DENTSPLY X-SMART Bedienungsanleitung

User Manual

2/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015

PAGE INTENTIONALLY LEFT BLANK

Table of contents

JAP / F190270.EN / 07 / 2004 / updated 10/2015 3/48

Table of contents

1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.1 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.2 Contra-indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.3 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

1.4 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

1.5 Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.6 Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1.7 Classifications of Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

2 Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3 Product Main Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

4 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

4.1 Operation Panel and LCD Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.2 Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.3 Speed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

4.4 Torque . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.5 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.6 Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4.7 Gear Ratio . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.8 Auto Reverse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.9 Memo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.10 CHARGE Lamp (Orange) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.11 AC IN Lamp (Green) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.12 Bar Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5 How to connect each part . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5.1 Connecting Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

5.2 Connecting AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5.3 Connecting Foot Pedal (Optional) . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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4/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015

6 Main Directions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.1 Charge (if batteries are used) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

6.2 Changing the Contra Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

6.3 Mounting and Removing File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

6.4 Preparatory Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

6.5 Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

6.5.1 Auto Reverse Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

6.6 Completion of Medical Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

7 Additional Directions For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7.1 Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

7.2 Initialization of Program (Factory-set configuration) . . . . . . . . . . . . . 27

7.3 Battery Refresh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

7.4 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

7.5 Alarm Sound Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

8 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

8.1 Lubricating Contra Angle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

8.2 Cleaning Motor Handpiece . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

8.3 Cleaning Control Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

8.4 Cleaning AC Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

9 Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

9.1 Autoclaving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

10 Changing batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

10.1 Changing Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

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11 Error Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

12 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

13 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

14 Disposing Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

15 Identification of Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Introduction

6/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015

FOR DENTAL USE ONLY

1Introduction

Thank you for purchasing the X-SMART®.

1.1 Indications

X-SMART®is an endodontic micromotor to drive NiTi instruments. This

motor has to be used only in hospital environments, clinics or dental

offices by qualified dental personnel. Read this User Manual carefully

before use for operation instructions, care and maintenance. Keep this

User Manual for future reference.

1.2 Contra-indications

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 to not use the X-SMART®.

This motor should not be used for severe curved root canal preparation.

Do not use X-SMART®for implant or any other dentist procedure

outside endodontics.

1.3 Warnings

• Use the specified batteries for this product. Never use any other

batteries than those that Dentsply Maillefer specifies.

• Do not disassemble or alter the motor handpiece.

• Do not expose X-SMART®unit, motor handpiece or battery charger

to any liquid.

• If you should notice battery fluid leak, deformation of the motor

handpiece casing or partial discoloring, immediately stop use and

contact your dealer.

Introduction

JAP / F190270.EN / 07 / 2004 / updated 10/2015 7/48

• Should the leaking battery fluid get 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 leak onto 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 will not use the product for a long period of time, remove the

batteries to avoid fluid leak.

• The system may present the possibility of malfunction when used in

the presence of electromagnetic interference wave. Do not install

the system in the vicinity of the device which emits magnetic waves.

• Do not use in the presence of flammable products.

• This motor is equipped with an electronic circuit to limit file

breakage. Nevertheless, files may still break due to higher torque

conditions or to fatigue resistance.

• When installing the device, leave approximately 10cm around the

control unit for easy access to the inlet and the power cord.

• Portable and mobile radio frequency (RF) communications

equipment can affect the proper functioning of X-SMART®.

•TheX-SMART®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.

•TheX-SMART®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®should be observed to verify normal

operation in the configuration in which it will be used.

• 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®as replacement parts for internal

components, may result in increased emissions or decreased

immunity of the X-SMART®.

• Clinical judgment needs to be applied by the end user of the device.

Introduction

8/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015

1.4 Precautions

• The appliance must only be used with the manufacturer's original

accessories.

• Use the Dentsply Maillefer AC adapter for this product. Never use

any other AC adapters.

• The RPM number indicates true instrument speed when the

appropriate reduction rate is selected. Make sure the selected

reduction matches the ratio of the contra angle handpiece.

• If the motor stops or runs too fast, discontinue use and call for

assistance.

• After sterilization, make sure the motor has reached a temperature

below 40°C before use.

• Do not introduce any oil into the micromotor.

• The system functions normally in the environment where the

temperature is at 10 - 40 °C (50 - 104 °F), humidity at 10 - 85% RH,

atmospheric pressure at 700 - 1060hPa, and no moisture

condensation in the Control Unit. Any use outside these limits may

cause malfunction.

• Do not use a bent, damaged, deformed or non-ISO-conforming file.

Using such a file may result in personal injury due to its unexpected

breaking or “flying off” during rotation.

• Check the product before use by rotating it, paying attention to

looseness, vibration, noise and temperature (heat generation). If

any abnormal condition is found even slightly at that time,

immediately stop use and contact your dealer.

• 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.

• Before changing the head or bur, turn off the power of the motor

handpiece. Changing with the power kept on may cause

unintended rotation by accidental touch of the ON/OFF button.

• Pay attention to the direction of batteries when setting. Forcible

setting in the wrong direction may cause damage and fluid leakage

due to a short circuit.

• EQUIPMENT not suitable for use in the presence of a flammable

anesthetic mixture with air or with oxygen or nitrousoxide.

• This product does not consider a patient’s age, gender, weight or

nationality.

• No special training is required for this device.

Introduction

JAP / F190270.EN / 07 / 2004 / updated 10/2015 9/48

1.5 Notice

• Fully-charged rechargeable batteries generally discharge gradually

over time even though the motor handpiece is not used. It is

recommended to recharge the batteries just before use.

• When the motor handpiece stops automatically by detecting a low

battery voltage, turning on the power again after a while may not

detect the low voltage immediately. This is not a failure, but due to

battery characteristics. Since the voltage drop does not coincide

with the remaining battery capacity, consider it only as a yardstick.

• Recharge rechargeable batteries after they deplete as much as

possible. Repeating shorttime use and subsequent recharging may

shorten their operating time due to the “memory effect.” Batteries

may recover after repeating complete discharge and full charge for

a few times. (This product is equipped with a “Refresh Mode” for

this purpose.).

• The used nickel metal hydride batteries are recyclable, but their

disposal may sometimes not be permitted by the country. Return

them to your dealer.

• When disposing of the control unit and foot pedal (optional), follow

the instructions of your local government for disposal, as they

contain materials which may become industrial waste.

• When discarding the contra angle head and motor handpiece,

dispose of them as medical waste.

• Users are responsible for operational control, maintenance and

inspection.

• Store the system in the place where the temperature is at -10 -

50°C (14 - 122°F), humidity at 10 - 85% RH, atmospheric pressure

at 500 - 1060 hPa, and the system is not subject to air with dust,

sulfur or salinity.

1.6 Adverse Reactions

None known.

Introduction

10/48 JAP / F190270.EN / 07 / 2004 / updated 10/2015

1.7 Classifications of Equipment

• Type of protection against electric shock :

- Class II equipment: and internally powered equipment.

• Degree of protection against electric shock :

- Type B applied part: .

• Method of sterilization or disinfection recommended by the

manufacture:

- See Sterilization procedure.

• Degree of protection against ingress of water as detailed in the

current edition of IEC 60529:

- Foot Pedal (Option) : IPX1 (Protected against vertically falling

water drops).

• Degree of safety of application in the presence of a flammable

anesthetic mixture with air or with oxygen or nitrousoxide:

- X-SMART®complies to IEC60601-1 safety standard and the

requirement of CE Marking of Conformity.

• Mode of operation:

- Continuous operation.

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