DENTSPLY CALAMUS PACK Handbuch

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: 1.800.597.2779

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

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.

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

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

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

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

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!

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

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

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