DENTSPLY CALAMUS PACK Manual

DIRECTIONS FOR USE
Vertical Compaction Device

Distributed By:
DENTSPLY Tulsa Dental Specialties
DENTSPLY International, Inc.
608 Rolling Hills Drive, Johnson City, TN 37604 USA
1.800.662.1202 • Fax: [phone]
www.tulsadentalspecialties.com
Manufactured By:
Aseptico, Inc.
8333 216th St. SE
Woodinville, WA 98072, USA
US and Foreign patents pending.
Rx Only
For Dental Use Only
i

1
Table of Contents
PACKAGE CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
SYMBOL DESCRIPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
WARNINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
ADVERSE REACTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
DIRECTIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Setting Up The Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Console Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
Handpiece Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
Fuse Replacement Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
STERILIZATION & MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Control Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Electric Heat Pluggers & Thermal Response Tip . . . . . . . . . . . . . . . . . . . . . . .15
CLINICAL TECHNIQUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16
Cone Fit & Plugger Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Calamus®Downpack: Vertical Condensation . . . . . . . . . . . . . . . . . . . . . . . . .18
Calamus®Downpack: Continuous Wave Technique . . . . . . . . . . . . . . . . . . . . .19
Calamus®Downpack: Hybrid Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . .20
Calamus®Backfill Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22
FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24
CCoonnggrraattuullaattiioonnss!!
Calamus®Pack Vertical Compaction Device is engineered to provide
consistent and reliable results. Please read all instructions for use
provided in this manual to achieve the optimal performance and
longevity of your device and all related components.

2
Package Contents
• Console Unit:
• Pack Handpiece (downpack)
• Calamus®Electric Heat Pluggers (EHP):
ªSmall - Black ISO 40/.03
ªMedium - Yellow ISO 50/.05
ªLarge - Blue ISO 60/.06
• Remote power cord (115V)
• User manual (DFU)
• Reference Card
Figure 1
System Contents
Pack Device
Electric Heat
Pluggers
Pack Handpiece

3
Specifications
•Console Dimensions: . . . . . . .4.6" x 7.4" x 4.4" cm
(11.7cm x 18.8cm x 11.2cm)
•Weight: . . . . . . . . . . . . . . . . .2.85 lbs (1.30 kg)
•Power Source: . . . . . . . . . . . .115V/60Hz, 230V/50Hz
•Current Rating: . . . . . . . . . . .115V/0.10A, 230V/0.05A
•Fuses: 115V: . . . . . . . . . . . . .0.10A/250V Slo-Blo®fuse
230V: . . . . . . . . . . . . .0.05A/250V Slo-Blo®fuse
•Note: The appliance inlet is the mains disconnect means.
•Battery Type: NiMH 9.6V, nominal 4500 mAh
•Plugger: . . . . . . . . . . . . . . . .Stainless Steel
•Thermal Response Tip: . . . . .Aluminum/Stainless Steel
•Environmental Conditions:
ªOperating Temperature: 50° to 82.4°F (10° to 28°C)
ªStorage Temperature: -4° to 140°F (-20 to 60°C)
ªRelative Humidity: 5 to 95 % non-condensing
ªAltitude: 0 to 10,000 feet (0 to 3,048 meters)
•Duty Cycle: . . . . . . . . . . . . . .25%
•Temperature range: . . . . . . .100 - 400°C
•Tone level range: . . . . . . . . .0 - 100%
Handpiece Maximum continuous heating time:
• 10 seconds for temperatures above 200°C.
• 15 seconds for temperatures at or below 200°C.
• One minute in thermal response mode.
Caution:
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 emissions from electrical devices, such as cellular phones, may disrupt the
performance of this device. To mitigate disruptive electromagnetic interference, position this
device away from radio frequency transmitters and other sources of electromagnetic energy.
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.
41EJ

4
Symbol Descriptions
Fuse ratings: 115V: 0.10A
230V: 0.05A
250V SLO-BLO
Type BF Applied Part
Attention – Consult Accompanying Documents
'ON' Switch
'OFF' Switch
Electric Heat Pluggers and Thermal Response Tips are Autoclavable
Class II Equipment
Dangerous Voltage
Alternating Current
Hot Surface
Nonreturnable if Seal Is Broken
115V: 100mA
230V: 50mA
250V SLO-BLO

5
Intended Use
The Calamus®Pack is intended to heat Electric Heat Pluggers for
warming and softening and searing off gutta percha cones as well as
severing obturator handles and obturator carriers. The device is also
intended to heat the Thermal Response Tip that subjects a tooth to heat
in order to determine pulp vitality. The Calamus®Pack device may only
be used in conjunction with the Calamus®pluggers and the Calamus®
thermal response tips.
Contraindications
• None Known

6
Warnings
Failure to adhere to the following instructions or blatant misuse of the
device and/or related components will be considered abuse of the device
and will void all warranty responsibilities.
• Electric Heat Plugger tips and Thermal Response Tips become hot
during use. Turn off the unit and allow the EHP's to cool before
exchanging tips.
•CAUTION: Do not contact the lips, gums or oral mucosa with the
EHP as it can cause tissue damage after exposure.
• Equipment not suitable for use in the presence of a flammable
mixture with air, oxygen or nitrous oxide.
• Risk of fire: Do not contact the heated tip or handpiece with
flammable gases or liquids.
• Do not use near standing water. Dropping the unit into water may
cause electric shock, will destroy the device and can lead to death.
• This equipment provides ordinary protection against harmful ingress
of liquids. Do not submerge the handpiece or cartridges in any liquid
or spray any fluid directly onto the handpiece.
• Chemclaving is not recommended for sterilization and maintenance of
the Electric Heat Pluggers or Thermal Response Tips as this would
cause corrosion.
• There are no serviceable components inside this unit. Do NOT Open!
• Battery packs may leak or explode if mishandled. Do not
disassemble, incinerate, or submerge battery packs in any fluid
• To avoid accidental activation, remove the battery pack prior to
storing the unit for extended periods of time.
• Do not ship the Calamus®Pack unit with the accessory Plugger or
Thermal Response tips attached.
•NOTE: Expended battery packs should be recycled or disposed of
properly. For information regarding free battery recycling programs
in your area, please call 1.800.822.8897.
•CAUTION: Do not stay in the root canal with a heated tip for
more than 4 seconds to prevent thermal injury to the patient!
•CAUTION: Place gutta-percha on the tip of the Thermal Response
Tip before applying to the patient’s tooth! Do not place the tip directly
on the tooth!

7
Precautions
• A dental dam should be used with any dental procedure.
• Always unplug the unit before changing fuses or adjusting the
voltage selector.
• When replacing Electric Heat Pluggers during a procedure, the
pluggers may be hot to the touch.
• Do not clean unit with a flammable cleaning solution.
• Do not clean unit with chlorinated solvents, as this will damage the
handpieces.
Adverse Reactions
None Known

8
Directions For Use
Setting Up The Pack
1. Unpack the console and check that the Voltage Selector is set to the
proper voltage. See Fig. 3.
• Use the 115V position for 110-120V 60Hz voltages, and the 230V
position for 220-250V 50Hz voltages. Always unplug the unit
before changing fuses or adjusting the voltage selector.
• To change voltage, use a flat head screwdriver to turn the Voltage
Selector on the back of the console to the proper voltage setting.
• To change fuse, replace the fuse to match voltage (see
Specifications). Replace with 0.10A, 250 V Slo-Blo®fuse (0.05A for
230 V). For replacement, press on the black plastic clip of the fuse
compartment, pull out and replace with the correct fuse.
2. Remove packaging from handpiece.
Figure 3
Back of Device Programming Port
(For Manufacturing
Use Only)
Voltage Selector
AC Power Cord Receptacle
Fuse Compartment
Battery Charge LED Indicator
Figure 2
Component & Console
Identification
On/Off Power Switch
Pack Handpiece
Preset Buttons
Thermal Response In Use LED
Tone Level
Increase/Decrease
Pack Activation Indicator
360° Activation Cuff
Temperature
Increase/Decrease
Numerical
LED Display
Electric Heat Plugger
Temperature LED
Tone Level LED
Preset Buttons In Use LEDs
Thermal Response Select

9
3. Handpiece: Clean the exterior of the handpiece with a soft cloth
moistened with mild non-chlorinated detergent or disinfecting
solution.
• Do not use disinfecting solutions which contain phenol, anti-
corrosives, very acidic or very alkaline solutions - do not
submerge handpieces.
4. Power Cord: Attach the power cord to the back of the console and
plug into a grounded electrical outlet.
5. Electric Heat Pluggers (EHP) and Thermal Response Tips:
Sterilize using steam autoclave for 15 minutes at 132°C.
6. Push EHP into handpiece tip and slowly rotate it until it clicks in with
handpiece tip. EHP must be fully engaged to achieve desired heat
settings. See Fig. 4.
7. The device is now ready for operation.
Warning: Do not touch hot EHPs.
Gently
Rotate
And Push
EHP Into
Handpiece
Figure 4
Attaching
EHP
EHP
Fully
Engaged
EHP

10
Console Instructions
Turning the device on:
• Press the power switch on the bottom left-hand side of the console to
the ‘ON’ position.
NOTE: This switch applies battery power to the unit – it does not
turn AC power On and Off. The Calamus Pack charges its battery
whenever the unit is plugged into an AC wall outlet, regardless if the
power switch is On or Off.
Programming:
Temperature Settings:
• Press the temperature buttons to set the desired temperature.
• The temperature LED will illuminate indicating the temperature
setting has been enabled.
ªPress either repeatedly to increase/decrease the temperature
in 10°C increments.
ªHolding down one arrow button will result in rapid scrolling through
the temperature range (100°C minimum to 400°C maximum).
ªTemperature setting is displayed on the numerical LED window.
NOTE: The Thermal Response Tip temperature is preset to 90°C and
is not adjustable.
Tone Level Settings:
• Press the tone level buttons to set the desired audible tone
volume.
• The tone level LED will illuminate indicating the tone level setting has
been enabled.
ªPress either tone level repeatedly to increase/decrease the
level in 20% increments.
ªHolding down one tone level arrow button will result in rapid scrolling
through the tone level range (0% minimum to 100% maximum).
ªTone level setting is displayed on the numerical LED window.
NOTE: The numerical LED window automatically defaults to
displaying the selected temperature setting. If the tone level button
is pressed, the numerical LED Window will display the tone level for 5
seconds and then revert to the selected temperature setting.

11
Factory Default Settings:
•EHP: 200°C temperature and 40% tone level.
• Thermal Response button is set at 90°C and is fixed.
Custom Preset Settings:
The Preset buttons can be manually programmed to store your
personal settings.
• Press and hold either preset button for at least two seconds.
• The preset button’s LED will illuminate indicating that it is active.
• Settings for both the temperature and tone level are now stored in
memory.

12
Handpiece Instructions
Operation:
• Press the 360° activation cuff on the handpiece to begin heating the
EHP to the selected temperature setting. See Fig. 5.
ªIf the temperature LED is illuminated, the selected temperature will
display on the numerical LED window.
ªAs the EHP’s temperature rises, one high frequency tone is heard.
ªOnce the tip is within 20°C of the selected temperature setting, the
tone will change to a lower frequency and remain at this tone until
the activation cuff is released.
ªWhen pressing the activation cuff, the tip will heat for 15 seconds for
temperature settings of 200°C or lower, and 10 seconds for settings
above 200°C before timing out.
CAUTION: Do not stay in the root canal with a heated tip for
more than 4 seconds to prevent thermal injury to the patient!
Thermal Response Tip:
ªThe Thermal Response Tip will heat for one minute while the 360°
activation cuff is depressed. To restart after a timeout has been
reached, release the activation cuff and press again.
• Always press the button to set the temperature to 90°C before
starting the pulp sensitivity test.
CAUTION: Place gutta-percha on the tip of the Thermal Response
Tip before applying to the patient’s tooth! Do not place the tip directly
on the tooth!
Electric Heat
Plugger (EHP)
Figure 5
Pack
Handpiece
Components
360°
Activation
Cuff
Activation Indicator Light

13
Fuse Replacement Instructions
Replacing the fuses:
Replacement Fuses:
115V: 0.10A, 250V rated Slo-Blo®type (Fuse size: 5 x 20mm)
230V: 0.05A, 250V rated Slo-Blo®type (Fuse size: 5 x 20mm)
NOTE: The Calamus®Pack is manufactured with 250V 0.10A rated
fuses installed for a 115VAC power source. If power source is 230
VAC, ensure that 250V 0.05A rated fuses are installed.
Warning: Turn the power off and unplug the unit before following
the fuse replacement steps.
1. Remove the fuseholder from the power inlet connector. See Fig. 6.
2. Replace the fuses in the fuseholder.
3.Replace the fuseholder.
Figure 6
Fuse
Replacement
AC Power
Inlet Connector
Fuse Holder

14
Sterilization & Maintenance
Failure to adhere to the following instructions or blatant misuse of the
device and/or related components will be considered abuse of the device
and will void all warranty responsibilities.
Control Console
• Clean the exterior of the console by wiping with a soft cloth
moistened with mild non-chlorinated detergent or disinfecting
solution.
• Do not use disinfecting solutions which contain phenol, anticorrosive
or very acidic or very alkaline solutions.
• Do not clean unit with chlorinated solvents, as this will damage the
handpieces.
CAUTION: Do NOT SUBMERGE the device in any fluid.
Handpiece
• Clean the exterior of the handpiece with a soft cloth moistened with a
mild non-chlorinated detergent or disinfecting solution.
• Do not use disinfecting solutions which contain phenol, anticorrosive,
very acidic or very alkaline solutions.
• Do not clean handpiece with chlorinated solvents, as this will damage
the handpiece.
CAUTION: Do NOT SUBMERGE the handpiece in any fluid.
CAUTION: When wiping down the handpiece cable, always wipe from
the middle of the cable out to the handpiece and then again out to
the console. Avoid gripping the cable tightly, as this will damage the
wire casing over time.
NOTE: Ensure the concentration of the cleaning or disinfecting
solution specified by the manufacturer is observed and followed.

15
Electric Heat Pluggers & Thermal Response Tip
Electric Heat Pluggers (EHP) and Thermal Response Tip (TRT) must be
disinfected and sterilized before every use:
1. Gently use a soft brush for removal of debris.
2. Clean the EHPs and TRTs under running water for a minimum of 1
minute using water and a mild, non-abrasive, detergent or
disinfectant.
3. Do NOT use disinfecting solutions which contain phenol, anti-
corrosives, very acidic or very alkaline solutions.
4. Rinse the EHPs and/or the TRT under running water for a minimum of
1 minute to remove all chemicals.
5. Dry thoroughly.
6. Steam autoclave Electric Heat Pluggers and Thermal Response Tips for
15 minutes at 132°C before initial use and between each patient.
7. Inspect the EHPs and TRTs regularly for damage.
• Deformed or oxidized pluggers and tips should be replaced.
• All EHPs and TRTs will gradually lose their heating efficiency over a
period of time.
• Use of damaged or contaminated tips is at the user’s own risk. All
liability is excluded in this case.
8. Dispose of EHPs and TRTs in a sharps receptacle.
NOTE: Observe the concentration of the cleaning or disinfecting
solution stated by the manufacturer!
WARNING: Do not touch Electric Heat Pluggers while hot!

16
Clinical Techniques
• Only use Calamus®Electric Heat Pluggers with the Calamus®Pack
device.
• Always use root canal sealer when obturating with any Calamus®
obturation device.
• Actual temperature in the root canal largely depends on the amount
of filling material used.
• Although the device is able to precisely control the heat transmission
to the tip, it is unable to prevent undesired heating up of the root.
• It is recommended to practice and test your technique on extracted
teeth, prior to patient application.
CAUTION: Do not penetrate the root canal with a heated tip for
more than 4 seconds for patient safety!
CAUTION: Do not contact the lips, gums or oral mucosa with the
EHP as it can cause tissue damage after exposure.

17
Cone-Fit & Plugger Selection
1. Prepare the canal optimally, recognizing shaping facilitates 3D
cleaning and filling.
2. Select a larger size Calamus®manual plugger that will work passively
and effectively over a range of a few millimeters in the coronal one-
third of the canal.
3. Select a medium size Calamus®manual plugger that will work
passively and effectively over a range of a few millimeters in the
middle one-third of the canal.
4. Select a smaller size Calamus®manual plugger that will work
passively, effectively and deeper in the straightaway portion of the
canal and to within 4-5 mm of the canal terminus.
5. Select the Calamus®Electric Heat Plugger (EHP) that will passively fit
through the straightaway portion of the canal and optimally to within
5 mm from the working length. Set the silicone stop at this depth to
promote safety and accuracy.
6. Fit a nonstandardized, fully tapered master cone in a fluid-filled canal
that visually goes to the working length, exhibits apical tugback and
is confirmed radiographically.
7. Dry the canal with appropriately sized paper points to determine final
working length.
8. Trim the master cone back to the canal terminus based on the paper
point drying technique.
9. Lubricate the master cone lightly with sealer and gently insert it to
length.

18
Calamus®Downpack: Vertical Condensation
1. Activate the Calamus®EHP and sear off the master cone at the level
of the orifice.
2. Select the larger size, prefit Calamus®manual plugger and step its
working end around the circumference of the canal using short, firm
strokes to move gutta-percha apically, clean the canal walls and
flatten the material.
3. Use this larger Calamus®manual plugger and press for 5 seconds to
compact warm gutta-percha vertically and laterally into this region of
the root canal system (First Wave of Condensation).
4. Activate the Calamus®EHP and plunge 3 to 4 mm into the previously
compacted material, deactivate, hesitate for 1 second, then remove
the cooling instrument along with a “bite” of gutta-percha.
5. Select the medium size, prefit Calamus®manual plugger and step its
working end around the circumference of the canal using short, firm
strokes to, again, move gutta-percha apically, clean the canal walls
and flatten the material.
6. Use this medium Calamus®manual plugger and press for 5 seconds
to compact warm gutta-percha into this region of the root canal
system (Second Wave of Condensation).
7. Activate the Calamus®EHP and plunge deeper, another 3 to 4 mm,
into the gutta-percha, deactivate, hesitate for 1 second, then remove
the cooling instrument along with another bite of gutta-percha.
8. Select the small size, prefit Calamus®manual plugger and step its
working end around the circumference of the canal using short, firm
strokes to, again, move gutta-percha apically, clean the canal walls
and flatten the material.
9. Use this small Calamus®manual plugger and press for 5 seconds to
deliver warm gutta-percha into the apical one-third of the root canal
system and to offset shrinkage during the cooling phase (Third Wave
of Condensation).
10. Select the Calamus®Flow delivery system to optimally backfill the
canal.