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