E-LITE MAX (Wireless Endo Motor with Apex Locator Built One)

ENDO MOTOR is a portable endodontic device that provides a low speed source of action up to 1000 RPM. It is generally used to complete root canal preparation with a rotary file.

ROGIN E-LITE MAX：

• Endo motor and root tip positioner, 1 machine 2 functions
• Users can preset a variety of file programs
• For Angels：16：1
• Super precision motor from Germany,low noise and small vibration.
• Large color OLED screen, visible from all angles
• Three working modes: reciprocating motion, continuous motion, automatic reversal
• Mini slow-motion contra-angle handpiece
• Built-in high-capacity rechargeable lithium battery, fully charged can work continuously for more than 2 hours.

Product Name: Endo Motor and Apex locator Unit (Models: E-LITE MAX / ELITE-INO)

Basic UDI-DI(s) ：6942007308EAF3

EMDN Code：Z121101 – INSTRUMENTS FOR DENTAL TREATMENT UNITS; Z121190 – VARIOUS DENTAL STOMATOLOGY INSTRUMENTS

Intended Use:

The Endo Motor and Apex locator Unit is a cordless, microprocessor-controlled endodontic handpiece with integrated root-canal length measurement, intended for the mechanical preparation and enlargement of root canals with rotary NiTi files and for the electronic determination of root-canal working length. During canal enlargement the device monitors the real-time position of the file tip and can automatically decelerate, reverse or stop the motor in the apical zone. Length measurement is based on the ratio of electrical impedance at two sine-wave frequencies (8 kHz and 400 Hz), approaching the characteristic resistance of the oral mucosa and periodontal membrane (approximately 6.5 kΩ) at the apical constriction. The on-screen scale indicates a trend towards the apex and does not represent an absolute distance in mm; the device is intended to support, not replace, radiographic examination.

Intended users and Environment of Use

The Endo Motor and Apex locator Unit is to be used only in a clinical or hospital environment (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 qualified dentists and is not intended for use by laypersons or in a home environment.

Safety Information：

<Warnings>

• Only qualified dentists and dental professionals trained and competent in endodontic treatment are allowed to use this device. Read the Instructions for Use carefully before first operation.

• Do not use this product except for dental service and endodontic treatment. Use it in accordance with the intended use; do not use it for implants or other non-endodontic procedures, and do not make any unauthorised change or modification to the device.

• Before Use: The device is not supplied sterile. The patient-contacting applied parts (contra-angle, lip hook, file clip and touch probe) must be cleaned, disinfected and steam-sterilised (134 °C / 5 min, fractionated pre-vacuum, EN ISO 17665) before each use; the motor handpiece, charging base and AC adapter may only be wipe-disinfected and must never be autoclaved. Use only original accessories and the contra-angle, adapter and 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 instruments may be very difficult to clean. Clean the contra-angle of the file and set it aside, 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. Extended use of the Reciprocating Motion Mode may cause the motor handpiece to overheat; allow it to cool before further use.

• 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.

• Before starting the motor, confirm that the file is correctly installed and locked and set speed and torque in accordance with the file manufacturer’s recommended specifications. Do not press the push cover of the contra-angle or remove the contra-angle before rotation has stopped; do not use broken, bent or non-ISO-conforming files.

• If any abnormality occurs (looseness, vibration, abnormal noise or heat, erratic readings, damaged cables, battery malfunction or device failure), stop using the device immediately and contact the local distributor or the manufacturer. Never open, service or repair the device yourself, and never clean, service or maintain any part of the equipment while a patient is connected.

• The on-screen scale indicates only the progression of the file towards the apex, not a distinct length or distance in mm. As a safety precaution against over-instrumentation, subtract 0.5-1.0 mm from the position indicated as ‘0.0’ when determining the working length for shaping, and always confirm the working length radiographically.

• 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:

○ Inaccurate working-length determination, leading to over-instrumentation or under-instrumentation of the root canal.

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

○ Breakage of the rotary NiTi file or of the contra-angle, and aspiration or swallowing of small detached parts.

○ Electric shock, fire or thermal injury from a damaged cable, liquid ingress, battery malfunction, an unapproved adapter/battery or an overheated motor handpiece.

○ Electromagnetic interference causing erratic readings, loss of essential performance, unintended motor reversal or device failure.

○ Toxic or allergic reactions caused by processing residues, and allergic reactions in patients with known metal allergy.

○ Device damage or measurement failure due to wear, cracks, brittleness or other material degradation of reusable components.

<Contraindications and prohibitions>

The device is not recommended for use in patients with a cardiac pacemaker or other implanted electrical devices,

Safety and effectiveness have not been established in pregnant women and children; pregnant or breastfeeding women 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 for implants or any non-endodontic dental procedure; use in humid surroundings, in contact with liquids, near heat sources, or in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide.

○ Use while the device is charging, with non-original accessories or cables, or after any unauthorised opening, modification or repair of the device.

○ Measurement in canals with an enlarged apical foramen, active bleeding or blood overflow beyond the apical foramen, a damaged crown, cracked roots, gutta-percha-filled canals, or a conductive fluid path between the inside and outside of the canal (e.g. metal crowns or bridges causing a short circuit).

<Adverse Reactions>

No device-specific adverse reactions or undesirable side effects have been identified for the Endo Motor and Apex locator Unit . 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 (input AC 100-240 V, 50/60 Hz, 0.4 A; output 5 V / 1 A). Connect the adapter plug to the rear socket of the charging 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 or flashes, 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 reusable applied parts (contra-angle, lip hook, file clip, touch probe) and wipe-disinfect the motor handpiece, charging base and AC adapter. Verify that all parts are dry, undamaged and legibly marked. Never autoclave the motor handpiece.

4. Assemble the device: align the locating points of the contra-angle and the main unit and connect them smoothly, then connect the measuring wire, the file clip (or touch probe) and the lip hook. Use the single-head measuring wire for the combined enlargement-with-apex-locator function.

5. Perform the apex-locator calibration/function check: with the accessories correctly connected, touch the file clip to the lip hook; a red screen displaying ‘-0.1’ confirms correct function. Run the automatic calibration after each change of contra-angle.

6. Switch on the main unit (press ON/OFF for more than 2 seconds; the unit shuts down automatically after 3 minutes of inactivity). The display recalls the last-used file system or parameters; press the ‘S’ key for more than 2 seconds to enter the main interface.

7. Select the working mode: forward rotation, reverse rotation, reciprocating motion (adjustable angles 30°-370°) or automatic torque control, then select a user-defined ‘Program’ (up to 9 programs) or a built-in ‘File System’.

8. Set speed and torque in accordance with the file manufacturer’s recommended specifications (speed 120-1000 rpm / 150-800 rpm; torque 0.6-4.0 N·cm / 0.6-3.9 N·cm). Confirm that the NiTi file is correctly installed and locked in the chuck before starting the motor.

9. Activate the apex function by setting the ‘Apex’ symbol to blue (grey = enlargement only; blue = combined enlargement with apex location) and set the auto-reverse position in the apical zone. In the combined mode the motor decelerates automatically near the apex, the buzzer sounds more rapidly, and the motor reverses at the preset position.

10. Isolate the tooth with a rubber dam, wear gloves, and dry the access cavity with a cotton pellet / air blower. Remove liquid, residual pulp tissue and old filling material; moisten very dry canals with saline and dry the access cavity again. Ensure that the file and file clip do not contact the gingiva, metal crowns/bridges, amalgam or other metal.

11. Hang the lip hook on the patient’s lip so that it contacts the oral mucosa as the reference electrode (moisten the mucosa if dry) and attach the file clip to the metal shaft of the file. Advance the file slowly towards the apex while observing the OLED/TFT display and the acoustic signal.

12. When the screen indicates ‘0.0’ (the major apical foramen), stop advancement and set the silicone stop at the coronal reference point; subtract 0.5-1.0 mm from the indicated position to determine the working length for shaping, in order to avoid over-instrumentation. Note that the on-screen scale is a trend indicator only and does not represent a distance in mm.

13. Confirm the working length with pre- and post-operative radiographs. If readings are unstable or inaccurate, check for blocked, cracked, perforated or extremely dry canals, excess fluid, dry oral mucosa, poor file-clip or measuring-wire connections, a double-head measuring wire, metal restorations and nearby sources of electromagnetic interference; correct the cause before continuing.

14. After treatment, switch the device off, disconnect the patient and the accessories, 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 (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&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.