Gutta Percha Obturation Device Instruction Manual

1 Product Introduction

1.1 Intended Use

This device is used to provide heat to the Work Tip, cut gutta-percha points, and soften and pressurize gutta-percha. The applied part is the Work Tip.

1.2 Diagram of Components and Control Buttons

The device includes the following components:

• 1. "ON/OFF" button
• 2. Heating button
• 3. Work Tip Protector
• 4. Work Tip
• 5. Connecting hole for power adapter
• 6. Temperature Level indicator
• 7. Battery level indicator
• 8. Charging base
• 9. Battery cartridge
• 10. Charging indicator
• 11. Power adapter plug
• 12. Power adapter unit

1) "ON/OFF" button:

• Under shutdown state, a short press of the "ON/OFF" button starts the device.
• Under shutdown state, a long press of the "ON/OFF" button starts the device and allows changing the screen display direction for left or right-handed operation.
• Under ON state, a long press of the "ON/OFF" button shuts down the device (approximately 1s).

Note: The Heating and Packing Instrument will automatically shut down if there is no operation for 10 minutes.

Under ON state, a short press of the "ON/OFF" button changes the preset temperature of the Work Tip. The preset temperatures cycle through 150°C → 180°C → 200°C → 230°C with each press, returning to 150°C after 230°C.

Figure 1 Preset temperature showing 150°C, 180°C, 200°C, 230°C with battery icons.

2) Heating button:

Under the ON state, connect the Work Tip and press the Heating button to start heating. Release the Heating button to stop heating, and the Work Tip temperature will fall.

Note: If the Heating button is held for more than 10 seconds, the device will stop heating. To continue heating, release and press the Heating button again.

3) Volume set:

After power-on, simultaneously press the “ON/OFF” button and the “Heating” button to enter the voice volume setting mode. Short press the "ON/OFF" button to select the desired voice volume. Short press the "Heating" button to exit the voice volume setting mode.

Figure 2a Low volume, Figure 2b Medium volume, Figure 2c High volume, each showing a speaker icon and 'VOL'.

4) Battery level:

The battery's actual power is displayed in real-time on the screen with five grids. One grid indicates low battery requiring charging. A blank space indicates very low battery requiring immediate charging.

Note: To prolong battery life, avoid letting the battery level reach the space status (completely no power) during normal use.

Warning: If the device has not been used for over a month, recharge the battery. If the device is not in use for an extended period, recharge it at least once a month to protect the battery. Prolonged periods in a low battery state or off the charging base will shorten the battery's service life.

5) Temperature Level:

The display screen shows the preset temperature value. Approximately 1 second after setting the temperature, the OLED screen displays the real-time temperature of the Work Tip. While heating, the temperature indicator also displays the current Work Tip temperature.

6) Charging base:

First, connect the power adapter plug to the power adapter (Figure 3). Then, connect the power adapter to the power connecting hole on the charging base (Figure 4) and plug into a standard socket. Place the Heating and Packing Instrument correctly on the charging base (Figure 5) to ensure the charging connector under the instrument connects to the charging base's output connector. When properly connected, the LED charging indicator on the base will be constantly lit. If the LED is flashing or not lit, check all cables.

The charging base has charging status indicators. When the instrument is not on the base, the indicator flashes yellow and green alternately. When charging, the yellow indicator is constantly on. When the battery is full, the yellow indicator turns off, and the green indicator stays on.

Notes: Charge the device immediately upon receipt. Ensure the battery is fully charged before use. A fully charged battery shows the highest level on the instrument's display screen. Recharging a depleted battery takes at least 2 hours and 30 minutes.

Figure 3 Installation of power adapter. Figure 4 Connection to power supply. Figure 5 Charging.

1.3 Device Includes

1. Heating and Packing Instrument
2. Charging base
3. Power adapter with cord
4. Work Tips (Models shown in Table 2)
5. Work Tip Protector
6. Instruction Manual
7. Qualified Certification
8. Warranty card
9. Packing list

1.4 Introduction and Scope of Application

1.4.1 Features:

• The display can be set to the right or left side to accommodate both left-handed and right-handed users.
• The cordless design of the Heating and Packing Instrument enhances operational space.
• Features sensitive temperature control, a simple display, and convenient operation. Press the temperature setting button to select the desired working temperature.
• Four preset temperatures are available: 150°C, 180°C, 200°C, 230°C.
• The Heating and Packing Instrument automatically shuts down after 10 minutes of inactivity.

1.4.2 Scope of Application:

Used during the root canal obturation stage in endodontic treatment.

1.5 Product Specifications

1.6 Technical Parameters

1.7 Environmental Parameters

• Temperature: +5°C ~ +40°C
• Humidity: 30% ~ 75%
• Air pressure: 70kPa ~ 106kPa

1.8 Storage and Transport

1. Handle the device carefully and lightly, keeping it away from vibration. Store in a cool, dry, and ventilated place.
2. Do not store the device with combustible, poisonous, caustic, or explosive materials.
3. Store the device in a room with relative humidity of 10% ~ 93%, air pressure of 70kPa ~ 106kPa, and temperature between -20°C and +55°C.
4. Avoid strong shock or vibration during transport. Handle with care.
5. Do not mix the device with hazardous articles during transport.
6. Avoid exposure to sun, rain, and snow during transport.

2 European Authorized Representative

EC REP MedNet EC-Rep GmbH, Borkstrasse 10, 48163 Muenster, Germany

3 Standard Icons

Icon	Description	Icon	Description
SN	Product serial number	Icon for 'Follow Instructions for Use'	Follow Instructions for Use
Icon for Manufacturer	Manufacturer	Icon for Date of manufacture	Date of manufacture
Icon for Type B applied part	Type B applied part	Icon for Class II device	Class II device
Icon for Power switch	Power switch	IPX0	Ordinary equipment
Icon for Used indoor only	Used indoor only	Icon for Caution, hot surface	Caution, hot surface
134°C Icon for Can be autoclaved	Can be autoclaved	DC 15V	DC 15V
CE0197	CE marked product	Icon for Device complies with WEEE directive	Device complies with WEEE directive
Icon for Attention! Please refer to the accompanying documents.	Attention! Please refer to the accompanying documents.	Icon for Humidity limit for storage: 10% ~ 93%	Humidity limit for storage: 10% ~ 93%
Icon for Atmospheric pressure for storage: 70kPa ~ 106kPa	Atmospheric pressure for storage: 70kPa ~ 106kPa	Icon for Temperature limit for storage: -20°C ~ +55°C	Temperature limit for storage: -20°C ~ +55°C
ECREP	Authorised Representative in the EUROPEAN COMMUNITY

4 Contraindications

1. People allergic to natural latex and metals (e.g., stainless steel, silver, copper) are forbidden to use this device.
2. Patients with hemophilia are forbidden to use this device.
3. Patients with heart pacemakers are forbidden to use this device.
4. Dentists with heart pacemakers are forbidden to use this device.
5. Patients with heart disease, pregnant women, and children should use the equipment with caution.

5 Installation and Disassembly Method of Accessories

5.1 Connection of Power Adapter

Connect the power adapter's output to the charging base and the input to a socket that meets the power adapter's standard. Follow the procedures in Figures 3, 4, and 5 for installation. (Note: Installation shown in Figure 3 was completed before delivery.)

5.2 Installation and Removal of Work Tip

1. After turning off the power switch, pull the Work Tip directly off the Heating and Packing Instrument.
2. Place the used Work Tip in a container for disinfection.
3. Select the desired Work Tip and insert it into the Heating and Packing Instrument according to the usage instructions (Figure 6 and 7).
4. Install the Work Tip Protector onto the Work Tip (Figure 8) to prevent scalding the patient's mouth during operation.
5. If the Work Tip is not installed or has a poor connection while the device is ON, an error code will appear on the display screen (Figure 9).

Figure 6 Work Tip. Figure 7 Installation of Work Tip. Figure 8 Installation of Work Tip Protector. Figure 9 Error code.

5.3 Installation and Replacement of Battery

To replace the battery (Figure 10), rotate the battery barrel counterclockwise to remove the battery tube. Remove the old battery, insert a new one, and tighten the battery tube clockwise.

Warning: When removing the battery, do not unscrew the screw under the battery barrel (indicated by the arrow in Figure 10). Simply push the connector slightly inward to remove the battery. Improper replacement of lithium batteries can lead to unacceptable risks; therefore, replacement requires trained personnel.

Figure 10 Replacement of battery, showing battery removal.

6 Operation Method

1. Select a suitable Work Tip based on the patient's condition and install it at a suitable angle.

Danger: Do not turn on the device while installing the Work Tip to prevent accidental burns from pressing the heating button.

1. After pressing the “ON/OFF” button, the display screen of the Heating and Packing Instrument will light up, showing the preheating temperature and power status.
2. Lightly press the temperature setting button to select the appropriate preheating temperature as indicated on the display screen.
3. During operation, lightly press the heating button to heat up to the preset temperature. Soften and pressurize the gutta-percha with a steady, continuous motion, using a vertical pressurizer.

Note: The continuous heating time on gutta-percha should not exceed 4 seconds to avoid the risk of scalding.

1. After operation, clean, disinfect, and sterilize the Work Tip as described in Chapter 9.

7 Charging Instruction

1. Use the provided charging base. Connect the power adapter to the charging base, connect to the power supply, and then place the Heating and Packing Instrument correctly onto the charging base.
2. The battery in this product has no memory and can be used or charged at any time.
3. Before the first use, charge the device for at least 3 hours.

Warning: Only unplug the adapter to disconnect from the network power.

8 Safety Precautions

1. Do not polish the Work Tip.
2. Do not knock or scratch the Heating and Packing Instrument.
3. Keep the heating pressurizer, Work Tip, etc., away from flammable and explosive materials when in use.
4. Keep the device clean before and after operation. Disinfect the Work Tip and accessories before each use.
5. Operate the product strictly in accordance with relevant medical authority specifications and regulations. Only trained doctors or technicians should operate this product.
6. Do not install, remove, or replace the Work Tip while it is heating. Power off the device before replacing the Work Tip.
7. Ensure the Work Tip is correctly installed to prevent it from falling off.
8. If the Work Tip is bent or worn, it may cause uneven heating. Replace the Work Tip promptly according to clinical conditions.
9. Turn off the power immediately after operation.

Woodpecker specializes in producing medical instruments. Woodpecker is responsible for safety only under the following conditions:

• Maintenance, repair, and modification are performed by the manufacturer or authorized dealers.
• The charged components are original "Woodpecker" products and operated according to the instruction manual.

9 Cleaning, Disinfection, Sterilization and Maintenance

This section details the cleaning, disinfection, and sterilization of the Work Tip (referred to as "product").

Warnings:

• Using strong detergents or disinfectants (alkaline pH > 9 or acid pH < 5) will reduce the product's lifespan. The manufacturer assumes no responsibility in such cases.
• This product should not be exposed to temperatures above 138°C.

9.1 Processing Limit

The product is designed for numerous sterilization cycles, using carefully selected materials. However, repeated preparation for use, thermal, and chemical stresses can cause aging. The maximum number of sterilizations for a Work Tip is 100. Maintain corresponding records for each cleaning and disinfection cycle.

9.2 Initial Processing

9.2.1 Processing Principles

Effective sterilization is only possible after thorough cleaning and disinfection. Ensure that only validated equipment and product-specific procedures are used for cleaning, disinfection, and sterilization, adhering to validated parameters for each cycle. Comply with applicable legal requirements and hygiene regulations of the hospital or clinic, including prion inactivation requirements.

9.2.2 Post-operative Treatment

Post-operative treatment must be performed immediately, no later than 30 minutes after the operation. The steps are:

1. Turn off the Heating Handpiece and place it on the base to cool down to room temperature at the Work Tip.
2. Use a cotton swab or clean soft cloth to remove any remaining Gutta-percha material from the Work Tip.
3. Dry the product with a clean, soft cloth and place it in a clean tray.

9.2.3 Preparation Before Cleaning

Steps: Tools: tray, clean and dry soft cloth.

1. Remove the Work Tip Protector from the handle and place it in a clean tray.
2. Remove the Work Tip from the handle and place it in a clean tray.
3. Wipe the Work Tip with a soft cloth until no dirt is visible on the surface. Dry it with a clean soft cloth and place it in a clean tray. Pure water can be used as a cleaning agent.

Notes:

• Pure water temperature should not exceed 45°C, as higher temperatures can solidify protein, making it difficult to remove.

9.3 Cleaning

Cleaning should be performed no later than 24 hours after the operation. Automated cleaning is recommended.

The cleaning procedure is as follows:

1. Pre-wash with pure water at 25°C for 3 minutes.
2. Clean with the recommended cleaning agent for 5 minutes (e.g., RUHOF ENDOZIME AW PLUS WITH APA, dilution ratio 1:270, temperature 25°C for 5 minutes).
3. Rinse twice with pure water at 25°C for 1 minute each.

Notes:

• Only freshly prepared solutions of pure water can be used.
• Adhere to the cleaner manufacturer's recommendations for concentration and time.
• The cleaner must be validated by CE certification according to EN ISO 15883.
• The cleaning procedure is suitable for the product, and the irrigating period is sufficient.

9.4 Disinfection

Disinfection must be performed no later than 2 hours after cleaning. Automated disinfection is preferred if conditions permit. For thermal disinfection, the temperature is 93°C for 5 minutes, with an A0 value greater than 3000.

Cleaning and Disinfecting Steps using Washer-Disinfector:

1. Carefully place the product into the disinfection basket. Secure the product if necessary; ensure products do not contact each other.
2. Start the program.
3. After the program finishes, remove the product from the washer-disinfector. Inspect (refer to "Inspection and Maintenance") and package (refer to "Packaging"). Dry the product if necessary (refer to "Drying").

The suitability of the product for effective cleaning and disinfection using these automated procedures has been verified by a certified facility.

Notes:

• Read the equipment manufacturer's operating instructions carefully before using the washer-disinfector.
• Cleaning, disinfection, and drying can be performed together using this equipment.
• Only pure water with a low microorganism count (<10 cfu/ml) is suitable for rinsing steps (e.g., water conforming to European or United States Pharmacopoeia).
• Drying air must be HEPA filtered.
• Regularly repair and inspect the disinfector.

9.5 Drying

If your cleaning and disinfection process lacks an automatic drying function, dry the product after cleaning and disinfection.

Methods:

1. Spread a clean white cloth on a flat surface. Place the product on the cloth and dry with filtered compressed air (max. pressure 3 bar) until no liquid is sprayed onto the cloth.
2. Alternatively, dry in a medical drying cabinet or oven at 80°C~120°C for 15~40 minutes.

Notes:

• Drying must be performed in a clean environment.
• Drying temperature should not exceed 138°C.
• The equipment used should be regularly inspected and maintained.

9.6 Inspection and Maintenance

This section covers visual inspection of the product. Ensure there are no issues after inspection.

1. Check the product for any remaining stains after cleaning/disinfection. If stains are present, repeat the entire process.
2. Check the product for damage (smashed, detached, corroded). If damaged, it must be scrapped and not used further.
3. If an accessory is damaged, replace it before use. The replacement accessory must be cleaned, disinfected, and dried.
4. If the product has reached its specified usage limit, replace it promptly.

9.7 Packaging

Package the disinfected and dried product quickly in a medical sterilization bag or a sterile box.

Notes:

• The packaging conforms to ISO 11607.
• It can withstand high temperatures of 138°C and has sufficient steam permeability.
• The packaging environment and tools must be cleaned regularly to ensure cleanliness and prevent contamination.
• Avoid contact between parts made of different metals during packaging.

9.8 Sterilization

Use only the following steam sterilization procedures (fractional pre-vacuum procedure*). Other sterilization methods are not recommended.

1. The steam sterilizer must comply with EN13060 or be certified according to EN 285 and EN ISO 17665.
2. Sterilization time is 5 minutes at 134°C with a pressure of 2.0 bar ~ 2.3 bars.

The suitability of the product for effective steam sterilization has been verified by a testing laboratory.

Notes:

• Only products that have been effectively cleaned and disinfected should be sterilized.
• Before sterilizing, read the equipment manufacturer's Instruction Manual and follow its instructions.
• Do not use hot air or radiation sterilization, as this may damage the product.
• Use the recommended sterilization procedures. Sterilization with ethylene oxide, formaldehyde, or low-temperature plasma is not recommended. The manufacturer is not responsible for procedures not recommended. If using unrecommended procedures, adhere to relevant standards and verify suitability and effectiveness.

*Fractional pre-vacuum procedure = steam sterilization with repetitive pre-vacuum.

9.9 Storage

1. Store in a clean, dry, ventilated, non-corrosive atmosphere with relative humidity of 10% to 93%, atmospheric pressure of 70KPa to 106KPa, and temperature of -20°C to +55°C.
2. After sterilization, package the product in a medical sterilization bag or a clean sealing container and store in a special storage cabinet. The storage time should not exceed 7 days. Reprocess before use if exceeded.

Notes:

• The storage environment should be clean and regularly disinfected.
• Product storage must be batched, marked, and recorded.

9.10 Transportation

1. Prevent excessive shock and vibration during transportation; handle with care.
2. Do not mix with dangerous goods during transportation.
3. Avoid exposure to sun, rain, or snow during transportation.

9.11 Cleaning and Disinfection of Main Unit and Charging Base

Warnings: Do not clean the main unit and charging base with an ultrasound cleaning machine.

• Before each use, wipe the surface of the main unit and charging base with a soft cloth or paper towel soaked in 75% medical alcohol. Repeat at least 3 times.
• After each use, wipe the surface with a soft cloth soaked in clean water (pure water) or a clean disposable wipe. Repeat at least 3 times.

9.12 Daily Maintenance

1. When the device is not in use, turn off the power and unplug the power supply plug.
2. If the Heating and Packing Instrument remains in a low battery state for an extended period, its battery life will be shortened. Charge it promptly when the battery level is low.
3. When the device is not in use, charge it for 1 hour once a month.

9.13 Repair of Device

This product contains no self-repairing spare parts. If any abnormality occurs, please contact the company for maintenance. Do not disassemble without authorization. With company consent, circuit diagrams, component part lists, descriptions, and calibration instructions can be provided to SERVICE PERSONNEL for repairs.

10 Troubleshooting

If the problem persists, please contact your local dealer or the company.

11 After-Sales Service

If the device malfunctions due to quality issues after the sales date, the company is responsible for repairs during the warranty period. Refer to the Warranty Card for warranty period and scope.

12 Environment Protection

The device does not contain harmful ingredients and can be handled or disposed of according to local regulations.

Note:

• Unauthorized private modification of the device may cause electromagnetic compatibility issues with the device or other equipment.
• The design and testing of the Heating and Packing Instrument comply with electromagnetic compatibility regulations.

13 EMC - Declaration of Conformity

The device has been tested and homologated according to EN 60601-1-2 for EMC. This does not guarantee immunity to electromagnetic interference. Avoid using the device in high electromagnetic environments.

Technical Description Concerning Electromagnetic Emission

Table 1: Declaration - electromagnetic emissions

Technical Description Concerning Electromagnetic Immunity

Table 2: Guidance & Declaration - electromagnetic immunity

Table 3: Guidance & Declaration - electromagnetic immunity concerning Conducted RF & Radiated RF

NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance & Declaration - electromagnetic immunity

The model Fi-P is intended for use in electromagnetic environments in which radiated RF disturbances are controlled. The customer or user of the model Fi-P can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model Fi-P, 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 transmitter's frequency, where P is the maximum output power rating 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.

Portable and mobile RF communications equipment should be used no closer to any part of the models Fi-P, including cables, than the recommended separation distance calculated from the equation applicable to the transmitter's frequency. Recommended separation distance d=1.2×P1/2, d=2×P1/2, d=1.2×P1/2 80 MHz to 800 MHz, d=2.3×P1/2 800 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: Symbol indicating potential interference.

NOTE 1: At 80 MHz and 800 MHz, 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, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model Fi-P is used exceeds the applicable RF compliance level above, the model Fi-P should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model Fi-P.

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

14 Statement

Woodpecker reserves the right to change the design of the equipment, the technique, fittings, instruction manual, and the content of the original packing list at any time without further notice. The pictures are for reference only. Final interpretation rights belong to Guilin Woodpecker Medical Instrument Co., Ltd.