Beyes GPRO P1 Gutta Percha Obturation System Instruction Manual

Gutta Percha Obturation System
Instruction for Use

Thank you for purchasing GoPro P1 Gutta Percha Obturation Pen developed by Beyes Dental Canada Inc. Beyes has an excellent Quality Control System. To guarantee correct and safe operation, please read this Instruction Manual carefully before use. Depending on the level of risk involved, safety requirements are classed under the following indications:

Danger: (Always refer to personal injury)
Warning: (Refer to possible damage to property)

Introduction

1.1 Features

• Cordless and easy to use
• Designed for both left-handed and right-handed individuals; both sides have display windows and operation button
• Heats and cools almost instantly for optimal safety and control
• Adjustable heating range (150°C, 180°C, 200°C, 230°C)
• Auto shut off after 10 mins of idling

1.2 Intended Use
It is used to heat, cut, soften, and down pack gutta-percha to obturate root canals in endodontic treatment.

1.3 Contraindications

• Patient allergic to known natural latex and metals such as stainless steel, silver, copper
• Patient with hemophilia
• Patient or dentist with a pacemaker implanted
• Patient with heart disease

1.4 Package includes

1. GoPro P1
2. Charging base
3. Power adapter with cord
4. Tips
5. Heat insulation sleeve
6. Instruction Manual

1.5 Diagram of Components and Control Buttons
The GoPro P1 is equipped with a display screen and a control button on both the left and right sides. And the design of the left and right sides are perfectly symmetrical, which enables either left- hand or right-hand operation;

1. “ON/OFF” button
2. Heating button
3. Heat insulation sleeve
4. Tip
5. Connecting hole for power adapter
6. Temperature| 7. Battery level
8. Charging base
9. Battery cartridge
10. Charging indicator
11. Power adapter plug
12. Power adapter
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Installation

2.1 Charge device

1. Install the adapter plug for the power supply (Figure 2)
2. Plug in the power supply and connect it to the charging base (Figure 3)
3. Seat the device on the base for charging (Figure 4)
   The display faces up and the bottom connecting pins mate the base

The light on the base will be yellow while the battery is charging and will turn green once the battery is fully charged.
If the device is off the base, light flashes between yellow and green. Full battery charge takes around 2hr 30min
Notes: Charge the battery for 3 hours before the first use.

Warning:
Do not drain the battery.
Always charge to full to maintain battery life.
Recharge the battery if the device has not been used for more than 1 month.

2.1 Install tip
Danger:
Do not turn on the device for tip installation
Hitting the heating button by mistake may cause a scald on the fingers.
Note: See Turn device on/off in Operation Select the right tip size A hexagonal plug on the tip allows various tip orientations Plug the tip into the heating chamber completely

Note:
To remove the tip, hold near the turn of the tip and gently pull out
Warning:
The needle remains hot after use. Wait till the display 0 °C
Warning:
Before each use, clean, disinfect and sterilize the tip
Do not autoclave this device.
Do not immerse this device into chemical disinfectant.
Turn on device

2.2 Fit insulation sleeve
Cover the thick part of the tip connecting the heating chamber
Note: Tip should not be covered

Operation

3.1 Turn device on/off
Press the on/off button. The device turns on. The display shows the current temperature of the tip and battery level.
Press and hold the on/off button for 1 sec. The device turns off. The display turns off.
Note: The device will automatically shut down after 10 mins of idling
3.2 Change left/right handed
Turn devise off
Press and hold on/off button. The device turns on and the display shows the previous direction and then toggle another direction
3.3 Select Temperature
Press and release on/off button to select the temperature setting.
Temperature setting cycles as shown below.

Note:
The display shows 0°C when no button is pressed If the tip heats up or cools down, the display shows the temperature of the tip
When selecting temperature, the display momentary shows the setting and then changes to the temperature of the top or 0°C.

3.4 Heat up the tip
Press and hold the heating button
Beep alert when the tip is heating up
The display shows the tip temperature Release button
Beep stop and display show tip temperature cooling down and back to 0°C

Note:
Pressing the heating button for more than 10 sec
Tip stops heating
Device stop beeping
The display turns back to 0°C

Canal Obturation

1. Select a tip for operation Install tip (see installation)
2. Shape the root canal with endo files and determine the working length. Select a master cone that closely matches the apical size.
3. Turn on the GoPro P1 device and select the temperature (see operation)
4. Lightly press the heating button to heat up the tip
5. Insert the GoPro P1 tip into the root canal to the point 4-7 mm short of the working length. Move and set the endo stop accordingly.
6. Insert the selected master Gutta Percha cone that is coated with sealer.
7. Insert the GoPro P1 tip in the orifice of the canal to soften and pressurize the gutta-percha continuously and in stable motion.

Danger:
Do not turn on the device for tip installation
Hitting the heating button by mistake may cause a scald on the fingers.
Warning:
Continuous heating gutta-percha exceeding 4s is not recommended; there would be a risk of scalding.
Note:
Clean, disinfect, and sterilize the tip after each patient use (see maintenance)

Technical Specification

5.1 Product specifications

5.2 Technical parameters

5.3 Environmental parameters

| Working| Storage
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Temperature| +5 C∼+40 C| -20°C∼ +55°C
Humidity| 30°0∼75°0| 10% ∼ 93%
Air pressure| 70kPa∼106kPa| 70kPa ∼ 106kP

Warning:
Do not transport and store this device with hazardous articles such as combustible poisonous, caustic, or explosive.

Signs

| Product serial number| | Follow Instructions for Use
---|---|---|---
| Manufacturer| | Date of manufacture
| Type B applied part| | Class II equipment
| Power switch| | Ordinary equipment
| Used indoor only| | The device complies with the WEEE directive
| Can be autoclaved| | Keep dry
| Handle with care| | Recovery
****| Attention! Please refer to the accompanying documents.
| Humidity limit for storage: 10% – 93%
| Atmospheric pressure for storage: 70kPa – 106kPa
| Temperature limit for storage: -20°C – +55°C

Battery Replacement

Note:
Do not unscrew the bottom screw Hold device facing bottom
Turn battery case counterclockwise
Push the battery out from bottom
Replace new battery
The battery should fit the opening at the bottom
Turn the battery case clockwise to close the device

Safety Precautions

1. Do not polish the tip.
2. Do not knock or scratch the GoPro P1 Gutta Percha Obturation Pen
3. Do not place the GoPro P1 Gutta Percha Obturation Pen near an electronic device, phone, radio or HD/satellite TV as these may affect the temperature control of the GoPro P1 Gutta Percha Obturation Pen.
4. Keep the heating pressurizer, tip, etc. under heating state away from inflammable and explosive materials.
5. Please keep the device clean before and after the operation. Before each use, please disinfect tip and its accessories.
6. Users should be equipped with adequate protection such as goggles, masks, etc. to prevent cross-infection.
7. The product should be in strict accordance with relevant operation specifications of medical authority and relative regulations. The product can only be operated by trained doctors or technicians.
8. Do not install, remove, or replace the tip under the heating state. Please power off before replacing the tip.
9. The tip must be correctly installed to prevent it from falling off.
10. When the working tip is bent or worn, it will cause uneven heating. The operator should replace the tip in time according to the clinical conditions;
11. After the operation, please turn off the power immediately.  Woodpecker is specialized in producing medical instruments. We are only responsible for the safety on the following conditions:
    a) The maintenance, repair, and modification are made by the manufacturer or authorized dealers.
    b) The charged components are original of “Beyes Dental Canada Inc.” and operated according to the instruction manual.

Maintenance

9.1 Cleaning, disinfection, and sterilization

1. The tip can be cleaned with clean water as well as can be cleaned in an ultrasonic cleaner.
2. After each use, please sterilize the tip under high temperature and high pressure (134°C, 0.22MPa) for at least 4 minutes.
3. If the other accessories need to be cleaned or disinfected, please use gauze to pick up a small amount of water or disinfectant to wipe the surface. Do not soak.
4. Do not use volatile and diffluent solvents for cleaning, which will damage the surface of the device or cause the markings on the machine to fade.

8.2 Daily maintenance

1. When the device is not used, please turn off the power and unplug the power supply plug.
2. If the GoPro P1 Gutta Percha Obturation Pen is in a low battery state for a long time, the service life of the battery will be shortened. Please charge it in time if the battery level is low.
3. When the device is not used, please charge it for 1 hour once a month.

8.3 Repair of device
This product does not contain self-repairing spare parts. Repair should be carried out by a designated professional or special repair shop.

Troubleshooting

No
indications, no response| 1. Inadequate battery power
2. Battery is damaged.
3. The charging interface is short-circuited, causing the lithium battery to enter a protection state;
4.GoPro P1 Gutta Percha Obturation Pen is damaged.| 1. Connect to a power supply to charge. / Replace the battery.
2. Replace the battery.
3. Remove the substance that causes the short circuit, put the device into the charging base to charge, and then the device will return to normal;
4. Contact a local distributor or manufacturer.
Automatic shutdown| If there is no operation for 10 minutes, the device will automatically power off.| Reboot
Tip works abnormally| 1. The tip is damaged.
2. Malfunction of the main unit| 1. Replace the tip
2. Send it to the repair center.
The pushing ram cannot be pulled out| The portion of the pushing ram that enters the interior of the heating chamber is fixed by the cooling of the gutta-percha.| 1. Power on and set the
temperature to 200 °C. After the temperature reaches the set value, pull out the pushing ram back;
2. Contact your local dealer or our company.
Charging failure after connecting to the power supply.| 1. The power supply is not correctly connected;
2. The power supply is damaged, or the specification doesn’t match.
3. There are impurities on the contact thimble of the charging base.| 1. Unplug and reconnect.
2. Replace the battery.
3. Wipe the thimble with alcohol, dry it, and reconnect.
The service time after
each charging is shortened| The battery ages and the battery capacity become smaller.| Contact a local distributor or manufacturer to
buy new batteries for replacement.
OPEN code appears
on the display screen| 1. The tip is damaged.
2. The tip is not installed.
3. The tip is not well installed.| 1. Replace the tip.
2. Install the tip.
3. Unplug the tip, and reconnect.

After-sales Service

Starting from the date of sales, if the device does not function up to standard due to a manufacturer defect, our company will be responsible for the repair of the device during its warranty period. Please refer to the warranty card for the warranty period and scope.

Environment Protection

The device does not contain any harmful substances. It may be handled or disposed of in accordance with the relevant local regulations.
Note:

1. Without Beye’s agreement and authorization, private modification of the device may result in the electromagnetic compatibility problem of that device or other devices.
2. The design and test of the Melting and Filling Gun comply with the related operation regulations of electromagnetic compatibility.

Beyes Limited Warranty Statement

13.1 SCOPE OF WARRANTY
BEYES Dental Canada Inc. warrants to the original retail purchaser that it will be at BEYES’s option to repair or replace components of the dental products manufactured by BEYES (except for components not warranted under ‘Exclusions’) that are defective in material or workmanship under normal use and service. BEYES’ obligation under this limited warranty is limited to the repair or replacement of the applicable components. This limited warranty shall only apply to defects that are reported to BEYES within the applicable warranty period and which, upon examination by Beyes, prove to be defective. This warranty extends only to the first retail purchaser of a product and is not transferable or assignable. Replacement components or products may be used and/or refurbished components or products, provided they are of like quality and specifications as new components or products.

13.2 APPLICABLE WARRANTY PERIOD
The applicable warranty period, measured from the date of invoice to the original user, shall be as follows GoPro P1 are warranted for a period of 12 months

13.3 EXCLUSIONS
This limited warranty does not cover and BEYES shall not be liable for the following;

1. Defects, damage or other conditions caused, in whole or in part, by misuse, abuse, negligence, alteration, accident, freight damage, negligent storage, tampering or failure to seek and obtain repair or replacement in a timely manner;
2. Products that are not installed, used, and properly cleaned and maintained as required or recommended in the BEYES ‘Installation’ and/or ‘Installation/Operation Manual’ for the applicable product, including the specified structural and operational environment conditions and electrical power requirements;
3. Products considered to be of a consumable or sterile nature;
4. Accessories or parts not manufactured by BEYES;
5. Charges by anyone for adjustments, repairs, replacement parts, installation or other work performed upon or in connection with such products which are not expressly  authorized in writing in advance by BEYES;
6. Costs and expenses of routine maintenance and cleaning;
7. Representations and warranties made by any person or entity other than BEYES;
8. Matching of color, grain or texture except to commercially acceptable standards;
9. Changes in color caused by natural or artificial light;
10. Custom manufactured products;
11. Alterations or modifications to the product by any person or entity other than BEYES;
12. Products that would otherwise by covered under Sections 1 and 2 of this limited warranty, but are acquired: (i) from a person or entity that is not BEYES or one of its authorized dealers; or (ii) from a BEYES dealer that is not authorized to sell the product at issue in the geographic territory where the purchaser is located, or is not authorized to sell the product at issue within the medical, animal health or dental market, as the case may be, in which purchaser intends to use the product.

13.4 EXCLUSIVE REMEDY; CONSEQUENTIAL DAMAGES DISCLAIMER
Beyes’ obligation under this limited warranty is the repair or replacement of defective parts. Beyes shall not be liable for and hereby disclaims any direct, special, indirect, incidental, exemplary or consequential damages or delays, including, but not limited to, damages for loss of profits or income, loss of use, downtime, cover and employee or independent contractor wages, payments, and benefits.
13.5 WARRANTY DISCLAIMER
This limited warranty is eyes only warranty and is in lieu of all other warranties, express or implied. Beyes makes no implied warranties of any kind including any implied warranties of merchantability or fitness for a particular purpose. This warranty is limited to the repair or replacement of defective parts.
13.6 STATUE OF LIMITATIONS
No actions may be brought against eyes for breach of this limited warranty or implied warranty if any, or for any other claims arising out of or relating to the products, more than ninety (90) days following the expiration of the limited warranty period.

**** Federal law restricts this device to sale by or on the order of a dentist, physician, or any other practitioner licensed by the law of the states in which he or she practices to use or order the use of this device.

Beyes Dental Canada Inc.
23-595 Middlefield Road
Toronto, Ontario, M1V 3S2
Canada
Tel: 1-855-603-1888
Fax: 1-855-720-1228
Email: info@beyes.ca
Website: www.beyes.ca| Lotus NL B.V.
Koningin Julianaplein 10, Ie Verd,
2595AA, The Hague,
Netherlands
Tel: +31645171879 (English)
+31626669008 (Dutch)
Email: info@beyes.ca
Website: www.beyes.ca
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Printed in Canada
ENI036
Rev.1/12.03.21

References

• Beyes Dental Handpiece and Equipment

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