DENTSPLY Xsmart plus User manual

FISDR-JAP / F1902124.X / 02 / 2011 – updated 07/2012 - 0 / 209 -
USER MANUAL

FISDR-JAP / F1902124.X / 02 / 2011 – updated 07/2012 - 1 / 209 -

FISDR-JAP / F1902124.X / 02 / 2011 – updated 07/2012 - 2 / 209 -
CONTENTS
English 5
Français 44
Deutsch 88
Español 126
Italiano 166
Português
Este manual de utilização est também disponível, quando requisitado, nas seguintes
línguas: Português (POR), Holandês (NL), Dinamarquês (DK), Sueco (S), Finlandês
(FIN), Grego (GR), Polacos (POL) Letónia (LV), Estónia (EE) e Lituânia (LT)..
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(POR)
, hollanti
(NL)
, tanska
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Holländska (NL), Danska (DK), Svenska (S), Finska (FIN), Grekiska (GR), Polska
(POL), Lettiska (LV), Estniska (EE) och Litauiska (LT).
Dansk
Denne brugsanvisning kan også rekvireres på følgende sprog: Portugisisk (POR),
Hollandsk (NL), Dansk (DK), Svensk (S), Finsk (FIN) græsk (GR) Polsk (POL), Lettiske
(LV), Estiske (EE) og Litauiske (LT).
Ελληνική
Αυτή
η
οδηγία
είναι
επ
ίσης
διαθέσι
µ
η
,
κατόπιν
ζήτησης
,
στις
ακόλουθες
γλώσσες
:
Πορτογαλέζικη (POR), Oλλaνδική (NL), ∆ανέζικη (DK), Σουηδική (S), Φιλανδέζικη
(FIN), Ελληνική (GR) Πολωνική (POL), Λετονίας (LV), Εσθονίας (EE) και Λιθουανίας
(LT).
Polski
Ta instrukcja obsługi
jest również dostępna, na zamówienie, w następujących wersjach
językowych: Portugalski (POR), Holenderski (NL), Duński (DK), Szwedzki (S), Fiński
(FIN), Grecki (GR), Polski (POL), Łotewski (LV), Estoński (EE) i Litewski (LT).
Lietuviųk.
Šį
instrukcijų vadovą pagal užklausą galima gauti ir šiomis kalbomis: Portugalų
(POR)
,
Olandų (NL), Danų (DK), švedų (S), Suomių (FIN), Graikų (GR) Latvių k (LV), Estų k.
(EE) ir Lietuvių k. (LT) .
Latviešu
Šī rokasgrāmata pēc pieprasījuma ir pieejama arī
šādās valodās: Portugāļu
(POR)
,
Holandiešu (NL), Dāņu (DK), Zviedru (S), Somu (FIN), Grieķu (GR), Poļu (POL),
Latviešu (LV), Igauņu (EE) un Lietuviešu (LT) valodās.
Eesti
See juhend juhend on saadaval ka taotluse korral järgmistes keeltes: Portugali
(POR),
Hollandi (NL), Taani (DK), Rootsi (S), Soome (FIN), Kreeka (GR), Poola (POL), Läti (LV)
ja Eesti (EE) ja Leedu (LT).

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FISDR-JAP / F1902124.X / 02 / 2011 – updated 07/2012 - 4 / 209 -
USER MANUAL
Table of Contents
Introduction 7
1. Indications for Use 8
2. Contraindications 8
3. Warnings 8
4. Precautions 10
5. Adverse Reactions 11
6. Step-by-Step Instructions 12
6.1. Standard Components 13
6.2. Operation Panel 14
6.3. LCD Panel 16
6.4. Preparation 18
6.5. Installation 18
6.5.1. Connecting the AC adapter 18
6.5.2. Connecting and Disconnecting the Motor Handpiece 19
6.5.3. Connecting and Disconnecting the Contra-angle 20
6.5.4. Inserting and Removing the File 20
6.5.5. Charging the Battery 21
6.5.6. Calibration 22
6.5.7. Sound Volume Adjustment 23
6.6. Operation 23
6.6.1. File Library 23
6.6.2. Switch-on and Switch off the Unit 24
6.6.3. Switch-on and Switch off the Motor Handpiece 24
6.6.4. Auto Reverse Function 25
6.7. Selecting a File System 26
6.7.1. Continuous Rotary File Systems 26
6.7.2. Reciprocating File Systems 27
6.7.3. “Program” for Continuous Rotary File Systems 28
6.7.4. Changing Torque and Speed 28
6.8. Factory Default Parameters 29
6.9. Battery Refresh 30
6.10.Displaying the Software Version 30
6.11.Maintenance 31
6.11.1.Changing the Battery 31
6.11.2.Lubricating the Contra-angle 32
6.12.Cleaning, Disinfection and Sterilization 33
6.12.1.Foreword 33
6.12.2.General Recommendations 33
6.12.3.Step-by-Step Procedure 34

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7. Technical Specifications 35
7.1. Classifications of Equipment 35
7.2. Product Main Specifications 35
8. Error Code 37
9. Troubleshooting 40
10. Warranty 41
11. Disposal of the Product 42
12. Identification of Symbols 42
13. Program – Individual Continuous Rotary Program 43
APPENDIX
Electromagnetic Emissions and Imm nity 206

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FOR DENTAL USE ONLY
Introduction
Congratulations on your purchase of the X-SMART
™
Plus endo motor.
Read this User Manual carefully before use for operating instructions, care and maintenance.
Keep this manual for future reference.

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1. Indications for use
The X-SMART
™
Plus endo motor is a medical device according to the Medical Device
Directive 93/42/EEC, designed for use by dentists for driving dental root canal instruments in
continuous rotation and in reciprocating movement.
This device must only be used in hospital environments, clinics or dental offices by qualified
dental personnel.
2. Contraindications
•In cases where a patient has been fitted with an implanted heart pacemaker (or other
electrical equipment) and has been cautioned against the use of small electrical appliances
(such as electric shavers, hair dryers, etc.) it is recommended not to use the X-SMART
™
Plus.
•X-SMART
™
Plus should not be used for severely curved root canal preparation.
•Do not use X-SMART
™
Plus for implant or any other dentist procedure outside
endodontics.
3. Warnings
In this chapter, a description of serious adverse reactions and potential safety hazards for the
product or the user/patient is included.
Read the following warnings before use.
WARNINGS
•The device must only be used in suitable locations and only by specialized physicians
licensed to practice dentistry.
•Use the specified battery for this device. Never use any other batteries than those that
Dentsply Maillefer specifies.
•Use the Dentsply Maillefer AC adapter for this device. Never use any other AC adapters.
•If you should notice battery fluid leak, deformation of the motor handpiece casing or partial
discoloring, immediately stop use and contact your distributor.
•Should the battery fluid come into your eyes, immediately wash eyes thoroughly with clean
water and see your doctor. Failure to do so may result in loss of sight.
•Should the battery fluid come into contact with skin or clothing, immediately wash the
exposed skin thoroughly with clean water and completely wash away the fluid. Failure to do
so may result in skin complications.
•If you do not use the device for a long period of time, remove the battery to avoid fluid leak.
•Do not expose the device to direct or indirect sources of heat. Operate and store the device
in a safe environment.
•When installing the device, leave approximately 10cm around the control unit for easy
access to the inlet and the power cord.
•Place the device on a flat and stable surface.

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•Do not disassemble or alter the device; Dentsply Maillefer declines any responsibility in
case of alteration or modification of the device.
•Do not expose the X-SMART
™
Plus unit, motor handpiece or AC adapter to any liquid.
•Do not drop the device.
•The X-SMART
™
Plus requires special precautions as regards electromagnetic compatibility
(EMC) and must be installed and commissioned in strict conformity with the EMC
information provided in this instruction manual. Specifically, do not use the device close to
fluorescent lamps, radio transmitters and remote controls.
•Portable and mobile radio frequency (RF) communications equipment can affect the proper
functioning of X-SMART
™
Plus.
•In order to avoid possible risks due to electromagnetic interference, do not use any
electrical medical device or electrical device of any other kind in close proximity to the X-
SMART
™
Plus. The electromagnetic radiation emitted by the device is below the
recommended limits set forth in pertinent regulations in force (EN 60601-1-2:2007).
•Do not use the device in the presence of free oxygen or anesthetic substances or
flammable products.
•The device may possibly malfunction if used in the presence of an electromagnetic
interference wave. Do not install the X-SMART
™
Plus in the vicinity of any device that emits
magnetic waves.
•The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the X-SMART
™
Plus as
replacement parts for internal components, may result in increased emissions or
decreased immunity of the X-SMART
™
Plus.
•The X-SMART
™
Plus should not be used adjacent to or stacked with other equipment. In
the instance that if adjacent or stacked use is necessary, the X-SMART
™
Plus should be
observed to verify normal operation in the configuration in which it will be used.
•None of the X-SMART
™
Plus components are delivered disinfected or sterilized:
components such as control unit, micromotor and micromotor cable need to be disinfected,
the contra-angle needs to be sterilized prior to first use and in between each patient!
•Never place the motor handpiece or any other device accessories in an autoclave unit or
ultrasonic tank.
•None of the components of the X-SMART
™
Plus may be sterilized (contra-angle excluded,
see chapter 6.12. Cleaning, Disinfection and Sterilization).
•Do not immerse the device in ultrasonic cleaners.
•The plastic enclosure is not sealed, do not use any liquid or spray directly on the unit,
especially on the monitor or near the electrical sockets.
•Do not crimp the cords exiting the motor handpiece and AC adapter.
•This device is equipped with an electronic circuit to limit file separation. Nevertheless, files
may still separate due to incorrectly set torque or speed, or the use of fatigued files.
•Follow the file manufacturer’s instructions for use of the endodontic files.
•The file system shown on the display must always match the file in use. This is of the
utmost importance in order to avoid misusing reciprocating files and continuous rotary files.
•Do not use files designed for continuous rotation in reciprocating motion.
•Do not use files designed for reciprocating motion in continuous rotation.

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•Torque and speed values are subject to change by the file manufacturers without notice.
Therefore, the preset values in the library must be checked prior to use. Torque values
shown on the screen are accurate and reliable only with X-SMART
™
Plus 6:1 contra-angles
properly maintained and lubricated.
•The accuracy of movement provided by the motor is guaranteed only if the original X-
SMART
™
Plus 6:1 contra-angle is used, properly maintained and lubricated (for more
details see chapter 6.11.2. Lubricating the Contra-angle).
•Do not use any other contra-angle or other reduction rate other than the original one.
•Do not insert any file in the contra-angle during calibration.
•Calibrate every time the contra-angle is lubricated or replaced after sterilizing, or at least
once a week (see chapter 6.5.6. Calibration).
•When lubricating the contra-angle, carefully check that no lubricant penetrates the motor
handpiece.
•Do not lubricate the motor handpiece for any reason, as lubricant contamination of the
motor handpiece might damage it and may have a strong negative effect on its safe
operation.
•Never introduce any foreign objects into the motor handpiece shaft.
•The motor handpiece may overheat if excessive force is applied. If the motor handpiece
overheats too often or overheating persists, contact your distributor.
•Before starting the motor handpiece, verify the correctness of the motor settings.
•The AC adapter must be supplied at a voltage ranging between: 100 – 240 V (+/- 10%), 47-
63 Hz. Use only original parts.
•Should any anomalies arise during operation, suspend work and contact your distributor.
•Clinical judgment needs to be applied by the end user of the device.
4. Precautions
Read these safety precautions thoroughly prior to use. These precautions allow you to use the
product safely, preventing harm to you and others.
It is of the utmost importance that this manual is preserved for future consultation. The manual
must accompany the system in all cases of sale or other transfer in order that the new owner
may reference the precautions and warnings.
Gloves and a rubber dam are mandatory during the use of X-SMART
™
Plus.
Refer to the WARNINGS chapter (see chapter 3) to verify any special care to exercise before
starting to use the complete device.
•The appliance must only be used with the manufacturer’s original accessories.
•Before changing the contra-angle or file, turn off the power of the unit. Changing with the
power kept on may cause unintended rotation by accidental touch of the ON/OFF key.
•Always clean the shank of the file to be installed. Allowing dirt to enter the chuck could
cause loss of concentricity and deterioration of chucking force.