SuperEndo B&L-alpha II Operation and Maintenance Instruction Manual.pdf
SuperEndo B&L-alpha II
Cordless Heat Carrier
Operation & Maintenance
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.
Table of Contents
2 Safety Instructions
4 Product Description
5 How to Install/Change the Battery Pack
5 Attaching Pluggers to the Heating Unit
6 Caution During the Usage of this Device
7 Charging the Battery
8 Technique Overview
8 Technique Tips
9 Sterilization & Maintenance
This equipment conforms to the requirements of Medical Device Directive
93/42/EEC and satisfies the electrical safety requirements of EN 60601-1
and Electromagnetic emissions and immunity standards of EN 60601-1-2.
These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the
proliferation of radiofrequency transmitting equipment and other sources
of electrical noise in healthcare environments (for example, electrosurgical units, cellular phones, mobile two-way radios, electrical appliances and
high-definition television), it is possible that high levels of such interference
due to close proximity or strength of a source, may result in disruption of
performance of this device.
Risk of Fire, Risk of Burning
Keep the heated tip away from skin and anything that is flammable.
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.
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
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.
B&L-ALPHA II PACKAGE CONTENTS
Adapter 12V, 1620mAH
Directions For Use
Available Pluggers Include (Tip Size / Taper):
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
Battery: Li-Ion 3.7V
Source: 100~240V / 50~60Hz, DC 12V, 850mA
Operating Temperature: 0ºC to 45ºC, Storage Temperature: -20ºC to 60ºC
Plugger Attachment Cap
Battery Level Indicator
Power “ON/OFF” Switch / Temperature SelectionPowers the unit on and off, and changes the
⑦ Battery Casing
① Charging Status Indicator
② Charging Contact Terminals
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.
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.
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
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
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
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.
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
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.
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.
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).
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
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
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.
Code Description or possible causes
Recommended action for the user
If this error code is displayed on the screen
please contact authorized dealer’s customer service department.
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
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.
Desired temperature not reached in
200 seconds: defective plugger or low
Recharge the battery or replace the plugger. If the code does not disappear, return
the unit to authorized dealer for replacement.
Temperature does not change within
5 seconds after activation: Defective
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.
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
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.
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:
B&L Biotech, Inc.
502, Gungjun tower, 727-3 Gojan-dong, Danwon-gu, Ansan-si,
Gyeonggido, Korea 425-906
Molenstraat 15, 2513 BH, The Hague, The Netherlands
tel. +31 70 345 8570
tel. +31 70 346 7299