CMS Dental TD-212-25 Heater for Endodontic Obturators Instruction Manual

TD-212-25 Heater for Endodontic Obturators

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Specifications

• Product: Heater for Endodontic Obturators
• System: One-Step Obturator system

Product Information

Heater

The Heater is designed for use with Endodontic Obturators in the
One-Step Obturator system.

Product Usage Instructions

1. Intended Purpose

The Heater is intended for heating Endodontic Obturators in the
One-Step Obturator system.

2. Device Description and Specification

The Heater is a device specifically designed to heat obturators
for endodontic procedures. It meets the technical specifications
outlined below.

3. Intended Users

The Heater is intended for use by dental professionals trained
in endodontic procedures.

4. Intended Patient Population

The Heater is intended for use on patients requiring endodontic
treatment.

5. Contra-indications

There are no specific contra-indications for using the Heater
with Endodontic Obturators, but caution should be exercised in
patients with known allergies to the materials used.

6. Limitations

The Heater should only be used as instructed and should not be
modified or altered in any way.

7. Precautions

– Follow the step-by-step guide provided in the manual.

– Ensure proper cleaning and sterilization of the device before
each use.

– Keep the device away from moisture and extreme
temperatures.

FAQ

Q: Can the Heater be used with other obturator systems?

A: The Heater is specifically designed for use with Endodontic
Obturators in the One-Step Obturator system and should not be used
with other systems.

Q: How often should the Heater be cleaned?

A: The Heater should be cleaned according to the cleaning
instructions provided in the manual, typically before and after
each use.

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INSTRUCTIONS FOR USE
Heater
for Endodontic Obturators
The Soft-Core® Obturator system
The One-Step Obturator system

Table of content

1 The Obturator System ………………………………………………………………………. 3

1.1

Reporting serious incidents……………………………………………………………..3

2 Heater ……………………………………………………………………………………………. 4

2.1

Intended purpose…………………………………………………………………………4

2.2

Device description and specification…………………………………………………..4

2.3

Intended users ……………………………………………………………………………4

2.4

Intended patient population…………………………………………………………….4

2.5

Contra-indications ………………………………………………………………………..4

2.6

Limitations …………………………………………………………………………………4

2.7

Side-effects / residual risks …………………………………………………………….4

2.8

Clinical benefits to be expected ………………………………………………………..4

2.9

Precautions ………………………………………………………………………………..4

2.10 Liability ……………………………………………………………………………………..5

2.11 Warnings …………………………………………………………………………………..5

3 Step-by-step guide…………………………………………………………………………… 6

3.1.1 Preparation ………………………………………………………………………………..6

3.1.2 Preheating………………………………………………………………………………….6

3.1.3 Obturator heating ………………………………………………………………………..6

3.1.4 Indication – light and sound …………………………………………………………….7

3.1.5 Cleaning ……………………………………………………………………………………7

3.1.6 Sterilization guide for removable obturator fixture …………………………………7

4 Technical Description ……………………………………………………………………….. 8

4.1.1 Device Classification and conformity route …………………………………………..8

4.1.2 Standard compliance …………………………………………………………………….8

4.1.3 Environmental Conditions ……………………………………………………………….8

4.1.4 Declaration of shelf life ………………………………………………………………….9

4.1.5 Disposal …………………………………………………………………………………….9

4.1.6 Technical specifications ………………………………………………………………….9

4.1.7 Materials ……………………………………………………………………………………9

4.2

Symbols used …………………………………………………………………………… 10

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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1 The Obturator System
The system consists of the Soft-Core® Endodontic Obturator, the Size Verifier and the Heater. This instructions for use contain information on how to handle and use the Heater.

Part Obturator
Size Verifier
Heater

Description
An endodontic obturator is used for root filling of a prepared tooth. The endodontic obturator is a biocompatible flexible gracile plastic carrier covered with thermoplastic guttapercha.
A Size Verifier is used to select the correct size obturator. The Size Verifier confirms if there is enough space in the prepared root canal for the selected obturator size.
The Heater is an oven designed to heat and soften the guttapercha that covers the plastic carrier of the obturator.

Picture

Read the instructions for use carefully before using the device. Instructions for use is also available on the company web shop after login, https://www.cmsdentalshop.dk.
Save the instructions for use for later use.
For information on how to use the Endodontic Obturator and the Size Verifier see the products instructions for use.
· TD 208-25 IFU Soft-Core · TD 234-25 IFU Size Verifier

1.1 Reporting serious incidents
Any serious incident that may occur because of the use of the device must be reported to the manufacturer and the relevant authority in the country where the incident occurs. In Denmark, the competent authority is the Danish Medicines Agency.

For further questions about the device please contact the manufacturer:

CMS Dental A/S Elmevej 8, 7870 Roslev, Denmark

+45 3257 3000 info@cmsdental.dk www.cmsdental.com

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2 Heater
The Heater must only be used with the described endodontic obturator systems. The Heater is for professional use only. As a safety precaution, keep Heater out of patient reach.
2.1 Intended purpose
The intended purpose of the Heater is to soften the endodontic obturator material prior to usage.
2.2 Device description and specification
The Heater consists of a plastic cabinet with a heat chamber where the obturator can be placed during heating. Up to 4 obturators can be heated in the same heating cycle. The Heater has a heat chamber that consists of 5 printed circuit boards with cobber lanes. By applying power to the cobber lanes heat is generated. The Heater is driven by an external power supply.
2.3 Intended users
The Heater is for professional use only. The Heater is to be used only in a dental clinic or hospital environment by qualified dental professionals such as general practitioners as well as endo specialists and dental assistants.
2.4 Intended patient population
Patients who have an endodontic condition that requires a root canal treatment. Patients are people of all ages who need dental treatment in endodontic procedures.
2.5 Contra-indications
There are no known contra-indications.
2.6 Limitations
The Heater is for professional use only. The Heater must only be used in a dental clinic or hospital by qualified dental professionals such as general practitioners, endodontists, and dental assistants. The Heater should only be used for heating of the Soft-Core and One-Step Endodontic Obturator systems.
2.7 Side-effects / residual risks
There are no known side-effects / residual risks.
2.8 Clinical benefits to be expected
The Heater is a device to soften the endodontic obturator material prior to usage.
2.9 Precautions
The Heater should only be used for softening of Endodontic Obturators.

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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2.10 Liability
The manufacturer disclaims all responsibility and liability for injury or damage to persons or property caused by faulty and/or inappropriate use.
2.11 Warnings
The Heater surface may be hot to touch. Do not touch the inside of the heat chamber before the oven is completely cooled off.

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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3 Step-by-step guide
3.1.1 Preparation
Connect the power supply to the DC inlet of the heater and the mains and switch on power.

3.1.2 Preheating
Heat indicator (A) emits a red light while the heater preheats. Pre-heating takes 3-7 minutes depending on surrounding temperature.
When the Heater is ready, the heat indicator emits a green light, and the Heater makes a long beep.
Tips & Tricks: The Heater can be left on the entire day.
3.1.3 Obturator heating
When the Heater is ready for use place the desired number of obturators in the obturator slots marked 1 to 4. Up to four obturators can be heated in the same heating cycle.
Activate the heating cycle by pressing the ON icon. The Heater will emit a short beep.
Time indicator (B) emits a red light during the heating cycle. The heating cycle last 60 seconds.
When the heating cycle is finished, and the obturator is ready for usage the time indicator changes to a green light and the Heater emits a long beep.
The obturator can be left hanging, ready for use, in the Heater for 15 minutes.
The Heater can be turned off by pressing the ON button for 2 seconds. 3 short beeps indicate that the Heater is turned off. The Heater can be reactivated by pressing the ON button for 2 seconds, by during so a long beep is emitted.
Tips & Tricks: Place the obturator to be used first in slot 1, the second in slot 2 etc. It is recommended to begin with the smallest size obturator.
Tips & Tricks: You do not have to turn off the Heater after finished treatment, the Heater can be left on standby all day.

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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3.1.4 Indication – light and sound

Time

Heat

Sound

Preheating Ready

Activation

Obturator ready

Turn off

Power on

Auto turn off

–

Long beep

Short beep

Long beep

3 x short beep

/

Long beep

–

Long beep

3.1.5 Cleaning
When the Heater has cooled completely, residues of gutta percha may easily be removed. To clean the obturator fixture, it can be removed by turning the fixture counterclockwise and lifting it upwards.
The Heater’s outer casing can be wiped down with a slightly damp cloth using standard cleaning agents and surface disinfectants. The gutta percha residues can be removed from the heating chamber using a blunt plastic instrument.

3.1.6 Sterilization guide for removable obturator fixture
The detached obturator fixture may be washed in a dishwasher and/or autoclaved. The gutta percha residues can be removed from the fixture using a blunt plastic instrument.

INSTRUCTIONS Dishwasher Sterilization in autoclave (maximum 250 cycles) Manual cleaning
Maintenance, inspection and testing

Follow dishwasher instructions.
Vacuum autoclave, minimum 18 minutes at 134ºC, pressure 2.2 bar. Do not exceed 1340C.
Rinse excess residues from top. Use a brush or suitable instrument, apply detergent solution to all surfaces. Rinse under clear running water.
Discharge damaged products

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4 Technical Description
4.1.1 Device Classification and conformity route

Region EU

Classification
Electrical Equipment for Laboratory use.

Conformity
IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements.

4.1.2 Standard compliance

Electrical Equipment for Laboratory use.

IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements.

Electromagnetic compatibility (EMC)

IEC 61326-1:2021 Electrical equipment for measurement, control and laboratory use ­ EMC requirements ­ Part 1: General requirements

Restriction of Hazardous Substances (RoHS)

RoHS Directive 2011/65/EU Restriction of the use of certain hazardous substances in electrical and electronic equipment.

4.1.3 Environmental Conditions

Transport

Normal transport conditions.

Storage Use

Store in original packaging. Store out of direct sunlight. Store in a dry place. Use environment Altitude Temperature Humidity

Mains supply fluctuations Installation category

Pollution degree

Temperature range -40oC to +60oC Humidity range 10-80% RH
Temperature range +5oC to +40oC Humidity range 30-80% RH
Indoor use
Up to 2000m
+10oC to +40oC
Maximum 80% RH for temperatures up to 31oC decreasing linearly to 50% RH at 40oC. +10% of nominal voltage
Defines level of transient overvoltage which the instrument is designed to withstand safely. Overvoltage Category II: 2500V for 230V supply and 1500V for 120V supply. Describes the amount of conductive pollution present in the operation environment. Pollution degree 2: Only nonconductive pollution, such as dust, occurs with the exception of occasional conductivity caused by condensation.

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4.1.4 Declaration of shelf life
The Heater consists of solid plastic parts and rigid electronics. Product lifetime is designed to be 15 years. Product warranty is 2 years. For laboratory electronic equipment there is no requirement to place a shelf time on the product. The product has no shelf time as this term is not applicable.

4.1.5 Disposal

Heater is an electrical device

Dispose electrical device to local recycling central.

4.1.6 Technical specifications
POWER SUPPLY

Input power

100-240V AC, 50/60Hz

Output power

9V DC, 1,7A

SAFETY

Auto turn off

The Heater turns off automatically after 9 hours.

Overheat protection

The Heater is protected from overheating by two independent circuits.

4.1.7 Materials
The Heater consists of a plastic cabinet, top and bottom, and a removable plastic part.

Part Heater top Heater bottom Plastic part (obturator fixture)

Materials Polybutylene terephthalate (PBT)
Polybutylene terephthalate (PBT)

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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4.2 Symbols used

Symbol

Meaning of the symbol Catalogue number

Serial number

Date of manufacturing Global Trade Identification Number Temperature Limits

Humidity Limits Keep out of sunlight

Used on Label
Label
Box and label Label Box and label
Box and label
Box

Keep dry

Box

Consult instructions for use
Electrical double insulation Class II according to Medical Electrical Equipment Directive, DS/EN 60601-1.
Restriction of Hazardous Substances according to RoHS Directive 2011/65/EU. Restriction of the use of certain hazardous substances in electrical and electronic equipment.
Waste handling according to Waste Electrical and Electronic Equipment Directive, WEEE Directive 2002/96/EC.
European conformity The sold product is in conformity with European health, safety, and environmental protection standards.

Box and label Label
Label
Label
Box and label

Manufacturer

Label

TD-212-25 IFU Heater_ver.17 EN 2024-08-16

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References

• CMS Dental Shop - produkter, tandplejemidler og udstyr til tandlæger

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