirety Manual Conventions The following manual conventions are used throughout the manual Warnings Cautions and Notes Warnings Cautions and Notes are used throughout this manual WARNING Indicates precautions and instructions which if not followed may result in personal injury or death CAUTION Cautions indicate instructions that if not followed may result in damage to the equipment or to the quality of treatment gt gt NOTE Are used to identify an explanation or to provide additional information for purposes of clarification Z Menus Screens and dialog boxes The names of menus screens and dialog boxes are presented in bold Terms and Acronyms Non 2 Warnings and Precautions Before use carefully read this manual and the precautionary information Pay attention to the following and to additional precautionary information that appears elsewhere in the manual to enable efficient operation of the Aerodentis System to prevent endangering the system operator and to prevent damage to equipment e T Handle the Electri
12. eletally narrow jaw adult patients in which the malocclusion is periodontally involved patients with dental implants in moving teeth General Risks to Patients e Dental tenderness may be experienced following Initial aligner placement e Gums cheeks or lips May be irritated by mouthpiece Temporary increase in salvation or dryness of mouth may occur The product may temporarily affect soeech and may result in a lisp Speech impediment associated with the product usually resolves within one or two weeks Failure to wear the appliances for the required treatment time and or not using the product as directed by your doctor can lengthen the treatment time and affect the ability to achieve the desired results If the prescribed treatment includes interproximal reduction creation of space to allow for tooth movement then risks associated with this procedure may be experienced Tooth decay periodontal disease and permanent markings from stains and decalcification may occur if patients do not brush and Floss their teeth properly before treatment or if foods are consumed while wearing the mouthpiece As with other orthodontic treatments teeth may shift position after treatment and wearing of retainers at the end of treatment should reduce this movement Dental restorations e g crowns may become dislodged and require treatment A tooth that has been previously traumatized and or Significantly restored may be aggravated by the tre
13. eth The space created by the track per tooth mechanism difference between the teeth and the final treated state with the force from the inflatable balloon allows for movement of teeth for which movement is intended The inflatable balloon is located in a predetermined position in the mouthpiece and has limited range of motion to ensure that pressure is applied in the desired direction on the treated tooth When inflated the balloon fills the pre designed opening and ensures that pressure is applied against the tooth to which it Is in contact In this manner pressure is applied to the entire surface area of the tooth that is exposed to the balloon Path of Moving Teeth Front Canal Silicon Outer Balloon Butyl Inner Balloon u 14 Non Return Valve R N Figure 1 A Retention Unmoving Teeth Depending on the desired direction of tooth movement the pressure element inflatable balloon is designed either be bucall or lingual Polyurethane Tubing The Polyurethane tubing is used to connect between the Mouthpiece and the Electrical Air Pump Unit D System Operation Using the Mouthpiece When you are going to sleep you should use the Aerodentis treatment system in a Pulsating Pressure Mode In PPM the PTC is permanently connected to the mouthpiece with the connecting tube and performing pulsating treatment by changing the amount of air in the internal balloon during all night WARNING
14. evice other than that which adheres to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in Appendix A Contact Dror Ortho Design at Dror Orthodesign Ltd 7 Hartom St Level 3 Jerusalem 97775 Israel Tel 972 7 4700 6700 Fax 972 7 4700 6767 TABLE OF CONTENTS System OVC EEN 1 What Is the Aerodentis System uussssnnsssnnnnnnneennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnn 1 Ta 21903 sie RE 1 ele UE e e det Ee EE 1 General RICKS 10 P allenle nee ee ee res 1 BICC MICA GlaSS ICAO UA ae ee ee ee ee 3 ABOUT TIS On EE 4 NEE EE 4 Warnings Cautions and Notes ssannnenennnnesennnnnsenrnnsnnrrreennrrerenrrresnnrrresnnrresnnrrnsnnrrresnnrrrennrrerennrreen nni 4 Menus Screens and dialog boxves eiiieaenii aaea iai 4 Be AIG AGT ONY EE 4 Warnings and PrecautioNs u een 5 SV SPO OM a aE E E E EE EEE E 7 Electrical Alr Pump UNIE Ee NEE 8 Mouihpiece Label ec sina Se secceccnsataeencctendesascesescecedcacdseenccseeadecee eT a Rer ER Eidg ONE SNCHEENERERREDTSHEREEHERDERBRRE 8 System ESC UO EEN 9 KOU IO E 9 VSEM COMPONETS nee ee ee 10 Elecwical Ar Pump KT EE 10 User Mena EE 12 Vleit gl ee 13 Polyurethane le IAG EE 14 System OD Cl e EE 15 MOOC UO EE NITAN NIX OO INN AW For the Dental Practitioner cccccccecccceseeeseeeeseeeeeseeeeeseeesseeeeesaaeesaeeeees TAM AIR NON Tou Unpacki
15. haracteristics Dimensions HxWxD 145mm x 140mm x 140mm approx Weight 500 gr Material Outer Box PC ABS Inner Box ABS Talc Dimensions HxWxD 80mm x 60mm x 10mm approx Weight 10 gr 28 Environmental Conditions for Pump Control Unit Relative Humidity 10 to 95 Ambient Operating 10 C to 40 C 50 F to 104 F Temperature nenn nn Temperature Range 20 C to 45 C 4 F to 113 F Relative Humidity 10 to 95 Environmental Conditions for Mouthpiece Relative Humidity 100 Ambient Operating 10 C to 40 C 50 F to 104 F Zn BEE Temperature Range 20 C to 45 C 4 F to 113 F Relative Humidity 10 to 95 Pressure Characteristics Electrical Switches Indicators 7 Control keys Power indication LED 29 12 Problem The Electrical Air Pump Unit does not start Air is not being released from the mouthpiece A Pump Error message appears on the screen followed by buzzer noise and the electrical air pump unit turns off During Inflation the mouthpiece pops from its place Possible Cause 1 No electrical power 2 Discharged Battery The air has been already released from the mouthpiece The tube is not connected properly Electrical malfunction The mouthpiece was not placed correctly Troubleshooting Solution 1 Check power in the wall socket Charge the Control Unit according to the charge in
16. he socket in the bottom of the Electrical Air Pump Unit on one end and into the electrical socket on the other 9 Menu and Advanced settings Some parameter can be changed in the Menu area 1 Turn on the PTC Press the Manu button OK menu 3 The first menu screen will show you can navigate through the menu screen by using the up and down keys 22 Time Date The internal clock is factory set If the control console s internal battery runs out reset the time and date from this menu Adjust the time and date using the arrow buttons When completed press OK Automatic Operation Reminder You can preset the system to operate automatically at a specific time and date or preset it for one time only Select Enable Choose the start time end time and frequency once only every day or for Friday night 23 Key and System Tones You can turn off all system tones by changing the status to Disabled To reactivate system tones switch to Enabled Cumulative Usage Meter Displays all data that has accumulated during the course of your treatment ce Total days oftrestment E AVE L KZ Treatment Program Displays your personal treatment program prescribed by your doctor It details the force exerted and the frequency of the pulsated force prescribed 24 System Calibration Please calibrate the control
17. n which the teeth do not align properly Tooth malocclusion is treated by applying force over time to teeth requiring alignment Traditionally the force has been created by attaching brackets to the teeth and creating tension through the stretching of flexible wire connected between the brackets Alternatively aligners are used for the treatment of tooth malocclusion In these devices a series of mouthpieces are used where the force created by each mouthpiece on the treated teeth is designed to push the teeth in Small one step increments toward the desired result The Aerodentis System is a individually fitted plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner s treatment plan The Aerodentis System is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure force on the selected teeth designed to be moved to a final treated state The inflatable balloon is inflated to the desired pressure using an electrical air Pump Unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software thus creating a course treatment specifically designed for each patient Intended Use The Aerodentis System is intended for the treatment of tooth malocclusion in patients with permanent dentition Contraindications for Use Severe open bite Severe overjet tooth malocclusion requiring surgical correction adolescent patients with a sk
18. ng the SY anne J7aIn AYR NMN ANAYW Using the Mouthpiece PPM Pulsating Pressure Model 15 Inserting and Inflating the Moutboece nenne nnnnn nennen ennenn DITAM AYR NAN 0nN HANAW Manually Stopping the Electrical Air Pump Un 17 Maintenance and Cleaning cccccsssseeesesseeeecesseeeeenseeeceesseeseoeeeeesoegsesssonsseesoonneesses 18 Care Of the Mouthpniece nnen 18 Cleaning the Electrical Air Pump Un 18 10 11 12 13 14 TABLE OF CONTENTS When to Contact Your Doctor 20 Charging the Baten yy E 21 Frequently Asked Questions ccccccesssseeeeeeeeceeseeeeseceasseeeeeceesseeeeeecoaaseeeeseoesseesssooanes 25 OS TNC e EE 25 ne BET EE 28 Environmental Conditions for Pump Control Un 28 Environmental Conditions for Mouthpiece nnnennnenn1nnnnnnennnnnnnnnennrrnnrnnsnnnrrrrensrnnrrrrenssnnrrrreenennnrrreenene 28 Wee 29 Seite E 29 VIN SS NIG EE 29 MOUS OO UN WE 30 Compliance with Standards cccccssssceccsssseeeceenseeeecenseeeeeeseeeeeeeseeeeeenseesseenseessoonseesaes 31 Support and Contact Information cccscseeeceesseeeeenseeeeeeseeeeecenseesecenseeeeoensesseeensessees 32 Disclaimer and Limited Warranty uuuu0002000002a000nnann0nnnnnunnnnnnunnnnnnnnnnnunnnnnnnnnnnnnnnnnnnnnn 33 1 System Overview What Is the Aerodentis System The Aerodentis System manufactured by Dror Orthodesign is intended for the treatment of tooth malocclusion a condition i
19. rger jack USB port for doctor use only Personal data card Coiled tube Medical charger J J A K Quick connector _G Personal Treatment controller PTC The PTC includes the following components e LCD Screen e Seven control buttons e SD Card socket e Pressure outlet tube connector e DC connector for charger supplied e Mini USB female connector 11 e Charging indication green led e Rechargeable battery User Interface Navigating the Manu and actions can be done by using the direction keys Personal Usage Meter For your convenience the control console is equipped with a personal usage meter to keep track of your daily treatment 12 hours While operating the usage meter is presented as 12 black dots on the system screen For each hour of treatment the back changes color The color of the dots indicates the number of hours operated Treatment time 1 8 hours 9 10 hours 11 12 hours The usage meter is reset every morning at 12 00 AM Treatment in Progress 13 Mouthpiece The mouthpiece is based on an initial mold of the patient s teeth taken by the dental practitioner Subsequent molds and the final mouthpiece are formed using off the shelf software by digitization of the initial mold The mouthpiece is worn by the patient prior to balloon inflation The individually designed mouthpiece fits the teeth snugly anchored by the retention clasps on non treated te
20. rn on the control console with the On button 16 Attach the quick Press the connector to the end eg DT Start Treatment button of coiled tube until EN rar you hear a click Instructions cont During the treatment Confirm that the usage meter display is flashing and the time counter advances Atthe end of the treatment Confirm that all the usage meter BEREOBPEBER8 dots are illuminated green Red or orange lights indicate that there has not been enough treatment time in the last 24 hours E Stopping the treatment You can stop the operation of the control console at any time by pressing the Stop treatment button or by disconnecting the quick connector from the personal dental device 17 6 Maintenance and Cleaning Care of the Mouthpiece e Wash your hands before handling the mouthpiece e Clean the mouthpiece every day by washing it with water e Rinse the mouthpiece before insertion WARNING Do not use strong solvents thinner benzene etc or abrasive cleansers or hot or boiled water for washing the device 18 Cleaning the Electrical Air Pump Unit Only clean the exterior of the Electrical Air Pump Unit using a cloth dampened with water WARNING N Never open the Electrical Air Pump Unit housing as this may damage the System WARNING Avoid placing liquids or food on any part of the System Do not allow conductive fl
21. structions Remove mouthpiece and contact your doctor Make sure that all connections are tight and try inflation procedure again Contact your doctor 30 Disconnect tubing deflate the balloon take out the mouthpiece and rinse with water Re insert the mouthpiece 13 _ Compliance with Standards The Aerodentis System was tested and found to be in compliance with the following standards Medical electrical equipment general IEC 60601 1 1988 requirements for safety Part 1 General A1 1991 A2 1995 UL Requirements for Safety 60601 1 2003 Medical Electrical Equipment Part 1 IEC 60601 1 2 2005 General Requirements for Safety Electromagnetic Compatibility Requirements and Tests Requirements for safet Medical devices Application of risk management to medical devices of medical devices Medical devices Symbols to be used ISO 15223 2004 with medical devices labels labeling and 21 information to be supplied 14 Support and Contact Information Dror Orthodesign Ltd 7 Hartom St Level 3 Jerusalem 97775 Israel Email info aerodentis com Tel 972 7 4700 6700 Fax 972 7 4700 6767 EU Representative 32 Aerodentis AG Wollerauerstasse 41b 8808 freienbach Swissland Email info aerodentis ch Tel Fax 15 _ Disclaimer and Limited Warranty a Dror Orthodesign Ltd warrants that the System with which this manual was delivered will be free from defects in design
22. t cause pain How often will I need to visit my doctor We recommend that you visit your doctor four weeks after starting your treatment Sometimes it is necessary to make minor adjustment to the Personal Dental Device After that you will probably only need to visit your doctor once every three to four months Does the Control Console always need to be connected to the electricity while am sleeping No The internal rechargeable batteries last for approximately 20 hours of operation But it is completely safe to leave the unit plugged in The unit complies with the strictest medical device regulations and standards including ISO 60601 1 ISO 13585 2003 that permit connection to the electrical current during treatment How does the Aerodentis system ensure proper alignment of my teeth Your Personal Dental Device is custom made for each patient The unique production process uses computerized 3D imaging and other peripheral technologies that ensure unprecedented accuracy and superior alignment The production process is governed by the strictest quality control and meets CE medical grade standards What do I need to bring to the doctor s when I come to the doctor s office All you need to bring with you is your Personal Dental Device and the smart card from the Control Console With this your doctor has all the information needed and if necessary can reprogram your treatment plan 27 11 Specifications Physical C
23. uids to leak into the active circuit components of the System as this may cause a short circuit which could result in an electrical fire In this event only fire extinguishers approved for use on electrical fires should be used CAUTION MN Handle the Electrical Air Pump Unit with care Do not drop knock or shake the Electrical Air Pump Unit Rough handling can break internal circuit boards 19 D When to Contact Your Doctor If any of the following situations occur immediately stop using the device and contact your doctor e If you are experiencing sharp pains or bleeding in your mouth e If you don t hear air being released when you insert the Air Release Adaptor e If the device repeatedly shuts down when attempting to connect the Electrical Air Pump Unit to the Mouthpiece 20 8 Charging the Battery The following icons on the electrical air pump unit display indicate the battery status e Full battery Green Oom je Low recharge before Charging mode WARNING A Do not attempt to replace the batteries Battery replacement should be performed by Dror Orthodesign personnel only and not by the user WARNING N Only use the charger provided with your system Never try to connect any other device and or cable to the Charging connector of the Electrical Air Pump Unit e g telephone device or cables 21 The battery should be charged whenever it is in the low or empty State Plug the Recharger into t
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