COXO C-Smart Nova Endo Motor User Manual

1. Safety

Warning:

Please read the safety warnings carefully before using this device. These security warnings will indicate you to use this device better.

1. The equipment must be used within the scope mentioned in the manual; do not operate or use the equipment for other purposes.
2. When using an external power supply, please ensure that the voltage is within the voltage range indicated by the power adapter, otherwise it may cause harm to the operator or the patient.
3. The use of non-original accessories, especially other contra angles or power adapters, may be dangerous to the patient or operator, causing damage to the instrument.
4. To avoid electric shock, do not insert other objects into the machine. This may cause electric shock or equipment damage.
5. Avoid cleaning agents from entering the instrument to prevent short circuits and failures.
6. If the instrument is seriously abnormal due to improper use or physical damage, the equipment should be stopped and shut down immediately. If repair is required, please contact the manufacturer or local distributor. Only the manufacturer and distributor can open the device.
7. Please use the ISO 3630 standard and intact root canal expansion files; otherwise, it may cause the root canal expansion file to break during operation and cause injury accidents.
8. The device has electromagnetic interference; do not use it in patients with cardiac devices or near electronic surgery.
9. Unstable voltage and electromagnetic fields will interfere with the normal operation of the equipment.
10. For the discarding of batteries and other accessories, please comply with local regulations.
11. Incorrect replacement of lithium batteries causes unacceptable risks, and untrained personnel cause hazards (such as overtemperature, fire, or explosion). Users should not replace the battery without authorization.

2. Symbols

Serial number format: SN YMXX - XXXX. The coding order is 0001, 0002, etc. 'lot number', 'X' represents batches, 'M' represents months, and 'Y' represents years.

3. Intended Use

For use in root canal treatment, the root canal preparation stage is formed and cleaned. It can only be used by professional dentists in hospitals or dental clinics.

4. Indication

Application disease: Pulpitis, Periapical inflammation.

5. Contraindications

• If the patient has a pacemaker (or other electronic device) and has been warned against small appliances (such as electric razor, hair dryer, etc.).
• This equipment shall not be used for the preparation of severely bent root canals.
• Use with caution in patients with heart disease, pregnant women, and children.

6. List of Accessories

7. Usage

7.1 Connecting and Disconnecting Contra Angle

Describe the process: Clean, disinfect, and sterilize all components that may come into contact with patients before use. Align the contra angle with the handle and install it directly. Ensure it is correctly inserted; a "click" sound indicates it is in place. The contra angle can be rotated 360° and inserted directly.

7.2 Operating

The device features a control panel with several components:

• Main switch: Powers the device on/off.
• Program switch: Selects between different programs.
• Display (Area B): Shows current settings like speed and torque.
• Adjust switch (Area A): Used to adjust parameters.

The display shows:

• Program (A): Indicates the selected program (P1-P5).
• Speed (B): Displays rotational speed in r/min.
• Torque (C): Displays torque in N.cm.
• Battery Power (D): Shows the remaining battery charge.
• Direction (E): Indicates the rotation direction or mode (e.g., continuous rotation, reciprocating).

7.3 Program Schema

• P1-P3: Continuous Rotation Mode: The file rotates forward at the set speed and automatically reverses when the torque exceeds the set value. The icon E is displayed. Adjustable parameters: rotational speed, rotational torque.
• P4: Reciprocating Mode: The file rotates clockwise, then counterclockwise, continuously. The icon E is displayed. Adjustable parameters: rotation speed, rotation angle.
• P5: Reciprocating Mode (OGP): Features a specific reciprocating cycle (e.g., 240° forward, 240° reverse). The icon OGP is displayed. Adjustable parameters: Rotation speed (200-500 r/min).

7.4 Select Rotation Direction

Press the adjustment button A to switch the rotation direction (forward/reverse). A buzzer will sound once every second when the file is reversed.

7.5 Pre-operation Check

Ensure the equipment is not abnormal before use. Run the instrument outside the oral cavity to confirm normal operation.

7.6 Start / Stop

Press the start/stop button ▶️ for rotation, and press again to stop rotation ⏹️.

7.7 Motor Calibration

Long press the buttons P and A simultaneously to start calibration. The screen will display calibration status, showing "OK" upon successful calibration, accompanied by a buzzer prompt.

Caution:

• Make sure the machine is inserted without resistance.
• The equipment cannot be calibrated while in the working state.

7.8 Battery Capacity

Battery power level is displayed in the battery power area D.

Caution:

• Users should not replace the battery without authorization.
• When the battery power is too low, a low voltage alarm is prompted. The battery frame flashes red. The alarm lasts for 5 seconds, and the device automatically shuts down. During operation, an alarm for 20 seconds leads to automatic shutdown.

7.9 Charging

Connect the power adapter output line to the charging interface of the host and plug the adapter into the power supply. The screen dynamically displays the charging status. After charging, the system automatically stops, and the battery icon indicates full power.

Charging states are indicated visually on the screen.

The equipment must be continuously charged for at least 2.5 hours to prevent power loss. The host should often be kept in the charging state.

Caution:

• Using a non-original charger may damage the device.
• Excessive charging time may damage the battery.
• If the user loses the charger, they should purchase a charger of the same specification and comply with IEC 60601-1 standard.

8. Lubrication

1. Remove the contra-angle from the handpiece.
2. Mount the tip nozzle into the spray can port and align it with the contra-angle. Spray lubricating oil into the contra-angle until clean liquid flows out.

Caution:

• When the head overflows with clean liquid, the entire cleaning and maintenance steps should be repeated.
• It is recommended to inject lubricating oil before sterilization.

9. Cleaning, Disinfection and Sterilization

This section details the procedures for the contra-angle and motor handpiece. Note that only the contra-angle can be cleaned, disinfected, and sterilized using automated methods. The motor handpiece and AC adapter require general wipe decontamination.

Automated Cleaning

Use a washer-disinfector meeting ISO 15883 standards. Place the instrument on a tray, connect it with a suitable adapter, and start the program: 4 min pre-washing (<40°C), 5 min washing (55°C), 3 min neutralizing (>40°C), 5 min intermediate rinsing (>40°C). Emptying steps are included between stages. The process has been validated with 0.5% neodisher MediClean forte.

Automated Disinfection

Use a washer/disinfector with a disinfection cycle of 5 min at 93°C, validated for an A0 value of 3000, considering national requirements.

Automated Drying

Drying of the instrument's exterior is done by the washer/disinfector's drying cycle. Manual drying with a lint-free towel and insufflation of cavities with sterile compressed air can be performed if needed.

Functional Testing, Maintenance

Visually inspect instruments for cleanliness and reassemble. Perform functional testing as per instructions. Discard defective accessories immediately. Plastic deformation and corrosion are signs of defects. Maintenance is not required, and instrument oil must not be used.

Packaging

Pack instruments in appropriate packaging material for sterilization, following EN ISO 11607 standards.

Sterilization

Sterilize instruments using a fractionated pre-vacuum steam sterilization process (EN 285 / EN 13060 / EN ISO 17665). Minimum requirements: 3 min at 134°C (EU) or 5 min at 134°C. Maximum temperature: 137°C.

Storage

Store sterilized instruments in a dry, clean, dust-free environment at moderate temperatures, following label and instructions for use.

Pre-Cleaning (Manual for Contra-angle)

Perform manual pre-cleaning until instruments are visually clean. Submerge instruments in a cleaning solution and flush lumens with a water jet pistol using cold tap water for at least 10 seconds. Clean surfaces with a soft bristol brush.

Automated reprocessing methods are preferred due to better standardization and industrial safety.

Reprocessing validation study information

The described reprocessing process (cleaning, disinfection, sterilization) has been successfully validated.

Additional Instructions

It is the user's responsibility to ensure that reprocessing processes, including resources, materials, and personnel, are capable of achieving the required results. State of the art and national laws often require these processes to be validated and maintained properly.

10. Operating, Transport and Storage Environment

This equipment should be carefully placed away from heat sources.

• Do not mix with toxic, corrosive, flammable, and explosive items during storage.
• Excessive impact and vibration should be prevented during transportation, and the equipment should be handled carefully.

11. Technical Specifications

12. Troubleshooting

If the equipment is not working properly, check the following table before contacting the sales service center.

This product can be maintained on-site by professional operators or nursing staff (e.g., replacing the contra angle). If damage is found, please contact the company's after-sales service department for maintenance.

13. Disposal of Medical Instruments

In accordance with the principles, standards, and requirements of the country/region, dispose of old electrical equipment. Ensure that pollution is not produced during waste disposal.

14. Guarantee

1. This equipment does not contain self-repair spare parts. Machine maintenance should be performed by manufacturer-certified professional personnel.
2. The host warranty is 24 months from the date of purchase, and accessories have a 6-month warranty. Damaged or used-up parts can be purchased from the company.
3. The guarantee is valid for normal usage conditions. Any modification or accidental damage will render the guarantee void.

15. EMC

This product requires special precautions regarding EMC and must be installed and put into service according to the provided EMC information. The instrument may be affected by portable and mobile RF communications equipment.

Caution:

• Do not use mobile phones or other devices that emit electromagnetic fields near the instrument, as this may result in incorrect operation.
• This instrument has been thoroughly tested and inspected to assure proper performance and operation.
• This instrument should not be used adjacent to or stacked with other instruments. If adjacent or stacked use is necessary, observe the instrument to verify normal operation in the configuration in which it will be used.

Serial number: [Adapter output line], Name: Adapter output line, Cable Length (m): 1.2, Whether to shield: No, Remarks:

Guidance and manufacture's declaration - electromagnetic emission

The C-Smart model is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

Guidance & Declaration - Electromagnetic Immunity

The C-Smart model is intended for use in the electromagnetic environment specified below. The customer or user should ensure it is used in such an environment.

Conducted RF

IEC 61000-4-6: 3 Vrms (150 kHz to 80 MHz), 6 Vrms in ISM and amateur radio bands.

Radiated RF

IEC 61000-4-3: 10 V/m (80 MHz to 2.7 GHz).

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communication equipment (Refer to table 9 of IEC 60601-1-2:2014+A1:2020):

Portable and mobile RF communications equipment should be used no closer to any part of the model C-Smart, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

• d=[3.5/√P]×√P (for frequencies not specified)
• d=1.2 × √P (80 MHz to 800 MHz)
• d=2.3 × √P (800 MHz to 2.7 GHz)

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer, and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: ⚡.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

a. Field strengths from fixed transmitters... (See original text for full details on fixed transmitters and site surveys).

b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile RF communications equipment and the model C-Smart

The model C-Smart is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model C-Smart, as recommended below, according to the maximum output power of the communications equipment.

For transmitters rated at a maximum output power not listed above, the recommended separation distance 'd' in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where 'P' is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.