- KaVo. Dental Excellence.

Instructions for use ESTETICA E30 Manufacturer: Kaltenbach & Voigt GmbH Bismarckring 39 D-88400 Biberach www.kavo.com Distributed by: KaVo Dental GmbH Bismarckring 39 D-88400 Biberach Phone +49 (0) 7351 56-0 Fax +49 (0) 7351 56-1488 Instructions for use ESTETICA E30 Table of contents Table of contents 1 User instructions............................................................................................................................................... 6 1.1 User guide................................................................................................................................................ 1.1.1 Abbreviations............................................................................................................................... 1.1.2 Symbols....................................................................................................................................... 1.1.3 Target group................................................................................................................................ 6 6 6 6 1.2 Service...................................................................................................................................................... 7 1.3 Terms and conditions of warranty............................................................................................................. 7 1.4 Transportation and storage....................................................................................................................... 7 1.4.1 Currently valid packaging regulations......................................................................................... 7 1.4.2 Damage in transit........................................................................................................................ 7 1.4.3 Information on the packaging: Storage and transportation......................................................... 9 2 Safety............................................................................................................................................................. 10 2.1 Description of safety instructions............................................................................................................ 2.1.1 Warning symbol......................................................................................................................... 2.1.2 Structure.................................................................................................................................... 2.1.3 Description of hazard levels...................................................................................................... 10 10 10 10 2.2 Purpose – Proper use............................................................................................................................. 10 2.2.1 General...................................................................................................................................... 10 2.2.2 Product-specific......................................................................................................................... 13 2.3 Safety instructions.................................................................................................................................. 14 2.3.1 General information................................................................................................................... 14 2.3.2 Product-specific......................................................................................................................... 15 3 Product description......................................................................................................................................... 18 3.1 Treatment unit versions.......................................................................................................................... 18 3.1.1 KaVo ESTETICA E30 S............................................................................................................ 18 3.1.2 KaVo ESTETICA E30 TM.......................................................................................................... 18 3.2 Patient chair............................................................................................................................................ 19 3.3 Unit with patient element........................................................................................................................ 20 3.4 Dentist unit versions............................................................................................................................... 21 3.4.1 TM table..................................................................................................................................... 21 3.4.2 S table....................................................................................................................................... 21 3.5 Assistant unit.......................................................................................................................................... 23 3.6 Triple-function handpieces...................................................................................................................... 24 3.7 Controls.................................................................................................................................................. 25 3.7.1 Dentist's unit TM table............................................................................................................... 25 3.7.2 Dentist's unit S table.................................................................................................................. 25 3.7.3 Assistant unit............................................................................................................................. 26 3.7.4 Groups of keys.......................................................................................................................... 26 3.7.5 Foot control................................................................................................................................ 28 3.8 Rating plate and serial number plates.................................................................................................... 29 3.9 Technical data........................................................................................................................................ 34 4 Operation........................................................................................................................................................ 39 4.1 Switching the device on and off.............................................................................................................. 39 4.2 Converting from right handed to left handed.......................................................................................... 39 4.3 Adjusting the dental chair....................................................................................................................... 43 4.3.1 Adjusting the armrest (optional)................................................................................................. 43 3 / 130 Instructions for use ESTETICA E30 Table of contents 4.3.2 4.3.3 4.3.4 4.3.5 Adjust head rest......................................................................................................................... 44 Positioning the dental chair manually........................................................................................ 45 Automatic positioning of dental chair......................................................................................... 47 Safety shut-off........................................................................................................................... 50 4.4 Moving the patient chair.......................................................................................................................... 53 4.5 Moving the dentist unit............................................................................................................................ 53 4.5.1 Moving the dentist unit TM........................................................................................................ 54 4.5.2 Moving the dentist unit S........................................................................................................... 55 4.6 Moving the patient unit............................................................................................................................ 55 4.6.1 Moving the patient element (optional)....................................................................................... 56 4.7 Attaching the tray holder (optional)......................................................................................................... 57 4.8 Using functions through the menu.......................................................................................................... 4.8.1 General menu navigation.......................................................................................................... 4.8.2 Using the user menu................................................................................................................. 4.8.3 Standby menu........................................................................................................................... 4.8.4 Selecting the dentist.................................................................................................................. 4.8.5 Instruments menu...................................................................................................................... 4.8.6 ENDO menu (optional).............................................................................................................. 4.8.7 Using the CONEXIOcom (optional)........................................................................................... 57 57 57 63 64 64 67 72 4.9 Using function through the dentist or assistant unit................................................................................ 4.9.1 Using the hygiene functions...................................................................................................... 4.9.2 Using the illumination functions for KaVoLUX 540 LED T......................................................... 4.9.3 Using the illumination functions for EDI and MAIA.................................................................... 4.9.4 Using the X-ray viewer.............................................................................................................. 4.9.5 Using the bell............................................................................................................................. 4.9.6 Using the timer.......................................................................................................................... 74 74 75 81 81 81 81 4.10 Operating the foot switch........................................................................................................................ 83 4.10.1 General functions...................................................................................................................... 83 4.10.2 Positioning the patient chair with the foot control...................................................................... 83 4.10.3 Preselect dentist........................................................................................................................ 83 4.10.4 Start and regulate instruments.................................................................................................. 83 4.10.5 Setting the cooling condition..................................................................................................... 84 4.10.6 Activating blown air (optional).................................................................................................... 84 4.10.7 Preselect counterclockwise motor rotation................................................................................ 84 4.10.8 Adjusting the instrument light.................................................................................................... 84 4.10.9 Using CONEXIOcom (fee-based additional option).................................................................. 85 4.11 Using instruments................................................................................................................................... 4.11.1 Setting spray air and spray water.............................................................................................. 4.11.2 Using suction hoses.................................................................................................................. 4.11.3 Using triple-function handpieces............................................................................................... 4.11.4 Using the PIEZOsoft/PiezoLED................................................................................................. 86 86 86 88 90 4.12 Using the KL 703 LED in ENDO mode (optional accessory).................................................................. 91 4.12.1 General information................................................................................................................... 91 4.12.2 Open ENDO mode.................................................................................................................... 92 4.12.3 Set torque mode........................................................................................................................ 93 4.12.4 Changing settings in the menu.................................................................................................. 94 4.12.5 Leaving ENDO Mode................................................................................................................. 94 4.13 Use USB interface.................................................................................................................................. 95 4.14 Using the camera.................................................................................................................................... 95 4 / 130 Instructions for use ESTETICA E30 Table of contents 4.15 Using the screen..................................................................................................................................... 95 5 Preparation methods DIN EN ISO 17664....................................................................................................... 96 6 Accessories and kits....................................................................................................................................... 97 6.1 Device..................................................................................................................................................... 97 6.2 Dental chair............................................................................................................................................. 97 6.3 Assistant unit.......................................................................................................................................... 97 6.4 Dentist element....................................................................................................................................... 97 7 Safety checks - testing instructions................................................................................................................ 99 7.1 Introduction............................................................................................................................................. 99 7.1.1 General instructions................................................................................................................... 99 7.1.2 Notes for medical electrical systems....................................................................................... 100 7.1.3 Essential parts of the safety check.......................................................................................... 101 7.1.4 Testing intervals...................................................................................................................... 102 7.1.5 Notes on the test method in accordance with IEC 62353....................................................... 102 7.1.6 Notes on repeat testing........................................................................................................... 102 7.2 Instructions for safety checks............................................................................................................... 7.2.1 Preparatory measures to be undertaken on the device.......................................................... 7.2.2 Visual inspection (inspection by examination)......................................................................... 7.2.3 Measurements......................................................................................................................... 7.2.4 Functional test......................................................................................................................... 7.2.5 Assessment and documentation ............................................................................................ 102 102 103 106 115 116 8 Appendix - Additional measuring sites......................................................................................................... 119 8.1 Additional scanning sites SL X in the protective conductor measurement........................................... 119 8.2 Additional measuring sites AP X for EUL/EPL measurement............................................................... 121 9 Troubleshooting............................................................................................................................................ 122 10 Information about electromagnetic compatibility in accordance with EN60601-1-2..................................... 125 10.1 Electromagnetic Transmissions............................................................................................................ 125 10.2 Resistance to electromagnetic interference.......................................................................................... 125 10.3 Recommended safe distance between portable and mobile HF telecommunications equipment and the treatment unit........................................................................................................................................ 126 10.4 Immunity to electromagnetic interference............................................................................................. 127 5 / 130 Instructions for use ESTETICA E30 1 User instructions | 1.1 User guide 1 User instructions 1.1 User guide Requirement Read these instructions prior to first use to avoid misuse and prevent damage. 1.1.1 Abbreviations Abbre‐ Explanation viation IfU Instructions for use CI Care instructions AI Assembly instructions TI Technician's instructions SC Safety checks IEC International Electrotechnical Commission RI Repair instructions RK Retrofitting kit AS Assembly set EP Enclosed parts EMC Electromagnetic compatibility PI Processing instructions 1.1.2 Symbols See the Safety/Warning Symbols section Important information for users and technicians CE mark according to EC Directive 93/42 for medical devices Action required 1.1.3 Target group This document is for dentists and dental office staff. 6 / 130 Instructions for use ESTETICA E30 1 User instructions | 1.2 Service 1.2 Service KaVo Customer Service: +49 (0) 7351 56-1000 [email protected] Please refer to the serial number of the product in all inquiries! For further information, please visit: www.kavo.com 1.3 Terms and conditions of warranty KaVo provides the final customer with a warranty that the product cited in the hand‐ over certificate will function properly and guarantees zero defects in the material or processing for a period of 12 months from data of purchase, subject to the following conditions: Upon justified complaints of flaws or a short delivery, KaVo will make good its warran‐ ty by replacing the product free of cost or repairing it according to the customer's wish‐ es. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded. In the event of default and gross negligence or intent, this shall only ap‐ ply in the absence of mandatory legal regulations to the contrary. KaVo cannot be held liable for defects and their consequences due to natural wear, improper cleaning or servicing, non-compliance with operating, servicing or connection instructions, calcification or corrosion, contaminated air or water supplies or chemical or electrical factors deemed abnormal or impermissible in accordance with factory specifications. The warranty does not usually cover bulbs, glassware, rubber parts and the colour‐ fastness of plastics. Defects or their consequences that can be attributed to interventions on or changes made to the product by the customer or a third party are excluded from the warranty. Claims from this warranty can only be asserted when the transfer form (copy) belong‐ ing to the product has been sent to KaVo, and the original can be presented by the operator or user. 1.4 Transportation and storage 1.4.1 Currently valid packaging regulations Note Only valid for the Federal Republic of Germany. Dispose of and recycle the sales packaging appropriately in accordance with current packaging regulations, employing waste management or recycling companies. Com‐ ply with the comprehensive return system. KaVo has had its sales packaging licensed for this purpose. Please comply with the regional public waste-disposal system. 1.4.2 Damage in transit In Germany If the packaging is visibly damaged on delivery, please proceed as follows: 7 / 130 Instructions for use ESTETICA E30 1 User instructions | 1.4 Transportation and storage 1. The recipient of the package must record the loss or damage on the delivery re‐ ceipt. The recipient and the representative of the shipping company must sign this delivery receipt. 2. Leave the product and packaging in the condition in which you received it. 3. Do not use the product. 4. Report the damage to the shipping company. 5. Report the damage to KaVo. 6. Consult with KaVo first, before returning a damaged product. 7. Send the signed delivery receipt to KaVo. If the product is damaged but there was no discernable damage to the packaging on delivery, proceed as follows: 1. Report the damage to the shipping company immediately and no later than 7 days after delivery. 2. Report the damage to KaVo. 3. Leave the product and packaging in the condition in which you received it. 4. Do not use a damaged product. Note Failure on the part of the recipient to comply with any of the above-mentioned obli‐ gations will mean that the damage will be considered to have arisen following deliv‐ ery (in accordance with the General German Freight Forwarders´ Terms and Condi‐ tions, Art. 28). Outside Germany Note KaVo shall not be held liable for damage arising from transportation. The shipment must be checked on arrival. If the packaging is visibly damaged on delivery, please proceed as follows: 1. The recipient of the package must record the loss or damage on the delivery re‐ ceipt. The recipient and the representative of the shipping company must sign this delivery receipt. Without this evidence, the recipient will not be able to assert a claim for damages against the shipping company. 2. Leave the product and packaging in the condition in which you received it. 3. Do not use the product. If the product is damaged but there was no discernable damage to the packaging on delivery, proceed as follows: 1. Report any damage to the shipping company either immediately or no later than 7 days after delivery. 2. Leave the product and packaging in the condition in which you received it. 3. Do not use a damaged product. Note If the recipient fails to comply with any of the above-mentioned obligations, the damage will be considered to have arisen following delivery (in accordance with CMR law, Chapter 5, Art. 30). 8 / 130 Instructions for use ESTETICA E30 1 User instructions | 1.4 Transportation and storage 1.4.3 Information on the packaging: Storage and transportation Note Please keep the packaging in case you need to return the product for servicing or repair. The symbols printed on the outside are for transportation and storage, and have the following meaning: Transport upright with the arrows pointing upwards! Fragile - protect against impact! Protect from moisture! Permissible stacking load Temperature range Humidity Air pressure 9 / 130 Instructions for use ESTETICA E30 2 Safety | 2.1 Description of safety instructions 2 Safety 2.1 Description of safety instructions 2.1.1 Warning symbol Warning symbol 2.1.2 Structure DANGER The introduction describes the type and source of the hazard. This section describes potential consequences of non-compliance. ▶ The optional step includes necessary measures for hazard prevention. 2.1.3 Description of hazard levels The safety instructions listed here, together with the three levels of danger will help avert property damage and injury. CAUTION CAUTION indicates a hazardous situation that can cause damage to property or mild to moder‐ ate injuries. WARNING WARNING indicates a hazardous situation that can lead to serious or fatal injury. DANGER DANGER indicates a maximal hazard due to a situation that can directly cause death or fatal injury. 2.2 Purpose – Proper use 2.2.1 General The user must ensure that the unit works properly and is in satisfactory condition be‐ fore each use. The KaVoESTETICA E30 equipment system is a dental treatment unit in accordance with ISO 7494 with a dental chair in accordance with ISO 6875. This KaVo product is designed for use in dentistry only and may only be used by trained medical personnel. Any other type of use is not permitted. "Proper use" includes following all the instructions for use and ensuring that all inspec‐ tions and service tasks are performed. 10 / 130 Instructions for use ESTETICA E30 2 Safety | 2.2 Purpose – Proper use The overarching guidelines and/or national laws, national regulations and the rules of technology applicable to medical devices for start-up and use of the KaVo product for the intended purpose must be applied and followed. KaVo accepts liability for the safety, reliability, and performance of components sup‐ plied by KaVo, provided: ▪ installation, instructions, expansions, adjustments, changes or repairs were carried out by technicians trained by KaVo or third parties authorised by KaVo, or by the personnel of authorised distributors. ▪ the unit was operated in accordance with the instructions for use, care and instal‐ lation. ▪ the IT components supplied by the operator meet the technical requirements in these instruction for use for hardware and software, and they are installed and set up according to the descriptions of these components. ▪ in the case of repairs, the requirements of IEC 62353 (DIN VDE 0751-1) "Repeat tests and tests before start-up of electrical items of medical equipment and sys‐ tems - general regulations" are met in full. It is a responsibility of the user: ▪ only use equipment that is operating correctly, ▪ protect him or herself, the patient and third parties from danger, and ▪ avoid contamination from the product.. The applicable national legal regulations must be observed during the use of the de‐ vice, in particular the following: ▪ Applicable regulations governing the connection and start-up of medical devices. ▪ Current occupational safety regulations. ▪ Current accident prevention regulations. Regular performance of maintenance and safety checks is essential for the permanent assurance of the operating and functional safety of the KaVo product and for the pre‐ vention of damage and hazards. Testing and maintenance intervals: Maintenance must be performed once a year, the safety check (STK) at intervals of 2 years. Shorter intervals for the safety check may be specified by the tester if necessary. The following persons are authorised to repair and service the KaVo product: ▪ Technicians of KaVo branch offices after appropriate product training. ▪ Specifically KaVo-trained technicians of KaVo franchised dealers. In Germany, operators, equipment managers and users are obliged to operate their equipment in accordance with the MPG regulations. The services encompass all the test tasks required in accordance with § 6 of the medi‐ cal devices operator ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV). Note The product must be cleaned and serviced according to instructions if it is not to be used for an extended period of time. 11 / 130 Instructions for use ESTETICA E30 2 Safety | 2.2 Purpose – Proper use Note The MULTIflex couplings, the current K/KL motors, and the ultrasonic scaler hoses of KaVo are equipped as standard with a protective device to prevent treatment wa‐ ter from being drawn back into the treatment centre via the handpieces. If products from other manufacturers are used at the standardised interfaces, it must be ensur‐ ed that they are equipped with an appropriate protective device! If this is not the case, they may not be used! Information about electromagnetic compatibility Note Based on IEC 60601-1-2 (DIN EN 60601-1-2) concerning the electromagnetic com‐ patibility of electrical medical devices, we must draw your attention to the following points: • Medical electrical devices are subject to special precautions concerning the elec‐ tromagnetic compatibility and must be installed and operated in accordance with the KaVo assembly instructions. • High-frequency communications devices may interfere with electrical medical de‐ vices. See also: 2 Information about electromagnetic compatibility in accordance with EN60601-1-2, Page 0 Note KaVo cannot guarantee the compliance of accessories, cables, and other compo‐ nents not supplied by KaVo with the EMC requirements of IEC 60601-1-2 (DIN EN 60601-1-2). Disposal Note Any waste which is generated must be recycled or disposed of in strict compliance with all applicable national regulations in a manner which is safe both for people and the environment. If you have any questions regarding proper disposal of the KaVo product, please contact the KaVo branch. Disposal of electronic and electrical devices Note According to EC directive 2002/96 concerning used electrical and electronic devi‐ ces, this product is subject to the cited directive and must be disposed of according‐ ly within Europe. For more information, please visit www.kavo.com or contact your specialised dental supplier. For final disposal, please contact: In Germany To return an electrical device, you need to proceed as follows: 12 / 130 Instructions for use ESTETICA E30 2 Safety | 2.2 Purpose – Proper use 1. On the homepage www.enretec.de of enretec GmbH, you can download a form for a disposal order under the menu item eom. Download the disposal order or com‐ plete it as an online order. 2. Enter the corresponding information to complete the order, and submit it as an on‐ line order or by fax +49 (0) 3304 3919-590 to enretec GmbH. The following contact options are also available for questions and for initiating a disposal order: Phone: +49 (0) 3304 3919-500 Email: [email protected] and Postal address: enretec GmbH, Geschäftsbereich eomRECYCLING® Kanalstraße 17 D-16727 Velten 3. A unit that is not permanently installed will be picked up at the office. A permanently installed unit will be picked up at the curb at your address on the agreed date. The owner or user of the device will have to bear the cost of disassembly, trans‐ portation and packaging. International For country-specific information on disposal, contact your dental supplier. 2.2.2 Product-specific Designated use and target group KaVoESTETICA E30 is designed for dental treatment of children and adults. The KaVoESTETICA E30 equipment system is a dental treatment unit in accordance with ISO 7494 with a dental chair in accordance with ISO 6875. The triple-function handpiece is a dental instrument in accordance with EN 1639. It aids the dental appli‐ cation in the mouth of the patient by supplying air, water or spray. This KaVo product is designed for use in dentistry only and may only be used by trained medical person‐ nel. Connecting devices KaVo-approved accessories for patient communication. These accessories must be used exclusively. Accessories Use Name Material code Monitors Monitor 19“ KaVo Screen HD 1.011.0302 Monitor 22“ KaVo Screen One 1.011.0300 Intraoral camera ERGOcam One 130 1.011.2130 ERGOcam One 160 1.011.2129 Caries diagnostic device DIAGNOcam 2170 U Cameras 1.011.0400 Cables between unit USB extension cord USB extension cord 1.004.6953 and PC - 5 meters 5m with 1:1 hub USB extension cord USB extension cord 1.011.3745 - 10 meters 2x5m with 1:1 hub Display port cable 5 metres LTG Display port 5m 1.011.3583 Standard Display port cable 10 metres LTG Display port 10m Standard 13 / 130 1.011.0298 Instructions for use ESTETICA E30 2 Safety | 2.3 Safety instructions Note The USB interfaces of the system may only be connected to IT devices approved by KaVo. Note When connecting IT equipment to the the medial electrical system, observe EN 60601-1. 2.3 Safety instructions 2.3.1 General information Note The safety and reliability of the system can only be ensured when the described procedure is followed. DANGER Explosion hazard. Risk of fatal injury. ▶ Do not use KaVo product in areas subject an explosion hazard. WARNING Inappropriate operating conditions. Impairment of the electrical safety of the device. ▶ It is essential to comply with the operating conditions specified in the "Technical Specifications" chapter. WARNING Use of un-authorised accessories or un-authorised modifications of the product. Accessories that have not been approved and/or inadmissible modifications of the product could lead to hazards and/or personal injury or material damage. ▶ Only use accessories that have been approved for the combination with the prod‐ uct by the manufacturer or are equipped with standardised interfaces (e. g. MUL‐ TIflex couplings, INTRAmatic). ▶ Do not make any modifications to the device unless these have been approved by the manufacturer of the product. WARNING Injury or damage from damaged functional parts. Damage to functional parts can cause further damage or personal injury. ▶ Check the device, electrical cables and any accessories for possible damage to the insulation and replace if necessary. ▶ If functional parts are damaged: discontinue your work and repair the damage or notify a service technician! CAUTION Risks from electromagnetic fields. Electromagnetic fields might interfere with the functions of implanted systems (such as pacemakers). ▶ Ask patients if they have a cardiac pacemaker or other system implanted before you start the treatment! 14 / 130 Instructions for use ESTETICA E30 2 Safety | 2.3 Safety instructions CAUTION Malfunctions due to electromagnetic fields. The product meets the applicable requirements regarding electromagnetic fields. Giv‐ en the complex interactions between equipment and cell phones, the product may be influenced by a cell phone that is in use. ▶ Do not use cell phones in medical offices, hospitals or laboratories! ▶ Put electronic devices such as e.g. computer storage media, hearing aids etc. down during operation! CAUTION Damage by liquids. Faults on electric components. ▶ Protect openings of the product from any ingress of liquids. ▶ Have a service technician remove liquids from the interior of the device. CAUTION Health hazard and property damage due to non-compliance with servicing schedule. Infection hazard to users and patients. Product damage. ▶ Comply with servicing schedule. CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Perform regular proper care and maintenance! 2.3.2 Product-specific WARNING Injury or infection hazard from laid down instruments. Given the arrangement of the instruments, injury or infections in the hand and under‐ arm can arise when reaching for the tray holder or operating device. Increased risk of infection from diseased patients. ▶ Be aware of the arrangement of the instruments when accessing the tray holder or operating device. WARNING Health impairment due to reverse suction via the instruments. Infection hazard. Products from other manufacturers, which are not equipped with a protective device to prevent the drawing of treatment water into the treatment unit via the instruments, may be used at standard interfaces ▶ If you are using products from other manufacturers at the standardised interfaces, ensure that the products are equipped with the corresponding protective devices. ▶ Do not use products without a protective device. 15 / 130 Instructions for use ESTETICA E30 2 Safety | 2.3 Safety instructions CAUTION Sitting down on a dental chair that is in horizontal orientation is associated with a risk of injury. ▶ Do not sit on the head or foot end of the patient chair when it is in a horizontal position. CAUTION The swinging arm may fall and cause injury. If the swinging arm is overloaded, it can become damaged and injure the patient or user. ▶ Never load the swinging arm, spring arm or dentist's unit by using it as a support. CAUTION Risk of injury by suspended instruments (S table). Patients may get injured by sharp instrument tips. ▶ When you move the dentist's unit, make sure that nobody is injured. ▶ Alert patients and care providers to the risk of injury. CAUTION Risk of injury during cleaning of the treatment unit. Lack of instructions to the cleaning staff and lack of preparation of the treatment unit can lead to the cleaning personnel sustaining injuries. ▶ Only trained professionals and instructed cleaning personnel may be present in the treatment rooms. ▶ Position the chair for cleaning and turn the device off. CAUTION Electrical power. Electrical shock. ▶ Set up the external PC outside of the patient environment keeping a minimal dis‐ tance of 1.5 m. ▶ Connect the PC and equipment connected to the PC in accordance with IEC 60601-1 / 60950. CAUTION Electrical power. Electrical shock from incorrectly connecting a non-medical system to the USB interfa‐ ces of the device. ▶ Connect any IT device to the medical system in accordance with IEC 60601-1. ▶ Use USB devices with no additional power supply (USB-powered) only. ▶ Applied parts connected to the USB interface of the dentist element must comply with the requisite insulation. ▶ USB-powered devices failing to meet the requisite insulation for applied parts must be placed appropriately such that direct contact of the USB device and the patient is excluded. ▶ It is not permissible to touch USB-powered devices failing to meet the requisite insulation for applied parts and the patient at the same time. 16 / 130 Instructions for use ESTETICA E30 2 Safety | 2.3 Safety instructions CAUTION Health damage due to germ formation. Infection hazard. ▶ Before start-up and after the device has not been used for a while (weekends, holidays, vacations, etc.), rinse or purge with air the air and water lines. ▶ Actuate the tumbler filler several times. ▶ Carry out a manual intensive germ reduction. CAUTION Long stay in the patient chair. Decubitus formation. ▶ Take precautions against the formation of decubitus in long treatments. CAUTION Risk of injury when the dental chair or headrest is moved. Hair of the patient or practice personnel may get caught when the headrest of the dental chair is moved. ▶ Mind the hair of the patient or practice personnel when moving the dental chair or the headrest. CAUTION Damage to the handpiece hoses from stickers. Handpiece hoses can burst. ▶ Do not affix stickers or adhesive tape. CAUTION Risk of injury when the dentist or assistant element is moved. The patient or office staff may be injured or bruised. ▶ Monitor the patient and office staff when moving the dentist or assistant element. 17 / 130 Instructions for use ESTETICA E30 3 Product description | 3.1 Treatment unit versions 3 Product description 3.1 Treatment unit versions 3.1.1 KaVo ESTETICA E30 S ESTETICA E30 S 3.1.2 KaVo ESTETICA E30 TM ESTETICA E30 TM 18 / 130 Instructions for use ESTETICA E30 3 Product description | 3.2 Patient chair 3.2 Patient chair 5 ① Headrest ② Backrest ③ Kickplate (base plate) ④ Seat ⑤ Armrest (optional) 19 / 130 Instructions for use ESTETICA E30 3 Product description | 3.3 Unit with patient element 3.3 Unit with patient element 8 ① Patient element ② Spittoon bowl ③ Tumbler filler ④ Unit body ⑤ Pressurised water bottle ⑥ Supply element Customer-provided connection of cen‐ tral control, electrical power, water, compressed air, wastewater, and suc‐ tion air ⑦ Intensive germ reduction bottle ⑧ Foot control Note The tumbler filler ③ of the pivotable spittoon bowl (optional) can be taken off. 20 / 130 Instructions for use ESTETICA E30 3 Product description | 3.4 Dentist unit versions 3.4 Dentist unit versions 3.4.1 TM table Note The holder assignment and arrangement of the instruments can be changed as needed and does not have to follow the picture. ① Handle ② Triple function handpiece ③ Turbine (multiflex coupling) ④ INTRA LUX Motor KL 701 / KL 703 ⑤ Scaler PIEZOsoft/PiezoLED ⑥ Tray holder ⑦ Knob for locking brake of spring arm ⑧ Small X-ray image viewer ⑨ Control element 3.4.2 S table Note The holder assignment and arrangement of the instruments can be changed as needed and does not have to follow the picture. 21 / 130 Instructions for use ESTETICA E30 3 Product description | 3.4 Dentist unit versions 1 1 6 2 3 3 4 4 4 4 5 8 7 6 2 5 10 9 7 S-table with handle trough | S-table with handle trough left/right (optional) ① Small X-ray image viewer ② Triple function handpiece ③ Turbine (multiflex coupling) ④ INTRAlux Motor KL 701 / KL 703 ⑤ Scaler PIEZOsoft/PiezoLED ⑥ Control element ⑦ Tray holder ⑧ Handle trough with pushbutton for locking brake of spring arm ⑨ Removable handle left/right (optional) ⑩ Knob for locking brake of spring arm 22 / 130 Instructions for use ESTETICA E30 3 Product description | 3.5 Assistant unit 3.5 Assistant unit ① Triple function handpiece ② High volume aspirator ③ Control element ④ Saliva ejector ⑤ KaVo Poly One / Satelec Mini LED ⑥ Tray holder for assistant 23 / 130 Instructions for use ESTETICA E30 3 Product description | 3.6 Triple-function handpieces 3.6 Triple-function handpieces 1 2 3 4 Triple function handpiece One ① Cannula ② Water button (green ring) ③ Air button (blue ring) ④ Handpiece and hose Triple-function handpiece ① Air button (A) ② Cannula ③ Gripping sleeve ④ Water button (W) ⑤ Ring blue 24 / 130 Instructions for use ESTETICA E30 3 Product description | 3.7 Controls 3.7 Controls 3.7.1 Dentist's unit TM table A C B D E F A Group of keys for the dental chair B Group of keys for illumination C Group of keys for the handpieces D Group of keys for the menu E Group of keys for hygiene F Group of keys for the timer 3.7.2 Dentist's unit S table A B C D E F A Group of keys for the menu B Group of keys for illumination C Group of keys for hygiene D Group of keys for the handpieces E Group of keys for the timer F Group of keys for the dental chair 25 / 130 Instructions for use ESTETICA E30 3 Product description | 3.7 Controls 3.7.3 Assistant unit A Group of keys for hygiene B Group of keys for illumination C Group of keys for the timer D Group of keys for the dental chair 3.7.4 Groups of keys Group of keys for the dental chair The keys of the assistant unit each have two functions and show two symbols. Assistant unit key Dentist unit key Labelling "Chair up" key "AP 0" key (automatic position 0) "Chair down" key "SP" key (rinsing position) "LP" key (last position) "AP" key (activate automatic posi‐ tion) "Backrest down" key "AP 1" key (automatic position 1) 26 / 130 Instructions for use ESTETICA E30 3 Product description | 3.7 Controls Assistant unit key Dentist unit key Labelling "Backrest up" key "AP 2" key (automatic position 2) "Collapsed position" key Group of keys for illumination/handpieces Key Name Control element Key "Operating light" Dentist element and assis‐ tant element "Operating light dimming" key Dentist element Key "X-ray viewer" Dentist element "Direction of motor rotation" Dentist element button "Preselected spray" button Dentist element "Cold light" button Dentist element Group of keys for hygiene Key Name Control element "Tumbler filler" key Dentist element and assistant element "Bowl rinsing" key Dentist element and assistant element "Bell" key Dentist element "Intensive disinfection" key Assistant element (unas‐ signed key) "HYDROclean" key 27 / 130 Assistant element (unas‐ signed key) Instructions for use ESTETICA E30 3 Product description | 3.7 Controls Group of keys for the menu Group of keys for the menu ① Menu function selection keys ② Display Group of keys for the timer Key Name Control element "Remote Control" key unassigned key "Additional motor drives" key Dentist element "Timer 1" key Dentist element and assistant element 3.7.5 Foot control The footswitches of the foot control have two functions. The functions of the foot‐ switches depend on if an instrument is mounted or removed. Item Name with mounted Handpiece with removed Handpiece ① "LP/preselected spray" footswitch Drives dental chair to previous position. Optional. Sets the spray pre-selection. ② U-shaped switch Switches the footswitch‐ es to the "Chair motion" function. 28 / 130 Instructions for use ESTETICA E30 3 Product description | 3.8 Rating plate and serial number plates Item Name with mounted Handpiece ③ "SP/blown air" footswitch Drives dental chair to rinsing position. ④ "Chair position/direction Changes the position of Selects the direction of of motor rotation" 4-way the dental chair. motor rotation (for KL switch 701 / KL 703 motor). ⑤ "Preselection of level/ handpieces" foot-pedal Preselection of level 3.8 Rating plate and serial number plates ESTETICA E30 and chair nameplate 2 1 Site for affixing the rating plate and serial number plate ① Serial number plate of the chair SN Serial number 29 / 130 ② Rating plate with removed Handpiece Optional. Sets the preset blown air (Chipblower) at the handpiece (does not apply to PiezoLED). Starts the handpieces and controls the speed/ intensity of the handpieces. Instructions for use ESTETICA E30 3 Product description | 3.8 Rating plate and serial number plates Read and take note of the content of accompanying documents Type B applied part Type BF applied part 2 min ED 10% 18 min Operating mode: Operating time of the patient chair: 2 minutes Pause time of the patient chair: 18 minutes (The permissible operating times correspond to common dental procedure.) Fuse ratings: 100/110/115/120/127/220/230/240 V AC = T6.3 A 250 V For disposal information, see also: Purpose - Intended use CE mark according to Medical Devices Directive EC 93/42 VDE mark DVGW ID (Deutscher Verein des Gas- und Wasserfaches e.V.) (Equipment-dependent DVGW mark with certification number) See also: 2 Technical Data Serial number plate and dentist element ID Rating plate dentist element (e.g. table T) / marking of the application parts of Type BF Site of attachment of rating plate and type BF applied parts ID on dentist element 30 / 130 Instructions for use ESTETICA E30 3 Product description | 3.8 Rating plate and serial number plates Type Device type SN Year of manufacture - serial number REF Material number 31 / 130 Instructions for use ESTETICA E30 3 Product description | 3.8 Rating plate and serial number plates Marks and labels of triple-function handpieces SN YY-??????? X.XXX.XXXX 3FH-One XXXX YYYY-MM Marks and labels of triple-function handpiece One ① Company logo of the manufacturer ② Can be sterilised at up to 135°C ③ Serial number ④ CE mark according to 93/42/EEC medical devices ⑤ Material number, name, production date 1 5 2 4 3 3 Marks and labels of the triple-function handpiece ① Company logo of the manufacturer ② Please note the instructions for use ③ Can be sterilised at up to 135°C ④ CE mark according to 93/42/EEC medical devices ⑤ Serial number 32 / 130 Instructions for use ESTETICA E30 3 Product description | 3.8 Rating plate and serial number plates Nameplate of water bottle and intensive germ reduction bottle 1 1 2 2 3 3 4 4 5 6 7 5 8 6 7 8 Nameplate of water bottle / intensive germ reduction bottle ① Manufacturer ② Concentration ③ Use-by date ④ Material number ⑤ Month manufactured ⑥ Expiration date (year) ⑦ Storage temperature ⑧ Please comply with accompanying documents Note The specified concentration of KaVo OXYGENAL 6 must not be exceeded. 33 / 130 Instructions for use ESTETICA E30 3 Product description | 3.9 Technical data 3.9 Technical data Drilling template and setup plan Layout plan (Mat. no. 1.009.2781) Electrical system 2 Electrical lead 3 x 1.5 mm (customer-provided fuse pro‐ 2 tection 10 A) 3 x 2.5 mm (customer-provided fuse protection 16 A) Free end above the floor 1 000 mm Input voltages 100/110/115/120/127/220/230/240 V AC Frequency 50/60 Hz Factory-set mains input voltage See nameplate Power consumption 100 to 900 VA Customer-provided fuse protection Auto-mat C16 or screw-plug fuse 10 A Protective conductor above floor See DIN VDE 0100-710, 1000 mm Heat emission 360 to 3240 kJ/h Heat emission Ø 900 kJ/h Degree of soiling 2 Installation category II Mark of approval CE / DVGW / VDE Foot control IPX1 (moisture protection) Triple-function handpiece One Flush the water and air passages for 20 to 30 seconds before working at the begin‐ ning of the day. Water pressure 1.5 ± 0.3 bar; flow pressure; probe tip (1.009.6634) Water flow 90 ± 15 ml/min Air pressure 1.5 ± 0.2 bar; flow pressure; probe tip (1.009.6634) Air flow 15 ± 3 Nl/min Triple function handpiece Flush the water and air passages for 20 to 30 seconds before working at the begin‐ ning of the day. 34 / 130 Instructions for use ESTETICA E30 3 Product description | 3.9 Technical data Water pressure 1.5 ± 0.3 bar; Flow pressure; 4 x manom‐ eter Max. static pressure water 2.5 ± 0.3 bar Water flow 80 ± 10 ml/min Air pressure 3.3 ± 0.1 bar; Flow pressure; 4 x manom‐ eter Max. dynamic pressure air 4 + 0.5 bar Air flow 14 ± 2 Nl/min Water supply CAUTION The ESTETICA E30 treatment centre, as delivered, is not equipped with an amalgam separator. Contamination of wastewater. ▶ Disposing wastewater, it is imperative to comply with the national regulations, in particular with regard to amalgam loads. Note KaVo recommends to connect an external amalgam separator to the ESTETICA E30 treatment centre in compliance with the specifications of the manufacturer of the device. Note If the water is very hard (above 12 °dH), a water softening device must be fitted in the ion-exchange process. Insufficient water hardness (below 8.4 °dH) can promote the formation of algae. Note The "water inlet block" assembly kit does not include a separation between the treatment water and water supplied by the local water supply. The operator must observe and adhere to relevant national directives concerning the prevention of backflow. If these rules are not adhered to, the manufacturer can assume no liability for the quality of the treatment water and the microbial re-contamination of the pub‐ lic drinking water network. WARNING Danger of infection if the national guidelines are not observed. Contamination of the treatment water or the drinking water network. ▶ Observe and adhere to the national guidelines concerning the quality of water for human consumption (potable water) – if available. ▶ Observe and adhere to the national guidelines concerning the prevent of reflux (flow of water from the treatment unit to the public water network) – if relevant. 35 / 130 Instructions for use ESTETICA E30 3 Product description | 3.9 Technical data WARNING Risk of infection if the "Water inlet block" is used without additional safeguards. Contamination of the treatment water and/or drinking water supply with germs. ▶ Regarding the use of the "Water inlet block" assembly kit, please note that no dis‐ infection facility is installed in the unit, and take appropriate safeguards. ▶ If the Water bottle assembly kit is used with the enclosed dosing attachment (Mat. no. 10020287), add the proper amount of KaVo OXYGENAL 6 (Mat. no. 04893451) with each filling. For the correct amount, please refer to the instruc‐ tions of the dosing attachment for water disinfection. Water germ reduction is integrated in combination with the water bottle with manual Oxygenal 6 dosing through the dosing attachment and the intensive germ reduction bottle. According to DIN EN 1717, each unit that is not listed by DVGW must be provided with an upstream type AA, AB or AD safety device. (The DVGW water bottle kit is cer‐ tified; see the following list.) When establishing a water connection, prevent brackish water pools with standing wa‐ ter (also in the house plumbing). For further information, please refer to www.dvgw.de Free drainage according to DIN EN 1717 - Water bottle DVGW, reg. no.: DVGW certified AS-0630BT0111 Water quality Tap water Water hardness 1.5 to 2.14 mmol/l ≙ 8.4 to 12 °dH pH 7.2 to 7.8 Customer water filtering 80 µm Water connection Shut-off valve with brass cone compres‐ sion screw connection 3/8" to Ø 10 mm provided Above-floor water connection min. 50 mm, max. 105 mm with valve opened Water inlet pressure 2.0 to 6.0 bar Water inlet pressure 4 l/min Diameter of the drain connection 40 mm Above-floor drain connection 20 mm Outflow quantity max. 4 l/min Slope of water drain pipe downstream from device: at least 10 mm per metre Air supply WARNING Non-adherence to national guidelines regarding the quality of the dental air. Infection hazard. ▶ Observe and adhere to the national guidelines regarding the quality of the dental air - if any. ▶ Blow through the air line prior to commissioning. 36 / 130 Instructions for use ESTETICA E30 3 Product description | 3.9 Technical data Air inlet pressure 5.5 to 7 bar Air consumption of standard device max. 60 Nl/min. Air consumption with 1 Venturi suction unit max. 105 Nl/min. Air consumption with 2 Venturi suction max. 150 Nl/min. units Customer air filtration 50 µm Air connection Shut-off valve with brass cone compres‐ sion screw connection 3/8" to Ø 10 mm provided Air connection above floor level min. 50 mm, max. 105 mm with valve opened Suction Suction air quantity at spray mist cannula Suction vacuum at device intake with wet suction minimal V~250 Nl/min > 70 mbar recommended V~300 Nl/min > 90 mbar Suction vacuum static max. < 180 mbar Note If the negative static pressure is > 180 mbar, the unit must be equipped with the negative pressure regulating valve assembly kit. Diameter of the suction connection 40 mm Above-floor suction connection 20 mm The values apply to the KaVo measuring set (Mat. no. 0.411.8500). Operating environment WARNING Inappropriate operating conditions. Impairment of the electrical safety of the device. ▶ It is essential to comply with the operating conditions specified in the "Technical Specifications" chapter and not to exceed those conditions. Floor quality The quality of the flooring must meet the load bearing ability for buildings DIN 1055 page 3 and have a pressure re‐ sistance in accordance with DIN 18560 T 1. o Ambient temperature +10 to +40 C Relative humidity 30 to 75% Air pressure 700 hPa to 1,060 hPa Max. elevation for operation up to 3000 m 37 / 130 Instructions for use ESTETICA E30 3 Product description | 3.9 Technical data Maximum loads Max. patient weight load 180 kg Tray holder of the dentist element - loada‐ 2 kg ble up to Assistant unit tray holder - loadable up to 1 kg Dentist element - loadable up to 2 kg Transportation and storage conditions o Ambient temperature -20 to +55 C Relative humidity 5% to 95% non-condensing Air pressure 700 to 1,060 hPa Weight Treatment unit with Standard patient chair 279 kg gross, 224 kg net For more information about the packages, please refer to Assembly Instructions 38 / 130 Instructions for use ESTETICA E30 4 Operation | 4.1 Switching the device on and off 4 Operation 4.1 Switching the device on and off Note Always switch the machine off before leaving the office. ▶ Switch on the device using the main switch. ð The display of the dentist unit ① shows the preselected basic menu. ð The green LED "Device turned on" lights up on the assistant unit ②. 1 2 4.2 Converting from right handed to left handed CAUTION Collision and damage to the unit. ▶ Ensure sufficient space for swinging. ▶ Turn off the device before conversion. 39 / 130 Instructions for use ESTETICA E30 4 Operation | 4.2 Converting from right handed to left handed CAUTION Let the instrument hose hang on the patient chair or another object. ▶ When swinging the dentist's unit and the articulation, make sure that the instru‐ ment hoses do not get caught. ① Right handed model ② Left handed model ▶ Remove the seat. 40 / 130 Instructions for use ESTETICA E30 4 Operation | 4.2 Converting from right handed to left handed ▶ Undo the screw. 41 / 130 Instructions for use ESTETICA E30 4 Operation | 4.2 Converting from right handed to left handed ▶ Swivel the dentist and assistant element to the other chair side and re-tighten the screw. 42 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair ▶ Undo the locking and swivel the patient unit by 180° until the locking snaps-in again. patient element ▶ Fasten the seat again proceeding in reverse order. 4.3 Adjusting the dental chair 4.3.1 Adjusting the armrest (optional) To make it easier for the patient to sit in the chair, the armrest can be swung up. 43 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair CAUTION The patient's hands are in a bad position when the chair is rising Danger of crushing fingers between the backrest and armrest. ▶ Make sure that the patient is sitting in the right position (especially children). 4.3.2 Adjust head rest Setting locking dial of 2-joint headrest CAUTION Adjusting the headrest. Injury of neck muscles. ▶ Make sure that the patient is aware of the headrest setting. ▶ Patients need to raise their head slightly during adjustment. 44 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair ▶ Push in or pull out the headrest depending on the patient's size. ▶ To swing the headrest, turn the locking dial to the left, move the headrest into po‐ sition, and turn the dial to the right to lock it. ▶ To remove the headrest cushion, remove the screw ②, pull the cushion ① up slightly, and remove it to the front. 4.3.3 Positioning the dental chair manually CAUTION Danger of injury from overload or dynamic load. The patient chair might collapse. ▶ Do not subject the patient chair to a load exceeding its limit (180 kg). ▶ Do not subject the patient chair to dynamic loads. CAUTION Motorised movement of the chair The patient or treatment personnel can be clamped or crushed. ▶ Monitor the patient and treatment personnel when changing the patient's position. 45 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair Positioning the chair and backrest manually using the dentist or assistant unit Use the following buttons to adjust the chair height and position of the backrest: Key Function The chair moves up. The chair moves down. The backrest moves upward. The backrest moves downward. ▶ Press the related key. ð The chair or backrest moves in the desired direction. Positioning the chair and backrest manually using the foot control The 4-way switch of the foot control assumes the function of the button wheel on the dentist unit when manually positioning the dental chair. See also: 2 Positioning the dental chair manually Requirement All instruments are in their holder. ▶ Chair up: Move the cross switch on the foot control in direction ①. ▶ Chair down : Move the cross switch on the foot control in direction ③. ▶ Backrest up: Move the cross switch on the foot control in direction ②. ▶ Backrest down: Move the cross switch on the foot control in direction ④. 46 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair 4.3.4 Automatic positioning of dental chair CAUTION Danger of injury from overload or dynamic load. The patient chair might collapse. ▶ Do not subject the patient chair to a load exceeding its limit (180 kg). ▶ Do not subject the patient chair to dynamic loads. CAUTION Danger of crushing during automatic chair movement. The patient or treatment personnel can be clamped. ▶ Monitor the patient and treatment personnel when changing the chair position. The chair position can be adjusted continuously. Automatic positions can be saved, and the saved positions can be recalled by the push of a button. Recalling automatic positions with the dentist unit The following keys can be used to recall saved chair positions. Key Operation Move to the rinsing position. The last position before actuating the SP is assumed. Move to automatic position 0. Move to automatic position 1. Move to automatic position 2. Move to the collapsed position. ▶ Briefly press the desired button. ð Chair automatically moves to the stored position. ð Upon arrival at the stored position, the display diode on the button is turned on. Saving automatic positions with the dentist unit Recommended assignment of buttons: "SP" button: rinsing position "AP 0" button: entry and exit position "AP 1" button: treatment position, e.g. for lower jaw treatment "AP 2" button: treatment position, e.g. for upper jaw treatment "Collape position" button: collapse position ▶ Move the chair to the desired position. 47 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair ▶ To save the chair position, press "AP 0", "AP 1", "AP 2", "SP" or "Collapsed posi‐ tion" button until you hear a signal. ð The display diode of the pressed button is turned on. The chair position is saved. See also: 2 Manual positioning of the patient chair using the MEMOdent control element Last position After the "LP" button is pressed, the chair moves into its position before the "SP" but‐ ton was pressed. Note The memory is erased when you turn off the device. After turning on the device again (for example in the morning or after lunch), the chair does not execute a spe‐ cific movement when you press the "LP" button. Recalling automatic positions with the assistant unit ▶ Briefly press the "AP" key. ð The LEDs of the "AP 0", " AP 1", " AP 2", "SP", and "LP" keys flash for approxi‐ mately four seconds. ▶ During these four seconds, briefly press the "AP 0", " AP 1", " AP 2", "SP" or "LP" key. ð The chair moves into the selected automatic position. Saving automatic positions with the assistant unit Note The automatic position "Last position" is saved on the "LP" button. Press the "LP" button for the chair to automatically move to the last position before the rinsing posi‐ tion. The "LP" button cannot be assigned to another automatic position. ▶ Move the chair to the desired position. ▶ Briefly press the "AP" key. ð The LEDs of the "AP 0", " AP 1", " AP 2", "SP", and "LP" keys flash for approxi‐ mately four seconds. ▶ During these four seconds, press the "AP 0", "AP 1", "AP 2", "SP" or "LP" button, until a signal sound is transmitted. ð LED of the pressed button lights up. The chair position is saved. 48 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair Recalling automatic positions with the foot control Note If an instrument is removed, the chair functions of the foot control are blocked. The blocking can be removed by briefly pressing the stirrup switch. The functions are then available. ① Spray preselection/AP footswitch ② Footswitch blowing air/AP (optional) ③ Foot pedal The chair positions can be recalled with two foot switches; the standard setting is as follows: ▪ "Spray selection" foot switch: automatic position "LP" (last position) ▪ "Blown air" foot switch: automatic position "SP" (rinsing position) Move the chair when the instrument is mounted ▶ Press the "SP" foot-operated button. or ▶ Press the "LP" foot-operated button. ð The chair moves into the selected automatic position. Move the chair when the instrument is removed Note If an instrument is removed, the chair functions of the foot control are blocked. The blocking can be removed by briefly pressing the stirrup switch. The functions are then available. 49 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair ▶ Press the stirrup switch and then the "Preselected spray" or "Blown air" foot switch. ð The chair moves into the selected automatic position. Saving an automatic position with the foot control ① Spray preselection/AP footswitch ② Footswitch blowing air/AP (optional) ③ Foot pedal The chair positions can be saved on two footswitches; the standard setting is as fol‐ lows: ▪ "Spray default" footswitch: "LP" automatic position (last position) ▪ "Blown air" footswitch: "SP" automatic position (rinsing position) ▶ Hold down the foot pedal and foot-operated button "SP", and simultaneously press any button for an automatic position ("AP 0", "AP 1", "AP 2" or "SP") on the dentist or assistant unit until you hear a beep. ð The automatic position is saved to the foot-operated button. or ▶ Hold down the foot pedal and foot-operated button "LP", and simultaneously press any button for an automatic position ("AP 0", "AP 1", "AP 2" or "SP") on the dentist or assistant unit until you hear a beep. ð The automatic position is saved to the foot-operated button. 4.3.5 Safety shut-off To prevent collisions arising from the movement of the patient chair, safety shutoff switches are installed to protect the patient and practice personnel from injury and the treatment unit from damage. 50 / 130 Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair CAUTION Damage to the assistant element and dental chair. Despite some safety shut-downs being present, certain positions of the assistant unit may collide with the dental chair. ▶ Keep the assistant unit out of the range of motion of the patient chair. ▶ Always monitor the chair movement. CAUTION Pinching from the treatment chair. The safety shutoff of the treatment chair is activated by lifting the respective compo‐ nent. Depending on the patient's body weight and the leverage, more force can be exerted on the object to be triggered than is necessary to trigger the switching func‐ tion. ▶ The treatment personnel must move outside of the chair's swinging range when‐ ever the chair moves. CAUTION Risk of injury when moving the patient or patient chair. The patient or treatment personnel can be pinched or crushed. ▶ Position all moving parts, such as dentist element, assistant element, operating light, screens, etc., outside the collision range when you move the patient or pa‐ tient chair. The safety cut-offs can be found at the following places on the treatment unit. 5 Pos. no. Safety switch-off actu‐ ated ① Bracket on the foot con‐ trol ② Assistant element 51 / 130 LED on assistant ele‐ ment LED on dentist element Instructions for use ESTETICA E30 4 Operation | 4.3 Adjusting the dental chair Pos. no. Safety switch-off actu‐ ated ③ Backrest ④ Kickplate LED on assistant ele‐ ment LED on dentist element ⑤ Seat For right/left conversion with bench removed The safety shutoff occurs went a movement angle has been exceeded, or part of the treatment unit collides with an object. If a person or object actuates a safety shutoff, the chair immediately stops moving. The fact that the safety shutoff has been activated is displayed by the corresponding display flashing on the dentist or assistant unit. Note The chair's position cannot be changed with the key wheels when a safety shutoff is activated. ▶ To deactivate an activated safety shutoff, remove the triggers from the to the range of movement of the stool. CAUTION Changing the chair's position when the safety circuit is on. Personal injury. Damage to the device. ▶ When changing position, do not move the chair against the active safety circuit when actively shutting off the safety circuit. CAUTION Pinching from the treatment chair. The safety shutoff of the treatment chair is activated by lifting the respective compo‐ nent. Depending on the patient's body weight and the leverage, more force can be exerted on the object to be triggered than is necessary to trigger the switching func‐ tion. ▶ The treatment personnel must move outside of the chair's swinging range when‐ ever the chair moves. To allow the chair to move freely, it can also be moved when the safety circuit is on. Use this function for repair purposes only. ▶ Press and hold down both the "SP" and "LP" keys on the dentist element. or ▶ Press and hold down the "LP/AP" key on the assistant element. ▶ Move the chair using the button wheel buttons of the chair. 52 / 130 Instructions for use ESTETICA E30 4 Operation | 4.4 Moving the patient chair 4.4 Moving the patient chair 45° 245 45° 245 +5° / - 5° 70° 765 mm 825 mm 360 mm 305 mm 4.5 Moving the dentist unit CAUTION Damage from overloading the dentist element. Exceeding the maximum weight of more than 2 kg by adding handpieces, accesso‐ ries, etc., can cause damage. ▶ Do not overload the dentist element! CAUTION Risk of injury when the dentist or assistant element is moved. The patient or office staff may be injured or bruised. ▶ Monitor the patient and office staff when moving the dentist or assistant element. The swinging range of the dentist unit is limited by stops. Note Do not pull the dentist unit by the instrument hose. 53 / 130 Instructions for use ESTETICA E30 4 Operation | 4.5 Moving the dentist unit ① Knob for locking brake of spring arm ▶ To adjust the height of the dentist unit, release the brake ① adjust the height, and lock the brake again. 4.5.1 Moving the dentist unit TM 12 80° 160° 0° 160° 80° 54 / 130 120 ° 25° 25° CAUTION Excessive load on the support system The patient or treatment personnel may be injured. The support system may be damaged. ▶ Do not exceed the permissible maximum weight (generated e.g. by instruments and accessories). ▶ Do not use the swinging arm for a support! Instructions for use ESTETICA E30 4 Operation | 4.6 Moving the patient unit 4.5.2 Moving the dentist unit S 80° 160° 120 ° 0° 12 25° 25° CAUTION Risk of injury by suspended instruments (S table). Patients may get injured by sharp instrument tips. ▶ When you move the dentist's unit, make sure that nobody is injured. ▶ Alert patients and care providers to the risk of injury. 160° 80° 4.6 Moving the patient unit The device body can be swivelled away from the patient chair by 60o. The spittoon bowl can be removed. 55 / 130 Instructions for use ESTETICA E30 4 Operation | 4.6 Moving the patient unit 4.6.1 Moving the patient element (optional) CAUTION The left armrest can collide with the manually adjusted patient's unit when the chair moves. Injury hazard. ▶ Each time before the chair is adjusted (automatic and manual), swing the manual‐ ly adjusted patient's unit into resting position. Note No liquids may be emptied into the mouth rising basin when the devices is turned off. Mechanical and electronic damage could occur as a result of overflowing liquid. The spittoon bowl of the swivelling patient element (optional) can be swivelled by ap‐ prox. 180o: 90o each to the left and right. 56 / 130 Instructions for use ESTETICA E30 4 Operation | 4.7 Attaching the tray holder (optional) 4.7 Attaching the tray holder (optional) ① Tray holder ② Holder The support ② for the tray holder ①is an optional accessory. 4.8 Using functions through the menu 4.8.1 General menu navigation The functions in the menu are used through the selections keys (S1 to S4) on the dis‐ play ① Selection keys (S1 to S4) for menu functions ② Display 4.8.2 Using the user menu The following options can be opened in the user menu: Option Feature Description 1 Users Set number of users. 2 Tumbler Set tumbler filling time. 3 Bowl Set bowl rinsing time. 4 Handpiece light Set cold light afterglow period. 5 ENDO Set ENDO holder. Available only with an ENDO license. 6 Time of day Set time of day. 7 Date Set date. 57 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Option Feature Description 8 Set display mode for time of day and date: Time/date display mode ▪ Time of day only ▪ Time of day without seconds ▪ Time of day and date ▪ Date only 9 LCD Set contrast of LCD display. 10 Language Set menu language: ▪ Deutsch ▪ English ▪ Italiano ▪ Français ▪ Castellano 13 License Display of activated licenses: ▪ ENDO: Endo function ▪ PLED: PiezoLED function ▪ FCR: (foot control) control of CONEXIO by foot control 14 Firmware Display current firmware version. ① Selection keys (S1 to S4) for menu functions ② Display ▶ Press the "Next" key (S4) to start-up the user menu. ð The user menu displays options and parameters that can be set and changed by the user. ▶ Press the "Save" (S1) key to save the selection made. 58 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Option 1: Set number of users S1 S1 S2 S2 S3 S3 S4 S4 ▶ Press the "S1", "S2", "S3" key to select user 1, 2, and 3, respectively. ▶ Press the "S4" button to call up the second level. ▶ Press the "S1", "S2", "S3" key to select user 4, 5, and 6, respectively. Option 2: Set tumbler filling time 2. Becherfüllzeit Einstellung: 7.0s S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to select a tumbler filling time from 0 - 51 seconds. Option 3: Set bowl rinsing time S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to select a bowl rinsing time from 1.0 - 50.0 seconds. Interval: 0.2 seconds. 59 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Option 4: Set LUX afterglow period S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to set the afterglow period be‐ tween 0 to 10 seconds. The default value is 3 seconds. Option 5: Set ENDO holder S1 S2 S3 S4 ▶ Press the "increase value" or "reduce value" keys to set the selected holder. Option 6: Set the time of day 6 S1 S2 S3 S4 ▶ Press the "SET" (S2) key to change the values of minutes and hours. ð The value to be changed flashes. ▶ Press the "Save" (S1) key to save the selection made. 6 S1 S2 S3 S4 60 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu ▶ Press the "reduce value" or "increase value" key to set the marked time of day. ▶ Press the "SS:MM" (S1) key to switch between hours and minutes. ▶ Press the "Save" (S4) key to save the values and switch to the SET display. Option 7: Set the date 7 S1 S2 S3 S4 ▶ Press the "SET" (S2) key to change the values of day, month, and year. ð The value to be changed flashes. ▶ Press the "Save" (S1) key to save the selection made. 7 S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to set the marked value. ▶ Press the "SS:MM" (S1) key to switch between day, month, and year. ▶ Press the "Save" (S4) key to save the values and switch to the SET display. Option 8: Set display mode for time of day and date 8 S1 S2 S3 S4 61 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu ▶ Press the "reduce value" or "increase value" key to set the display mode of date/ time. ▶ The following displays can be selected: time of day only, time of day<no seconds> only, time of day and date, date only, day of the week, no display Option 9: Setting the display contrast 9 S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to set the contrast of the LCD display. Option 10: Setting the menu language 0 S1 S2 S3 S4 ▶ Press the "reduce value" or "increase value" key to select the menu language. ▶ The following languages can be selected: Deutsch, English, Italiano, Francais, Castellano. Option 13: Displaying the activated licenses 13 Lizenz ENDO PLED FCR S1 S3 S2 S4 Displays the activated licenses: ▪ ENDO: Endo function ▪ PLED: PiezoLED function ▪ FCR: (foot control) control of CONEXIO by foot control 62 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Option 14: Displaying the firmware version 14 S1 S2 S3 S4 The firmware version is displayed 4.8.3 Standby menu The stand-by menu is used to start the device. The device switches to the stand-by menu upon closing of the handpiece and endo menus. S1 S2 S3 S4 ▶ Press the "Next" key (S4) to start-up the user menu. Service and error messages in the stand-by menu Service and error messages are displayed in the stand-by menu through the "!" sym‐ bol. S1 S2 S3 S4 ▶ Press the "S2" button to display messages. S1 S2 S3 S4 ▶ Press the function keys to navigate between the messages. 63 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Key Settings S2 Previous message S3 Next message S4 Switch to stand-by menu Error messages in the status display See also: 2 Troubleshooting 4.8.4 Selecting the dentist The first symbol in the stand-by menu displays the current user. S1 S2 S3 S4 ▶ Press the "S1" key to start the user selection menu. User selection (max. 6 users) The user selection menu displays the available users. S1 S1 S2 S2 S3 S3 S4 S4 ▶ Press the "S1", "S2", "S3" key to select user 1, 2, and 3, respectively. ▶ Press the "S4" button to call up the second level. ▶ Press the "S1", "S2", "S3" key to select user 4, 5, and 6, respectively. 4.8.5 Instruments menu handpiece-specific values are displayed and adjusted in the menu. The display depends on which instrument was withdrawn. 64 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Changing motor settings in the menu Note Following instructions for use, service instructions and installation instructions in the instrument packaging. Motor status The status of a handpiece is displayed on the display or control keys once a hand‐ piece is taken out. S1 S2 S3 S4 Setting Actuation Pane Motor speed Foot control Display Light intensity Foot control, control keys Display Direction of motor rotation Foot control, control keys LED control keys Spray status Foot control, control keys LED control keys Adjusting the motor ▶ Settings can be changed using the corresponding keys on the control panel or on the foot control. Motor speed is set with the foot control only. The direction of motor rotation, cooling status and light intensity are set with the foot control or the control keys. ð The current settings are saved and activated the next time the handpiece is taken out. PIEZOsoft/PiezoLED Note The setting of the mode is only available in combination with a PiezoLED Ultrasonic Scaler. The PiezoLED menu and all PiezoLED functions are only available if a Pie‐ zoLED license is existent. Setting the PIEZOsoft The status of the handpiece is shown on the display when the PIEZOsoft is being tak‐ en out: ▪ Intensity ▶ Settings can be changed using the corresponding keys on the control panel or on the foot control. The light intensity is set with the foot control only. Modus, spray, is set with the foot control or the control keys. 65 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu ð The current settings are saved and activated the next time the handpiece is taken out. S1 S2 S3 S4 Setting the PiezoLED The status of the handpiece is shown on the display when the PiezoLED is being tak‐ en out. ▪ Intensity ▪ Mode ▪ Light intensity ▶ Settings can be changed using the corresponding keys on the control panel or on the foot control. The light intensity is set with the foot control only. Modus, spray, light on/off are set with the foot control or the control keys. ð The current settings are saved and activated the next time the handpiece is taken out. S1 S2 S3 S4 Power output as a function of operating mode and tip load 66 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Power output as a function of device pre-setting (foot control) and tip load (shown using modes P3 and E as examples) Note If you stay in the range of dynamic response, the treatment is ensured to be gentle. The output is adjusted according to load. 4.8.6 ENDO menu (optional) Note The functions of the ENDO menu are available only if an ENDO license is existent. Start-up ENDO menu The ENDO menu is started-up through: ▪ taking the ENDO motor out of the dentist element (setting in user menu, option 5) ▪ activating the (M) "Additional motor drives" key afterwards ENDO status menu S1 S2 S3 S4 The status of the ENDO motor is displayed in the ENDO menu: Parameters Values Transmission factor 1:1, 3:1 Parameter memory P1,P2,P3,P4,P5,P6 Torque mode TQ-Ctrl, Autoreverse, AutoRev/Forw. Direction of motor rotation R, L Speed 100 to 6,000 rpm Torque Transmission ratio 1:1: 0.15 to 2.50 Ncm Transmission ratio 3:1: 0.4 to 8.0 Ncm 67 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Using the ENDO menu Displaying parameters ▶ Press the respective keys on the display to navigate between parameters. S1 S2 S3 S4 Key Settings S1 (short) (Briefly) press the "SP/ Blown air" foot-operated button Displays the next set of parameters 1,2,3,4,5,6,1,..(ring counter) S4 Selects the ENDO options menu Setting the ENDO menu ▶ Press the "S1" key for an extended time to select the ENDO settings menu. The individual parameters can be set and changed in this menu. S1 S2 S3 S4 Key Settings S1 Saves the parameters. Selects the ENDO menu. S2 Changes the value. S3 Changes the value. S4 Moves the flashing cursor: Torque mode, speed, torque, torque mode, ... (ring counter). Set torque mode ▶ The torque mode parameter can be changed after selecting it in the settings menu. ð The selected parameter is marked by a flashing cursor on the display. 68 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu S1 S2 S3 S4 Key Settings S1 Saves the parameters Selects the ENDO menu S2 Changes the torque mode Autoreverse, Torque Control only, Autorev. / Forward, Autoreverse,..(ring counter) S3 Changes the torque mode Autoreverse, Autorev. / Forward, Torque Control only, Autoreverse,..(ring counter) S4 Moves the flashing cursor Setting the speed ▶ The speed parameter can be changed after selecting it in the settings menu. ð The selected parameter is marked by a black triangle on the display. S1 S2 S3 S4 Key Settings S1 Saves the parameters Selects the ENDO menu S2 Changes the speed Range: 100 rpm to 500 rpm: in 10 rpm increments Range: 500 rpm to 1,000 rpm: in 50 rpm increments Range: 1,000 rpm to 6,000 rpm: in 100 rpm increments S3 Changes the speed Range: 100 rpm to 500 rpm: in 10 rpm increments Range: 500 rpm to 1,000 rpm: in 50 rpm increments Range: 1,000 rpm to 6,000 rpm: in 100 rpm increments S4 Moves the flashing cursor Setting the torque ▶ The torque parameter can be changed after selecting it in the settings menu. ð The selected parameter is marked by a black triangle on the display. ▶ Sets the maximum torque. ð The torque is limited to the set maximal value. ð The ENDO warning signal is issued when 90% of the pre-set maximal value are reached. 69 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu S1 S2 S3 S4 Key Settings S1 Saves the parameters Selects the ENDO settings menu S2 Changes the torque 1:1 transmission ratio Range: 0.15 Ncm to 2.5 Ncm: in 0.05 Ncm increments Range: 1% to 100%: in 2% increments 3:1 transmission ratio Range: 0.4 Ncm to 8.0 Ncm: in 0.05 Ncm increments Range: 1% to 100%: in 1% increments S3 Changes the torque 1:1 transmission ratio Range: 0.15 Ncm to 2.5 Ncm: in 0.05 Ncm increments Range: 1% to 100%: in 2% increments 3:1 transmission ratio Range: 0.4 Ncm to 8.0 Ncm: in 0.05 Ncm increments Range: 1% to 100%: in 1% increments S4 Moves the flashing cursor ENDO options menu ▶ Press the "S4" key to select the ENDO options menu. S1 S2 S3 S4 Option 1: Transmission ratio ▶ Press the "S2" or "S3" key to set the transmission factor. S1 S2 S3 S4 70 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Key Settings S1 Saves the option Selects the ENDO menu S2 Changes the transmission factor 1:1 or 3:1 S3 Changes the transmission factor 1:1 or 3:1 S4 Selects the next option Option 2: Torque ▶ Press the "S2" or "S3" key to change the torque setting display. S1 S2 S3 S4 Key Settings S1 Saves the option Selects the ENDO menu S2 Changes the torque setting display Unit: % or Ncm Transmission ratio 1:1: 100% = 2.5 Ncm Transmission ratio 3:1: 100% = 8.0 Ncm S3 Changes the torque setting display Unit: % or Ncm Transmission ratio 1:1: 100% = 2.5 Ncm Transmission ratio 3:1: 100% = 8.0 Ncm S4 Selects the next option Option 3: AutoRev. / Fwd ▶ Press the "S2" or "S3" key to set the period of time after which the motor rotates clockwise automatically. This dispenses with having to stop it using the foot con‐ trol. S1 S2 S3 S4 Key Settings S1 Saves the option Selects the ENDO menu 71 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu Key Settings S2 Sets the time 1 second to 10 seconds S3 Sets the time 1 second to 10 seconds S4 Selects the next option 4.8.7 Using the CONEXIOcom (optional) Note To start the CONEXIOcom menu, no handpiece may be removed. Note For all CONEXIOcom functions, the dental unit must be connected to an installation of the KaVo "CONEXIO" software. The function of the CONEXIOcom menu is to control the display of previously recor‐ ded and saved images and videos. In order to use the function, the unit must have ac‐ cess to the data of the KaVo Software "CONEXIO" software. For details on the config‐ uration, please refer to the "CONEXIO" installation instructions. Opening the CONEXIOcom menu In order to display existing images, open the menu with the "Remote Control" button. Select the proper patient on the corresponding PC for this purpose. It is also feasible to automatically transfer the patient from your invoicing programme to CONEXIO. For details on the configuration, please refer to the "CONEXIO" installation instructions. If no patient is selected, images from the clipboard are displayed. If the clipboard is empty, no image is displayed. The clipboard is deleted automatically when the patient is logged off the corresponding PC. The CONEXIOcom menu is opened automatically for recording of images or videos as soon as a device (DIAGNOcam U, ERGOcam One) is taken out. To close CONEXIOcom: Replace the active device to its holder or close the CONEX‐ IOcom menu with the "Remote Control" button. No Icon Setting 1 - Info line This line displays the active patient name (if se‐ lected in CONEXIO) under which the data ob‐ tained are stored. If no patient is selected, images and videos are stored in the clipboard under "unassigned pa‐ tient". 72 / 130 Instructions for use ESTETICA E30 4 Operation | 4.8 Using functions through the menu No Icon Setting 2 - If a device is active, the device type is shown. The following is implemented at this time: DIAGNOcam U ERGOcam One 3 Next image/video To be able to communicate efficiently with the pa‐ tient, individual images can be selected and dis‐ played directly. This uses a rolling system that advances from left to right and from top to bot‐ tom. 4 Save image/video Press briefly - saves the selected image/video. Press long - all images/videos are saved in the Swap Tray. If no patient is selected, the images stay in the clipboard and cannot be saved permanently. As soon as a patient is selected, these temporary data in the clipboard are deleted. When an active patient is logged off (or a new patient is logged on) in CONEXIO, a query is shown asking whether the images in the shall be deleted or saved. Data deleted at this point can‐ not be restored subsequently. 5 Discard image/video Press briefly - deletes the selected image/video Press long - all images/videos in the clipboard are deleted 6 Screen display: This button changes the display on the monitor. The following settings can be made: 1/2/4/6 – number of images displayed. The live image is always shown as the last image in split view. 73 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit 4.9 Using function through the dentist or assistant unit 4.9.1 Using the hygiene functions The following buttons are available for the hygiene functions: Key Name Control element "Tumbler filler" key Dentist element and assistant element "Bowl rinsing" key Dentist element and assistant element "Bell" key Dentist element "Intensive disinfection" key Assistant element (unas‐ signed key) "HYDROclean" key Assistant element (unas‐ signed key) Note The preparation methods can be found in the care instructions. The following settings can be changed: ▪ Tumbler filling time ▪ Bowl rinsing time Using the tumbler filling ▶ Press the "Tumbler" button briefly to start filling the tumbler. ð Tumbler filling is started and then stopped after the saved period of time. ð Default = 7 s. ð An on/off operation is not supported. ▶ Press the "Tumbler filling" key for more than 4 seconds to start the programming mode. Set the period of time in 200 ms increments. Minimum: 0.4 s. ð If the key stays depressed, the elapsed time is counted in 200 ms steps and an acoustical signal is issued each second. ð Once the key is released, the current value is saved. Using the bowl flush ▶ Press the "Bowl flush" key briefly to start the bowl flush. ð The bowl flush is started and then stopped after the saved period of time. ð Default = 7 s. An on/off operation is not supported. 74 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit ▶ Press the "Bowl flush" key for more than 4 seconds to start the programming mode. Set the period of time in 200 ms increments. Minimum: 0.4 s. ð If the key stays depressed, the elapsed time is counted in 200 ms steps and an acoustical signal is issued each second. ð Once the key is released, the current value is saved. 4.9.2 Using the illumination functions for KaVoLUX 540 LED T WARNING Unintentional activation of the KaVo KEY Laser III and KEY Laser 3+. Simultaneous application of the operating light KaVoLUX 540 LED and the KaVo KEY Laser III or KEY Laser 3+ can lead to the unintentional activation of the KaVo KEY Laser III and KEY Laser 3+. ▶ When using the KaVo KEY Laser III or the KEY Laser 3+, switch the treatment light to laser mode. ▶ Or switch off the treatment light, do not use KaVo KEY Laser III or KEY Laser 3+ simultaneously with treatment light KaVoLUX 540 LED. WARNING Wrong handling. Reversible blinding (temporary sight impairment). ▶ Do not direct the light field at patients, users or/and third parties while you switch on the light. ▶ Do not direct the light field at the patient´s eyes when you move the light head. ▶ Maintain a clearance of ca. 700 mm between the light and the mouth of the pa‐ tient. CAUTION Stroboscopic effect of the rotating instrument. A stroboscopic effect could arise in instruments rotating at a certain speed during ap‐ plication of the KaVoLUX 540 LED. This is an optical illusion, where the instrument appears to be standing still or rotating extremely slowly. Injury hazard. ▶ If the stroboscopic effect appears, change the speed fractionally and continue op‐ erating in the usual manner. CAUTION Faulty measurement in connection with KaVo DIAGNOdent. Simultaneous application of the treatment light KaVoLUX 540 LED and the KaVo DI‐ AGNOdent can lead to faulty measurements. ▶ Switch the treatment light to laser mode when using the KaVo DIAGNOdent. ▶ Or switch off the treatment light, do not use KaVo DIAGNOdent and treatment light KaVoLUX 540 LED simultaneously. CAUTION Premature hardening of composite fillings. A light intensity that is too high can have a negative impact on the durability of the treatment. ▶ Select the appropriate dimming level according to the processing time. 75 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit Note The KaVoLUX 540 LED T cannot be operated through the control functions of the treatment centre. The operating light an only be switched on and off. The KaVoLUX 540 LED operating light can be used in the following modes: ▪ Normal light: preset at 5,500 Kelvin and 30,000 Lux corresponding to daylight quality ▪ COMPOsave-Modus: enables longer processing periods for composites by filter‐ ing the blue components of the light ▪ Dimmed light: approx. 4,000 Kelvin; equivalent to the light of a halogen operating lamp ▪ Laser mode: Light mode, which has no negative influence on the KaVo KEY Laser III, the KEY Laser 3+ or the KaVo DIAGNOdent. When operated In dimmed mode, the LED lamp functions according to a dimmed hal‐ ogen lamp. The colour temperature is approx. 4,000 K and the composite can harden prematurely. This can have a negative impact on the durability of the treatment. The COMPOsave modes prevents the composite from hardening prematurely. As op‐ posed to the dimmed light, the blue components of the light are filtered in the process. Therefore the composite can be processed longer in COMPOsave mode. Control panel KaVoLUX 540 LED T ① "Treatment lamp" key ② "Treatment lamp dimming" key ③ "Mode/ colour temperature" button Turning the operating light On and Off The KaVoLUX 540 LED operating light can be used in the following modes: ▪ Normal light: preset at 5,500 Kelvin and 30,000 Lux corresponding to daylight quality ▪ COMPOsave-Modus: enables longer processing periods for composites by filter‐ ing the blue components of the light ▪ Dimmed light: approx. 4,000 Kelvin; equivalent to the light of a halogen operating lamp ▪ Laser mode: Light mode, which has no negative influence on the KaVo KEY Laser III, the KEY Laser 3+ or the KaVo DIAGNOdent. ▶ Press the "Operating light" button on the dentist or assistant element. 76 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit ð The operating light is switched on in its most recent active state: operating light on, COMPOsave mode on or dimmed light. ▶ Press the "operating light" button once again. ð Operating light is switched off. A sensor can be used to switch the operating light on or off as follows: Sensor KaVoLUX 540 LED ▶ Put your hand just in front of the sensor of the operating light. ð Operating light is switched on. ▶ Again put your hand just in front of the sensor of the operating light. ð Operating light is switched off. Setting the brightness Note The maximum possible brightness of the light is set in five steps using the "Treat‐ ment light" key. ▶ Press and hold down the "operating light" button. ð Brightness varies between five stages. ▶ When the desired brightness is reached, release the "Treatment light" key. Changing between COMPOsave mode res. dimmed light and normal light The KaVoLUX 540 LED operating light can be used in the following modes: ▪ Normal light: preset at 5,500 Kelvin and 30,000 Lux corresponding to daylight quality ▪ COMPOsave-Modus: enables longer processing periods for composites by filter‐ ing the blue components of the light ▪ Dimmed light: approx. 4,000 Kelvin; equivalent to the light of a halogen operating lamp 77 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit ▪ Laser mode: Light mode, which has no negative influence on the KaVo KEY Laser III, the KEY Laser 3+ or the KaVo DIAGNOdent. When operated In dimmed mode, the LED lamp functions according to a dimmed hal‐ ogen lamp. The colour temperature is approx. 4,000 K and the composite can harden prematurely. This can have a negative impact on the durability of the treatment. The COMPOsave modes prevents the composite from hardening prematurely. As op‐ posed to the dimmed light, the blue components of the light are filtered in the process. Therefore the composite can be processed longer in COMPOsave mode. ▶ Press the "Mode/colour temperature" button ð The treatment light switches from COMPOsave mode to dimmed normal light. ▶ Press the "Mode/colour temperature" button once again. ð The treatment light switches back to COMPOsave mode. ð The COMPOsave mode can be recognised by the yellow light. Switch on COMPOsave mode When operated In dimmed mode, the LED lamp functions according to a dimmed hal‐ ogen lamp. The colour temperature is approx. 4,000 K and the composite can harden prematurely. This can have a negative impact on the durability of the treatment. The COMPOsave modes prevents the composite from hardening prematurely. As op‐ posed to the dimmed light, the blue components of the light are filtered in the process. Therefore the composite can be processed longer in COMPOsave mode. Note The COMPOsave mode switches on. when the "Dim operating light" button is acti‐ vated. The light can be dimmed in COMPOsave mode. Sensor KaVoLUX 540 LED ▶ Press the "operating light" button. or ▶ Hold your hand in front of the sensor for 2 sec. ð The COMPOsave mode or dimmed light switches on. 78 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit ð The COMPOsave mode can be recognised by the yellow light. ▶ Press the "Dim operating light" button once again. or ▶ Hold your hand in front of the sensor for 2 sec. ð The treatment light switches back to normal light mode. Setting the brightness of the dimmer Note The brightness of the light is set in five stages using the "Dim treatment light" key. Note The time it takes for composites to harden is dependent on the brightness or the effective radiation intensity of the light: The processing time is reduced with increas‐ ing brightness / effective radiation intensity. The processing time for composites is prolonged with reducing brightness / effective radiation intensity. ▶ Press and hold down the "Dim operating light" button. ð Brightness is increased in five stages. ▶ Release the "Dim operating light" button when the desired brightness is achieved. Set colour temperature Note The colour temperature of the treatment light KaVoLUX 540 LED T can be is set between five stages with the "Mode/Colour temperature" button. The visual percep‐ tion of the teeth can be adapted or enhanced by changing the colour temperature. 4.000 to 4.500 Kelvin: similarity to halogen light 5.500 Kelvin: daylight quality ▶ Press and hold down the "Mode/colour temperature" button ð Colour temperature changes in five steps. ▶ Release the button when the desired colour temperature is achieved. Turning the laser mode On and Off Note The "laser mode" function is available only from the following version: - Operating light V1.2.1 Older versions must be updated prior to download. Note Falsified colour reproduction: the laser mode only possesses a restricted spectrum output. Therefore a colour comparison should not be carried out in laser mode. In laser mode, another light mode is generated, which has no negative influence on the KaVo KEY Laser III, the KEY Laser 3+ or the KaVo DIAGNOdent. 79 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit Sensor KaVoLUX 540 LED ▶ Press the „operating light“ button and the "operating light dimming" button on the operating light simultaneously. ð The laser mode switches on. ð Laser mode is activated: the operating light shines for 1 second in green and then changes to a white light. or ▶ Hold your hand in front of the sensor for 3 sec. ð The laser mode switches on. ð Laser mode is activated: the operating light switches initially in COMPOsave mode and then shines for 1 second in green and then changes to a white light. 80 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit Operation of the 3D joint ▶ Turn the switching ring to the left until it snaps into place. ð Treatment light can be rotated 45° to the left or 45° to the right. ▶ Turn the switching ring to the right and it will spring back to its original position. ð If the treatment light is turned to the centre position (zero position), it will automati‐ cally lock into place in the centre position. 4.9.3 Using the illumination functions for EDI and MAIA ▶ Press the "operating light" key briefly to turn the operating light on or off. 4.9.4 Using the X-ray viewer ▶ Press the "X-ray viewer" key to turn the X-ray viewer on or off. 4.9.5 Using the bell ▶ Press the "Bell" key to activate the bell relay. ð The bell relay is activated for as long as the key is being pressed. 4.9.6 Using the timer ▶ Press the "Timer" key briefly to start or stop the timer. 81 / 130 Instructions for use ESTETICA E30 4 Operation | 4.9 Using function through the dentist or assistant unit ð LED flashes while the timer counts down. Setting the timer ▶ Press the "Timer" key for an extended period of time to start the timer program‐ ming mode. The programming mode can be started in the stand-by menu only. S1 S2 S3 S4 Key Settings S1 Saves the parameters. Quits the programming mode. S2 Changes the value. S3 Changes the value. S4 Switches counter/timer function. 82 / 130 Instructions for use ESTETICA E30 4 Operation | 4.10 Operating the foot switch 4.10 Operating the foot switch 4.10.1 General functions The footswitches of the foot control have two functions. The function of the control de‐ pends on whether an instrument is in its holder or whether it has been removed. See also: 2 Foot control 4.10.2 Positioning the patient chair with the foot control See also: 2 Automatic positioning of patient chair 2 Position the dental chair using the button cross or 4-way switch 4.10.3 Preselect dentist Requirement All instruments are in their holder. ▶ Hold down the foot pedal and press the stirrup switch. ð Each time the stirrup switch is pressed, the selection advances to the next dentist (dentist 1 to 6). The number of dentists can be set in the user menu. Two dentists are set as the default. 4.10.4 Start and regulate instruments ▶ Remove the handpiece (such as turbine, motor) from the holder. ð The handpiece is active. ▶ Press the foot pedal. ð The removed handpiece runs at the set speed or intensity. ▶ Changing speed or intensity with the foot pedal. ð The left stop corresponds to the minimum speed/intensity. ð The right stop corresponds to the maximum speed/intensity. 83 / 130 Instructions for use ESTETICA E30 4 Operation | 4.10 Operating the foot switch 4.10.5 Setting the cooling condition ▶ Remove the handpiece (e.g., turbine, motor) from the holder. ð The handpiece is active. ▶ Press "Preselected spray" footswitch. ð The cooling status is switched each time the foot switch is pressed: spray air spray. ð The cooling status is displayed on the dentist and assistant element. 4.10.6 Activating blown air (optional) ▶ Remove the handpiece (such as turbine, motor) from the holder. ð The handpiece is active. ▶ Press the "Blown air" foot-operated button. ð As long as the foot-operated button is pressed, blown air exits from the removed handpiece (does not apply to PiezoLED). 4.10.7 Preselect counterclockwise motor rotation ▶ Take motor off the holder. ð The handpiece is active. ▶ Slide the cross switch upward. ð The direction of motor rotation is reversed each time the cross-switch is actuated: counterclockwise rotation - clockwise rotation. ð The direction of motor rotation is displayed on the dentist element. 4.10.8 Adjusting the instrument light ▶ Slide the cross switch to the right. (spotlight function) ð Cold light "On" (even if Cold light "Off" is preselected). 84 / 130 Instructions for use ESTETICA E30 4 Operation | 4.10 Operating the foot switch ▶ Slide the cross switch to the left. ð Change the cold light status: "On/Off". 4.10.9 Using CONEXIOcom (fee-based additional option) No Setting ① U-shaped switch Discard image/video Press briefly - deletes the selected image/video Press long - all images/videos in the clipboard are deleted ② Previous image/video Select previous image/video ③ Next image/video Select next image/video ④ Screen display The number of displayed images (Split View) is reduced: The live image is always shown as the last image in split view. ⑤ Screen display The number of displayed images (Split View) is increased: The live image is always shown as the last image in split view ⑥ Capture Mode Toggles between the recording modes, video recording and image recording ⑦ Screen display Toggles between full screen and normal view ⑧ Save image/video Press briefly - freezes the live image Press long - saves the live image directly. If no patient is selected, the images are stored directly under "unassigned patient". 85 / 130 Instructions for use ESTETICA E30 4 Operation | 4.11 Using instruments Note If no patient is selected, the images stay in the "Swap Tray" and are not saved per‐ manently. As soon as a patient is selected, these temporary data in the "Swap Dry‐ ing" are deleted. When an active patient is logged off (or a new patient is logged on) in CONEXIO, a query is shown asking whether the images shall be deleted or saved. Data deleted at this point cannot be restored subsequently. 4.11 Using instruments Note Consult the pertinent separate instructions for information regarding the installation, use and servicing of the individual handpieces (such as the turbine, PIEZOsoft, Sat‐ elec Mini LED, etc.). 4.11.1 Setting spray air and spray water The adjusting screws for spray air and spray water are situated on the underside of the table and correspond to the handpiece that is actually connected. For KaVo Midwest handpieces, spray air and spray water are pre-set suitable at the factory such that no re-adjustment is required. 2 1 3 ▶ Use the short adjusting screw ② on the control valve to adjust the spray air. ð Counterclockwise rotation (seen from below) increases the flow rate. ▶ Use the long adjusting screw ① on the control valve to adjust the spray water. ð Counterclockwise rotation (seen from below) increases the flow rate. Borden handpieces Note In the case of Borden handpieces, the drive air needs to be adjusted for each hand‐ piece by a Service Technician using adjusting screw ③. The adjustment can be made using the measuring set Mat. no. 0.4179807 (Mat. no. 10039374) or the test manometer for Borden handpieces Mat. no. 04118531. 4.11.2 Using suction hoses ▶ Remove the spray mist suction device and/or saliva ejector from the holder. 86 / 130 Instructions for use ESTETICA E30 4 Operation | 4.11 Using instruments ð The spray mist suction device and/or saliva ejector is turned on automatically and turned off when it is replaced in the holder. The suction flow of the saliva ejector or spray mist suction device can be reduced or blocked with the slide valves integrated in the handpieces. 1 2 3 6 5 4 6 5 ▶ Move the slide valve completely upward. ð The slide valve is open: maximum suction. ▶ Move the slide valve down all the way. ð The slide valve is closed: no suction. Note Connectors for the spray mist suction and the saliva ejector without slider as well as reducing pieces for the spray mistsuction are available as accessories. ▪ Cannula holder, short, for spray mist ejector ② (Mat. no. 0.764.5783) ▪ Cannula holder, long, for spray mist ejector ② (Mat. no. 0.764.5853) ▪ Cannula holder, short, for saliva ejector ① (Mat. no. 0.764.5863) ▪ Cannula adapter, reducing handpiece to 7 mm ② (Mat. no. 0.764.5873) ▪ Cannula adapter, reducing handpiece to 11 mm ② (Mat. no. 0.764.5883) Vacuum stop CAUTION Danger of backflow Swallowing or choking hazard for the patient ▶ Only actuate the vacuum stop when the suction cannula is not in the patient's mouth. 87 / 130 Instructions for use ESTETICA E30 4 Operation | 4.11 Using instruments Note Vacu-Stop is available in combination with Venturi suction, external wet suction sys‐ tem, and suction valve. When the base switch is actuated, the suction of the removed hose is stopped. ① Vacu-Stop 4.11.3 Using triple-function handpieces CAUTION Cannulas that are worn, not screwed in or not locked into place. Injury from swallowing the cannula. ▶ Before each treatment, ensure that the cannula is properly locked or screwed into place and firmly seated. ▶ Use original KaVo cannulas only. 88 / 130 Instructions for use ESTETICA E30 4 Operation | 4.11 Using instruments CAUTION Risk of injury from touching the cheek with the handpiece. Irritation of the mucosa. ▶ Rotate the cannula of the handpiece into an operating position where there is no contact of the mucosa. Triple function handpiece One ① Cannula ② Water button (green ring) ③ Air button (blue ring) ④ Handpiece and hose Triple-function handpiece ① Air button (A) ② Cannula ③ Gripping sleeve ④ Water button (W) ⑤ Ring blue Note The cannulas can be rotated 360o.. ▶ Remove the turbine from the holder. ▶ Press the air button ① and continuously increase or decrease the exiting air flow by applying more or less pressure on the air button ①. or 89 / 130 Instructions for use ESTETICA E30 4 Operation | 4.11 Using instruments ▶ Press the water button ④ and continuously increase or decrease the exiting water jet by applying more or less pressure on the water button ④. or ▶ Simultaneously press the air button ① and water button ④ and continuously in‐ crease or decrease the exiting spray by applying more or less pressure on the two buttons. Removing the cannulas ▶ Hold the valve body of the triple-function handpiece and screw off the cannula. 4.11.4 Using the PIEZOsoft/PiezoLED CAUTION Handpiece inserts can be damaged from long-term use, or when dropped or bent. They cannot be guaranteed to function properly. Injury from insert breakage. ▶ Check the handpiece inserts before each use. CAUTION Sharp-edged tips. Risk of injury. ▶ When not in use, always keep the supplied torque wrench attached to the tip! Note Please comply with the enclosed "PIEZOsoft/PiezoLED" Instructions for Use. Controlled through the menu See also: 2 4.8.5.2 PIEZOsoft/PiezoLED, Page 65 Operation with the foot control ▶ Press the foot pedal. 90 / 130 Instructions for use ESTETICA E30 4 Operation | 4.12 Using the KL 703 LED in ENDO mode (optional accessory) ð The PIEZOsoft/PiezoLED works at the pre-set intensity. ▶ To adjust the intensity, press the foot pedal and move it to the side. 4.12 Using the KL 703 LED in ENDO mode (optional accessory) 4.12.1 General information Note The endo drive can only be operated with the INTRA LUX KL 703 LED. INTRA LUX KL 703 LED CAUTION Use of impermissible filing systems. Do not use impermissible filing systems which can damage the product or cause per‐ sonal injury. ▶ Only use approved NiTi filing system with a conicity >2% that are suitable for rota‐ ry preparation. ▶ Only use files with shafts in conformance with DIN EN ISO 1797-1, DIN EN ISO 1797-2, DIN EN ISO 3630-1 and DIN EN ISO 3630-2 having a shaft diameter of 2.334 to 2.350 mm ▶ Follow manufacturer's instructions (mode of operation, speed, torque levels, tor‐ sion resistance, etc.), and use the files according to their intended use. CAUTION Use of damaged files. Injury to the patient or damage to the medical device. ▶ Before preparing each root canal, insert a dental dam for safety reasons. ▶ Before each use, the files must be checked for possible signs of material fatigue, deformation or excessive stress and if such signs appear, they must be replaced. CAUTION Incorrect transmission ratio. Damage from incorrect speed / incorrect torque. ▶ Only use KaVo 1:1 reducing shanks 20LH or 20LP with 1:1 INTRA LUX head L68 B (Mat. no. 1.008.1834) or 3:1 INTRA LUX head L66 BU (Mat. no. 1.008.1831). CAUTION Excessive torque. Injury or damage to instruments. ▶ Use root canal instruments in ENDO mode only. 91 / 130 Instructions for use ESTETICA E30 4 Operation | 4.12 Using the KL 703 LED in ENDO mode (optional accessory) Technical specifications for the KL 703 LED in ENDO mode Note The technical specifications apply to the KL 703 LED in ENDO mode.LED Speed range up to 6,000 rpm Maximal torque 2.5 Ncm Operating mode Note 30 seconds operating time/9 minutes pause is the potential load threshold of the motor (full load at maximum speed). In practice, pulse loads lasting seconds or pause times lasting seconds or minutes are realistic given that the maximum possible motor current is not normally reached. This equates to the dentist's normal way of working. 4.12.2 Open ENDO mode ▶ Remove the endomotor INTRA LUX KL 703 LED from the holder. ▶ Press the "Additional motor drives" key. ð The display switches to the "ENDO" menu. The device exits from Endo mode as soon as the INTRA LUX KL 703 LED endomotor is returned to the holder. The Endo mode is activated automatically once the endomo‐ tor is removed, providing that the Endo mode was previously ended by putting the en‐ domotor back in place. Note The device does not automatically start when endo mode was left by pressing the "Motorised auxiliary drives" button, or if endo mode has never been activated since the last time the unit was turned on. A service technician can deactivate the automated start. Note Before using the endomotor, always check the speed and transfer ratio. S1 S2 S3 S4 Parameters Values Transmission factor 1:1, 3:1 Parameter memory P1,P2,P3,P4,P5,P6 Torque mode TQ-Ctrl, Autoreverse, AutoRev/Forw. Direction of motor rotation R, L 92 / 130 Instructions for use ESTETICA E30 4 Operation | 4.12 Using the KL 703 LED in ENDO mode (optional accessory) Parameters Values Speed 100 to 6,000 rpm Torque Transmission ratio 1:1: 0.15 to 2.50 Ncm Transmission ratio 3:1: 0.4 to 8.0 Ncm CAUTION Incorrectly set parameters. Injury or property damage from incorrect input values. ▶ Check all input values before use. 4.12.3 Set torque mode Three different torque modes are available: ▪ Autoreverse ▪ Torque Control only ▪ Autorev / Forward ▶ Press the "Up" or "Down" key to select the desired torque mode. ð The torque mode is shown on the display and is effective immediately. Torque mode Torque Control only ▶ Press the foot pedal. ð The motor starts by rotating clockwise (if not selected otherwise). The torque is limited to the set threshold. The speed reduces until it stops depending on the load. The direction of rotation is always to the right. A tone sounds when the set torque threshold is reached. ▶ Push 4-way button on the foot control upward in order to switch to counterclock‐ wise rotation. Torque mode Autorev / Forward ▶ Press the foot pedal. ð The motor starts by rotating clockwise (if not selected otherwise) 93 / 130 Instructions for use ESTETICA E30 4 Operation | 4.12 Using the KL 703 LED in ENDO mode (optional accessory) When the set torque is reached, a signal sound is emitted, and the motor switches to counterclockwise rotation. After the set time, the motor automatically reverts to clock‐ wise rotation. The time can be set in the option menu (Option 3). See also: 2 ENDO menu, Page 0 Note The motor's rotational direction can be reversed with the cross-switch on the foot‐ switch in all torque modes. ▶ To stop this, release the foot pedal. ▶ Press the foot pedal. ð The motor rotates clockwise again. 4.12.4 Changing settings in the menu See also: 2 ENDO menu (optional) 4.12.5 Leaving ENDO Mode ▶ Press the "Additional motor drives" key. or ▶ Place the INTRA LUX KL 703 LED back in the holder. Note If the unit was switched to "Instant ENDO" mode, ENDO mode is only interrupted when the ENDO motor is placed in the holder, and it is continued when the ENDO motor is removed. The function can be set by the service technician. See also: 2 Call up ENDO mode 94 / 130 Instructions for use ESTETICA E30 4 Operation | 4.13 Use USB interface 4.13 Use USB interface CAUTION Electrical power. Electrical shock. ▶ Set up the external PC outside of the patient environment keeping a minimal dis‐ tance of 1.5 m. ▶ Connect the PC and equipment connected to the PC in accordance with IEC 60601-1 / 60950. CAUTION Electrical power. Electrical shock from incorrectly connecting a non-medical system to the USB interfa‐ ces of the device. ▶ Connect any IT device to the medical system in accordance with IEC 60601-1. ▶ Use USB devices with no additional power supply (USB-powered) only. ▶ Applied parts connected to the USB interface of the dentist element must comply with the requisite insulation. ▶ USB-powered devices failing to meet the requisite insulation for applied parts must be placed appropriately such that direct contact of the USB device and the patient is excluded. ▶ It is not permissible to touch USB-powered devices failing to meet the requisite insulation for applied parts and the patient at the same time. The treatment unit may be fitted with up to three USB ports. Camera interfaces are sit‐ uated on the underside of the dentist element (T-table) or in the dentist element (Stable). Only the cameras approved/enclosed in the delivery by KaVo may be connec‐ ted to these interfaces. The USB port in the back is connected directly to the back-of-the-head PC (in the presence of the corresponding wiring). USB devices meeting the specifications listed above can be connected to this interface. To use USB devices that have been con‐ nected, it may be necessary to install a suitable driver software on the back-of-thehead PC. Getting the USB ports ready for use ▶ To run an USB device, connect the USB port in the terminal box of the treatment centre to an external back-of-the-head PC. Use one or maximally two USB exten‐ sion cables 5 m (Mat. no. 1.004.6953) according to need. ▶ USB devices connected to the dentist element must meet the USB standards, USB 1.0, 1.1 or 2.0, and consume max. 500 mA of electrical power. 4.14 Using the camera See also: 2 Instructions for Use ERGOcam One See also: 2 Instructions for Use DIAGNOcam 2170 U 4.15 Using the screen See also: 2 Instructions for use Screen One 95 / 130 Instructions for use ESTETICA E30 5 Preparation methods DIN EN ISO 17664 5 Preparation methods DIN EN ISO 17664 Note The preparation methods can be found in the care instructions. 96 / 130 Instructions for use ESTETICA E30 6 Accessories and kits | 6.1 Device 6 Accessories and kits 6.1 Device Name Description Water inlet block Without DVGW permit. With water filter and pressure controller. Water bottle For a water supply for tumbler and handpieces inde‐ pendent of the public water supply. External wet suction sys‐ tem with bowl valve Suction handpieces and bowl valve are suctioned cen‐ trally. External wet suction sys‐ tem, direct discharge with no bowl valve Suction handpieces are suctioned centrally. Venturi suction system Compressed air-operated saliva ejector Venturi suction system Compressed air-operated spray mist Operating light KaVoLUX 540 LED T / EDI / MAIA Operating light. Tray support For the small handpiece tray. Warm water heater Heats the tumbler water. Low-pressure regulator Regulator for suction air when the suction vacuum is too high. Intensive germ reduction, manual Intensive germ reduction with increased Oxygenal 6 dos‐ ing See also: 2 PA ESTETICA E30 Electrical water shut-off Water pressure shut-down during off-times 6.2 Dental chair Name Description Armrest The armrest can be swung up to make it easier for the patient to get in and out. Child’s seat For paediatric treatment. Trendelenburg (optional) Bench movement synchronous to backrest 6.3 Assistant unit Name Description Satelec Mini LED and KaVo Poly One LED polymerisation light. Triple-function handpiece One / triple-function hand‐ piece Handpiece featuring air, water, no heating, and no cold light. 6.4 Dentist element Name Description Air handpiece hose For connection of turbine and SONICflex and all hand‐ pieces fitting on the multiflex coupling. 97 / 130 Instructions for use ESTETICA E30 6 Accessories and kits | 6.4 Dentist element Name Description Borden hose For Borden (2-hole) handpieces. Assembly kit INTRA LUX motor KL 703 LED Brushless motor with light. Assembly kit INTRA LUX motor KL 701 Brushless motor with light. Triple function handpiece One / triple function hand‐ piece Handpiece featuring air, water, no heating, and no cold light. PiezoLED Handpiece with LED light for removal of dental calculus with Scaler tip sets. PIEZOsoft Handpiece without light for removal of dental calculus with tip sets, Scaler / Paro / Endo / Prep. X-ray viewer 1440 For installation on the light mounting pole. X-ray viewer 5x5 For image size of 5 x 5 cm (install on left or right side of dentist element). Tray holder for a standard Standard tray, US tray, and/or 2x-standard trays (install tray / US tray / 2x-standard on left or right side of dentist element). tray Torque control (endo) Drive for endodontic treatment. Chip blower (optional) Sets the preset blown air at the handpiece (does not ap‐ ply to PiezoLED and PIEZOsoft). Patient communication: Control of the display of previously recorded and saved images and videos. ▪ Screen One ▪ DIAGNOcam 2170 U ▪ ERGOcam One 98 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.1 Introduction 7 Safety checks - testing instructions 7.1 Introduction 7.1.1 General instructions Note The safety checks may only be carried out by one or more electricians (as defined in IEC 61140) who have received appropriate training for the device to be inspec‐ ted. Note The contents and specified tests in this document are based on the international standard IEC 62353 (DIN VDE 0751-1). This standard applies to testing and inspec‐ tions of medical electrical devices or medical electrical systems, which are defined in IEC 60601-1 (DIN EN 60601-1). Note In order to evaluate the safety of medical devices, systems or components of medi‐ cal devices or systems, the safety checks must be carried out at the times specified below: ▶ Prior to first use ▶ during servicing ▶ during inspections and maintenance ▶ following service and maintenance ▶ on the occasion of repeat testing Note In the case of devices that have not been manufactured in accordance with IEC 60601-1, (DIN EN 60601-1) these requirements can be employed taking the man‐ datory safety standards for the production of these devices into consideration. Note If the unit comprises several electrical devices or electrical devices from several manufacturers that are connected to a system in connection with the KaVo dental unit, the manufacturer data contained in the instructions for use for all products sub‐ ject to safety controls must also be observed. Note Accessories to ME devices that could have an impact on the safety of the device to be tested or the measured results must be included in the safety checks. 99 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.1 Introduction Note All tests concerning the included safety checks of accessories must be documen‐ ted. Note Furthermore, the manufacturer data contained in the instructions for use must be adhered to in all products to be tested and inspected. Note KaVo offers a medical device book for keeping an inventory and recording essential master data on the medical device. The medical device book is only available in German (Mat. no. 0.789.0480). Note The following tests and measurements must be documented, for example in the medical device book. We recommend using the templates at the end of the docu‐ ment Note The sequence of testing recommended by the manufacturer must be followed. 7.1.2 Notes for medical electrical systems Note An ME System is the combination of individual devices (as defined by manufactur‐ ers) that must meet the following conditions: ▶ At least one of these devices must be a medical electrical device. ▶ The devices must be functionally connected or at least they should be connec‐ ted by the application of a multiple socket outlet. Note With ME systems, the person responsible for putting the system together must em‐ ploy the necessary measuring parameters and measuring procedures defined in IEC 60601-1 (DIN EN 60601-1). Note Each individual device in an ME system, which has a separate connection to the power supply network, or which can be connected to or separated from the power supply network without the aid of a tool, must be checked individually. Moreover, the ME system must be checked as one unit to avoid the situation, in which the „ag‐ ing“ of individual devices lead to unacceptable values in sum. 100 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.1 Introduction Note An ME system that is connected to the supply network by means of a multiple sock‐ et outlet must be treated as one device during checks and testing. Note If the ME system or part of the system is connected to the supply network by means of a isolating transformer, the transformer must be included in the measurements. Note In ME systems, in which more than one ME device are interconnected via data lines or otherwise, e. g. via electrically conductive attachments or coolant tubes, the earth wire resistance of every single device must be checked. Note If it should be impossible to check single ME devices that are functionally connected to an ME system individually for technical reasons, the ME-System must be checked as a whole. 7.1.3 Essential parts of the safety check Visual inspection Optical appraisal of the safe and usable condition of the medical device and its acces‐ sories. Measurements ▪ Measurement of the earth wire resistance in accordance with IEC 62353 (DIN VDE 0751-1) ▪ Measurement of the leakage current of the device EUL in accordance with IEC 62353 (DIN VDE 0751-1) ▪ Measurement of the leakage current of the user part EPL in accordance with IEC 62353 (DIN VDE 0751-1) Note A measurement of the isolation resistance in accordance with IEC 62353 (DIN VDE 0751-1) need not be carried out. This check is covered by the measurement of the leakage current on application of a prescribed safety tester defined in IEC 62353 (DIN VDE 0751-1) Annex C! Functional test Medical device function test as well as testing of all safety shutdowns with reference to accompanying documentation/ instructions for use. 101 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks 7.1.4 Testing intervals ▪ Check every 2 years in accordance with Type II 7.1.5 Notes on the test method in accordance with IEC 62353 ▪ Protection class 1 ▪ Type BF ▪ The device is firmly connected / threshold: SL < 0,3 Ω ▪ Measurement according to EUL / threshold: < 10mA* ▪ Measurement according to EGA / threshold: < 5 mA *The EUL threshold is compatible with the value defined in IEC 60601 (DIN EN 60601), taking comment 2 from table 2 into consideration. 7.1.6 Notes on repeat testing Note The value determined in these tests must be documented and evaluated together with the measuring processes. The measured values may not overshoot the speci‐ fied values. Note Comparisons with previous measurements must be carried out if the measured val‐ ues undershoot the threshold values by more than 10 %. The test intervals should be reduced if a deterioration in values is determined! 7.2 Instructions for safety checks 7.2.1 Preparatory measures to be undertaken on the device WARNING Electrical power. Death or injury from electric shock. ▶ Before servicing, pull the mains plug out of the socket or completely disconnect the device from the power to de-energise it! ▶ After conversion, check the electrotechnical safety in accordance with IEC 62353 (DIN VDE 0751-1). ▶ Turn off the main switch before any servicing work. 102 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▶ Lift the upholstery at the foot end ① and remove from the chair. ▶ Remove two screws ② from the cover of the junction box. ▶ Take the cover off proceeding in upward direction. 7.2.2 Visual inspection (inspection by examination) Check the following points in advance: ▪ Has the equipment of the ME device or the ME system been changed since the last inspection? ▪ Was the change documented and approved (test protocol, STK)? ▪ Are there any indications of insufficient safety? 103 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks Check the ratings of fuses that are accessible from outside ▶ Verify whether the main fuse on the main switch ② of the unit complies with the specified nominal data ①. Visual inspection and appraisal of the medical device and accessories The following list is an example and makes no claim of being complete. Check the following items: ▪ Stability of the device ▪ No damage to the cladding or casing (cracks, breakage) ▪ Functioning of the carrier systems on dentist and assistant side, treatment lamp, and display (brakes, height adjustment, etc.) ▪ Condition of the handpiece and suction hoses ▪ Condition of all installed application parts ▪ Condition of the control panels ▪ Condition of the threads for the fitting of tips to the ultrasound scaler handpiece ▪ Condition of the operating light ▪ Absence of leaks on the body of the device ▪ Condition of the power connection provided by the treatment centre ▪ Condition of air and water connections ▪ Any damage on the sight window and the casing of the camera ERGOcam ▪ Expiry date of the water bottle inserted in the BS water bottle not exceeded Check of legibility and completeness of the safety-related labels ▶ Check if all safety-related markings (plates and labels) are present and legible. 104 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▶ Check if the rating plate and serial number plates are present and legible. ESTETICA E30 and chair nameplate 2 1 Site for affixing the rating plate and serial number plate ① Serial number plate of the chair 105 / 130 ② Rating plate Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks E30 TM E30 S Attachment locations for serial number plate and BF labelling Control of the availability of the necessary documents ▶ Verify whether the required instructions for use and care instructions are available in the surgery. Note Any irregularities determined in the visual inspection must be recorded in the test protocol. It is essential to determine whether defects and deficiencies could have an adverse impact on the safe operation of the unit. If the determined irregularities present a safety hazard and cannot be rectified directly, the unit must be closed down until the safe operation is restored. 7.2.3 Measurements WARNING Danger to persons due to a lack of care exercised during the safety checks and test‐ ing. ▶ Prior to connecting the treatment centre to the sight window, disconnect from the mains supply network. ▶ Carry out all safety checks and tests in a manner that will ensure that there will be no danger to the testing personnel, patients or other persons. Note The safety tester must comply with the requirements defined in IEC 62353 (DIN VDE 0751-1), Annex C. Note If no other specifications have been made, all values relating to voltage and current are effective values of alternating voltage, direct voltage or pulsating voltage res. al‐ ternating current, direct current or pulsating current. 106 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks Note Cables and wires e.g. supply cables, measuring circuits and data lines must be ar‐ ranged in such a manner that will ensure that their influence on measurements will be restricted to a minimum. Note Connection cables such as data cables and cables for the functional earth could simulate protective conductor connections. These types of supplementary but unin‐ tentional protective earth connections could lead to erroneous measurements. Note The following measuring aid can be ordered: KaVo measuring cable (Mat. no. 0.411.8811) Using the measuring cable ① the unit is disconnected from the mains supply and con‐ nection of the treatment centre to the sight window is enabled. Hence, the customerprovided mains supply L & N on the power input board need not be disconnected. The adapter cable ② is included in the delivery of the KaVo measuring cable and is re‐ quired for older treatment centres that are not equipped with an X2 connector. Connecting the safety tester to KaVo measuring cables on the treatment centre 107 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▶ Disconnect plug X2 from the unit control and plug it into the matching connector X2 of the KaVo measuring cable (Mat. no. 0.411.8811). ▶ Connect the second plug X2 of the KaVo measuring cable to the unit control (X2). ▶ Insert the protective contact plug of the KaVo measuring cable into the sight win‐ dow. Connecting the safety tester without the KaVo measuring cable to the treatment centre. 1 ① Protective earth conductor terminal (PE) ▶ Switch L + N of the on-site power supply cord to be voltage-free. ▶ Disconnect L + N on terminals X8.L Mains (mains supply) and X8.N Mains (mains supply). ▶ Connect the safety tester directly to terminals X8.L Mains (mains supply) and X8.N Mains (mains supply) and protective earth conductor terminal (PE). Note The main switch of the ME device / ME system must be turned on during measure‐ ment. Connect the application parts [AP] to the safety tester: ▶ Connect ① to ③ to the safety tester. ▶ Connect the safety tester to additional measuring points AP X. 108 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks Note Additional measuring points AP X must be taken into consideration in the presence of accessories: e.g. accessories such as PIEZO ultrasound scaler, HF surgery etc. See also: 2 Annex - Additional measuring points, Page 0 Connect accessible conductive parts [ACP] with PE ACP = accessible conductive parts ACP ACP Note Additional measuring points ACP X must be taken into consideration in the pres‐ ence of accessories: e.g. accessories such as saline pump etc. See also: 2 Annex - Additional measuring points, Page 0 ACPs on the treatment centre No ACPs need to be connected to the protective conductor (PE) during the measure‐ ment on the treatment unit ESTETICA E30, as all relevant parts are connected to the PE and included in the test before they leave the factory. 109 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ACPs on treatment lamps No ACPs need to be connected to the treatment lights during the measurement with the protective conductor (PE) because all relevant parts have already been connected with the protective conductor (PE) in the factory and are included in the test. Measure protective conductor resistance Threshold: < 0,3 Ω (maximum value!) Note The integrity of the power supply cable, in particular the protective earth wire of the power cable must be ensured. As this is a fixed installation, the evaulation can be conducted by means of a visual inspection. If damage is determined, the further procedure to be taken is specified in the general instructions. Note In this measurement the resistance of the protective earth connection of the supply network can be taken into consideration. Note If applicable: all removable supply connection lines, which are retained for use, should be taken into consideration and the respective PE measured. Protective earth measurement The protective conductor resistance must be measured at the following parts of the device: ▪ Treatment centre ▪ Treatment lamp ▪ Accessories Note Additional measuring points SL X need to be taken into consideration in the pres‐ ence of accessories: e.g. if accessories are connected, connection to external devi‐ ces, camera module of the multimedia system, etc. See also: 2 Annex - Additional measuring points, Page 0 110 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks Scan the treatment centre with the test tip Measuring points on the device base ① Surroundings of the protective earth conductor terminal ② Main switch holding plate ③ Stand cover base plate ④ Top part of the chair ⑤ Foot control floor plate (bottom side) 111 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▶ Slide cover ① in upward direction. Standard dental chair measuring points ▶ Check firm seating of the PE headless screw ②. ▶ Scan headless screw ② with the measuring probe. ① Dentist element S: installation site of the tray holder 112 / 130 ② Dentist element TM: installation site of the tray holder Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ① Assistant element: fastening screw on bottom side of assistant element Scan the treatment lamp with the test tip Operating light KaVoLUX 540 LED U ① Fastening screw of the handle support when the gripping sleeve has been re‐ moved Operating light EDI/MAIA No measuring points need to be scanned on the operating lights EDI and MAIA. Touch monitor with test tip 113 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▶ Touch measuring point ① with the test tip. or ▶ Sample the measuring point ② after removing the display cover. Measure protective conductor resistance of accessories See also: 2 Annex - Additional measuring points, Page 0 Measure equivalent unit leakage current Threshold: < 10 mA (maximum value!) ACP Protection class 1 WARNING Electrical power. Death or injury from electric shock. ▶ Conduct test for leakage current in devices of Protection Class 1 only after the protective earth test has been passed. WARNING Electrical power. Death or injury from electric shock. ▶ Prior to connecting the treatment centre to the sight window, disconnect the treat‐ ment unit from the mains supply network. Measure equivalent patient leakage current Threshold: < 5 mA (maximum ) 114 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ACP Protection class 1 WARNING Electrical power. Death or injury from electric shock. ▶ Conduct test for leakage current in devices of Protection Class 1 only after the protective earth test has been passed. WARNING Electrical power. Death or injury from electric shock. ▶ Prior to connecting the treatment centre to the sight window, disconnect the treat‐ ment unit from the mains supply network. Note In the testing of ME devices with several application parts, the parts must be con‐ nected in succession. The measured results must be evaluated using the threshold values. Application parts, which are not included in the measurement, remain open. Note An additional measurement of the leakage current from type B application parts need only be carried out if this is specified by the manufacturer (see accompanying documents). Note A separate measurement is not usually required for type B application parts. The application parts are connected to the casing (see diagram) and included in the measurement of the leakage current of the casing, whereby the same reliable val‐ ues are applicable. 7.2.4 Functional test The following conditions must be fulfilled in all function tests: ▪ The basic function of the treatment centre must be guaranteed. ▪ The treatment centre must be fit for use. ▪ It must not exhibit any irregularities, noise or abrasion etc. The following list is an example and makes no claim of being complete. ▪ Function test of the safety circuits (see diagram below) ▪ Functioning of the master switch of the device ▪ Functioning of the displays 115 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks ▪ Function test of the holder switch of the dentist and assistant element ▪ Functional test of the 3F handpiece – seating of the cannula ▪ Functional test of operating light ▪ Function test of the suction hoses ▪ Function test of the foot control ▪ Function of the chair: - Travel on all axes - Testing of the limit switches ▪ Functional test ... 5 Pos. no. Safety switch-off actu‐ ated ① Bracket on the foot con‐ trol ② Assistant element ③ Backrest ④ Kickplate ⑤ Seat For right/left conversion with bench removed LED on assistant ele‐ ment 7.2.5 Assessment and documentation 116 / 130 LED on dentist element Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks Note All tests conducted must be documented comprehensively. The documents must contain at least the following particulars: ▶ Name of the test centre ▶ Name of the test engineer ▶ Name of the tested device (e. g. type, serial number) ▶ Tests and measurements ▶ Data, type and measured results of the visual inspections ▶ Data, type and measured results ▶ Data, type and measured results of function tests ▶ Measuring/test equipment including SN/test equipment number and calibration period ▶ Final evaluation ▶ Name, date and signature of test engineer There is a copy of a test report template at the end of chapter STK. KaVo recom‐ mends the use of this template. Note Following testing, maintenance or adjustment, it must be verified whether the ME device or ME system has been restored to the state that is required for the intended usage before it is employed once again. Note If the safety of the tested ME device or ME system has not been established, e.g. the tests have not been completed with positive results, the device or system must be marked accordingly and the potential hazard emanating from the device or sys‐ tem must be communicated in writing to the RESPONSIBLE ORGANISATION (to the operator, as a rule). This action is not required if the cause of the malfunction could be determined and rectified. The defect must be recorded in the protocol. 117 / 130 Instructions for use ESTETICA E30 7 Safety checks - testing instructions | 7.2 Instructions for safety checks 118 / 130 Instructions for use ESTETICA E30 8 Appendix - Additional measuring sites | 8.1 Additional scanning sites SL X in the protective conductor measurement 8 Appendix - Additional measuring sites Note With reference to accessories, which are not listed here, the specifications of the relevant instructions for use must be observed. Example: ERGOcam 5. 8.1 Additional scanning sites SL X in the protective conductor measurement Connecting third-party equipment ▶ Position the test tip on the middle contact ①. 119 / 130 Instructions for use ESTETICA E30 8 Appendix - Additional measuring sites | 8.1 Additional scanning sites SL X in the protective conductor measurement Ceiling adapter for operating light assembly kit 2 3 ① Base plate for the ceiling adapter ② Surroundings of the protective con‐ ductor connector ③ Surroundings of the protective earth conductor terminal Touch monitor with test tip ▶ Touch measuring point ① with the test tip. or 120 / 130 Instructions for use ESTETICA E30 8 Appendix - Additional measuring sites | 8.2 Additional measuring sites AP X for EUL/EPL measurement ▶ Sample the measuring point ② after removing the display cover. 8.2 Additional measuring sites AP X for EUL/EPL measurement Scan the PIEZO ultrasonic scaler with test probe 1 Exemplary presentation of the measuring point on the PiezoLED ultrasonic scaler ① Test probe on ultrasonic scaler tip in ultrasonic scaler handpiece 121 / 130 Instructions for use ESTETICA E30 9 Troubleshooting 9 Troubleshooting Note In case of malfunctions of the individual handpieces (e.g. turbine, motor, camera, Satelec, Mini LED etc.), consult the separate instructions for the use and care of the individual instruments. Malfunction Cause Remedy Nothing works. Main switch is off. ▶ Turn on the main switch. Main service fuse interrup‐ ▶ Unplug the unit from the mains. ted the electric circuit. ▶ Check and replace, if required, the main service fuse. The main service fuse is situated next to the mas‐ ter switch. ▶ For this purpose, open the bayonet closure with a screwdriver and replace the fine-wire fuse (T 6.3 H Mat. no. 0.223.2783). ▶ The re-close the bayonet closure with the screw‐ driver. The patient chair does not The safety shutoff is acti‐ move. vated. ▶ Check the safety shutoff and eliminate the reason for the shutoff. (The LED on the control panel flashes.) Display without indicator. ▶ Turn the device off and on. Bus / hardware error. ▶ Call the service technician to look into the problem if it continues to exist. Operating device no func‐ Bus / hardware error. ▶ Turn the device off and on. tion. ▶ Call the service technician to look into the problem if it continues to exist. Turbine making loud run‐ ▶ Replace turbine wheels. Follow the operating instructions for the turbine. Turbine wheel faulty. ning noises. Satelec Mini LED / KaVo Also refer to: Instructions Poly One does not work. for Use of the Satelec Mini LED / KaVo Poly One No cold light on the hand‐ Cold light not preselected. ▶ Preselect cold light. pieces. The high-pressure lamp or ▶ Replace the high-pressure lamp or Multi LED. Also refer to: Instructions for Use of the handpiece Multi LED on the hand‐ piece is defective. No spray in the handpie‐ ces. No spray preselected. See also: 2 Instructions for Use of the handpiece ▶ Preselect spray. Check setting on butterfly valves of the dentist ele‐ ment. 122 / 130 Instructions for use ESTETICA E30 9 Troubleshooting Malfunction Cause Remedy ▶ Open the ring for controlling the spray on the hand‐ pieces. ling the spray on the hand‐ Check setting on butterfly valves of the dentist ele‐ pieces. ment. Spray throttle Ws20 con‐ Close the ring for control‐ nected to control valve. The main water valve in ▶ Open main valve. the office is closed. ▶ Turn on the compressor. The compressor is not turned on. No water in the tumbler Water bottle is empty. ▶ Fill the water bottle. and spittoon bowl No air pressure in the unit. ▶ Turn on the compressor. insufficient. dirty/clogged. ▶ Clean the spray nozzles according to the accom‐ panying instrument operating instructions. Leaks in instruments. O-rings at MULTIflex or ▶ Replace O-rings. Spray at the instruments is The spray nozzles are motor coupling, gripping sleeve or cannula of the tri‐ ple-function handpiece are damaged. PiezoLED or PIEZOsoft PiezoLED or PIEZOsoft without function. not pivoting. ▶ Also refer to: Instructions for Use of the PIEZOsoft/ PiezoLED The suction hoses do not Slides on the conical sec‐ ▶ Open the slide valve. have any suction. tions are closed. Sieves in suction connec‐ ▶ Replace sieves. tor are blocked. Base plate for vacu-stop ▶ Relieve base plate. has been activated. Suction machine not run‐ ▶ Turn on the suction machine. ning. ▶ Check the suction machine fuse. Water in the return air fil‐ O-rings of the MULTIflex ▶ Replace all O-rings of the MULTIflex coupling. ter. coupling are damaged. The operating light cannot Switch on the lamp head is ▶ Turn on the switch. be switched on. switched off. ERGOcam/DIAGNOcam PC is switched off. ▶ Turn on the computer. does not work. USB cable too long. ▶ Make sure that the cable length does not exceed 10 m (2 x 5 m passive with repeater). No data transmission to No or faulty ethernet con‐ ▶ Notify network administrator. the multimedia menu of the nection between dental unit. unit and office network. 123 / 130 Instructions for use ESTETICA E30 9 Troubleshooting Malfunction Cause Remedy Camera images shows im‐ Electrical or electromag‐ ages only as black/white netic interference by other images. equipment. Camera image freezes Electrical or electromag‐ without the release button netic interference by other ▶ Restart the CONEXIO PC. ▶ Replace the camera in the holder and then take it out again. or foot control having been equipment. triggered. Camera image fails to return to live image mode. Camera image freezes Electrical or electromag‐ ▶ Restart the software. without the release button netic interference by other or foot control having been equipment. triggered. Taking the cam‐ era out again did not solve the problem. Camera image freezes Electrical or electromag‐ ▶ Restart the treatment unit and the CONEXIO PC. without the release button netic interference by other or foot control having been equipment. triggered. The monitor turns itself off. An acoustic signal is is‐ Leaking water switch rec‐ sued every second. ognises leaking water. ▶ Remove water from the unit body. If necessary, have a technician fixed the leak. 124 / 130 Instructions for use ESTETICA E30 10 Information about electromagnetic compatibility in accordance with EN60601-1-2 | 10.1 Electromagnetic Transmissions 10 Information about electromagnetic compatibility in accordance with EN60601-1-2 10.1 Electromagnetic Transmissions The ESTETICA E30 treatment unit is for use in an environment like the one cited be‐ low. The customer or user of the ESTETICA E30 should ensure that it is used in the correct environment. Measurements of emitted interfer‐ ence Conformance Electromagnetic environment Guidelines HF emissions according to CISPR 11 Group 1 The ESTETICA E30 device uses HF energy for its internal functions ex‐ clusively. Therefore, the HF emis‐ sion of the device is very low and in‐ terference with adjacent electronic devices is unlikely. HF emissions according to CISPR 11 Class B The ESTETICA E30 device is suita‐ ble for use in all facilities including residential ones, and facilities that are directly connected to a public power supply that also supplies resi‐ dential buildings. Emission of harmonics according to Class A EN 61000-3-2 The ESTETICA E30 device is suita‐ ble for use in all facilities including residential ones, and facilities that are directly connected to a public power supply that also supplies resi‐ dential buildings. Emission of voltage fluctuations/ flicker according to EN 61000-3-3 The ESTETICA E30 device is suita‐ ble for use in all facilities including residential ones, and facilities that are directly connected to a public power supply that also supplies resi‐ dential buildings. Conforms 10.2 Resistance to electromagnetic interference The ESTETICA E30 treatment unit is for use in an environment like the one cited be‐ low. The customer or user of the ESTETICA E30 should ensure that it is used in the correct environment. Interference immunity tests EN 60601 test level Compliance level Electromagnetic environ‐ ment - Guidelines Electrostatic discharge (ESD) according to EN 61000-4-2 ± 2/4/6 kV contact dis‐ charge ± 2/4/8 kV atmospheric discharge Floors should be made of wood or concrete or be fit‐ ted with ceramic tiles. If the floor is fitted with synthetic material, the relative hu‐ midity must be at least 30%. ± 6 kV contact discharge ± 8 kV atmospheric dis‐ charge Fast transient electrical in‐ ± 2 kV for power lines ± 2 kV for power lines terference / bursts accord‐ ± 1 kV for input and output ing to EN 61000-4-4 lines 125 / 130 The quality of the supply voltage should correspond to that of a typical business or hospital environment. Instructions for use ESTETICA E30 10 Information about electromagnetic compatibility in accordance with EN60601-1-2 | 10.3 Recommended safe distance be‐ tween portable and mobile HF telecommunications equipment and the treatment unit Interference immunity tests EN 60601 test level Compliance level Electromagnetic environ‐ ment - Guidelines Surges according to EN 61000-4-5 ± 1 kV push-pull voltage ± 1 kV push-pull voltage The quality of the supply ± 2 kV common mode volt‐ ± 2 kV common mode volt‐ voltage should correspond age age to that of a typical business or hospital environment. Voltage interruptions, short-term interruptions and fluctuations of the sup‐ ply voltage according to EN 61000-4-11 < 5% UT (> 95% interruption) for ½ period 40 % UT (60% interruption) for 5 periods 70 % UT (30% interruption) for 25 periods < 5% UT (> 95% interruption) for 5 s (250 periods) < 5% UT (> 95% interruption) for ½ period 40 % UT (60% interruption) for 5 periods 70 % UT (30% interruption) for 25 periods < 5% UT (> 95% interruption) for 5 s (250 periods) Magnetic field at a supply frequency (50/60 Hz) ac‐ cording to EN 61000-4-8 3 A/m 3 A/m The quality of the supply voltage should correspond to that of a typical business or hospital environment. If the user needs the ESTE‐ TICA E30 to work even if the power supply is inter‐ rupted, we recommend supplying energy to the ESTETICA E30 from an uninterruptible power sup‐ ply or battery. Magnetic fields at the mains frequency should correspond to typical val‐ ues in a business and hospital environment. NOTE: V T is the alternating mains voltage before the test level is used. 10.3 Recommended safe distance between portable and mobile HF telecommunications equipment and the treatment unit The ESTETICA E30 is intended for use in an electromagnetic environment in which the HF interference parameters are controlled. The customer or user of the ESTETICA E30 can help prevent electromagnetic interference by maintaining the minimum clear‐ ance between portable and mobile HF telecommunication devices (transmitters) and the ESTETICA E30 depending on the output of the communication device as indicated below. Safe distance depending on the transmission frequency: Rated power of the trans‐ mitter in W 150 kHz to 80 MHz d=1.17 P m 80 MHz to 800 MHz d=1.17 P m 800 MHz to 2.5 GHz d=2.33 P m 0.01 0.1 0.1 0.2 0.1 0.4 0.4 0.7 1 1.2 1.2 2.3 10 3.7 3.7 7.4 100 11.7 11.7 23.3 For transmitters whose maximum rated power is not in the above table, the recom‐ mended safe distance d in meters (m) can be calculated using the equation for the re‐ spective gap, where P is the maximum rated power of the transmitter in Watts (W) ac‐ cording to the manufacturer's information. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not be applicable in every case. The spread of electro‐ magnetic waves is absorbed and reflected by buildings, objects and people. 126 / 130 Instructions for use ESTETICA E30 10 Information about electromagnetic compatibility in accordance with EN60601-1-2 | 10.4 Immunity to electromagnetic in‐ terference 10.4 Immunity to electromagnetic interference The treatment unitESTETICA E30 is designed for operation in an environment as specified below. The customer or user of the ESTETICA E30 should make sure that the device is used in an environment of the specified type. Interference immunity tests EN 60601 test level Compliance level Wire-based HF interfer‐ ence according to EN 61000-4-6 Wireless HF interfer‐ ence according to EN 61000-4-3 3 Veff 3 Veff 150 kHz to 80 MHz 3 V/m outside the ISM bandsa V/m 80 MHz to 2.5 GHz Electromagnetic environment Guidelines Handheld and mobile wireless devi‐ ces should not be used at a shorter distance from theESTETICA E30 in‐ cluding cables than the recommen‐ ded safe clearance calculated using the appropriate equation for the emission frequency. Recommended safe distance: d = 1.17 P d= 1.17 P for 80 MHz to 800 MHz d= 2.33 P for 800 MHz to 2.5 GHz where P is the maximal nominal power of the transmitter in watts (W) as specified by the transmitter manufacturer and d is the recom‐ mended safe clearance in metres (m). b The field strength of stationary wireless radio transmitters as meas‐ ured locallycshould be lower than the conformance level at all fre‐ quencies. d Interference is possible in the vicin‐ ity of devices bearing the following icon. NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not be applicable in every case. The spread of electro‐ magnetic waves is absorbed and reflected by buildings, objects and people. a The ISM frequency bands (for industrial, scientific, and medical applications) between 150 kHZ and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz, and 40.66 MHz to 40.70 MHz. b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz to 2.5 GHz are intended to reduce the proba‐ bility of mobile/handheld communications facilities causing interference when they are inadvertently introduced into the patient area. For this reason, the additional factor of 10/3 is applied in the calculation of the recommended safe clearances in these ranges of frequencies. c The field strength of stationary transmitters, such as, e.g. base stations of mobile phones and mobile terrestrial radio devices, amateur radio stations, AM and FM radio and television transmitters, cannot be determined exactly based on theoretical consid‐ erations. A site study should be considered to determine the electromagnetic environ‐ ment in terms of stationary transmitters. If the measured field strength at the site, at which the ESTETICA E30 is used, exceeds the compliance levels shown above, the ESTETICA E30 should be monitored to demonstrate proper function. If any uncom‐ 127 / 130 Instructions for use ESTETICA E30 10 Information about electromagnetic compatibility in accordance with EN60601-1-2 | 10.4 Immunity to electromagnetic in‐ terference mon performance characteristics are observed, additional measures may be required, such as, e.g., changing the orientation or using a different location for the ESTETICA E30. d In the frequency range of 150 kHz to 80 MHz, the field strength should be less than 3V eff V/m. 128 / 130 1.009.5295 · Fk · 20151102 - 5 · en
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