SyAct Endo Bi-ME System Instruction Manual

SyAct Endo Bi-ME System Instruction Manual

Introduction

Foreword
SyAct International LLC is a Hi-tech enterprise in researching and developing dental equipment with its primary focus in the field of Endodontics.
Introduction
This system is meant for the disinfection of minimally prepared root canals and the preparation of the root canal space for 3-dimensional obturation.
Features:
a) Cordless portable endo handpiece with proprietary light conducting tips and solutions to enhance root canal treatment.
b) The built-in high-capacity battery in the base is equipped with a wireless charging system to ensure long enough battery life.

Product configuration

The Endo Bi-Me handpiece (Fig 1.1) along with its charging base and USB C charging cable

Components (Sold Separately) (Fig 1.2)

consisting of 4 color-coded solutions containers (Yellow, Red, Green, and Black). A light-conducting polymer S-shaped tip, a tapered polymer light- conducting straight tip, a 30 gauge notched endodontic irrigation needle (red), and a 30 gauge side vented endodontic irrigation needle (green).
Indications for use
The Endo Bi-ME handpiece (Fig 1.1) is a cordless handpiece that forms a part of an endodontic disinfection system. It is used in conjunction with SyAct Solutions and tips to disinfect the canal before the final obturation of the root canal system.
Scope of application
The device must be operated in hospitals and clinics by a qualified Doctor or staff.
Caution: Federal law restricts this device to sale by or on the order of a doctor

Contraindications:
In cases where a patient has been fitted with an implanted heart pacemaker (or other electrical equipment) and has been cautioned against the use of small electrical appliances (such as electric shavers, hair dryers, etc) it is recommended not to use this device.
Device safety classification
Type of operation mode:

1. Mode 1 : Dis-Sol 1 with the S-shaped tip and yellow-coded solution.
   The tip is placed in the handpiece with the yellow-coded solution within the canal, where the tip is activated. (ON: 30 secs then auto off).

2. Mode 2 : Dis-Sol 2 with the S-shaped tip and red-coded
   solution. The tip is placed in the handpiece with the redcoded solution within the canal, where the tip is activated.
   (ON : 1 minute then auto off.

3. Mode 3: Bio-Sol 1 with the Tapered tip and green-coded solution. The tip is placed in the handpiece with the greencoded solution within the canal, where the tip is activated.
   (ON : 1 minute then auto off).

4. Mode 4 : Bio-Sol 2 with the Tapered tip and black-coded solution. The tip is placed in the handpiece with the blackcoded solution within the canal, where the tip is activated.
   (ON: 30 secs then auto off, motion of the tip only). (5) Mode 5: Testing red light (only light emission and 2 red spots should be noted).

5. Mode 6 : Testing green light (only light emission and 2 green spots should be noted).

Type of protection against electric shock: Class II equipment with internal power supply.
Degree of protection against electric shock: B-type applied part.
Degree of protection against harmful ingress of water: Ordinary equipment (IPX0)

Degree of safety application in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide: Equipment cannot be used in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
The contact duration of the applied part: Max 1 minute/Cycle
The temperature of the surface of the applied part may reach 45℃.
Primary technical specifications
Battery:
Lithium battery in motor handpiece: 3.7V/800mAh
Power adapter : nil
Torque rang : 10N.cm max.
Speed rang: 130rpm +/- 15rpm (reciprocation motion)
The contra-angle uses precision gear transmission inside, and the gear ratio is 100 :1 (Model: N20-12-Ø2-37.5)
First release of software : V1
Working environment
Environment temperature : +5℃~+35℃
Relative humidity : 30%~75%
Atmosphere pressure: 80kPa~106kPa
Warnings
The device must only be used in suitable locations and only by specialized Doctors licensed or staff to practice dentistry.
Use the specified battery for this device. Never use any other batteries.
Do not expose the device to direct or indirect sources of heat. Operate and store the device in a safe environment.
The device requires special precautions as regards electromagnet 5 compatibility (EMC) and must be installed and commissioned in strict conformity with the EMC information provided in this instruction manual. Specifically, do not use the device close to fluorescent lamps, radio transmitters, and remote controls.
Long continuous-time use of the device will lead to overheating of the micromotor. If this occurs let it cold down before use. If the motor handpiece overheats persists, contact your distributor.
The USB Type-C port of the base must only be connected to the USB Type-C port wire. Never use it for other purposes.
Over-heat scorching: the handpiece cannot be used for 10 minutes continuously.
Never remove the tip from the motor handpiece during operation.
Only use new disposable tips provided by SyAct International for each case.
Only insert the polymer tips when the motor is off.
Never place your fingers on the moving parts of the polymer tips while it is running or coming to a stop.
Before treatment, check the testing mode for red and green lights for sufficient light power.
Replacement of lithium-ion batteries is not feasible by the operator. If there are any issues, please contact SyAct International.
There are no power adapters provided please use any 5amp 2V adapter with a USB A output to charge the device.
Please charge the device before use

Operation buttons and screen indicators

The Endo Bi-ME handpiece is powered on with the power button (Fig 2.1) ,

and then the mode is selected between Disinfection Mode Dis-Sol 1, Disinfection Mode Dis-Sol 2, Bioactive Solution Mode Bio-Sol 1, Bioactive Solution Mode Bio-Sol 2, and Green or Red light only. The mode selected is denoted on the LCD screen and the presence of a colored light, red or green, is shown at the window on the base of the handpiece. The red light indicates the Dis Sol 1 Mode or DisSol 2 Mode has been selected. The green light indicates the Bio-Sol 1 Mode has been selected. The white light indicates the Bio-Sol 2 Mode has been selected.
According to the selected mode, a tip needs to be attached to the handpiece. The S-shaped tip will be used with Disinfection Mode Dis-Sol 1 and Disinfection Mode Dis-Sol 2. The Tapered tip will be used with Bioactive Solution Mode Bio-Sol 1 and Bioactive Solution Mode Bio-Sol 2.
The Endo Bi-ME handpiece has the following operation buttons and screen indicators:

1. The Power On button activates the handpiece. (Fig 2.1).
2. The Mode Selection Button allows you to choose between Dis-Sol 1, Dis-Sol 2, Bio-Sol 1, Bio-Sol 2, and green or red light only.
3. The LCD screen indicates the mode selected above.
4. The color indicator button shows the color at the tip : The red color for Dis-Sol 1 and Dis-Sol 2 Mode. The green color for Bio-Sol 1. The white color light for BioSol 2 Mode (means no light is emitted at the tip).
5. The Red and Green mode is used for testing purposes to make sure that both LEDs are functioning to maintain the light intensity required for optimal function

 Detailed Modes of operation

Once the canal has been prepared and flushed with saline as the final rinse, then the canal is dried with paper points. The S-shaped tip is placed into the handpiece (Fig 3.1)

Press the power button to start the handpiece. The screen will show the current mode of use (Fig 3.2a).

This means that the current mode of selection is Dis-Sol 1.
The Dis-Sol 1 container (Fig 3.2b )

with the yellow color connector is selected and the cap is removed. A 30 gauge side venting Endodontic irrigation red needle (Fig 3.2c )

is inserted and locked onto the container (Fig 3.2d )

with the luer lock connection.
It is recommended that a rubber stop be used to ascertain the necessary working length is achieved during use. The tip of the needle is pre-curved according to the operators’ preference and the needle is inserted into the root canal up to 4mm of the working length. The vial is lightly pressed to allow the solution to be expressed into the canals up to the pulp chamber. The tip rotates clockwise for 3 seconds and counterclockwise for 3 seconds with the red light conducted through the tip to activate the solutions. This mode runs for a 30-second cycle, and it is auto-deactivated indicating the end of the cycle.
The excess fluid is then aspirated with an endodontic irrigation syringe and needle or with paper points. Then the same 30-gauge irrigation needle (Fig 3.3a)

is inserted into the second solution Dis-Sol 2 (Fig 3.3b )

with the red connector similarly placed into the canal as the previous solution (Fig 3.3c)

The tip of the needle is pre-curved according to the operators’ preference and the needle is placed into the root canal up to 4mm of the working length of the canal. The vial is lightly pressed to allow the solution to be expressed into the canals up to the pulp chamber. The S-shaped tip ( Fig 3.1) is placed into the canal gently to the working length as determined by the operator. The mode of the handpiece is then changed to the Dis-Sol 2 (Fig 3.3d )

mode and the tip is activated by pressing the power button. The tip is activated clockwise for 3 seconds and counterclockwise for 3 seconds with the red light conducted through the tip to activate the solution. This mode runs for a 60-second cycle, and it is auto deactivated indicating the end of the cycle.
Once the first two cycles are completed the canal is flushed with saline or distilled water and the canal is dried with paper points.
The S-shaped tip on the handpiece (Fig 3.1 ) is removed with the tip remover provided with the equipment and then changed to the Tapered tip (Fig 3.4)

The Bio-Sol 1 container (Fig 3.4a )

with the green color connector is selected and the cap is removed. A 30-gauge notched Endodontic irrigation green needle ( Fig 3.4b )

is placed and locked onto the container (Fig 3.4c )

with the luer lock connection. The mode on the handpiece is then changed to the Bio-Sol 1 mode ( Fig 3.4d).

The tip of the needle is pre-curved according to the operators’ preference and the needle is placed up to the working length of the root canal. The solution is expressed into the canals up to the pulp chamber. The Tapered tip is placed into the canal up to the working length as determined by the operator. The mode of the handpiece is then changed to the Bio-Sol 1 mode (Fig 3.4d) and the tip is activated by pressing the power button. The tip rotates clockwise for 3 seconds and counterclockwise for 3 seconds with the green light conducted through the tip to activate the solution. This mode runs for a 60-second cycle, and it is auto-deactivated indicating the end of the cycle. If resin-based sealers are used, then the canal is dried with paper points and the canal obturated. If Bioceramic sealers are used then the Bio- Sol 2 solution is used.
The Bio-Sol 2 container (Fig 3.5a )

with the black color connector is selected and the cap is removed. A 30 gauge notched Endodontic irrigation green needle (Fig 3.5b)

is rotated, locked, and placed onto the container ( Fig 3.5c )

with the luer lock connection. The mode on the handpiece is then changed to the Bio-Sol 2 mode (Fig 3.5d).
The tip of the needle is pre-curved according to the operators’ preference and the needle is placed up to the working length of the root canal. The solution is expressed into the canals up to the pulp chamber. The Tapered tip ( Fig 3.4) is placed into the canal up to the working length as determined by the operator. The mode of the handpiece is then changed to the Bio-Sol 2 mode (Fig 3.5d)

and the tip is activated by pressing the power button. The tip moves clockwise for 3 seconds and counterclockwise for 3 seconds with no light conducted through the tip to activate the solution. This mode runs for a 30-second cycle, and it is auto-deactivated indicating the end of the cycle.
Once completed, then the canal is aspirated dry with an endodontic irrigation needle or dry with paper points, and the canal is obturated with bioceramic sealers according to the manufacturer’s instructions.
There are 2 more mode s (Fig 3.6 & 3.7)


in the handpiece for selection which indicates that the lights are functioning properly.

Troubleshooting

USB cable

Reprocessing process

Foreword
For hygiene and sanitary safety purposes, the Handpiece must be cleaned and disinfected. This concerns the first use, as well as all subsequent uses.
General recommendations
Use only a disinfecting solution that is approved for its efficacy (VAH/DGHM- listing, CE marking, FDA and Health Canada approval) and by the DFU of the disinfecting solution manufacturer.
Do not place/submerge the contra-angle in a disinfectant solution or an ultrasonic bath. Do not use chlorine detergent materials.
Do not use bleach or chloride disinfectant materials.
For your safety, please wear personal protective equipment (gloves, glasses, mask).
The user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments where applicable after sterility.
All accessories are single-use and should be discarded after each use.

Cleaning and disinfection steps for the motor handpiece and the base.
Before and after each use, all the objects that were in contact with infectious agents should be cleaned using towels impregnated with a disinfecting and detergent solution (a bactericidal, fungicidal, and aldehyde- free solution) approved by VAH/DGHM-listing, CE marking, FDA and Health Canada. Warning: Do not sterilize the motor handpiece, the AC adapter, and the base.
Pre-Op processing
Before each use, the handpiece, charger, and base must be cleaned and disinfected. The specific steps are as follows: Warning: The handpiece, charger, and base cannot be cleaned and disinfected with automatic equipment. Manual cleaning and disinfection is required.

Manual cleaning steps:

1. Take out the handpiece, charger, and base on the workbench.
2. Wet the soft cloth completely with distilled water or deionized water, and then wipe all the surfaces of the components such as the handpiece, charger, base, etc. until the surface of the component is not stained.
3. Wipe the surface of the component with a dry soft nap-free cloth.
4. Repeat the above steps at least 3 times

Note:
a) Use distilled water or deionized water for cleaning at room temperature.

Manual disinfection steps :

1. Soak the dry soft cloth with 75% alcohol.
2. Wipe all surfaces of the handpiece, charger, base, and other components with a wet soft cloth for at least 3 minutes.
3. Wipe the surface of the component with a dry soft nap-free cloth.

Note:
a) The cleaning and disinfection must be performed within 10 minutes before use.
b) The disinfectant used must be used immediately, no foaming is allowed.
c) In addition to 75% alcohol, you can use non-residue disinfectants such as Oxytech from Germany, but you must respect the concentration, temperature, and time specified by the disinfectant manufacturer
Post-Op processing
After each use, clean and disinfect the handpiece, charger, and base within 30 minutes. The specific steps are as follows:
Tools: Nap-free soft cloth, tray

Storage, maintenance, and transportation

Storage
This equipment should be stored in a room where the relative humidity is 10% ~ 85%, atmospheric pressure is 70kPa to106kPa, and the temperature is 5°C ~ +50°C.
Avoid storage in a too-hot condition. High temperatures will shorten the life of electronic components, damage the battery, and reshape or melt some plastic.
Avoid storage in a too-cold condition. Otherwise, when the temperature of the equipment increases to a normal level, there will be dew that will possibly damage the PCB board.
Maintenance
This device does not include accessories for repair usage, the repair should be carried out by an authorized person or authorized after-service center.
Keep the equipment in a dry storage condition.
Do not throw, beat, or shock the equipment.
Do not smear the equipment with pigments.
Transportation
Excessive impact and shake should be prevented in transportation. Lay it carefully and lightly.
Don’t put it together with dangerous goods during transportation.
Avoid solarization and getting wet in rain and snow during transportation.

Statement

All rights to modify the product are reserved to the manufacturer without further notice. The pictures are only for reference. The final interpretation rights belong to SyAct International LLC. The industrial design, inner structure, etc, have claimed for several patents by SyAct International LLC, any copy or fake product must undertake legal responsibilities

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>