DENTSPLY Tulsa Dental Calamus Flow Manual

DIRECTIONS FOR USE
®

TABLE OF CONTENTS:
Specifications . . . . . . . . . . . . . . . . . . . . . . .1
Indications for Use . . . . . . . . . . . . . . . . . . .1
Contraindications . . . . . . . . . . . . . . . . . . . . .1
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Precautions . . . . . . . . . . . . . . . . . . . . . . . . .2
Adverse Reactions . . . . . . . . . . . . . . . . . . .2
Package Contents . . . . . . . . . . . . . . . . . . . .2
Setting Up the Unit . . . . . . . . . . . . . . . . . . .3
Operation . . . . . . . . . . . . . . . . . . . . . . . . . . .4
Replacing a Cartridge . . . . . . . . . . . . . . . . .5
Obturation Technique . . . . . . . . . . . . . . . . .5
Sterilization, Disinfection & Maintenance . .6
Troubleshooting . . . . . . . . . . . . . . . . . . . . . .6
Symbol Descriptions . . . . . . . . . . . . . . . . . .6
Warranty . . . . . . . . . . . . . . . . . . .Back Cover
Console Dimensions: 4.6" x 7.2" x 3.4"
(11.7cm x 18.3cm x 8.6cm)
Hand piece Dimensions: 7.35" L x 0.84" W
(18.7cm x 2.1cm)
Weight: 2.1 lbs (0.95 Kg)
Power Source: 110V/60Hz, 230V/50Hz
Fuses: 110V: 0.315A/250V Slo-Blo®fuse
230V: 0.160A/250V Slo-Blo® fuse
NOTE: The appliance inlet is the mains disconnect means.
Environmental Conditions:
Operating Temperature 10 to 28°C (50 to 82.4°F)
Storage Temperature -20 to 60°C (-4 to 140°F)
Relative Humidity 5 to 95% non-condensing
Altitude 0 to 3048 meters (0 to 10,000 feet)
INDICATIONS FOR USE:
The Calamus Flow Obturation Delivery System is an obturation
delivery system and hand piece device that is used for heating
and placement of gutta-percha. The Calamus Singles cartridges
deliver warm gutta-percha into the canal during root canal therapy.
CONTRAINDICATIONS:
• Do not use on patients with a known sensitivity to latex.
• Do not use on patients with a known sensitivity to silver.
• Do not use on patients with a known sensitivity to copper.
WARNINGS:
• This product contains dry natural rubber.
• When replacing a cartridge during a procedure, the hand piece
cartridge nut and expended cartridge may be hot to the touch.
• Equipment not suitable for use in the presence of a flammable
mixture with air or with oxygen or nitrous oxide.
• Do not use near standing water. Dropping the unit into water
may cause electric shock.
• This equipment provides ordinary protection against harmful
ingress of liquids (IPX0). Do not submerge the handpiece or
cartridges in any liquid.
SPECIFICATIONS:
MEDICAL ELECTRICAL EQUIPMENT
WITH RESPECT TO ELECTRIC SHOCK,
FIRE AND MECHANICAL HAZARDS
ONLY IN ACCORDANCE WITH UL
60601-1 (First Edition) and CAN/CSA
C22.2 No 601.1-M90.
1
41EJ
This device has been tested and found to comply with the emissions
requirements of IEC 60601-1-2:2001-09. These requirements provide
reasonable protection against harmful electromagnetic interference in
a typical medical installation. However, high levels of radio-frequency
(RF) emissions from electrical devices, such as cellular phones, may
disrupt the performance of this device. To mitigate disruptive electro-
magnetic interference, position this device away from RF transmitters
and other sources of electromagnetic energy.
Manufactured for:
DENTSPLY Tulsa Dental Specialties
DENTSPLY International, Inc.
608 Rolling Hills Drive, Johnson City, TN 37604
1-800-662-1202 • Fax: [phone] • www.tulsadentalspecialties.com
by Aseptico, Inc. Woodinville, WA USA
RX: FEDERAL LAW RESTRICTS THIS DEVICE TO
SALE BY OR ON THE ORDER OF A DENTIST
0459
EU Authorized Representative:
Advena Ltd, Hereford, HR4 9DQ UK
®

2
PACKAGE CONTENTS:
• Calamus Flow Obturation Delivery Device
• Remote Power Cord (110V)* . . . . . . . .PN: 840079
• Cartridge Needle Bending Tool . . . . . . .PN: 461270
• Hand piece Cleaning Brush . . . . . . . . . .PN: 600014
• Replacement Cartridge Nut . . . . . . . . . .PN: 461273-08
• Calamus Singles II - Gutta-Percha Cartridges:
23 gauge . . . . . . . . . . . . . . . . . . . . . . . .PN: GP-025EP
20 gauge . . . . . . . . . . . . . . . . . . . . . . . .PN: GP-035EP
• Directions for Use . . . . . . . . . . . . . . . . .PN: 420391
• Hand Piece Heat Shield . . . . . . . . . . . . .PN: 461493
• Quick Reference Card . . . . . . . . . . . . . .PN: 420416
• DVD . . . . . . . . . . . . . . . . . . . . . . . . . . . .PN: ED-35
* Hospital grade power cord must be used with this device
PRECAUTIONS:
• Always unplug the unit before changing fuses or adjusting Voltage Selector.
• Applying excessive downward pressure or not allowing the device to back out of the
canal may result in a broken needle.
• Place the cannula gently into the canal. Too much pressure will stop the motor from
turning.
• When replacing a cartridge during a procedure, the hand piece cartridge nut and
expended cartridge may be hot to the touch.
• The forward portion of the hand piece becomes warm during use. The heat shield
(included with the system) may be used optionally to reduce the hand piece surface
temperature. If the heat shield is not utilized, avoid contact with the forward portion
of the hand piece.
• Do not clean unit with a flammable cleaning solution.
ADVERSE REACTIONS:
Use in patients with a known sensitivity to latex may cause an allergic reaction. Such
reaction may result in swollen eyelids, lips or face. It may also cause difficulty in
breathing. The patient should be advised to notify you immediately if any of these
symptoms occur.

3
1. Unpack the console and check that the Voltage
Selector is set to the proper voltage. Use the110
setting for 110-120V 60Hz voltages, and the 220
setting for 220-250V 50Hz voltages. To change
voltage, replace the fuse to match voltage (see
specifications on page 1). Use a flat head
screwdriver to turn the Voltage Selector on the
back of the console to the proper voltage
setting.
2. Remove packaging from hand piece. Wipe down
hand piece with a mild disinfecting solution - do
not submerge hand piece. A disposable sanitary
plastic barrier may by used over the hand piece.
Set hand piece in holder on the control console.
The forward portion of the hand piece becomes
warm during use. The heat shield (included with
the system) may be used optionally to reduce
hand piece surface temperature. If the heat
shield is not utilized, avoid contact with the
forward portion of the hand piece. Sterilize the
heat shield before first use and between each
patient use. See sterilization instructions on
page 5.
3. Attach the power cord to the back of the console
and plug into a grounded electrical outlet.
4. Remove a Calamus Singles Cartridge from blister
pack. Store cartridges at room temperature.
5. Install a cartridge into the hand piece: Unscrew
and remove the cartridge nut from the hand
piece. Insert a cartridge into the hand piece,
needle facing outward. Slip front cap over
needle and screw the cap on clockwise lightly -
do not tighten. Note: Do not remove hot
cartridge.
6. If the cartridge doesn't fit completely into the
hand piece, press the Power switch on the front
of the console to the 'ON' position, and press
the Return button on the console. The plunger
must be in neutral position to accept the
cartridge.
7. Turn the unit to the ‘OFF’ position before
replacing the cartridge.
8. Gently place the heat shield over the cannula
and hand piece as necessary.
9. Use the needle bending tool to place a smooth
radius curve on the needle so the needle can
extend to within 5 mm of the working length of
the canal. Place the needle between the two
raised bending posts and gently bend the
needle to the desired angle.
10.Place the needle between the two raised
bending posts. Gently bend the needle to the
desired angle.
Fuses
FUSES AND VOLTAGE SELECTOR
STEP-BY-STEP INSTRUCTIONS
SETTING UP THE UNIT:
Hand Piece
Cartridge Nut
Gutta-percha
Level Indicator
Ventilation Gap
Hand Piece Activation Cuff
Hand Piece
Heat Shield
HAND PIECE COMPONENTS
Voltage Selector
Programming Port
For Service/Production Use Only

4
After the unit has been set up, you are ready for
operation as follows:
1. Press the Power switch on the front of the console
to the ‘ON’ position. (The last used temperature
and flow settings are retained in memory).
2. Select either preset button to recall preset
temperature and flow rate or manually adjust
settings as follows: (Preset values: 180°C, 60%
flow rate)
a. Press the Temperature Increase or Decrease
button to set the desired temperature. (The yellow
temperature LED will illuminate for approximately
five seconds indicating that the target temperature
is being displayed.) While the system’s
temperature increases, the numerical LEDs will
blink until the target temperature is reached. Once
the target temperature is achieved, the LEDs will
display a steady reading.
b. Press the Flow Rate % Increase or Decrease
button to select the desired flow rate. (The yellow
Flow Rate LED will illuminate for approximately
five seconds indicating that the numerical LEDs
are displaying flow rate.) We suggest starting at
the preset temperature and flow rate. Adjust from
there to your preference.
c. To store your new settings, press and hold either
Preset button until the Preset LED illuminates
(approximately two seconds).
3. Dispense gutta-percha into canal: Press the
activation cuff to start the flow of filling material.
You will notice a short delay as the plunger
engages and pushes gutta-percha to the tip of the
needle. Extrude a small amount of gutta-percha
from the needle. Wipe the excess gutta-percha
from the tip before inserting the needle into the
canal. Engage the needle within the root canal in
accordance with your preferred technique. Hold
the hand piece lightly when placing material to
allow the device to readily back out of the canal.
As the material is expressed, the indicator will
help you estimate how much material remains in
the cartridge.
Note: Applying excessive downward pressure
or not allowing the device to back out of the
canal may result in a broken needle.
4. Standby Mode: After five minutes of inactivity, the
device will enter standby mode, indicated by the
Numerical LED Window displaying a scrolling dot
pattern. The hand piece heat chamber will turn off
and slowly cool to room temperature. Press any
control to reactivate the device.
Numerical LED Window
Temperature Decrease
Flow Rate % Decrease
Preset In Use LED
Presets
Temperature Increase
Flow Rate % Increase
RETURN LED
Indicates plunger return
operation is in progress
Temperature LED
Flow Rate LED
RETURN select. Press to
return cartridge plunger to
neutral position in order to
replace cartridge
OPERATION:
®

5
REPLACING A CARTRIDGE:
NOTE: When replacing a Calamus Singles II cartridge during a procedure, the hand piece
cartridge nut and expended cartridge are hot to the touch.
1. Select a 20 or 23 gauge cartridge.
2. Retract the delivery plunger by pressing the Return button.
3. Turn the unit off.
4. Allow the hand piece to cool.
5. CAUTION: Do not remove hot cartridge.
6. Unscrew and remove the hand piece cartridge nut.
7. Using the included bending tool, remove the cartridge from the hand piece.
8. Dispose of used cartridge in an appropriate biohazard container.
9. Insert a new cartridge, needle out, into the open end of the hand piece.
10. Slip hand piece cartridge nut over needle and screw on clockwise lightly - do not tighten.
OBTURATION TECHNIQUE:
This is one of many technique options. Selection of a preferred technique is at the discretion
of the clinician.
DOWNPACK
1. Clean and shape the canal using the instruments and techniques you prefer. It is essential
to thoroughly remove bacteria and diseased tissue from the canal before obturation.
2. Fit a tapered master cone in a prepared canal and confirm it is at length using a radiograph.
3. Dry the canal with appropriately sized paper points. Determine the final working length.
4. Trim the master gutta-percha cone back to the foramen, if indicated.
5. Lightly coat the master cone with sealer and gently slide it to length.
6. Sever the placed master cone about 5 mm from the apex. Heat-soften, condense and
downpack the master cone in the apical 5 mm of the canal. Use vertical condensation,
continuous wave or other hybrid technique to achieve the downpack.
BACKFILL
1. Before backfilling, select appropriately sized pluggers for the procedure.
2. Position the tip of the hot Calamus Singles needle against the downpacked filling material.
Press the activation cuff on the hand piece and dispense a few mm of material into the canal.
3. Allow the flow of filling material to lightly back the hand piece out of the canal.
4. Use a small plugger to pack and adapt the injected, heat-softened material into this region
of the canal. To offset filling material shrinkage, sustain plugger pressure for 5 seconds as
the material cools.
5. Position the tip of the hot Calamus Singles needle against the obturation filling material.
Press the activation cuff on the hand piece and dispense another few mm of material into
the canal.
6. Use a larger plugger and step its working end circumferentially around the canal to three-
dimensionally mold and tightly adapt the filling material into this region of the canal. To off-
set filling material shrinkage, sustain plugger pressure for 5 seconds as the material cools.
7. At your discretion, continue this backfilling technique (steps 5 and 6) until the canal is com-
pletely filled or stop at any point to facilitate placement of a post.

6
SYMBOL DESCRIPTIONS:
Type BF
Applied Part
Fuse Ratings
Dangerous
Voltage
Attention - Consult
Accompanying
Documents
Class II
Equipment
Hot Surface
Alternating
Current
TROUBLESHOOTING:
1. Device does not turn on:
(a) Check that power cord is plugged into device and wall outlet.
(b) Unplug device and check fuse. If fuse is blown, replace with 0.315A, 250V Slo-Blo®type
fuse (0.160A, for 230V).
2. Cannot remove hand piece cartridge nut: (a) Press the Return button to retract the
plunger and to relieve pressure on the hand piece front cap.
3. Gutta-percha does not flow through needle: (a) Verify that the needle is not kinked - avoid
over bending the cartridge needle.
(b) Verify that the device has reached operational temperature (numerical LED has stopped
blinking). Increase temperature if needed.
4. Delivery plunger does not retract: (a) If, after pushing the Return button, the gutta-percha
indicator does not fully retract to the end of the indicator window, push the Return button again.
5. Motor stops turning: (a) If the motor stops turning, the cannula may have been placed too
firmly in the canal. Reduce the pressure applied to the cannula and the motor may begin
turning again.
STERILIZATION, DISINFECTION & MAINTENANCE:
Control Console – Clean the exterior of the console by wiping with a soft cloth moistened with
a mild detergent or disinfecting solution. The system is designed to allow for a disposable sani-
tary plastic barrier to be utilized over control console and/or hand piece.
Hand Piece – Wipe off the hand piece with a soft cloth moistened with mild detergent or disin-
fecting solution. NOTE: When wiping down the hand piece cable, gently wipe from the middle
of the cable out toward the hand piece and console. Avoid gripping the cable tightly. DO
NOT SUBMERGE the hand piece in any fluid or spray any fluid
directly on the hand piece.
Hand Piece Cartridge Nut – Steam autoclave for 10 minutes at 132°C.
Hand Piece Delivery Plunger – Annually: Without a cartridge inserted, press the activation
cuff until the gutta-percha indicator moves all the way forward. Then, push the Return button
and allow the indicator to completely retract.
Hand Piece Cartridge Heater – If gutta-percha gets into the cartridge heater section of the
hand piece, turn on the unit and press the Return button on the console to fully retract the
plunger. Allow the heater section to reach operation temperature (180°C). Turn off unit. Insert
the included hand piece cleaning brush into the heating chamber. Rotate the brush several
times to remove the gutta-percha from the chamber.
Cartridges – Store cartridges at room temperature. Cartridges are intended for single patient use.
Dispose of used cartridges in a biohazard container. Do not immerse the cartridges in any liquid.
Heat Shield – Steam autoclave for 15 minutes at 132°C.

WARRANTY
DENTSPLY warrants this product against defects in material or
workmanship for a period of one year from date of original invoice.
DENTSPLY’s sole obligation under the product warranty is (at its
sole option and discretion) to repair or replace any defective
component or product in part or whole. DENTSPLY shall be the sole
arbiter of such action.
In the event of an alleged defect under warranty, the purchaser is to
notify DENTSPLY Customer Service Department promptly.
Customer Service will provide instructions, usually directing that the
product be returned for service. Shipment to DENTSPLY and the
cost thereof is always the responsibility of the purchaser.
Accidental misuse, inappropriate installation, or failure to perform
directed maintenance voids the warranty.
DENTSPLY does not assume, under this warranty, any risks or
liabilities arising from the clinical use of its products, whether or not
such use involves coincidental utilization of products manufactured
by others.
DENTSPLY makes no warranty other than that stated above,
expressed or implied.
Contact DENTSPLY Tulsa Dental Specialties Technical Department
at 1-800-662-1202 for repair authorization and shipping instructions.
NOTE: In the interest of serving our customers more efficiently, customers receiving
service on non-warranted repairs are expected to accept charges that are less than
$250.00 without further notification.
PN 420391 • Rev. C • ECO 11335 • Date 1/07
Printed in the USA
DENTSPLY International, Inc.
608 Rolling Hills Dr.
Johnson City, TN 37604
1-800-662-1202
For Dental Use Only Rx only