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Eighteeth E-CONNECT User Manual

Endo motor
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0197
E-CONNECT
Endo Motor USER MANUAL
Changzhou Sifary Medical Technology Co., Ltd.

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Summary of Contents for Eighteeth E-CONNECT

  • Page 1 0197 E-CONNECT Endo Motor USER MANUAL Changzhou Sifary Medical Technology Co., Ltd.
  • Page 2 P/N: IFU-6035105 Version: 09 Issued: Nov. 18, 2022 Size:130mmX85mm Page 2 / 54...
  • Page 3 E-CONNECT Charging ..........17 5. Use Interface ..................18 Panel key ............... 18 Screen display ............... 20 Display the root canal on E-CONNECT ......20 Combination Function ........... 21 Terms and definition ............23 6. Setting....................24 General function setting ..........24 Operation steps ..............
  • Page 4 10. Technical Data ................. 41 11. EMC Tables ..................43 12. Statement ..................53 Page 4 / 54...
  • Page 5 Scope of E-CONNECT 1. Scope of E-CONNECT arts Identification ③ ② ① ④ ⑥ ⑤ ⑦ ○ Contra Angle ○ Motor Handpiece ○ Data Transfer Cable ○ Adapter ○ Insulating Sleeve ○ Spray Nozzle ○ Handpiece Base Page 5 / 54...
  • Page 6 Scope of E-CONNECT 1.2 Components Motor Handpiece Handpiece Contra Angle (1pcs) Part No:6036006 (1pcs) Base(1pcs) Part No:6051012 Part No:6005002 Insulating Sleeve Spray Nozzle (1pcs) Data Transfer Cable Part No:6051038 (1pcs) (1pcs) Part No:6004027 Part No :6015003 For different regions, there are several different adapter options to be selected as follows.
  • Page 7 Scope of E-CONNECT British standard power plug (1pcs) Part No: 6016009 Adapter (1pcs) Australian standard power Part No:6016007 plug (1pcs) Multi- Part No: 6016010 standard Argentina standard power plug (1pcs) Part No:6016014 Page 7 / 54...
  • Page 8 Symbols Used 2. Symbols Used General warning sign Caution Serial number Catalogue number Medical device Authorized representative in the European Community Manufacturer Country of manufacture Class II equipment Type B applied part Keep dry CE marking 0197 Dispose of in accordance with the WEEE directive Direct current Consult instructions for use Manufacturer‘s Logo...
  • Page 9 Symbols Used 5 5℃ Temperature limit -2 0 ℃ 80 % Humidity limitation 2 0 % 106 kPa Atmospheric pressure limitation 7 0 k Pa Washer-disinfector for thermal disinfection Page 9 / 54...
  • Page 10 3.2 Contraindications Do not use E-CONNECT together with high frequency surgical equipment. Patients with heart disease should be cautious. The E-CONNECT is contraindicated in cases where patient/user carry medical implants such as pace makers or cochlear implants etc.
  • Page 11 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-CONNECT, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 12 Before Use manufacturer.  Before use, please confirm whether the device connection is loose, if any abnormality is found, please contact the supplier or manufacturer.  It is forbidden to use non-original parts for the equipment.  Do not load and use the device for a long time. Otherwise, the temperature of the device will rise, which may cause minor burn to the operator or the patient.
  • Page 13 Installing the E-CONNECT 4.Installing the E-CONNECT 4.1Installation 4.2Install and Remove the contra angle file Install the file: Insert the file and Connect the contra angle and turn the file, make sure that file is handpiece properly. inserted. *Make sure the motor is stopped Remove the file: Keep pressing the when installing the contra angle.
  • Page 14 Installing the E-CONNECT  Take care not to touch the Main switch when installing files, which will cause the file to rotate.  Pull the file gently to make sure that the file is installed securely in handpiece, otherwise, it may pop out and hurt the patient.
  • Page 15 3. Press the main switch of E- CONNECT. All the root canal length strips in the screen will After connecting the cable, the light up. That means the system is screen of E-CONNECT will working normally. display “CONNECTED!”, which means the connection is proper. E-PEX...
  • Page 16 Installing the E-CONNECT the patient's mouth, and start the treatment. Page 16 / 54...
  • Page 17 Installing the E-CONNECT 4.4E-CONNECT Charging  Keep away from the heat The number of cells in the battery source, and make sure that there symbol shows current is no combustible surrounding. available battery power. When  When the battery power is low...
  • Page 18 Use Interface 5.Use Interface Turn Power On 5.1Panel key ● more than 0.5 seconds to Press turn on the instrument Memory Change Press < > during standby state Operation mode Change Press once during standby state, press < > to change, ①...
  • Page 19 Press 2) Choose memory: By press </> E-CONNECT has 10 memory mode (M0 to M9). Users can set the memory mode (combine different speed, torque and reverse direction) by themselves. Memory M0 is reciprocating mode, there are 5 units reciprocating degrees in M0, press S key to switch.
  • Page 20 ○ ⑧ Reverse torque cursor 5.3Display the root canal on 1. The white band on handpiece E-CONNECT screen will display the progression of the file into the canals. 2. The closer the file tip to the apical foramen, the more rapid the beep sound makes.
  • Page 21 The position of the reference point is automatically set with the E-PEX, and the cursor is displayed on the E-CONNECT screen. When the file reaches the reference point, E-CONNECT will start Apical Reverse, Apical Slow Down and Apical Torque Reduction function.
  • Page 22 Use Interface  Do not use a non-specified data transfer cable, otherwise, it will damage the device.  Do not hit device and splash liquids on it.  Make sure to connect the two devices with right position.  After connecting the two devices with the cable, gently push and pull the interface to ensure that the connection is stable, otherwise the data transmission may not be accurate.
  • Page 23 Use Interface 5.5Terms and definition Forward ( Clockwise rotation ) Reverse ( Counter clockwise rotation ) Be applied to special file, inject calcium hydroxide and other solutions Reciprocation Be applied to reciprocating file, path file and rotary file protection by setting some special angle During combined length determination, normally Reference apical reverse must active before reaching major...
  • Page 24 Setting 6.Setting 6.1General function setting General function: rotate speed, reverse torque, rotate direction Speed setting Display the standby interface Reverse torque setting Direction setting 6.2Operation steps 1. Press +/-to choose a memory number 2. Press the S key to select a function that needs to be set 3.
  • Page 25 Setting The torques (N·cm) in different operation mode are not the same, and even in the same operation mode, when the speed changing, the possible torque is difference, details are listed below. Fwd/Rev（120-1000rpm） 3.0 3.5 There are 5 fixed values of reciprocating Angle in M0 reciprocating mode, and the Angle cannot be changed., as shown in the table below.
  • Page 26 5. If exceed 5 seconds without any operation ( factory setting is 5 seconds，it could be change), display will switch to standby interface Connect Function E-CONNECT E-PEX connected to use, the following online function will be activated. Apical Reverse Close to root canal apex, automatic reverse / stop.
  • Page 27 Setting When the file enters the root canal orifice, the motor will start running automatically. When the file leaves the canal orifice, the motor will stop automatically. Apical Slow Down Automatic deceleration when the file reaches to the root canal apex. ...
  • Page 28 Setting 6.4Additional function settings Factory set as shown below: Right hand or left Beep volume Right hand hand Automatic Automatic standby 10 mins shutdown time time 1. When the device is shutdown press key S and main switch at the same time. 2.
  • Page 29 Setting By press +/- to select the ‘ON’ then press main switch to activate the calibration program. 6.5Calibration 1. Install the contra angle into the E- CONNECT handpiece  Do not insert the file. 2. Enter the calibration option interface (See 9.5 Additional function settings) 3.
  • Page 30 Error Warning 7.Error Warning While operating, E-CONNECT will detects the real time performance of the system, if the state is unsuitable, the device will self-protect and inform user. The power is too low, there will be auto power off, charge the device immediately.
  • Page 31 Cleaning, Disinfection and Sterilization 8.Cleaning, Disinfection and Sterilization 8.1 Foreword For hygiene and sanitary safety purpose, the components ( Contra Angle , Insulating Sleeve ) must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well use the subsequent uses.
  • Page 32 Cleaning, Disinfection and Sterilization  Thoroughly clean and wash the components before auto- claving. Do bleach chloride disinfectant materials. Only the components above can be autoclaved. Before first use and after each use, sterilize the above components heat sources. Autoclave Procedure: Reprocessing Instructions Disconnect the components (Contra Angle, Insulating Sleeve) from the handpiece.
  • Page 33 Cleaning, Disinfection and Sterilization (acidic electrolyzed water, strong alkaline solution, or ozone water), medical agents (glutaral, etc.), or any other special types of water or commercial cleaning liquids. Such liquids may result in metal corrosion and adhesion of the residual medical agents to the components.
  • Page 34 Cleaning, Disinfection and Sterilization Carefully put the instrument into the washer- disinfector on a tray and set the parameters as follows and start the program: 4 min pre-washing with cold water (<40°C) emptying 5 min washing with a mild alkaline cleaner at 55°C emptying 3 min neutralising with warm water (>40°C)
  • Page 35 Cleaning, Disinfection and Sterilization Automated Thermal Disinfection washer/disinfector under consideration of national requirements in regards to A0 value (see EN ISO 15883). A disinfection cycle of 5 min disinfection at 93°C Disinfection has been validated for the device to achieve an A0 value of 3000.
  • Page 36 Cleaning, Disinfection and Sterilization Before autoclaving, the contra angle must be lubricated. Attaching the spray nozzle to oil can and contra angle, press the oil can button more than 3 seconds, till all the black oil flow out from the head of the contra angle.
  • Page 37 Cleaning, Disinfection and Sterilization Respect the maintenance procedure of the autoclave device given by the manufacturer. Use only this recommended sterilization procedure. Control the efficiency (packaging integrity, no humidity, color change sterilization indicators, physicochemical integrators, digital records of cycles parameters). The sterilization procedure must comply with EN ISO 17665.
  • Page 38 Cleaning, Disinfection and Sterilization  The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result.
  • Page 39 Troubleshooting 9.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. Ref.
  • Page 40 Troubleshooting reverse rotation. Sound too low Beep volume set to low. Set beep volume to, mid or high Beep sound The motor is set to REV If it is the expected an alarm even mode, ignore the though alarm. instrument is being used.
  • Page 41 Technical Data 10.Technical Data Manufacturer Changzhou Sifary Medical Technology Co.,Ltd Model E-CONNECT Dimensions 21.4cm x 9.98cm x10cm±1cm (package) Gross weight 690g ±10% Gear ratio: 1:1 Compatible with rotary and reciprocating instruments, equipped with φ2.35 mm nickel Contra angle titanium root canal file conforming to ISO 1797:2017, Type 1, Files length 11-31mm.
  • Page 42 Technical Data Atmospheric pressure: 70kPa~106kPa Ambient temperature: -20 °C ~ +55 °C Transport and Relative humidity: 20% ~ 80%, non-condensing storage conditions Atmospheric pressure: 70 kPa ~ 106 kPa Page 42 / 54...
  • Page 43 EMC Tables 11.EMC Tables Guidance and manufacturer’s declaration – electromagnetic emissions The E-CONNECT is intended for use in the electromagnetic environment specified below. The customer or the user of the E- CONNECT should assure that it is used in such an environment.
  • Page 44 EMC Tables Guidance and manufacturer’s declaration – electro-magnetic immunity The E-CONNECT is intended for use in the electromagnetic environment specified below. The customer or the user of the E- CONNECT should assure that it is used in such an environment.
  • Page 45 EMC Tables Surge Line to line: Line to line: Mains power quality IEC 61000- ±0.5kV, ±0.5kV, should be that of a ±1kV ±1kV typical commercial hospital Line to earth: Line environment. ±0.5kV, earth: ±1kV, ±2kV ±0.5kV, ±1kV, ±2kV Voltage Mains power quality 0% UT;...
  • Page 46 EMC Tables Rated 30 A/m 30 A/m Power frequency Power 50Hz 50Hz magnetic field frequency 60Hz 60Hz should be at levels magnetic characteristic of a field typical 61000-4-8 location in a typical commercial hospital environment. Note: UT: rated voltage(s); E.g. 25/30 cycles means 25 cycles at 50Hz or 30 cycles at 60Hz Page 46 / 54...
  • Page 47 EMC Tables Guidance and manufacturer’s declaration – electromagnetic immunity The E-CONNECT is intended for use in the electromagnetic environment specified below. The customer or the user of the E- CONNECT should assure that it is used in such an environment.
  • Page 48 EMC Tables ation minimum separation equipment distances" table Proximity Complies "Recomm fields ended from RF minimum wireless separation communi distances" cation equipmen 61000-4-3 Page 48 / 54...
  • Page 49 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-CONNECT has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2.
  • Page 50 EMC Tables 800/900 TETRA Pulse 800, 800- modula iDEN tion 820, 18Hz CDMA 850, Band 5 1720 1800; 1845 CDMA 1900; Pulse 1700- 1900; modula 1990 DECT; tion 1970 217Hz Band 1, UMTS Bluetoo Pulse WLAN, 2400- modula 2450 802.11 2570 tion b/g/n,...
  • Page 51 5785 217Hz Guidance and manufacturer’s declaration – electromagnetic immunity The E-CONNECT is intended for use in the electromagnetic environment specified below. The customer or the user of the E- CONNECT should assure that it is used in such an environment.
  • Page 52 Adapter Cable Measuring Wire  Use of E-CONNECT adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, E-CONNECT and the other equipment should be observed to verify that they are operating normally.
  • Page 53 Statement 12.Statement Service Life The service life of E-CONNECT 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 54 Changzhou Sifary Medical Technology Co., Ltd. Add: NO.99 Qingyang Road, Xuejia County, Xinbei District Changzhou, 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@sifary.com All rights reserved.