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Summary of Contents for Eighteeth E-xtreme
- Page 1 0197 E-xtreme Endo Motor USER MANUAL Changzhou Sifary Medical Technology Co., Ltd.
- Page 2 P/N: IFU- 6035009 Version: 04 Issued: 18, 2022 Size: 160mm X 92mm...
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Page 3: Table Of Contents
Content 1. Scope of E-xtreme .................. 5 1.1Parts Identification ..................5 1.2Components ...................... 6 2. Symbols Used ..................8 3. Before Use ..................... 10 3.1Scope of application ..................10 3.2Contra-indications ..................10 4. Installing the E-xtreme ................ 12 4.1Installation of the contra angle ..............12 4.2Install the file .................... - Page 4 10. Troubleshooting ................. 40 11. Technical Data ..................42 12. EMC Tables ..................44 13. Statement .................... 52 Page 4 / 53...
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Page 5: Scope Of E-Xtreme
1 Scope of E-xtreme 1. Scope of E-xtreme 1.1 Parts Identification Note: This product does not contain root canal file ○ Contra Angle ○ Motor Handpiece ○ Handpiece Base ○ Insulating Sleeve (optional) ○ Spray Nozzle ○ Adapter Page 5 / 53... -
Page 6: Components
1 Scope of E-xtreme 1.2 Components Motor Handpiece Handpiece Base Contra Angle (1pcs) (1pcs) (1pcs) Part No:6051058 Part No:6051059 Part No:6036100 Spray Nozzle (1pcs) Insulating Sleeve Part No:6051108 (optional) Part No:6004027 For different regions, there are several different adapter options to be selected as follows. - Page 7 1 Scope of E-xtreme Australian standard power plug (1pcs) Part No: 6016010 Argentina standard power plug (1pcs) Part No:6016014 Page 7 / 53...
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Page 8: Symbols Used
2 Symbol Used 2.Symbols Used General warning sign Caution Serial number Catalogue number Batch code Medical device Authorized representative in the European Community Manufacturer Country of manufacture Class II equipment Washer-disinfector for thermal disinfection Type B applied part Keep dry CE marking Dispose of in accordance with the WEEE directive Direct current... - Page 9 2 Symbol Used Humidity limitation Atmospheric pressure limitation Page 9 / 53...
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Page 10: Before Use
(including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the E-xtreme, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. - Page 11 3 Before Use Gloves and a rubber dam are compulsory during treatment. Never open or repair the device yourself ，otherwise, void the warranty. If irregularities occur in the device during treatment, switch it off. Contact the local dealer for treatment. ...
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Page 12: Installing The E-Xtreme
Installing the E-xtreme 4. Installing the E-xtreme 4.1 Installation of the contra angle Make sure 4 pins on contra angle alignment the slots of handpiece, plug them together until it “click” securely into place. The contra angle can be 360... -
Page 13: Charging
4 Installing the E-xtreme Inspect the file head before inserting the file. Do not use the damaged file head. Be careful when inserting and removing files to avoid injury to fingers. Pull the file gently to make sure that the file is secure in handpiece properly, otherwise it may pop out and hurt the patient. -
Page 14: Install The Insulation Sleeve
4 Installing the E-xtreme 4.4 Install the Insulation Sleeve Install：assemble according to the left figure Remove：pull out the cover in the opposite direction The insulating sleeve is mainly used secondary isolation to avoid cross infection. Page 14 / 53... -
Page 15: Use Interface
Use Interface 5. Use Interface 5.1 Panel key Power on ● Press more than 0.5 seconds to turn on the instrument. Memory Change Press to change at st- andby mode. Operation Mode Change Press once at standby mode, press to switch, then ●... -
Page 16: Screen Display
Use Interface 5.2 Screen display Standby interface ① Residual battery power ② Speed ③ Unit of speed (Revolutions Per Minute) N cm · ④ Memory mode number ⑤ Torque ⑥ Unit of torque (Newton Centimeter) ⑦ Operation mode Working mode interface ①... -
Page 17: Terms And Definition
Use Interface 5.3 Terms and definition Fwd/Fw Forward (Clockwise rotation) Rev/Rv Reverse (Counter clockwise rotation) Reciprocation: Be applied to reciprocating file, path file and rotary file protection by setting some special angle Memory mode Such as M0-M9 Such as Fwd, Rev (set in M1-M9)， Operation mode Reciprocation (M0) Torque... -
Page 18: Setting
Setting 6. Setting 6.1 Set memory mode The device has 10 memory mod- es (M0-M9) ， press at standby mode ， memory number (②) will change accordingly. Each memory mode includes its N cm N cm · · own speed (①)，operation mode (④) and torque (③). -
Page 19: Set Parameters
Setting 6.2 Set parameters All parameters must be set according to the recommended values of root canal file manufacturer. Before starting the device for operation, make sure that all parameters are correct, otherwise there is a risk of instrument separation. Before starting the motor, check whether the operation mode (①) is correct. - Page 20 Setting In different operation modes, the values of parameters will be different according to the corresponding logic (Adjust parameters according to chapter 7.2). In M1-M9 memory mode, the s- peed can be 120rpm-650rpm. Pr- at standby mode till sp- eed (①②) is displayed,press SPEED: to set，then press...
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Page 21: Preset Programs
Setting device is started to remind the operator that the motor is in reverse rotation. 30 ° 150° 150 ° 30° The left figure describes the set- 180 ° ting of M0(REC mode):Press 30° at M0(①)to switch different reci- procating preset programs. Th- ere are altogether 5 sets of pre- 210 °... - Page 22 Setting the next page). Then press to con- ● firm. If you select one of the preset program- ms, such as "one curve" (①) , the corr- esponding operation mode(②), speed (③) and torque(④) will be automatically set. Protaper , Pro.Glider is a registered ®...
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Page 23: Advanced Setting
Setting 6.4 Advanced setting Hold then press ● (for about 0.5 seconds) at off mode to enter adva- nced set mode. It will be about 1 second at SET logo an- d then enter ①“BEEP VOL”(beep vol- ume set). Press to set (②) （Mute、Low、Mid、High）, then pres-... - Page 24 Setting Press again at hand habit set will enter①“Calibration”auto calibration， press to set③(ON、OFF)， ● Choose“ON”and press C alib ra tion confirm and the device will auto cali- · O F F brate.The left figure ② means when choose “OFF”and press again w- ill enter restore settings (R.S).
- Page 25 Setting will be covered by the factory default parameters. If necessary, please record parameters before restoring factory settings. Page 25 / 53...
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Page 26: Parameter Logic
Setting 6.5 Parameter logic The factory default parameters of the ten memory modes are shown in the table below. The parameters can be adjusted as needed. The default advanced settings parameters are shown in the following table. The parameters can be adjusted as needed. Parameter M8 M9 Operation... - Page 27 Setting The rotational speed (RPM) varies in different operating modes, as shown in the table below Torque (N·cm) in different operation modes, the torque value can be set differently even in the same operation mode when the speed value is set differently. See the table below for details. There are 5 fixed values of reciprocating Angle in M0 reciprocating mode, and the Angle cannot be changed., as shown in the table below.
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Page 28: Operation
Operation 7.Operation 7.1 Charge Display the remaining power. The remaining charge is less than 15%. If the battery power is less than 15%, it must be rechar- ged within 30 days, otherwise the battery will irretrievably damaged due to low power. ... - Page 29 Operation When charging, the charging indicator will appear on the display screen and flicker sl- owly (①) . When the battery is fully charged or in the state of nearly full charge, the display will stop flashing, charging indication is shown in the figure (②) .
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Page 30: Motor Operation
Operation 7.2 Motor Operation In the standby mode, the root canal preparation device is started by pres- ● sing the main switch After startup, the progr- ess bar will be displayed display screen (for details of the pro- gress bar, please refer to chapter display screen interface). - Page 31 Operation When there is any abnormality, please stop using the equipment. This equipment is not suitable for all types of root canals. It is recommended to use according to the instructions of root canal file. The root canal file is easy to fracture at high speed. Please follow the rotation speed recommended by the manufacturer.
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Page 32: Cleaning, Disinfection And Sterilization
Maintenance 8.Cleaning, Disinfection and Sterilization 8.1 Foreword For hygiene and sanitary safety purpose, the components (contra angle, and insulating sleeve) must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well as the subsequent uses. Comply with your national guidelines, standards and requirements for cleaning, disinfection and sterilization. -
Page 33: Autoclavable Components
Reprocessing Instructions Disconnect the components (Contra Angle, Insulating Sleeve) from the handpiece. Refer to "Chapter 4-Installing the E-xtreme" of this man- ual for disassembly instructions. Remove gross contaminations from the components with cold water (<40°C) immediately after use. Don’t use a fixating detergent or hot water (>40°C) as this... - Page 34 Maintenance devices must reprocessed disassembled state. Preparation for Decontaminati- Do not fail to take out the file before cleaning the contra angle. Observe suitable personal protective measures. Do a manual pre-cleaning, until the components are visually clean. Submerge the components in a cleaning solution and flush the lumens with a Pre-Cleaning water jet pistol with cold tap water for at least 10...
- Page 35 Maintenance · 5 min intermediate rinsing with warm water (40°C); · emptying The automated cleaning processes have been validated by using 0.5% neodisher MediClean forte (Dr. Weigert). Note Acc. to EN 17664 no manual reprocessing methods are required for these devices.
- Page 36 Maintenance free towel. Insufflate cavities of instruments by using sterile compressed air. Functional Visual inspection cleanliness Testing, instruments and reassembling. Functional testing Maintenance according to instructions of use. If necessary, perform reprocessing process again until instrument is visibly clean. Before packaging and autoclaving, make sure that the components have been maintained acc.
- Page 37 Maintenance Minimum requirements: 3 min at 134 °C (in EU: 5 min at 134 °C) Maximum sterilization temperature: 137°C Flash sterilization is not allowed on lumen instruments! Use only approved autoclave devices according to EN 13060 or EN 285. ...
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Page 38: Disinfection Components
Maintenance achieves the desired result. This requires verification and/or validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. Disinfection Components Disinfection components Motor Handpiece Handpiece Base Adapter... -
Page 39: Error Indication
Error Warnings 9.Error Indication This warning will appear on the display screen if the load exceeds capacity standby machine during reversal. Please press the main switch key to restart the standby machine. The power is very low, charge it immediately. Page 39 / 53... -
Page 40: Troubleshooting
Troubleshooting 10.Troubleshooting When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor. Problem Cause Solution... - Page 41 Troubleshooting The handpiece is protected Check according to error damaged warning system There is a short Press the "s" key to stop motor circuit the motor and contact the cannot internal circuit dealer stop The reverse value of Check whether the torque the torque setting motor limit is too small...
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Page 42: Technical Data
Technical Data 11.Technical Data Manufacturer Changzhou Sifary Medical Technology Co., Ltd. Model E-xtreme 17.5cm x 10.9cm x 8.4cm±1cm Dimensions (package) Gross weight 0.6kg±15% Gear ratio: 1:1 Compatible with rotary reciprocating instruments, equipped Contra angle with φ2.35 mm nickel titanium root canal file conforming to ISO 1797:2017, Type 1, Files length 11-31mm. - Page 43 Technical Data Ambient temperature: -20 °C ~ +55 °C Transport and Relative humidity: 20% ~ 80 % storage conditions Atmospheric pressure: 70kPa ~ 106kPa Page 43 / 53...
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Page 44: Emc Tables
Guidance and manufacturer’s declaration - electromagnetic emissions The E-xtreme is intended for use in the electromagnetic environment specified below. The customer or the user of the E-xtreme should assure that it is used in such an environment. Electromagnetic Emissions test... - Page 45 Guidance and manufacturer’s declaration – electromagnetic immunity The E-xtreme is intended for use in the electromagnetic environment specified below. The customer or the user of the E-xtreme should assure that it is used in such an environment. Immunity IEC 60601...
- Page 46 EMC Tables Mains power quality should Voltage dips be that of a IEC 61000-4- typical cycle cycle commercial at 0°, 45°, 90°, at 0°, 45°, 90°, hospital 135°, 180°, 135°, 180°, environment. If 225°, 270°, 225°, 270°, user and 315° and 315°...
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Page 47: Immunity Test
EMC Tables Guidance and manufacturer’s declaration – electromagnetic immunity The E-xtreme is intended for use in the electromagnetic environment specified below. The customer or the user of the E-xtreme should assure that it is used in such an environment. Compli- Electromagnetic... - Page 48 When they are used in close proximity to medical equipment and/or systems, the medical equipment and/or systems’ basic safety and essential performance may be affected. The E-xtreme has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2020.
- Page 49 EMC Tables CDMA 850, Band 5 1800; 1720 CDMA 1900; Pulse 1700 1900; modu- 1845 DECT; lation 1990 217Hz Band 1, 1970 4, 25; UMTS Bluetoo- WLAN, Pulse 2400 802.11 modu- 2450 b/g/n, lation 2570 RFID 217Hz 2450, Band 7 Pulse 5240 5100...
- Page 50 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the E-xtreme, including cables Page 50 / 53...
- Page 51 EMC Tables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. If the use location is near (e.g. less than 1.5 km from) AM, FM or TV broadcast antennas, before using this equipment, it should be observed to verify that it is operating normally to assure that the equipment remains safe with regard to electromagnetic disturbances throughout the expected service life.
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Page 52: Statement
Statement 13.Statement Service Life The service life of E-xtreme series products is 3 years. It is recommended that the equipment be checked and repaired at the dealer once a year. Maintenance MANUFACTURER will provide circuit diagrams, component part lists, descriptions,... - Page 53 Changzhou Sifary Medical Technology Co., Ltd. Add: No.99 Qingyang Road, Xuejia County, Xinbei District, Changzhou City, 213000, Jiangsu, P.R. China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: info@sifary.com Web: www.sifary.com Caretechion GmbH Tel: +49 211 2398 900 Add: Niederrheinstr. 71, 40474 Düsseldorf, Germany Email: info@caretechion.de All rights reserved.
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