Instructions for use
KaVo polymerisation light Poly One
Always be on the safe side.
Page 1: ...Instructions for use KaVo polymerisation light Poly One Always be on the safe side ...
Page 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 0 7351 56 0 Fax 49 0 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...
Page 3: ...se Proper use 6 2 2 1 General information 6 2 2 2 Product specific 7 2 3 Safety instructions 9 2 3 1 General information 9 2 3 2 Product specific 9 3 Description of the Product 11 3 1 Technical Specifications 12 4 Commissioning 14 5 Operation 15 6 Reprocessing methods according to ISO 17664 17 6 1 Cleaning 17 6 1 1 Manual cleaning 17 6 1 2 Automated cleaning 18 6 2 Disinfection 18 6 2 1 Manual dis...
Page 4: ...fitting kit AS Assembly set EP Enclosed parts EMC Electromagnetic compatibility PI Processing instructions 1 1 2 Symbols Important information for users and technicians Action request Warning symbol 1 1 3 Target group This document is for dentists and dental office staff 1 2 Service KaVo Customer Service 49 0 7351 56 1000 Service Einrichtungen kavo com Please refer to the serial number of the prod...
Page 5: ... or water supplies or chemical or electrical factors deemed abnormal or impermissi ble in accordance with factory specifications The warranty does not usually cover bulbs glassware rubber parts and the col ourfastness 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 Cl...
Page 6: ...gations will mean that the damage will be considered to have arisen following delivery in accordance with the General German Freight Forwarders Terms and Conditions 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 p...
Page 7: ...on 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 Instructions for use KaVo polyme...
Page 8: ... CAUTION CAUTION indicates a hazardous situation that can cause damage to property or mild to moderate 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 information This KaVo product is intended for use in den...
Page 9: ... medical purposes The user must ensure that the device works safely and is in a satisfactory condi tion before each use Information on electromagnetic compatibility Note Based on IEC 60601 1 2 DIN EN 60601 1 2 concerning the electromagnetic compatibility of electrical medical devices we must draw your attention to the fol lowing points Electrical medical devices are subject to special precautionar...
Page 10: ...enretec GmbH you can download a form for a disposal order under the menu item eom Download the disposal or der or complete it as an online order 2 Enter the corresponding information to complete the order and submit it as an online 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 39...
Page 11: ...urer of the product CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Perform regular proper care and maintenance 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 Decommissioning WARNING Disposa...
Page 12: ...ble rupture of the lines in the handpiece hose Do not pull on the handpiece hose CAUTION Product damage from improper cleaning The handpiece surface light exit aperture or light inlet aperture may become damaged Do not use abrasives or aggressive cleansers Do not immerse the handpiece in liquids CAUTION Damage from improper use Damage to the curing light Always place the handpiece in the holder wi...
Page 13: ...Manufacturer Comply with the safety related infor mation in the instructions for use Made in Germany Optical radiation warning in accord ance with DIN 4844 2 SN YYYY MM XXXX CE mark according to 93 42 EEC medical devices Handpiece hose 1 600 mm for as sistant element The curing light Poly One emits visible blue light of a wavelength between 450 to 460 nm for photopolymerisation of dental materials...
Page 14: ...ute Pause time 1 minute Dimensions Length including fibre optic cable 200 mm Diameter 25 mm Cross section of the optically active surface of the fibre optic cable 38 5 mm2 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 Tech nical Specifications chapter and no...
Page 15: ...nditions Ambient temperature 20 to 55 C Relative humidity 5 to 95 non condensing Air pressure 700 to 1 060 hPa Instructions for use KaVo polymerisation light Poly One 3 Description of the Product 3 1 Technical Specifications 13 22 ...
Page 16: ...e glare protection onto the optical fibre until it hits against the limit stop Insert the optical fibre into the handpiece until it hits against the limit stop Check the proper positioning of the optical fibre Instructions for use KaVo polymerisation light Poly One 4 Commissioning 14 22 ...
Page 17: ...oducts Infection hazard for care provider and patient Sterilise the optical fibre prior to first use and after each use CAUTION Damage from improper use Injury to the patient Check the secure fit of the fibre optic cable glass rod before each use The following curing times are available for selection 20 seconds 40 seconds 60 seconds Instructions for use KaVo polymerisation light Poly One 5 Operati...
Page 18: ... curing time to 40 seconds Curing light is on for 40 seconds and then shuts off Press button until you hear three acoustical signals to set the curing time to 60 seconds Curing light is on for 60 seconds and then shuts off Press the button to terminate the curing time The curing light shuts off Hold the handpiece in an ergonomic hand position and place it on the respec tive curing site Instruction...
Page 19: ... in the hot air steriliser Do not place the curing light Poly One in a disinfection or ultrasound bath Note For cleaning reprocessing of the fibre optic cable of the curing light Poly One the fibre optic cable must be removed from the handpiece 6 1 Cleaning 6 1 1 Manual cleaning Note Combine manual cleaning with disinfection Internal cleaning Not applicable External cleaning Accessories required T...
Page 20: ...lcohol Clean the handpiece with a soft moist cloth 6 1 2 Automated cleaning CAUTION Damage caused by improper cleaning disinfection Do not sterilise the fibre optic cable in a hot air steriliser Subject the fibre optic cable to thermodisinfection and sterilisation 6 2 Disinfection 6 2 1 Manual disinfection External disinfection Approved disinfectants Mikrozid AF Liquid made by Schülke Mayr FD 322 ...
Page 21: ...nfection and sterilisation 6 3 Drying 6 3 1 Manual drying Blow off the outside of handpiece protective shield fibre optic cable and sili cone holder with compressed air until no water drops are visible any longer 6 3 2 Automatic Drying Not applicable 6 4 Sterilisation Note The fibre optic cable can be subjected to sterilisation Sterilization in a steam sterilizer in compliance with DIN EN 13060 CA...
Page 22: ...s 134 C 1 C overpressure 2 13 bar 6 5 Storage Reprocessed products should be stored protected from dust with minimum ex posure to germs in a dry dark and cool place Instructions for use KaVo polymerisation light Poly One 6 Reprocessing methods according to ISO 17664 6 5 Storage 20 22 ...
Page 23: ...rv ice technician Operating button is non functional Handpiece is defective Button is defective Stop working and call the serv ice technician No timer signal Handpiece is defective Trigger is defective Stop working and call the serv ice technician Fibre optic cable is attached loose ly Socket on fibre optic cable is de fective O rings in handpiece are defective Replace fibre optic cable Replace O ...
Page 24: ...s and spare parts Material number Accessories 3 000 3812 Fibre optic cable 3 000 3811 Protective shield 3 000 4240 O ring Instructions for use KaVo polymerisation light Poly One 8 Accessories and spare parts 22 22 ...
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