1. INDICATION FOR USE
This device is designed to measure implant stability using the tapping method. It determines the time it takes for the device's tapping rod to contact the dental implant, abutment, or related structure within the oral cavity. The measurement result is displayed on the IST scale, which provides a numerical representation of the implant's stability. A higher IST value indicates greater implant stability and reduced mobility. This device is intended for use by dentists and registered dental assistants.
2. PRODUCT CHARACTERISTS
Convenient usage thanks to the compact and lightweight design
Easy operation with a simple control method
Fast measurement time of less than 3 seconds
Safe measurement using a gentle tapping technique and an automatic safety system (tapping stops after two taps if osseointegration is unstable; otherwise, it continues up to six taps)
Allows early detection of potential implant failure
3. COMPONENT INTERVIEW
Control Interface
The main body of the OsseoSense Pro instrument.
Tapping Probe (applied Part)
A tapping probe that contacts the abutment of the implant to measure stability and osseointegration.
Primary Guide
The front guide of the tapping probe, responsible for contacting the abutment and guiding the rod's movement.
Switch
A multifunctional button that powers the device ON/OFF and controls the tapping motion. To turn the device ON or OFF, press and hold the button briefly. Press the button once to initiate the tapping function.
LCD Display
Display function: On/Off display
Operation display (check/Ready)
Charging display (Charging/Charged)
IST scale display (1-99) IST scale represents the degree of implant stability.
Error display (error)
IST Tester
A IST tester is used to test the precision of measurement values. After connecting to the control interface, measurements between 0° and 30° are required, with an acceptable deviation of ±3 from the standard value.
Base
The docking station for the handpiece when not in use.
Socket Wrench
A tool for connecting and disconnecting the tapping probe from the control interface (main body). The wrench enables secure screwing or loosening of the rod.
USB Type-C Adapter
A USB Type-C cable used to charge the device by connecting to the control interface (main body).
Disposable Sleeves
Single-use sleeves are designed for patient-specific applications. Dispose of after each use in accordance with standard medical waste protocols.
Tapping Probe
A spare tapping probe for use during the disinfection process.
Primary Guide
A spare primary guide for use during the disinfection process.
4. TECHNICAL SPECIFICATIONS
Protection Type: Class II electrical shock protection
Protection Degree: Type B electrical shock protection
Battery Type: Rechargeable lithium battery
Battery Model: 16340
Battery Capacity: 850 mAh
Battery Protection Features: Overvoltage, overcurrent, and short circuit protection
Adapter Input: 100-240V ~ 50/60 Hz
Adapter Output: 5 V (Direct Currect) 1 A
Operating Environment: Ambient temperature: 5° to 40° C (60°-104° F)
Relative Humidity: 10%-85% Rh. Atmospheric pressure: 500 hPa- 1060 hPa (0.5-1.0 atm)
Atmosphere Pressure: 70kPa to 106kPa
Transport and Storage: Ambient temperature: -20° to 40° C (-4°-104° F).
Operation mode: Continuous Operation
Performance Features
Accuracy: Display value ±3
Tapping Speed: 0.5 seconds per tap
Tapping Strength: ≤ 1.0 N to 1.3 N
Number of Taps:
2 to 4 taps for measured values of 1 to 59
6 taps f or measured values of 60 to 99
5. SAFETY SIGNS
6. PREPARATION
BEFORE USE
Charging: Charge the device for a minimum of 3 hours before first use. (The battery is rechargeable.)
Sterilization: Ensure that the control interface of the device and the tapping probe are disconnected and sterilized prior to use. (Refer to the section below for the tapping probe removal and sterilization procedures.)
7. WORKFLOW DIAGRAM
Preparation Before Use
↓
Performance Test → NG → Contact Customer Service
↓
Measuring Process
↓
Disassembly
↓
Cleaning & Sterilization
↓
Assembly
↓
Storage
8. OPERATIONAL PROTOCOL
Power On
When the device is OFF, press the ON/OFF button once to turn on the LCD display and wait for the "READY" message to appear.
Action
When the device is in ready mode, briefly press the ON/OFF button to start. The device will emit a short beep, and the tapping motion will commence immediately. The measured value will then be displayed on the LCD screen, as shown below.
Power OFF
To turn off the device, press and hold the ON/OFF button until the device emits a short beep and powers down. If the device is not in use for two minutes, it will automatically turn off.
Number displayed on the LCD screen
The larger number on the right side of the reading shown in Figure 2 represents the current reading, while the smaller number on the left indicates the last reading. In Figure 1, the display shows two red bars, indicating that the control interface has no reading or data error.
9. OPERATIONAL PROCESS
Place a disposable sleeve on the control interface before use.
Turn on the power by pressing the ON/OFF switch.
Carefully position the tip of the tapping probe at the upper edge of the healing abutment, ensuring not to push the abutment.
Maintain the contact angle within the range of 0° to 30° upward
When the tapping probe on the control interface is positioned 90° from the side of the top of the healing abutment, pressing the ON/OFF switch once will initiate the tapping motion after 0.5 seconds.
The measured value is more accurate when the angle between the healing abutment and the primary guide is closer to perpendicular.
Check the number displayed on the LCD screen of the device.
Due to variations in bone width and the different directions of the implant, the measurement data may be biased. It is recommended to measure the stability value from multiple angles to obtain a more accurate reading.
If the contact angle is off the range (0° to 30° upward from the surface) an alert sound will be on and the LCD screen display “TOO LOW” or “TOO HIGH” the control interface will not operate. In this case tilt the device until the contact angle is back in the range and then, try measuring again.
Measurement error may occur if the tip of the guide applies too much force to the healing abutment or is too far away from the healing abutment during measurement.
Empty tapping motion results is no reading or obvious data error.
10. CHECKING MEASURED VALUE
(IST Scale)
The measured value is similar to the ISQ scale (Implant Stability Quotient):
A value above 60 indicates that a bridge is recommended.
A value above 70 indicates that single case loading is possible.
The range of measured values is displayed as a number between 01 and 99.
The color of the number indicates the following:
RED: 01 to 59
YELLOW: 60 to 64
GREEN: 65 to 99
A green light will be displayed below the LCD screen in the status bar.
A lower measured value on the IST scale indicates greater implant mobility and a weaker degree of osseointegration.
The measured value may differ depending on the height of the healing abutment. To calculate the correct IST scale, refer to the chart below: the standard height of the healing abutment is set at 4 mm, and the IST scale will change as the height of the healing abutment varies.
11. PRODUCT PERFORMANCE TEST
Insert the primary guide fully into the IST tester until the tapping probe makes contact with the back of the IST tester, as shown in the image below.
After installation, measure the IST scale by briefly pressing the switch while adjusting the angle of the device within the range of 0° to 30° upward. An error notification will sound if the device attempts to measure outside of this range.
The device is functioning correctly if the measured value displayed on the LCD is within ±3 of the standard value. The standard value refers to the reading from the target bar, as shown in the example below.
The standard value is based on the label on the target bar.
If the displayed value differs by more than ±3 from the standard value on more than three occasions, please contact our customer service center for assistance.
12. PRECAUTIONS DURING USE
It is imperative that users fully understand the intended use of this product and are thoroughly familiar with all precautions prior to operation.
The device must not be disassembled or modified under any circumstances without proper authorization.
This product is to be used exclusively for its designated purpose, as outlined in this manual.
Ensure that the device is used in a controlled, appropriate environment within a dental clinic or hospital.
The product should only be operated by a licensed dental professional, with the patient properly positioned and seated in a dental chair.
13. CHARGING BATTERY
To charge the device, connect the USB Type-C cable to the 5V adapter charger. While the battery is charging, "Charging" will appear on the LCD display. Once the device is fully charged, "Charged" will be displayed on the LCD screen.
Charging typically takes about 3 hours, depending on the conditions. A fully charged battery allows for approximately 4,000 measurements.
If the battery icon on the screen turns red, this indicates that the battery is depleted. In this case, the device will not perform the tapping motion. Please recharge the device promptly.
Use only the adapter provided by the manufacturer. Using adapters from other brands may result in fire, explosion, or damage to the product. The device cannot be used while charging.
If the battery drains unusually quickly, this may indicate the end of the battery’s lifespan. In such cases, please contact our customer service for a battery replacement.
If battery leakage occurs, stop using the device immediately and contact our customer service for assistance.
14. ASSEMBLING & DISASSEMBLING PROTOCOL
Position the Tapping Probe: Ensure that the tapping probe is securely held in place to prevent movement during disassembly.
Locate the Primary Guide: Identify the primary guide connected to the tapping probe.
Turn Counterclockwise: Grasp the primary guide firmly and turn it counterclockwise to loosen the connection.
Remove the Primary Guide: Once the primary guide is loose, gently pull it away from the tapping probe to complete the disassembly.
Identify the socket Wrench: Ensure you have the correct size Socket wrench for the tapping probe.
Locate the Connection Point: Find the designated socket or connection point on the tapping probe where the Socket wrench will be inserted.
Insert the Socket wrench: Carefully insert the Socket wrench into the socket of the tapping probe, ensuring it is fully seated.
Verify Proper Connection: Check that the Socket wrench is securely connected to the tapping probe, ready for use.
Locate the Socket wrench: Ensure you have the appropriate Socket wrench ready for disassembly.
Position the Tapping Probes: Hold Tapping Probe 1 and Tapping Probe 2 securely to prevent movement.
Turn Counterclockwise: Insert the Socket wrench into the appropriate socket and turn it counterclockwise by hand to loosen the connection between Tapping Probe 1 and Tapping Probe 2.
Separate the Probes: Once the connection is loose, gently pull Tapping Probe 1 away from Tapping Probe.
Gather All Components: Ensure you have all the disassembled parts of the tapping probe.
Connect Components in Reverse Order: Begin assembling the tapping probe by connecting each part in the reverse order of disassembly.
Secure Each Connection: As you connect each component, ensure that all parts are securely tightened.
Final Check: Once fully assembled, double-check all connections to ensure they are tight and secure.
Hold the Primary Guide: Ensure you have a firm grip on the primary guide.
Connect to the External Tube: Align the primary guide with the external tube.
Turn Clockwise: Rotate the primary guide clockwise to initiate the connection.
Tighten the Connection: Continue turning clockwise until the connection is secure. Ensure there are no gaps between the primary guide and the external tube.
Check for Security: Confirm that the connection is tight and stable before proceeding.
15. CLEANING AFTER USE
Immediate Removal:
Immediately remove the tapping probe and primary guide from the device following the disassembly methods outlined in the manual.
Immersion in Ethyl Alcohol:
Immerse the primary guide and tapping probe in 75% ethyl alcohol to disinfect the surface.
Brush Cleaning:
Use a soft brush and/or pipe cleaner to gently scrub the primary guide and tapping probe, ensuring the removal of any foreign matter or blood.
Initial Rinse:
Rinse the alcohol-washed part thoroughly with water to remove any traces of blood or debris.
Target Difficult Areas:
For areas that are difficult to clean, use a syringe or pipe cleaner to reach and wash away any remaining contaminants.
Final Wash:
Perform a final rinse with flowing purified water for at least one minute to ensure all cleaning agents are removed.
Drying:
Wipe the cleaned surfaces with a dry cloth or use a warm air circulator set at 60°C for thirty minutes to completely remove moisture.
Surface Cleaning:
If the surface of the control interface (The main body of the OsseoSense Pro instrument) needs cleaning, gently wipe it with a cloth soaked in water.
Important Warning
Do Not Use Disinfection Spray
Avoid the use of disinfection sprays, as these fluids can penetrate the inner components of the product, potentially causing damage and compromising its functionality. Please note that using disinfection sprays will void the warranty.
Avoid Oils and Lubricants
Never apply oil or lubricants to this product. The introduction of these substances can adversely affect the performance and integrity of the device, resulting in the voiding of the warranty.
16. STERILIZATION AFTER CLEANING
Autoclave Pre-Vacuum Selection
The autoclave pre-vacuum option can be selected for sterilization.
Sterilizable Components
Only the following items can be sterilized and are reusable:
Separated tapping probe
Primary guide
Socket wrench
Use of FDA-Clean Wrap
End users are required to use an FDA-approved sterilization pouch for packaging the components prior to sterilization.
Sterilization Conditions
Follow the sterilization conditions outlined below:
Cycle Type: Pre-Vaccum
Temperature: 135°C
Pressure: 0.22Mpa
Exposure Time: 4 minutes
Dry Time: 30 minutes
DO NOT autoclave the main body.
Sterilization Temperature:
The sterilization temperature must not exceed 135°C (275°F).
Post-Sterilization Handling:
Remove the items from the autoclave immediately after the cycle is complete. Allow them to cool down before use, as they may be hot.
Dishwasher Use:
Do not use dishwashers as it will damage the instrument’s coating.
Reusable Instruments:
Our instruments are engineered for repeated use and are capable of enduring a minimum of 200 sterilization cycles when processed according to the specified criteria.
17. STORAGE AFTER STERILIZATION
Reassembly:
The sterilized tapping probe must be reassembled into the control interface before storage.
Safe Storage:
Store the assembled control interface in a safe location to protect it from water, vibrations, external shocks, and potential damage.
Avoid Direct Sunlight:
Ensure that the control interface is kept away from direct sunlight to prevent any degradation of materials.