E-LITE PRO ( Endo Motor)

• Japanese ultra-precision motor: low noise and small vibration.
• Rotational speed range:150-1000rpm, torque Range:0.6-4.0N.cm.
• Editable torque, speed and FWD/REV rotation angel (30-250°).
• Memory Programs: 10(M0-M9).
• Humanized and switchable mode of left and right-hand.
• 3.7V/1500mAh ultra-large battery

Perfectly combined with APEX-S, both length measuring and enlargement

Product Name: Endo Motor (Model: E-LITE PRO)

Basic UDI-DI(s) ：6942007308EMFT

EMDN Code：Z121101 – INSTRUMENTS FOR DENTAL TREATMENT UNITS

Intended Use:

The Endo Motor is a cordless, microprocessor-controlled endodontic motorised handpiece intended for the mechanical preparation and enlargement of root canals with rotary NiTi files, and for cutting and grinding in preparation for root canal surgery. The device drives the file mounted in the contra-angle at an adjustable rotary speed and torque, with software-controlled forward, reverse and reciprocating motion and automatic torque reversal when the preset torque limit is reached. The Endo Motor does not provide root-canal length measurement or apex location; the working length must be determined independently, for example by radiography or with a stand-alone apex locator.

Intended users and Environment of Use

The Endo Motor is to be used only in a clinical or hospital environment (qualified hospitals and dental clinics), following good dental practice, by qualified dental professionals such as general practitioners as well as Endo specialists (Endodontists) and Dental Assistants who have been trained in the use of the device. It must be operated by professional and qualified dentists and is not intended for use by laypersons or in a home environment.

Safety Information：

<Warnings>

• Only professional and qualified dentists and dental personnel trained in endodontic treatment are allowed to use this device. Please read the Instructions for Use carefully before first operation.

• Use the device only for dental service and endodontic treatment, in accordance with the intended use. Do not use it for implants or other non-endodontic procedures. Do not make any unauthorised change or modification to the device, as this may violate safety requirements and cause harm to the patient.

• Before Use: The device is not supplied sterile. The contra-angle (the only reusable patient-contacting applied part) must be cleaned, disinfected and steam-sterilised (134 °C / 5 min, fractionated pre-vacuum, EN ISO 17665) before each use; the motor handpiece, charge base/handle holder and AC adapter may only be wipe-disinfected and must never be autoclaved. Use only the original contra-angle, power adapter, charging wire and lithium battery approved by ROGIN.

• After use: Remove gross soiling with cold water (<40 °C) immediately after use and complete reprocessing within 15 minutes. Do not use a fixating detergent or hot water (>40 °C), as residues may become fixed and the instrument may be very difficult to clean. Clean the contra-angle of the file, as the internal parts may be damaged once contaminated.

• Do not directly or indirectly place the device near heat sources, and do not use or store it in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. The device is ordinary equipment (IPX0) and must be protected against liquid ingress. Prolonged use of the Reciprocating Motion Mode may cause the motor handpiece to overheat; allow it to cool before further use and contact the distributor if overheating recurs.

• Special precautions for electromagnetic compatibility (EMC) are necessary. Install and operate the device strictly in accordance with the EMC information (IEC 60601-1-2:2014+AMD1:2020); do not use it near active HF surgical equipment, the RF-shielded room of an MRI system, fluorescent lamps, radio transmitters, remote controls or portable/mobile RF communication equipment, and keep portable RF equipment at least 30 cm from any part of the device. Do not use the device while it is charging.

• Confirm that the NiTi file is correctly installed and locked before starting the motor, and set speed and torque in accordance with the file manufacturer’s recommended specifications. Do not use broken, bent or non-ISO-conforming files. Do not press the push cover of the contra-angle or remove the contra-angle before rotation has stopped, otherwise the contra-angle and the internal gear will be damaged.

• Monitor the real-time torque display bar during use (orange at 60 % of the preset torque, red with an acoustic signal at 80 %, continuous alarm and automatic reverse at 100 %). Do not change the default parameters of the built-in file systems unless you are certain of the change, as this carries a risk of file breakage. If any abnormality occurs (looseness, vibration, abnormal noise or heat, motor connection failure or device failure), stop using the device immediately and contact the local distributor or the manufacturer.

• Never open, service or repair the device yourself. Do not clean, service or perform any maintenance on any part of the equipment while a patient is connected; always disconnect the patient first. Only a trained technician or the distributor may replace the lithium battery, and only with the original ROGIN-approved part.

• Strictly follow this Instruction for Use and the General Processing Instructions For Endodontic Products to minimise the following risks to the device, the patient

and/or the user:

○ Separation (breakage) of the rotary NiTi file inside the root canal due to excessive torque, inappropriate speed, cyclic fatigue or the use of damaged or non-ISO-conforming files.

○ Cross-contamination due to inadequate cleaning, disinfection or sterilisation of the reusable contra-angle.

○ Over-instrumentation, under-instrumentation, ledging, transportation or perforation of the root canal when the working length is not determined independently.

○ Thermal injury or patient discomfort from an overheated motor handpiece or contra-angle during prolonged reciprocating operation.

○ Electric shock, fire or burns from a damaged cable, liquid ingress, battery malfunction or the use of an unapproved adapter or battery.

○ Electromagnetic interference causing unintended motor reversal, loss of torque control or device failure.

○ Toxic or allergic reactions caused by processing residues, allergic reactions in patients with known metal allergy, and device damage due to wear, cracks, brittleness or other material degradation of the contra-angle.

<Contraindications and prohibitions>

The Endo Motor is not recommended for use in patients with a cardiac pacemaker or other implanted electrical devices, or who have been cautioned by their physician against the use of small electrical appliances (e.g. shavers, hair dryers); the same restriction applies to the operating dentist. It is not recommended for patients allergic to metals or for children. Pregnant or breastfeeding women and patients with heart disease should be treated only under the guidance of a physician, weighing the benefits against the risks and avoiding unnecessary procedures.

The following uses are prohibited:

○ Use with non-original or unapproved contra-angles, adapters, charging wires, cables or lithium batteries; any unauthorised modification, opening or repair of the device; and use of the device while it is charging.

○ Use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide; in humid surroundings or in contact with liquids; near heat sources; and in the vicinity of active HF surgical equipment or magnetic resonance imaging systems.

○ Autoclaving or immersing the motor handpiece, charge base/handle holder or AC adapter; pressing the push cover of the contra-angle or removing the contra-angle before rotation has stopped; and any cleaning, servicing or maintenance while the device is connected to a patient.

<Adverse Reactions>

No device-specific adverse reactions or undesirable side effects have been identified for the Endo Motor. Any serious incident occurring in relation to the device should be reported to the manufacturer and to the competent authority of the Member State in which the user and/or patient is established.

Direction for Use

1. Charge the battery for more than 4 hours before first use with the original adapter / charging wire (input AC 100-240 V, 50/60 Hz, 0.4 A; output 5 V / 1 A). Connect the charging wire USB plug to the rear socket of the charge base, leaving approximately 10 cm clearance around the base; the green charging indicator extinguishes when charging is complete (approximately 4 hours). Do not use the device while charging.

2. When the power indicator turns red, stop using the device and recharge it. Remove the battery if the handpiece will not be used for an extended period; only a trained technician or the distributor may replace the lithium battery, using the original ROGIN-approved part. Dispose of waste batteries in accordance with local regulations.

3. Before each patient, clean, disinfect and steam-sterilise the contra-angle (134 °C / 5 min) and wipe-disinfect the motor handpiece, charge base/handle holder and AC adapter. Verify that all parts are dry, undamaged and legibly marked. Never autoclave or immerse the motor handpiece.

4. Assemble the device: align the locating points of the contra-angle and the main unit so that they connect smoothly. Before using the instrument, clean all parts that may come into contact with the patient.

5. Switch on by pressing the main button for more than 0.5 seconds; the device shuts down automatically after 8 minutes without operation. To switch off, hold the ‘S’ button and then press the main button. Adjust volume, handedness (left/right), display theme and brightness in the user setting menu if required.

6. Select a memory mode (M0-M9) with the ‘<‘ / ‘>’ buttons in standby mode, or enter the built-in file menu by long-pressing ‘S’ and select the file brand, series and model. Do not change the default parameters of a built-in file system unless you are certain, as this carries a risk of file breakage.

7. Set the speed in the speed setting menu (short-press ‘S’ in the FWD/REV running state, then use ‘<‘ / ‘>’): 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700 or 800 rpm. Always follow the file manufacturer’s recommended specifications.

8. Set the torque in the torque setting menu: 0.6, 0.8, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5 or 3.9 N·cm at speeds below 700 rpm; 0.6, 0.8, 1.0, 1.5, 2.0 or 2.5 N·cm at 700 rpm and above. The device returns to standby after 30 seconds of inactivity in any setting menu.

9. Select the operating mode: FWD (forward / clockwise), REV (reverse / counter-clockwise, indicated by a slow beep) or REC (reciprocating). In REC mode set the forward angle (30°-370°) and reverse angle (90°-370°); the speed is fixed at 300 rpm in reciprocating mode.

10. Confirm that the NiTi file is correctly installed and locked in the contra-angle chuck; do not use broken, bent or non-ISO-conforming files. Isolate the tooth with a rubber dam and wear gloves.

11. Determine the root-canal working length independently by radiography and/or with a stand-alone apex locator and set the silicone stop on the file accordingly. The Endo Motor has no length-measuring or apex-location function and must not be used as a substitute for working-length determination.

12. Start the motor with the main button and advance the file slowly into the canal. Observe the real-time torque display bar: orange at 60 % of the set torque, red with an acoustic signal at 80 %, and a continuous alarm with automatic reverse motion at 100 % to disengage and withdraw the file from the canal.

13. If an error warning appears (load greater than the motor force, very low battery, motor connection failure), or if the handpiece shows looseness, vibration, abnormal noise or overheating, stop immediately, press the main switch to restart only after the cause has been resolved, and consult the Troubleshooting section or contact the distributor. Never open, modify or repair the device yourself.

14. After treatment, switch the device off, disconnect the patient and the contra-angle, and reprocess immediately: remove gross soiling with cold water (<40 °C), pre-clean manually, then use an automated washer-disinfector (ISO 15883 series; 5 min thermal disinfection at ≥93 °C, A0 >3000), dry, inspect, pack (ISO 11607) and steam-sterilise the contra-angle (134 °C / 5 min, EN ISO 17665). Discard any component showing deformation, cracks, brittleness or illegible markings; store sterilised parts in a dry, clean, dust-free environment. Dispose of the lithium battery and electrical/electronic components in accordance with WEEE 2012/19/EU and local regulations.

Manufacturer Information

• Manufacturer Name: Shenzhen Rogin Medical Co., Ltd
• Manufacturer Address: Room 3109, Block 6, Tian’an Cloud Park, Bantian street, Longgang District, Shenzhen, 518129 Guangdong P.R. China
• Factory Address: Room 101, 201, 301B, 401,701&801, Block 5, Renluo 6 Road No. 6, Shuikou Street, Huicheng District, Huizhou, 516000 Guangdong, P.R. China
• Single Registration Number (SRN) of Manufacturer: CN-MF-000012192

Notified Body Information

• Notified Body Name: TÜV Rheinland LGA Products GmbH
• Address: Tillystraße 2, 90431, Nürnberg, Germany
• Notified Body Number: 0197

Authorised representative (AR) Information

• Authorised representative Name: MedNet EC-REP GmbH
• AR’s Address: Borkstraße 10, 48163 Münster, Germany
• Single Registration Number (SRN) of AR: DE-AR-000000002

This device is supplied with paper instructions for use. Please carefully read the instructions before use.