English 1.Indication for use 2. Instruction for Use 3. Cautions
Contents
1. English 1 Indication for use Instruments used to place dental implants 2 Instruction for Use For operation procedures and detailed instructions and procedures for each product please see our manual catalogue or website www dioimplant com eng manual do For product code specification date of manufacture expiration date please see the label on our product If you want to receive user s manual by mail please e mail us at dio dio co kr 3 Cautions before use Check the product before use All equipment for surgery should be sterilized in advance Non sterilized products must be sterilized at 132 C for 15 minutes or at 135 C for 10 minutes with a high pressure steam sterilizer before use After high pressure steam sterilization they should be dried for 30 minutes Determine suitability of the bone in which an implant will be put Inform the patient of the instrument well so that excessive masticatory force is avoided during treatment 4 Handling Check if surgery equipment is polluted before surgery The product should be used only for dental surgery It should be used in the proper order Check if the blade of cutting part of the surgery instrument is blunt in the naked eye When a cutting surgery instrument is used spray saline solution to prevent the bone from being overheated The operator should determine the status of the bone precisely and cut it with an instrument at the proper speed As sm2. Tel 44 1392 829500 Fax 44 1392 823232 DIO Corporation 66 Centum Seoro Haeundae gu Busan Tel 051 745 7777 Fax 051 745 7778 Revision 1 2014 04 29 DIO Corporation Information of Symbol US GB CE Marking US GB Catalogue number US GB Non sterile US GB Do not use if package is damaged US GB Caution US GB Manufacturer s Name and Address US GB Consult instruction for use US GB Authorized representative in Europe US GB Use by Expiration Date US GB Serial number US GB Batch code US GB Date of manufacture ee US GB Caution Federal law USA restricts this device to sale US GB Temperature limitation Storage Temperature by or on the order of a licensed dentist
3. all instruments may go into the patient s throat during surgery fix them with wires when used Our surgery instruments may be re used Please replace them with new ones when their cutting force decreases 5 Cleaning and sterilization for re use Surgery instruments must be cleaned and sterilized before re use Please follow the following procedure lt Cleaning gt 1 Remove pollutants skin tissue blood pieces of bones etc off the surface of the used instrument Till the next step is implemented place the instrument in a humid place 2 1 Cleaning surgery instruments with hands a Put surgery instruments in water mixed with enzyme cleansing solution or similar cleansing solutions b Scrub the surface of the surgery instrument with a soft brush till all visible pollutants are removed Wash small parts of the instrument with a cleaning needle c Remove cleansing solutions off the surface of the instrument with water 2 2 Automatic cleaning with an ultrasonic cleaner a Put surgery instruments in a container of an ultrasonic cleaner and fill it with water completely b Wash it at room temperature for 10 or 15 minutes and drain the water c Wash the surgery instrument with water again and drain the water Follow the drying process of the cleaner and dry the surface of the instrument Repeat the cleaning process till the instrument is clean Then carry out a visual inspection Dry the cleaned surgery instrument with non abrasive cloth a
4. nd keep it before sterilization lt Sterilization gt Make sure to sterilize a non sterilized product with a high pressure steam sterilize at 132 C for 15 minutes or at 135 C for 10 minutes before use After high pressure steam sterilization make sure to dry it for 30 minutes Make sure to store the sterilized surgery instrument in a clean place at 15 30 C 6 Prohibition Patients who have had heart attack or arteriosclerosis Non cooperative patients or patients with mental or physical disabilities which may cause unstable prosthesis failure in fixing prosthesis or complications during post surgery treatment Patients who may be affected by surgery due to bone regeneration microcirculation or blood Pregnant women m Patients with high blood pressure or diabetes As wrong surgery may cause damage of prostheses or surrounding osseous tissues prostheses should be placed by experienced dentists Dentists must fully understand directions and cautions about the product before use Defective products should be returned Operations on patients who are not supposed to have implant surgery may cause failure of implant surgery and loss of supporting bones 8 Side effects and complications Dehiscence delayed healing and edema due to anesthesia Hematoma infection and inflammation General hypersensitivity reaction DONGBANG ACUPRIME 1The Forrest Units Hennock Road East Marsh Barton Exeter EX2 8RU U K
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