KntrlFlex Enddntic Rtary Files KntrlFlex Enddntic Rtary Files are available Nn-Sterile with varius ISO tip sizes and wrking lengths. The devices are intended t be cleaned and sterilized using steam sterilizatin in a gravity r prevacuum cycle prir t initial use. The devices are fr single patient use nly. Intended Use KntrlFlex Enddntic Rtary Files fit int a dental handpiece allwing the user t perfrm rt canal debridement. Warnings The device is t be used n the instructin f, r by a dentist r ther licensed practitiner. Failure t fllw these instructins may cause the fllwing: apex perfratin, insufficient cleaning f the rt canal, preparatin site damage, injury t the patient r user, r pssible aspiratin r swallwing f the file. Attentin shuld be paid t the speed f wrk (RPM) and trque: RPM range (500-600 RPMs). Use f the file beynd the RPM range may cause the file t break and result in patient r user harm. Trque range 1.8-2.3 Ncm. Use f the file beynd the trque range may cause the file t break and result in patient r user harm. Operating an Enddntic File with t high f an RPM may generate undesirable heat and cause patient discmfrt, tth r tissue necrsis, r patient burns. KntrlFlex Enddntic Rtary Files must be thrughly cleaned and steam sterilized prir t the first use t prevent infectin r cntaminatin. D nt use chemical r dry heat t sterilize KntrlFlex Enddntic Rtary Files, as these prcesses have nt been validated fr use. Use f these prcesses may be crrsive t the files and culd result in premature file failure. KntrlFlex Files are fr single patient use nly. Use n mre than ne patient may cause file failure r infectin/ crss-cntaminatin. Irrigatin with ultrasnics is recmmended. Inadequate use f irrigatin may generate undesirable heat and cause patient discmfrt, tth r tissue necrsis, r patient burns. Always clean the file after every engagement. Failure t clean the file may cause the file t break r unwind causing patient r user harm r may generate undesirable heat and cause patient discmfrt, tth r tissue necrsis, r patient burns. Use a rubber dental dam while using Enddntic Files t avid pssible aspiratin r swallwing f the file. D nt apply excessive pressure n the Enddntic Files as this culd cause undesirable heat r may cause the file t fail and cause patient r user injury. Carefully read package labels t ensure use f the apprpriate device. Failure t d s may cause patient r user injury. Always wear glves when handling cntaminated instruments t avid pssible infectin/crss-cntaminatin. Surgical masks must be wrn t avid inhalatin f any aersl r dust generated which culd cause user injury. Eye prtectin must be wrn t prtect against eject particles which culd cause user injury. Cntraindicatins KntrlFlex Files cntain nickel and shuld nt be used fr individuals with knwn allergic sensitivity t this metal at it may cause hypersensitivity. This prduct cntains nickel, a chemical knwn t the state f Califrnia t cause cancer, birth defects r ther reprductive harm. Page 1 f 5
Precautins Brasseler USA KntrlFlex Enddntic Rtary Files Instructins fr Use D nt use if the package is damaged. Files may becme damaged r cntaminated if the packaging is cmprmised. Use n mre than three canals (single patient) may cause the file t break r unwind and cause patient r user injury. D nt use Enddntic Files that are wrn-ut, dull r that exhibit unwinding as this culd cause undesirable heat r may cause the file t fail. Mve the Enddntic File cntinuusly when in use t avid lcalized heating and/r damage t the file. Undesirable heat generatin can cause patient discmfrt, tth r tissue necrsis, r patient burns. Maintain handpieces in gd wrking cnditin t ensure maximum effectiveness f the device. Failure t prperly maintain handpieces may lead t patient discmfrt, injury f the patient r user, aspiratin r swallwing f the Enddntic File r damage t the preparatin site due t vibratin f a wrn chuck r turbine. Ensure the Enddntic File is fully seated and securely gripped in the handpiece cllet prir t use. Failure t d s may cause the File t walk ut f the handpiece and may lead t injury f the patient r user r aspiratin r swallwing f the Enddntic File. Never frce a file int a handpiece as this culd cause damage t the handpiece cllet. General Instructins RPM range is 500-600 RPMs. Use f the file beynd the suggested RPM range may cause the file t break and result in patient r user harm. Trque range is 1.8-2.3 Ncm. Use f the file beynd the suggested trque range may cause the file t break and result in patient r user harm. Shaping and Cleaning Crwn Dwn Technique with Cnstant Tapers 1. Establish wrking length using radigraphs and an apex lcatr. 2. Reach full wrking length with a #15/.02 file nting the level f resistance t achieve wrking length. 3. Prceed utilizing a crwn dwn technique using the fllwing file sizes based n the level f engagement t achieve wrking length with the #15/.02 file. Significant resistance t reach wrking length= Small File Assrtment (30, 25, 20). Mderate resistance t reach wrking length= Medium File Assrtment (40, 35, 30). Minimal resistance t reach wrking length= Large File Assrtment. (45, 40, 35). 4. Begin crwn dwn with the largest file. Use each file with 4-5 strkes f 1 single gentle engagement. After each engagement clean the flutes prir t reengagement (single strke and clean). Mve t the next smallest file after 4-5 single engagements. Irrigate between each rtary file with yur irrigant f chice. 5. The first file t wrking length with resistance cmpletes the preparatin.* *If desired finish the preparatin t the next largest size rtary file. Page 2 f 5
Variable Tapered Technique 1. Establish wrking length using radigraphs and an apex lcatr. 2. Reach full wrking length with a #15/.02 file nting the level f resistance t achieve wrking length. 3. Begin sequence with the 19/07 rifice shaper taking it nly 2-3 mm int the canal (d nt take t wrking length). 4. Prceed utilizing a variable tapered technique using the fllwing files in a prgressive series (mve t the next file after the previus file reaches wrking length): 17/05, 20/06, 25/05, 30/05. See technique ntes belw: Technique Ntes: After each engagement clean the flutes prir t reengagement (single strke and clean). Irrigate between each rtary file with yur irrigant f chice. 5. If it is desired t finish the preparatin t a larger apical size utilize the 35, 40 r 45.04 KntrlFlex files t cmplete the preparatin utilizing the same single strke and clean technique. Obturatin Obturate the canals using BC Sealer and the crrespnding BC Pint. Select the EndSequence BC Pint that matches the last rtary file taken t wrking length. Deliver BC Sealer thrughut the canal using a small file. Cat the selected BC Pint with BC Sealer and slwly seat the BC Pint t full wrking length. Cleaning and Sterilizatin Instructins Scpe These instructins are applicable t all KntrlFlex Rtary Files. KntrlFlex Files are prvided mechanically clean, but are nt sterile. Therefre, KntrlFlex Files shuld be sterilized befre first use. Warnings Reprcessing Limitatins Cntainment/ Transprtatin Manual Cleaning Prcedure 1. Cleaning agents with chlrine r chlride as the active ingredients are crrsive t NiTi and must nt be used. Cleaning agents with neutral ph are recmmended. 2. D nt use Cld Sterilizing Methds fr the sterilizatin f NiTi files. These agents ften cntain strng xidizing chemicals that may dull r weaken NiTi files. 3. Vigrus scrubbing f the files may cause damage. Care shuld be taken t ensure that files are nt brken r damaged during the cleaning prcess. The end f life is determined by the wear and damage in use. NiTi files shuld be inspected fr defects during the cleaning prcess. Nt applicable fr single use devices If hand cleaning is the nly available ptin, NiTi files shuld be cleaned in a sink reserved fr cleaning instruments. Rinse the NiTi File (and dedicated instrument blck, if applicable) under cl running water fr at least ne (1) minute. Prepare a fresh bath f neutral-ph cleaning slutin. Fllw the cleaning agent s manufacturer s instructins. Immerse the NiTi File (and instrument blck) and sak fr at least ten (10) minutes. After saking, and keeping it immersed, brush thrughly away frm the bdy using the neutral cleaning agent fr at least ne (1) minute. Care shuld be taken t avid spreading cntaminants by spraying r splashing during the brushing prcess. Use wire brushes with cautin as brass particles may result in galvanic crrsin and steel particles may cause disclratin f stainless steel. Special care shuld be taken t clean crevices and ther hard t reach areas thrughly. Visually inspect t cnfirm the remval f debris. Repeat the cycle if needed. Page 3 f 5
Thrughly rinse the NiTi file under running warm water fr at least ne (1) minute and until visibly clean. Dry the device using a nn-shedding wipe r clean cmpressed air. Ultrasnic Cleaning Prcedure Prepare a fresh ph-neutral cleaning slutin; place the NiTi File in the dedicated instrument blck (if applicable) and then place in a snicatin unit. Fllw the cleaning agent manufacturers' instructins fr crrect cncentratin, expsure time, temperature, and water quality. Cmpletely submerge the device in the cleaning slutin and snicate fr at least fifteen (15) minutes. Perfrm a final thrugh rinse f the device under running warm tap water fr at least (1) minute. Visually inspect t cnfirm the remval f debris. Repeat the cycle if needed. Dry the device using a nn-shedding wipe r clean cmpressed air. Inspectin Testing 1. Carefully inspect each device t ensure that all debris has been remved. 2. Visually inspect the device fr damage/ wear that wuld prevent prper peratin. a. D nt use if the tip is brken. b. D nt use if there is a brken sectin f a file. c. D nt use if there is evidence f crrsin. d. D nt use if the reference markings are illegible. Packaging Sterilizatin Singly: Pack the NiTi File in puches validated fr sterilizatin Use the fllwing cycle fr steam sterilizatin Cycle Type Minimum Sterilizatin Expsure Time (minutes) Minimum Sterilizatin Expsure Temperature Minimum Dry Time (minutes) Gravity 10 135 C (275 F) 30 Pre-vacuum 3 134 C (273 F) 30 (4 Pulses) Ensure that the sterilizer manufacturer s maximum lad is nt exceeded. The minimum dry time has been validated t ensure that the files will nt be left wet. Failure t achieve the minimum dry time may cause misture t remain n the files that culd result in crrsin. Strage Additinal Infrmatin The NiTi File shuld be stred in the sterilizatin puch until required. These prcesses have been validated as being capable f preparing NiTi Files fr use. Any deviatin frm these instructins shuld be prperly validated fr effectiveness and ptential adverse results. Page 4 f 5
Glssary f Symbls Symbl Meaning Standard Catalgue Number ISO 15223-1 Use-by date ISO 15223-1 Batch Cde ISO 15223-1 Revlutin (RPM) ISO 21531 Quantity N/A Cnsult instructins fr use ISO 15223-1 Cautin ISO 15223-1 Nn-sterile ISO 15223-1 D nt re-use ISO 15223-1 D nt use if package is damaged ISO 15223-1 Files cntain nickel and shuld nt be used fr individuals with knwn allergic sensitivity t this metal Cautin: Federal law restricts this device t sale by r n the rder f a dentist/physician licensed by the law f the State in which he/she practices t use r rder the use f the device. ISO 15223-1 FDA 21 CFR Part 801.109 (b)(1) Manufacturer/Legal Manufacturer ISO 15223-1 Brasseler U.S.A. Dental, LLC One Brasseler Blvd. Savannah, GA 31419 USA Telephne 800-841-4522 Page 5 f 5