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Summary of Contents for Mikrona LX MASTER MIRROR
- Page 1 LX MASTER MIRROR INSTRUCTIONS FOR USE...
- Page 2 1.3 Accessories LX Master Mirror (REF) 450.0036.01........Replacement tool 450.0036.01 450.7002.01........USB-C Charger cable 450.7002.01 USB-C to USB-C - 1m For assembling of LX Master Mirror medical device the following individual 1.4 Assembling LX Master Mirror (REF) components are provided in the compatibility: 450.0002.10 BeamHub UDI: 111929426394 450.4001.10 Charger Station...
- Page 3 Instructions for use Contents 1. Scope of delivery ......................................2 1.1 Package contents LX Master Mirror Starter Kit Day ............................2 1.2 Components LX Master Mirror ..................................2 1.3 Accessories........................................2 1.4 Assembling LX Master Mirror .................................... 2 2. Notes ........................................... 4 2.1 Warranty / Liability ......................................
- Page 4 * Classication according to RKI Lotnumber / reference number / UDI The individual components of the LX Master Mirror are labelled with a lot number. This references the date of manufacture and the article number so that each individual component can be identied and traced.
- Page 5 MIKRONA GROUP AG cannot guarantee safe operation and function. No warranty claims can be made for such defects. MIKRONA GROUP AG is responsible for the product with focus to safety, reliability and function only, if readjustments and repairs are carried out...
- Page 6 LX MASTER MIRROR Instructions for use Labeling of warning For correct, hazard-free and professional use of the device, it is necessary to know and follow the relevant safety regulations and instructions. It is essential that you observe the warnings and notes and hazard information listed here.
- Page 7 Ÿ the lot number Ÿ Technical support for the device is provided by Mikrona. If you have any 2.10 Technical customer support questions, please contact: MIKRONA GROUP AG Tel.: +41 (0)56 418 45 45 Wiesenstrasse 36 E-Mail: swiss@mikrona.com...
- Page 8 Non-compliance can lead to a reduction in the performance characteristics of the medical device. Mikrona Group AG guarantees the conformity of the appliance with the EMC directives only if original Mikrona Group AG accessories and spare parts are used. The use of accessories and spare parts that are not...
- Page 9 Instructions for use Electromagnetic Compatibility The device meets the requirements of EN 60601-1-2. Using accessories other than those specied in this manual may result in increased electromagnetic emissions or decreased electromagnetic immunity for the device. The device or its components should not be used adjacent to or stacked with other equipment.
- Page 10 LX MASTER MIRROR Instructions for use Guidance and Declaration - Electromagnetic Immunity The device is intended for use in the specied electromagnetic environment. The customer or the user of the Health Monitor should assure that it is used in such an environment as described below.n of the test level.
- Page 11 Instructions for use The device and the accessories are for dental use. The LX Master Mirror Not intended use should only be used by trained specialists. Any other use or use beyond this is considered improper. MIKRONA GROUP AG is not responsible for any damage resulting therefrom.
- Page 12 MicroBeam module. Fully discharged MicroBeam modules require approximately one hour for full recharge. With a charged MicroBeam module, the LX Master Mirror can be used continuously for approx. 120 min. As normal with all battery-powered devices, the battery capacity will slowly be reduced with aging which will reduce the operating times.
- Page 13 Instructions for use The product is not delivered sterile. Clean, dry and sterilise the 5. Operation BeamHub before rst use. (see chapter 6) STERIL Insert MicroBeam in BeamHub Wear single-use gloves according to DIN EN 455 in the correct size during treatment.
- Page 14 Instructions for use LX MASTER MIRROR MicroBeam Day The light of the MicroBeam LED can be evaluated with two parameters: The LED light performance of the MicroBeam Day is in a wavelength range that can lead to premature polymerisation of composite materials.
- Page 15 Instructions for use Mirror replace Caution, pressures and forces can damage the glass. Handling and especially cleaning must be carried out with appropriate care. Avoid incrustations by soaking the instrument in a disinfectant solution after treatment. push out Do not clean in an ultrasonic! The rhodium coating has the effect of a non-stick coating.
- Page 16 Instructions for use LX MASTER MIRROR Reprocessing Disinfection means placing the instruments in a condition where there is no risk of infection. This can be done manually, in a wet-chemical dipping process with nal thermal disinfection in a steam steriliser or by machine in a...
- Page 17 Instructions for use Processing should preferably be done by machine in accordance with the Machined cleaning in the washer-disinfector RKI recommendation. Facilities: 1. Thermal Disinfector (washer), e.g. from Miele with Vario-program. It must reach an Ao value of at least 3000. 2.
- Page 18 LX MASTER MIRROR Instructions for use Sterilization BeamHub Use a steam steriliser, in accordance with EN ISO 17665 moist heat.The quality of sterilisation depends crucially on the cleanliness of the instrument. Only sterilise clean instruments. To improve the effect of...
- Page 19 Instructions for use Cleaning and disinfection Charger Station Disconnect the charger from the power supply by pulling the plug. When cleaning the Charger, make sure that no liquid ows into the inside of the device, as this can produce irreparable damages. The charger is made of metal and easy to clean.
- Page 20 LX MASTER MIRROR Instructions for use Packing and transport The BeamHub has to be stored in a dry condition in a sterilisation bag. The temperature must not exceed 55°C (131°F). If the BeamHub is not Storage, packaging and transport used for 7 days or more after sterilisation, remove the BeamHub from the BeamHub sterilisation pouch and store it in the original packaging.
- Page 21 Instructions for use 8. Troubleshooting If a malfunction is detected, do not continue to use the product.. (See chapter 3.3) Do not use the product again until the fault has been solved. (See chapter 2.6) If faults cannot be localised with the help of this troubleshooting, technical customer service must be contacted.
- Page 22 LX MASTER MIRROR Instructions for use 9. Technical data 1. Manufacturer MIKRONA GROUP AG CH-8952 Schlieren 2. Distribution Specialised trade 3. Product name LX Master Mirror 4. Color Stainless stell 5. Material BeamHub polished, stainless steel 316 6. Dimension BeamHub L x W x H: 172mm x 23mm x 16mm 7.
- Page 23 Instructions for use 10. System components CureSafe -performance LED & • High •Intuitive printing function with LED Replaceable high-resolution Conrmation Rhodium-mirror • Multi-charger up to 4 MicroBeams • 3 Types of light: MicroBeam Day, UV & CureSafe • Rechargeable: 120 minutes Use with a single load and recharging in 60 minutes •...
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