SuperEndo B&L-alpha II Operation and Maintenance Instruction Manual

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SuperEndo B&L-alpha II

Cordless Heat Carrier

Operation & Maintenance

Instruction Manual

PLEASE READ ALL INSTRUCTIONS PROVIDED FOR THIS DEVICE BEFORE USING IT.

Caution: This product should only be used by dental professionals after reading the instruction for use.

FULLY CHARGE BATTERY IMMEDIATELY UPON RECEIPT AND PRIOR TO FIRST USE.

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Introductions

Thank you for purchasing the Alpha II obturation device from B&L Biotech,

Inc. The Alpha II supports obturation techniques that require warm vertical

compaction of gutta-percha or Resilon® root canal filling materials. READ

THIS MANUAL CAREFULLY AND BE FAMILIAR WITH ALL SAFETY PRECAUTIONS PRIOR TO USING THIS DEVICE.

Safety Instructions

1 Improper usage of this device may cause injury to patients, operators and

dental assistants, and/or damage to the product.

It is intended exclusively for use by licensed dentists and endodontists only.

Plugger Tips are very hot when device is activated, thus care must be taken

2 by the dentist, assistant and patient not to contact the tip while hot. Usage

of a rubber dam is strongly recommended for proper isolation of the tooth.

3 The temperature of the Plugger can reach 230°C, therefore, it should not be

used inside the root canal for more than 5 seconds at a time.

Plugger Tips must be sterilized before first use and between patient uses.

For sterilization of tip, temperature must not exceed more than 135°C in the

autoclave.

Contraindications

1 Do not use any other Plugger Tips except the ones supplied by B&L Biotech. Use of any Plugger or battery that is not supplied by B&L may result

in electrical shock, fire, or explosion and void Warranty.

2 Do not use the Alpha II device on patients with pacemakers.

3 Do not use the Alpha II device when the battery level displays red light.

Charge the unit and wait for the device to display the green light.

4 It is recommended that battery be fully charged before using the Alpha II

device for the first time. Allow approximately 3 hours for full charge.

5 The actual temperature of a Alpha II Plugger is within a range of +/- 40°C of

the temperature displayed on the unit.

6 DO NOT use disinfectants that contain Bleach or Ammonium Chloride to

clean the device.

7 DO NOT autoclave the Heating Unit or Charging Base.

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Features

B&L-ALPHA II PACKAGE CONTENTS

•

•

•

•

•

•

•

Heating Unit

Charging Base

Battery

Adapter 12V, 1620mAH

Power Cord

Directions For Use

Pluggers

Available Pluggers Include (Tip Size / Taper):

•

•

•

•

30/04

• 35/04

• 40/04

• 45/04

55/06

• 55/08

• 55/10

• 60/12

55/08L

• Spreader/S

• Spreader/T

Thermal Tester

SPECIFICATIONS

Charging Base Dimensions: 81mm X 137mm X 36mm

Charging Base Weight: 207g

Heating Unit Dimensions: 12.5mm X 150.5mm X 21.5mm

Heating Unit Weight: 63g

TECHNICAL DATA

Battery: Li-Ion 3.7V

Source: 100~240V / 50~60Hz, DC 12V, 850mA

Operating Temperature: 0ºC to 45ºC, Storage Temperature: -20ºC to 60ºC

STANDARD SYMBOLS

Class II

Equipment

Type B

Applied Part

Consult

Instructions

Keep Dry

-20ºC

For Use

Date of

Manufacture

CE Mark

3

Serial

Number

Caution

60ºC

Temperature

Limitaion

Authorized

Representative

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Product Description

HEATING UNIT

Plugger

Plugger Attachment Cap

Heater Switches

Battery Level Indicator

Temperature Display

Power “ON/OFF” Switch / Temperature SelectionPowers the unit on and off, and changes the

temperature setting

⑦ Battery Casing

①

②

③

④

⑤

⑥

①

②

③

④

⑤

CHARGING BASE

⑥

① Charging Status Indicator

② Charging Contact Terminals

⑦

②

①

POWER

ADAPTER

BATTERY

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How to Install/Change the Battery Pack

① Insert the Battery Pack into the Heating Unit as shown in the pictures.

② Thread the Battery Casing onto the Heating Unit. Caution: Ensure threads

are aligned and avoid excessive forces when threading the Battery Casing

onto the Heating Unit.

③ When replacing the battery, turn the Battery Casing counterclockwise.

Separate the Battery from the connector of the Heating Unit. See ① and ②

above for installation instructions.

(Caution: When inserting the battery, make sure the connector is properly set).

Attaching Pluggers to the Heating Unit

① Press the Power “ON/OFF” Switch

button. If lights do not display, check

the Battery connection. If the display

window shows ‘oPn’, this indicates

that the Plugger is not connected

properly. When the Plugger is connected properly, the default temperature

of 200°C or the last temperature setting will appear.

② To change the temperature setting, press the Power “ON/OFF” Switch until

reaching the setting you desire. Pressing the switch will rotate temperature

settings in the following order; 150°C >180°C > 200°C > 230°C >150°C.

Recommended Temperatures: Gutta-percha - 200°C Resilon® - 150°C

Caution: Plugger is extremely hot during use. Avoid direct contact with the

patient’s soft tissue in the oral cavity.

Inserting Plugger

Note: The mouth of the Heating Unit has 6 different slots for inserting the

Plugger. Select the appropriate one based on your preferred orientation of

the Heater Swiches in relation to the Plugger tip.

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Heating the Plugger

① Once the Plugger is properly connected to the Heating Unit, press the Power

“ON/OFF” Switch to turn on the unit. When the power is on and the Plugger

has been properly installed, the temperature will be displayed on the screen.

② Change the temperature if necessary.

③ Heating the Plugger occurs by pressing (and holding) either one of the two

Heater Switches. Releasing the Heater Switch allows the Plugger to return to

room temperature. During normal operation, a beeping noise will indicate that

the Plugger is hot. Do not touch the Plugger until it has a chance to return to

room temperature.

Caution During the Usage of this Device

① The Alpha II Heating Unit is designed to turn-off automatically if the battery

should begin to overheat. While the chance of this occurring is rare, if it occurs, please allow the Heating Unit sufficient time to cool. Then, recharge the

Heating Unit by placing it on the Charger Base for at least 30 seconds before

attempting to use again.

② Heat activation of the Plugger inside the canal should not exceed more than 5

seconds.

③ This device shuts off automatically if not used for more than 10 minutes. Press

the Power “ON/OFF” Switch to turn on the unit.

④ The tip of the Plugger is very hot during use. Please perform all endodontic

procedures with a rubber dam.

⑤ For safety purposes, place the tip of the Plugger at the orifice of the root canal

before activating the Heater Switches. Use caution to avoid contact to the soft

tissue of the oral cavity while the Plugger is hot.

⑥ When replacing the Plugger, turn the power off and ensure the Plugger has

cooled down sufficiently.

⑦ The Plugger should be sterilized prior to use. The Plugger can be sterilized in

an autoclave in accordance with the sterilization guidelines of the autoclave’s

instruction manual.

NOTE: This device is only intended for use during root canal therapy. Use extreme caution with the Heating Unit so as not to burn the patient or oneself.

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Charging the Battery

Keep the Heating Unit on the Charging Base while the unit is not in use. The

Device is ready for use when the LED charging status indicator displays a green

light. Once a red light on the Battery Indicator of the Heating Unit starts to flash,

the unit needs to be recharged by carefully positioning the Heating Unit on the

Charging Base ensuring

the proper contact is made.

Once the battery is fully

charged, the LED charging

status indicator will turn

green.

Charging (Amber)

Fully charged (Green)

① Connect the Power Adapter to the Charging Base.

② Position the Heating Unit on the Charging Base

correctly so that the Battery Charging Contact

Terminals on the bottom of the Heating Unit align

with the two Charging Contact Terminals on the

Charging Base with the temperature display window facing upwards.

③ If the correct connection is made, the LED charging status will display an amber light during charging. Once the battery is fully charged, the LED charging

status indicator will turn green.

Note: If the LED is neither yellow or green, the charging terminals are not

properly connected. Re-align the Heating Unit on the Charging Base and also

check that you are getting power to the Charging Base.

Pluggers should be removed while charging. Please keep the pluggers

disconnected from the unit after each treatment.

Reamaing Battery Level

④ To confirm whether the battery is fully charged, separate

the unit from the Charging Base and turn on the Heater

Switch. If there are 3 levels of the green LED displayed,

the unit is fully charged.

100%

70%

40%

10%

Note: If the unit has not been in use for more than a month, it may not function

correctly due to natural discharge of the battery. Monthly recharging is recommended even when the unit has been fully charged but is not in use.

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Technique Overview

STEP 1: CONE FIT

Select a cone that fits snuggly to Working Length (WL). Trim 0.5mm from the

tip. Note: Do not use sealer for this step.

STEP 2: PLUGGER FIT

Choose the Alpha II Plugger which most closely matches the taper of the prepared canal. Place the Plugger into the canal until it binds.

Note: Plugger tip should be approximately 4 to 7 mm short of WL. Move the

rubber stop to indicate the maximum depth of penetration.

STEP 3: CONDENSE CONE WITH HAND PLUGGER

Coat the cone (fitted in step 1) with sealer and push it as far into the canal as

possible. Note: Tip should be approximately 0.5mm from WL. Use the Alpha

II to sear off excess cone material at the canal orifice. Use a hand plugger to

condense the cone.

STEP 4: CONDENSE CONE WITH ALPHA II PLUGGER

Activate the button to bring the Alpha II Plugger to the desired temperature.

Note: 150°C for Resilon and 200°C for GP is recommended. Advance the

Plugger apically until reaching the depth indicated by the rubber stop (set in

step 2). Release the button to allow the Plugger to begin cooling, while at the

same time holding continuous apical pressure, hold for 5 seconds. Remove the

Plugger from the canal. Note: if there is a tendency for the cone to come out

with the Plugger – activate the button to heat the Plugger again (allow it time to

reach set temperature) before trying to remove the Plugger from the canal.

STEP 5: CONDENSE SHORTENED CONE WITH HAND PLUGGER. BACKFILL

Use a small hand plugger to condense the remaining cone apically. Set the

rubber stop (same depth as Step 2) and condense the remaining material.

Backfill to the orifice with SuperEndo Beta (see Beta instructions for details).

Technique Tips

① It is important to select the appropriate Plugger size and taper. The Plugger’s

Tip should meet resistance within 4 to 7 mm of the Working Length.

② Do not advance the gutta-percha beyond the binding point. If the gutta-percha

is advanced beyond the binding point, there will be no pressure applied to the

gutta-percha while it is cooling. Therefore, use a hand Plugger and apply direct

pressure.

③ If the temperature exceeds 200°C, the gutta-percha may become soft and

could be ineffective during compression.

④ If a large amount of gutta-percha is used, raise the temperature setting to

230°C.

⑤ After “sustained push”, let the Plugger cool before the removal from the canal.

This reduces the chance of pulling the filling back out with the Plugger.

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Troubleshooting

Code Description or possible causes

Recommended action for the user

Er0

Defective Microprocessor

If this error code is displayed on the screen

please contact authorized dealer’s customer service department.

oPn

This message will be displayed on

the screen if the Plugger is not correctly connected to the unit and if the

heating mechanism is not working

properly.

Separate the Plugger from the unit and reconnect the Plugger. If proper temperature

setting is displayed, it indicates normal

state. If the same message is displayed,

replace with a new Plugger and check

to see if same problem occurs. If same

problem occurs, please contact authorized

dealer’s customer service department.

SHR

Desired temperature not reached in

200 seconds: defective plugger or low

battery power.

Recharge the battery or replace the plugger. If the code does not disappear, return

the unit to authorized dealer for replacement.

HD1

Temperature does not change within

5 seconds after activation: Defective

plugger.

Replace the plugger. If the code does not

disappear, return the unit to authorized

dealer for replacement.

Power turns off while in use and

power does not turn on again.

A. This may result from the Device overheating. Let the unit cool and retry.

B. Recharge.

C. If the same problems occur after

recharging, change the battery.

Sterilization & Maintenance

Keep this device at room temperature away from external shock or direct

sunlight.

Heating Unit and Charging Base – Clean the exterior of the Heating Unit and

Charging Base by using a soft cloth moistened with a mild detergent or rubbing

alcohol. The surfaces should be sheathed with plastic barrier to prevent contamination and discoloration. The use of non-recommended cleaning agents

could result in damage to the outer surface of the Alpha II Device.

DO NOT use strong disinfectants or those that contain Bleach or Ammonium

Chloride to clean the device.

DO NOT autoclave the Heating Unit or Charging Base.

Plugger – After each use, the Plugger should be sterilized by autoclave for 60

minutes at 121ºC, 15 PSI. Dispose of used Plugger into a biohazard container.

Notice: If the unit is not used for an extended period of time (more than once

per month), it may not work because of battery discharge. Periodical (once per

month) recharge is recommended even if the Device is not used. It is recommended to change the battery every 6 months. Please contact authorized

dealer to purchase a replacement battery.

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Warranty

B&L Biotech, Inc. warrants the Alpha II Obturation Device against defects in

material and workmanship for 12 months from the date of purchase with proper usage. During that twelve-month period, B&L Biotech will repair or replace

a defective unit. Defects caused by misuse, neglect, accident or abuse are not

covered by this warranty. B&L Biotech, Inc. assumes no liability resulting from

improper use, damage or breakage due to misuse of the Alpha II Obturation

Device product by the purchaser.

The manufacturer is not responsible for breakage of any component of the

Alpha II Obturation Device, including the Plugger, resulting from forceful

compaction of gutta-percha or Resilon® or use of the Plugger outside of the

methods noted in this Instruction for Use.

The battery and Pluggers in the Alpha II Obturation Device are replaceable.

New batteries and Pluggers can be ordered from B&L Biotech, Inc.

B&L Biotech, Inc. assumes no liability for damage to the Alpha II Obturation

Device, injuries to patients or users or other problems resulting from use of

accessories or other materials not supplied by B&L Biotech, Inc.

For Sales Orders and Product Information Contact:

Manufactured by:

B&L Biotech, Inc.

502, Gungjun tower, 727-3 Gojan-dong, Danwon-gu, Ansan-si,

Gyeonggido, Korea 425-906

www.bnlbio.com

EMERGO EUROPE

Molenstraat 15, 2513 BH, The Hague, The Netherlands

tel. +31 70 345 8570

tel. +31 70 346 7299

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UM-A1-01

Rev.002