PRESENTATION OF MANUAL - Saevo · 2020. 8. 28. · ABNT NBR IEC CISPR 11 Group 1 This Endus Duo R...

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PRESENTATION OF MANUAL

INSTRUCTIONS FOR USE

CAUTION

Technical Name: Micromotor DentalTrade Name: Electric Micromotor With Apex LocatorModel: Endus Duo RBrand: Saevo

Manufacturer / Distribuitor:Alliage S/A Indústrias Médico OdontológicaC.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500Ribeirão Preto - S.P. - BrasilTelefone +55 (16) 3512-1212

Technical Duties: Daniel R. de CamargoCREA-SP: 5062199650

Registration ANVISA #: 10069210071

For improved safety:Read and understand all the instructions contained in the Instructions for Use before installation or operation of this equipment.Note: The Instructions for Use must be read by all persons that operate this equipment.

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INDEX02 PRESENTATION OF MANUAL

04 IDENTIFICATION OF EQUIPMENT

06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION

10 TECHNICAL SPECIFICATIONS10 General features11 Electromagnetic emission15 Packing symbols 15 Product symbols

17 INSTALLATION OF EQUIPMENT

20 EQUIPMENT OPERATION

26 PRECAUTIONS, RESTRICTIONS AND WARNINGS26 Recommendations for preserving the equipment 26 Transportation, storage and operation26 Sensitivity to predictable environmental conditions in ordinary situations of use27 Precaution and warnings “during the installation” of the equipment27 Precautions and warnings “during the use” of equipment28 Precautions and warnings “after” the use of equipment28 Precautions and warnings during the “cleaning and disinfection” of equipment28 Precautions in case of alteration in the functioning of equipment29 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivationand abandoning of equipment

29 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION29 Additional procedures for reuse29 Cleaning29 Disinfection 30 Lubrication of the counter-angle31 Preventive Maintenance31 Corrective Maintenance

32 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS

33 EQUIPMENT’S WARRANTY

33 FINAL CONSIDERATIONS

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IDENTIFICATION OF EQUIPMENTDear CustomerCongratulations. You have made a good choice when you decided to buy a SAEVO QUALITY productcomparable to the best products available in the World. This manual is a general presentation of your product and it will give you important details to help you to solve possible problems.Please, read it and keep this with you.

Equipment indicationThis equipment is for exclusive odontological use, and it should be handled and used by an expert professional (professional properly certified, according to local legislation of the country) observing the instructions contained in this manual.It’s an user obligation to use the equipment in perfect working conditions and to protect himself/herself, the patients and third parties against eventual dangers.

IDENTIFICATION OF PRODUCTTechnical Name: Micromotor DentalTrade Name: Electric Micromotor With Apex LocatorModel: Endus Duo RBrand: Saevo

Equipment end purpose- For routine situations of the endodontics treatment;- Detection of perforations, fractures and radicular reabsorptions;- Realization of Odontometrics procedures;- Realization of rotatory instrumentation of radicular ducts.

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Equipment descriptionThe micromotor and Apex locator Endus Duo R is a high-precision electronic equipment, modern and that should be used in endodontics to aid in canal treatments. It is used to measure the real length of the tooth - (it determines the working length) – until where the instrumentation and filling will take place, in order for the endodontics treatment to respect the biologic limits of the dental structure. Combined with the pen for rotatory instrumentation it allows that the micromotor be manipulated in various patterns, in rotatory mode or reciprocal mode of the instrument.

Main characteristics:- Easy-access LCD visible panel;- Activation on the own handpiece;- Adjustable speed of rotation and torque;- It has 9 pre-defined programmings;- Double-frequency apex locator;- Four modes of operation;- It allows the use of diverse types of drills and files;- Automatic reverse by torque and reduction of speed by torque;- Adjustable direction of rotation (left/right);- 2 reciprocal systems (VDW e DENTSPLY);- Automatic bivolt switched power supply which allows the use of the equipment in any voltage source from 100 to 240V~ - 50/60Hz;- Rechargeable high capacity Li-ion battery;- Automatic Power off;- Low noise and vibration level.

Principles and foundations applied to the proper functioning of the productApex Locator: It is understood that the tooth works like a capacitor with the accumulation of electric charges at the periodontium and on the inside of the radicular canal. The dentine works as an isolator for the propagation of electric current along all the extension of the radicular canal.The Apex locators work with the principle of the constancy of electric current between the oral mucosa and the periodontal ligament. The electronic method considers the difference on the electric conductivity of a metallic instrument on the inside of the radicular canal and the conductivity of the periapical tissue. The electric current existing on the radicular canal would complete the circuit at the moment that the electrode, file, would touch the tissue fluid, indicating the most apical portion of the radicular canal, “the apical foramen”.

Electric micromotor: Its functioning principle is based on the magnetic field, which will induce the rotor to spin when a direct current is applied to its poles.

IDENTIFICATION OF EQUIPMENT

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MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-SUMPTION

01 - Connection of the apex meter02 - Connection of the micromotor03 - LCD Panel04 - Support for the micromotor05 - Battery charger input06 - Pedal input07 - Control panel

08 - On/Off Key09 - Reverse mode (it changes the direction of spinning)10 - Pre-programmed modes11 - Adjustment (+/-)12 - Personalized configuration 13 - Operation mode

Main Unit

04

07

01

06

05

02

03

a

b

Rear view a

b

08 09 10

11

1213

The contents of this page are of an informative nature, the equipment being able to differfrom that illustrated. So, upon acquiring the product check the technical compatibilty between equipment, coupling and accessories.

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LCD Panel

Micromotor

03 0201

01 - Micromotor Body02 - Button activation/stop03 - Counter angle

01 - Operation modes02 - Reverse mode (changes the direction of spinning)03 - OVER (apex exceeding area)04 - APEX (ideal level of the root apex)05 - Program Selection06 - Torque intensity value07 - Torque indicator (N.cm)

08 - Power level indicator (battery)09 - Speed indicator (rpm)10 - Advancement on the canal indicator11 - Manual functions, the file spins at the programmed speed 12 - Reciprocal mode VDW/DENTSPLY 13 - Apex locator

12

11

13

01 02 03

04

05

06

07

10 09

08

RECIPROC

AUTO REV

NORMAL

APEX

N.cm4.0


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Accessories that come with the product

01

04

02 03

05

08

11

06

09

12

07

10

Drill fixing system- Lock Blade *- Push Button *

*

* Optional items


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01 - Main unit02 - Cable for measurement Apex locator (main unit)03 - Cable for measurement apex locator (micromotor)04 - Stainless steel labial Clip (04 units)05 - Pedal06 - Power supply07 - File support (02 units)08 - Contra Angle*

09 - Micromotor10 - Adapter for lubrication*

11 - Support for micromotor12 - Battery

Accessories that come with the product

Attention The use of any part, accessory or material neither specified nor foreseen in those use operation instructions and it is of the user’s entire responsibility.


* Optional items

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TECHNICAL SPECIFICATIONSTechnical characteristics of the equipment and its accessoriesModel

Endus Duo R

Protection against electric shock

Energized internally / class II - Applied Part Type B

Protection against harmful ingress of water or particulate matter

IPX I (pedal)

Application security degree in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide

Not suitable

Mode of Operation

Continuous operation

Li-ion battery

DC 7.4V 1000mAh - rechargeable

Full battery charging time

4 hours

Voltage (power supply)

Ve: 100 - 240V~ - 50/60Hz Vs: 10V DC / 1.5A

Frequência

50/60Hz

Power

5VA

Micromotor spinning speed

125-625rpm - predetermined intervals: 125-250-300-375-425-500-625

Torque variation

0.3 - 4.0 N.cm

Exhibition mode

LCD Display 5”

Automatic turning off

After 3 minutes without a signal, automatic turning off

Gross Weight (Main Unit and Micromotor)

1,610 kg

Net Weight (Main Unit)

0,360 kg

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Electromagnetic emissions

Net Weight (Micromotor)

0,206 kg (including handpiece cable)

Dimensions (main unit) Width x Depth x Height

W145 x D140 x H75 mm

Dimensions (Micromotor)

Ø23 x C 130mm

Relationship Contra Angle

1:1

Docking of files

Ø2,334-2,35mm

Stem length

9-12mm

Drill attachment system

*Lock blade / *Push Button

* Optional items

TECHNICAL SPECIFICATIONS

Electromagnetic EmissionsThe Endus Duo R is made to be used in the electromagnetic environments specified below. The client or the user of the Endus Duo R must be sure that it is used in such environment.

Emission test Compliance Eletromagnetic environment - Guide

RF emissionsABNT NBR IEC CISPR 11

Group 1 This Endus Duo R uses RF energy only for internal functions.However, its emissions are too low and it's unlikely to cause any interference in the equipments next to it.RF emissions

ABNT NBR IEC CISPR 11Class B

Emissions of harmonicsIEC 61000-3-2

Class A This Endus Duo R is proper to be used in all establishments; including domestic settings and those directly connect to a public low voltage distribution which feeds domestic buildings.

Fluctuation of Voltage /Emissions of flicker

IEC 61000-3-3

As per

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Guidelines and manufacturer's declaration - electromagnetic immunityThe Endus Duo R is made to be used in the electromagnetic environments specified below. The client or the user of the Endus Duo R must be sure that it is used in such environment.

Immunitytest

ABNT Test levelNBR IEC 60601

Level ofcompliance

Electromagneticenvironment Directives

Electrostaticdischarge (ESD)IEC 6100-4-2

± 6 kV Contact± 8 kV Air

± 6 kV Contact± 8 kV Air

Floors should be wooden, concrete or ceramic. If the floor is covered with synthetic material, the relative humidity should be at least 30%.

Quick electrictransitory phases/ train of pulses(”Burst”)IEC 61000-4-4

± 2 kV in powersupply lines± 1 kV in input /output lines

± 2 kV in powersupply lines± 1 kV in input /output lines

It is advisable that the quality of the power supplyshould be that of hospital or typ ical commerc ia l environment.

SurgesIEC 61000-4-5

± 1 kV lines (s) tolines (s)± 2kV lines (s) toground

± 1 kV lines (s) tolines (s)± 2kV lines (s) toground

It is advisable that the quality of the power supplyshould be that of hospital or typ ical commerc ia l environment.

Reduction,i n t e r r u p t i o nand variance ofvoltage in powersupply input lines

IEC 61000-4-11

< 5% Ut(>95% drop in Ut)for 0,5 cycle40% Ut(60% drop in Ut)for 5 cycles70% Ut(30% drop in Ut )for 25 cycles< 5%Ut(>95% drop in Ut )for 5s

< 5% Ut(>95% drop in Ut )for 0,5 cycles40% Ut(60% drop in Ut)for 5 cycles70% Ut(30% drop in Ut )for 25 cycles< 5% Ut(>95% drop in Ut )for 5s

The recommended power supply quality is the same as used for commercial or hospital environment. If is required a continuous use during energy supply outages, it is recommendedthat the Endus Duo R be feed by an uninterruptible power supply or a battery.

Magnetic field inf re q u e n c y o fpower supply(50/60Hz)

IEC 61000-4-8

3 A/m 3 A/m If an image distortion occurs,may be necessary place the equioment far from the supply frequency or to installa magnetic armour.The frequency magnetic field shall be measured at the installment place to assure that it is low enough.

NOTE Ut is the a.c. power supply voltage before the application of the test level

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Guidelines and manufacturer's declaration - electromagnetic immunityThe Endus Duo R is made to be used in the electromagnetic environments specified below. The client or the user of the Endus Duo R must be sure that it is used in such environment.

Immunitytest

ABNT test levelNBR IEC 60601

Level ofcompliance

Electromagnetic EnvironmentDirectives

RF conductedIEC 61000-4-6

RF radiatedIEC 61000-4-3

3 vrms150 kHz up to 80 MHz

3 V/m80MHz up to 2,5 GHz

3 Vrms

3 V/m

It is advisable that portable and mobile RFcommunication equipment is not used near any part of the Endus Duo R, including cables, with a separation distance less than the one recommended, calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d = 1,2√P

d = 1,2√P 80 MHz thru 800MHzd = 2,3√P 800 MHz thru 2,5MHz

Where P is the nominal maximum power ofoutput of the transmitter in watts (W), as per the manufacturer of the transmitter, and d is the recommended separation distance in meters (m).It is advisable that the fiel intensity from the RF, transmitter as determined by means of electric inspection on-sitea,is less than the level of compliance in each frequancy rangeb.There may be interference near the equipmentmarked with the following symbol:

NOTE 1 At 80MHz and 800MHz, the highest frequency range applies.NOTE 2 These directives may not be applicable in every situation. The electromagnetic transmission is affected by the absorption and reflection of structures, objects and people.

a - The field intensities set by the fixed transmitters, such as radio base stations, telephones (mobile phone, wireless) land mobile radio, amateur radio, AM and FM radio transmissions and TVtransmissions can not be predicted with accuracy. Due to the RF fixed transmitters is recommendedto install an electromagnetic inspection at the local in order to evaluate the electromagnetic environment. If at the place where the Endus Duo R is be using the field intensity level exceeds the conformity level for the RF above, is recommended to observe if the operations are normal. Whether abnormal operations are observed, additional procedures shall be necessary such as reorientation or replace the Endus Duo R. b - Whether above the frequency range of 150kHz to 80 MHz is recommended a field intensity below than 3 V/m.

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Attention The materials used to produce the equipment are Biocompatible.

TECHNICAL SPECIFICATIONSRecommended distances between portable and mobile RF communication equipments and the Endus Duo R

The Endus Duo R is made to be used in an electromagnetic environment in which RF disturbances are controlled. The client or the user of the Endus Duo R may help preventing electromagnetic interference by keeping a minimal distance between mobile and portable RF communication equipment (transmitters) and the Endus Duo R as recommended below, in accordance with the maximal voltage output of the communication equipment.

Transmitter MaximumOutput (W)

Separation distance according to transmitter frequency (M)

150 kHz to 80 MHzd= 1,2√p

80 kHz to 800 MHzd= 1,2√p

800 kHz to 2,5 GHzd= 2,3√p

0,01 0,12 0,12 0,23

0,1 0,38 0,38 0,73

1 1,2 1,2 2,3

10 3,8 3,8 7,3

100 12 12 23

For transmitters with a maximum nominal output power not listed above, the recommended d separation distance in meters (M) can be determined using an equation applicable to the frequencyof the transmitter, where P is the transmitter maximum nominal output in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80MHz and 800MHz, is applied the separation distance for the higher frequency range.

NOTE 2 These guidelines may not apply to all situations. The absorption and reflection from structures, objects and people affect the electromagnetic propagation.

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Packing symbols

Product symbols

It determines the maximum quantity of boxes which can be stacked during transportation andstorage “as per packaging”

Packing to be transported and / or stored avoiding humidity, rainsand wet floor

Packing to be transported and / orstored with the harrows up

The packing must be stored and transported away from direct sunlight exposure

Packing to be transported and / orstored with care (should not sufferdrop and neither receive impact)

Temperature limit for the packingto be stored or transported

General warning:If the instructions are not properlyfollowed, the use can lead to damage to the product, user or patient

Attention:Check the functioning instructions

Note:It indicates useful information foroperation of the product

B type equipment

On / Off Button Power level indicator (battery)


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Product symbols

Reciprocating standard VDW Reciprocating standard DENTSPLY

START/STOP Pedal connection

Pre-programmed modes Key Operation mode Key

Reverse mode Key (changes the micromotor direction of spinning) Direction of spinning indicator

Personalized configuration key Battery charger connection

Adjustment Key (lesser)Adjustment Key (higher) Torque intensity scale

Micromotor connection Apex locator connection


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INSTALLATION OF EQUIPMENT

01

02

03

The installation procedure is simple. Follow the steps below to correctly install the product.

- Position the equipment on a firm and leveled place.- Connect the plug of the battery charger in the main unit – only for recharge (fig.01).

The battery comes already installed, even though it needs an initial charge.

Main unit

01

NOTECharge the battery for 08 hours before using the equipment for the first time.

- Leave the battery charging for at least 4 hours.

Connect the measurement cable to the main unit (fig.02).

Configuring for the MODE M1 – Apex Locator

03

Connect the labial clip (A) and file support (B) to the measurement cable (fig.03).

ATTENTION Always hold by the connectors to connect or disconnect the cables.

a

b

18

06Place the handpiece, correctly connected, at rest on the support of the main unit (fig.06) or over the detached support provided with the equipment.

04

05

Connect the pedal on the rear part of the main unit (fig.04).

Connect the micromotor cable at the main unit (fig.05).Couple the counter-angle to the micromotor.

Configuring for the M2/M3/M4 MODE- Micromotor


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08

09

10

Counter-angle type lock-blade* - Fixation of the file/drill

- Couple the counter-angle on the micromotor.- Turn the lever counterclockwise (fig.08).- Introduce the drill on the orifice and turn untill it locks on the limiter (fig.09).- By touching the limiter with the drill, turn the lever to the initial direction to lock the drill (fig.10).

12 13

11

Counter-Angle Push Button type* - Fixation of the file/drill- Couple the counter-angle on the micromotor.- In the PB (Push Button) system, place the drill on the guide and turn it until it locks inside the limiter (fig.11). Afterwards press the head button and displace the drill until it reaches the bottom of the limiter, releasing the head button (fig.12).- Make sure that the drill is placed until the bottom for a deep fixation (fig.13).

OBS: Use only good quality and standardized drills. Drills with a too long shaft can produce excessive vibration lowering the lifespan of the bearings.

07

Connecting and disconnecting the counter-angleConnectingThe counter-angle can be connected in 6 adjustable head positions. Align the positioning pins (A) of the counter-angle with the positioning indentations (B) of the handpiece and introduce the head until you listen a click (see fig.07).

DisconnectingWhen removing the counter-angle, pull it rectilinearly (fig.07).

a b

Attention Before connecting or disconnecting the counter angle, turn off the motor. Check if the counter-angles is well placed on the handpiece.

* Optional items


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EQUIPMENT OPERATION

Beginning - Apex Locator Function (M1)After having installed correctly the equipment press the POWER key to turn the equipment on, 2 beeps will sound.- Press the MODE key and select the mode M1.

Insert the labial clip on the patient’slip and fasten the file to its support.Introduce the file to the canal, according to the figure.

Functions and programmingsThe equipment has 4 operation modes and 4 function options according to the table below.

MODE

FUNCTIONS

Inversionof the

automaticspinning

ReciprocatingMovement 1

(VDW Standard)

ReciprocatingMovement 2

(DENTSPLY Standard)Apex

Locator

M1 - - - √

M2 √ - - -

M3 - √ - -

M4 - - √ -

WARNINGIn order to assure a precise measurement, you shouldn’t continue the procedure while you don’t hear the orientation beeps.

ApexLocator

On/Off Switch

Lip

File Support

Tooth Stainlesssteel labial clip

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Fixing the file on the support- Press the thumb to the direction of the arrow (A) and fasten the file (B) and release it (C).

a

b

c

On the LCD panel the levels of the scale of the canal length are divided in the colors yellow, blue and red.As soon as the area becomes visible on the canal apex the yellow color will blink, alerting the start of the measurement.The scale is divided in 3 levels, where each level represents 0,1 mm of the apex area. The spare yellows represent the narrow area of the canal apex where they are defined in 5 levels and can be adjusted.

When you reach the apex, slowly spin the file counterclockwise until the meter reaches again 0.5 mm. When the scale of length of the narrow area on the LCD Display is in 0,5 mm the file will have reached the desired position, i.e., in the area of the root apex.Position the rubber stop on the tooth surface as a reference point to determine the length of work of the root canal. Reminding that as soon as the file reaches the 2,0 mm position of the canal apex, continuous beeps will sound.

M 1

M 1

EQUIPMENT OPERATION

early measurement (blue scale)

Press the SET key, the apex mode will blink; the last position of the apex configured will blink, adjust the apex position in a 0,0 to 1,0mm range by pressing the keys “ADJUST+” and “ADJUST-”. Three (3) seconds after the last touch the apex mode will stop blinking and the configuration will be saved.Generally the narrow area is between 0.2 and 0.3mm of the canal apex. By initiating the procedure the equipment will detect the beginning of the measurement.By initiating the procedure the equipment will show the distance between the tip of the file (A) and the canal apex (B), according to scale below on the LCD panel.

FLASHING

(yellow scale)(red scale)

M1

Support file

Stoprubber

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After the 0,5mm scale the beeps shall be short and frequent reaching the ideal level “APEX”, where this word will be blinking on the panel, when the tip of the instrument reaches the foramen.ATTENTION: If the instrument outreaches the apex, the word “OVER” (which represents the exceeding area of the apex) will be blinking followed by intermittent beeps.The labial clip can be disconnected from the instrument and connected again during the measurement cycle. It can be exchanged for one or another more adequate during the root canal treatment or when another canal is measured. In these cases the equipment automatically detects that a new measurement has been initiated.

NOTE- The length of work on the canal varies from case to case due to different forms of the teeth and canals of the dental roots;- After the length of work has been defined turn off the equipment and disconnect all cables.

With this function enabled, when pressing the command pedal (a) or button (b) on the own handpiece the motor will spin clockwise. If, during its operation, the force reaches the predefined limit concerning the torque, two beeps will sound and the handpiece will automatically spin in the reverse direction. Once the force is eliminated, the handpiece starts to spin clockwise again. Activating the REVERSE mode, beeps will sound alerting the alteration in the spinning direction, spinning it counterclockwise, when disactivating and activating again the equipment the spinning direction will go back to the initial clockwise direction (NORMAL).

a b

M 2

AUTO REV

Function (M2) – Inversion of the Automatic Spinning

2.7 N.cm

EQUIPMENT OPERATION

Load within the torque limit value

More load beyond the configured torque limit value

I f the appl ied load is maintained, the file will spin inversely (reverse).When the load is removed

Forward spinning Reverse spinning Forward spinning

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Function (M3/M4) Reciprocating Movement

M3/M4: With this function enabled by pressing the command pedal (a) or the button (b) at the own handpiece, the motor will spin propellingthe instrument in a cutting direction (reversespinning) and afterwards the movement is inverted to release the instrument (forward spinning).

a b

M4 “DENTSPLY”

standard

RECIPROC

350

M3 “VDW”

standard

RECIPROC

300

Programming of the Operative Sequence (M2) The Endus Duo R micromotor allows the programming of up to 9 stages for the rotatory instrumentation on the M2 mode.- Press the MODE key to select the operacional mode and PROGRAM to choose between one of the pre-defined programmings, which will be saved for the other modes.To adjust the values choose the M2 mode.The torque value and the number of the programming will blink one after the other, press SET to select the next option and, at this moment press the “ADJUST+” key or the “ADJUST-“ to choose the desired value. Three (3) seconds after the last key has been pressed, the numeric value will be saved. Then, press the SET key again to confirm the numeric value to be saved or to edit a new value. Pressing the REVERSE key the micromotor retrocedes, spinning on the counterclockwise direction.

EQUIPMENT OPERATION

Reverse spinning

Forward spinning

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Examples of programmings:

N.cm

N.cm

N.cm

N.cm

N.cm

N.cm

N.cm

N.cm

N.cm

0.3

2.7

3.3

1.3

2.3

3.8

1.8

3.0

4.0

Systems of oscillatory filesThe WaveOne™ and RECIPROC® files are specifically conceived for use in reciprocating movement, which the instrument is propelled first in a cutting direction and then the movement is inverted to release the instrument. The oscillatory angles are precise and specific for the design of the instrument and for the Endus Duo R.

NOTES- The programmings can only take place on the M2 Mode.- The programmings will be saved for all the modes even after the equipment has been turned off.

WARNINGS- Follow the manufacturer’s instructions for the utilization of the endodontics files.- Do not use own files for reciprocating movement in continuous spinning. Risk of fractures and other clinical problems.- Do not use own files for continuous spinning in reciprocating movement. Risk of fractures and other clinical problems.- When the equipment is in use, please, do not use the battery charger to avoid electromagnetic interference.

EQUIPMENT OPERATION

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NOTES- For oscillatory files, the configurations, including speed and torque, can’t be adjusted.- The oscillatory files distinguish themselves from the continuous ones because of their special design:The spiral is inverted and the shaft is equipped with a colored plastic ring.- On the reciprocating movement, the auto-reverse function is off.- On the reciprocating movement, you can hear a sound when the load approximates the limit value for the torque. If this happens, do not press the file inside the root canal.Remove it from the canal and clean the stretch marks.- If the maximum torque is achieved, the motor will stop. Should this happen, remove the file from the radicular canal, clean the stretch marks and restart.- When the equipment is connected to the charger, it will automatically turn off (nonoperating).Automatic Shutoff:- The equipment will automatically turn off when it’s not in use for more than 3 minutes.To turn it on again, press the onn/off button.

ATTENTION Low battery warning:The LCD Display shows the actual charge of the battery, when the scale is full, it means the battery charge is complete. If there is not enough charge, the scale will blink, meaning that the charge is about to go away. At this point, the beep will sound for 3 seconds and the instrument will turn off after 60 seconds.To recharge the battery completely you should connect the equipment to the charger for, at least, 4 hours. (A new battery should be charged for 8 hours or more) The sign will be ON during the battery charging time.- The battery doesn’t present the memory effect and can be recharged even if it is not completely charged.

EQUIPMENT OPERATION

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PRECAUTIONS, RESTRICTIONS AND WARNINGSRecommendations for preserving the equipmentYour Saevo equipment has been designed and developed according to the standards of modern techology. Similarly to other kinds of equipment, it requires special care, which is many times neglected due to several reasons and circunstances. Therefore, here are some important remindersfor your daily routine. Try to follow these simple rules, which will save you a lot of time and will avoid unnecessary expenses once they start making part of your working procedure.

Transportation, storage and operationThis equipment must be transported and stored observing the following directions:- Avoid falls and impacts;- Keep it dry, do not expose it to rain, water drops or wet floor;- Keep it away from water and direct sunlight, and in it original wrapping;- Don’t move it over irregular surfaces, protect it from rain and observe the maximum stack quantityspecified in the packaging;

Environmental condition for transportation or storage:- Room temperature range for transportation or storage -29ºC to +60ºC.- Relative humidity range for transportation or storage 20% to 90%.- Atmospheric pressure range 500hPa to 1060 hPa (375 mmHg to 795 mmHg).

Environmental operation condition:- Room temperature range for functioning +10ºC to +40ºC.- Recommended room temperature range +21ºC to +26ºC.- Relative humidity range for functioning 30% to 75%.- Atmospheric pressure range 700 hPa to 1060 hPa (525 mmHg to 795 mmHg).- Operation altitude: ≤2000m.

Attention The Equipment maintains its condition of safety and efficacy, provided that it is maintained (stored)as mentioned in this instruction of use. Thus, the equipment will not lose or alter its physical and dimensional features.

Sensitivity to predictable environmental conditions in ordinary situations ofuse

WARNINGS - Endus Duo R needs special care regarding the electromagnetic compatibility and needs to be installed and positioned to work according to information about electromagnetic compatibility provided in this manual.- The RF mobile communications equipment and portables can affect the electromedical equipment.- The use of a cable, transducer or any other accessory different from those specified in this manual, and/or the substitution of internal components in this equipment may result in raising the emission or reducing the electromagnetic immunity of the equipment.- It is not suitable that Endus Duo R be used in the proximity with or piled over another equipment. In case there is a need of using the equipment near another one or piled, it’s appropriate that the Endus Duo R equipment be observed to check if it’s working normally in the configuration for which it’ll be used.

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Precaution and warnings “during the installation” of the equipment- Position the equipment in a place where it will not get wet. - Install the equipment in a place where it will not be damaged by the pressure, temperature, humidity, direct sunlight, dust, salts. - The equipment should not be submitted to inclination, excessive vibrations, or blows (including during transportation and handling).- This equipment was not planned for use in an environment where vapors, anesthetic mixtures inflammable with air, or oxygen and nitrous oxide can be detected.- Before turning the equipment ON, check the electrical network. The transformer shall be plugged in an outlet whose voltage is within the interval: 100 - 240 V 50/60 Hz.Use original parts only.- In general, the batteries fully charged gradually discharge with time even though the device is not in use. It is recommended that the battery be charged immediately before use.- Before its first use and/or long work interruptions such as vacations, clean and disinfect the equipment (see Page 29 “Conservation and corrective and preventive maintenance” - General cleaning, Disinfection and Lubrication).

Precautions and warnings “during use” of the equipment- The equipment should only be operated by duly enabled and trained technicians (Dental Surgeons, Capacitated Professionals).- If any maintenance should be required, only use services of the Saevo Authorized Technical Assistance.- The equipment has been manufactured to handle both continuous.- Although this equipment has been planned in accordance with the standards of electromagnetic compatibility, it can, in very extreme conditions, cause interference with other equipment. Do not use this equipment together with other devices very sensitive to interference or with devices which create high electromagnetic disturbance.- When the file accidentally touches the internal part of the canal of the dental root, the length meter of canal advancement will become a bit abnormal, but, after a few seconds, it will automatically go back to normal.- Do not use damaged file supports; a precise measurement cannot be made with a damaged file-holder.- Only use files and file support with plastic cables. If the file has a metallic cable, there will be a current leakage when the fingers touch the cable, which will impede a precise measurement of the root canal. Even if the file cable is made of plastic, check to not touch the metallic part with the fingers.- Follow the manufacturer’s instructions for the use of the endodontics files.- Do not use designated files for continuous spinning in reciprocating movement.- Do not use designated files for reciprocating movement in continuous spinning.- The precision of the movement proportioned by the motor is only assured if you use an original counter-angle, properly maintained and lubricated.- When lubricating the counter-angle, have special care so that the lubricant does not penetrate on the motorized handpiece.- Do not lubricate the motorized handpiece under any circumstances, since the contact with the lubricant may damage it and have a strongly negative effect in terms of safety during use.- The motorized handpiece can heat up excessively if an excessive force is used. If the motorized handpiece overheats with frequency or if the overheating persists, contact your Saevo representative.- Before changing the counter-angle or file, turn the equipment off. The substitution with the equipment ON may determine an undesired spinning by accidental touch on the Start/Stop button.- Always clean the base of the file to be installed. The entry of dirtiness on the mandril might provoke the loss of concentricity and deterioration in its force.

PRECAUTIONS, RESTRICTIONS AND WARNINGS

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Saevo shall not be responsible for: - Use of the equipment for other purposes that are not specified in the instructions of use and maintenance.- Modifications or reparations executed by personnel non-authorized by the manufacturer.- Use of non-original parts or parts different from those specified.- Fractures of files due to bad use.- Malfunction in the equipment or its accessories due to inadequate cleaning.

- Never use the equipment if the power indicator of the batteries is blinking. It’ll not work properly if the batteries are worn out.- If you find a leakage of fluid in the battery, deformation of the casing of the motorized handpiece or its partial discoloration, immediately interrupt its use and contact your Saevo representative.- Always hold the connector for connecting and disconnecting cables.- After coupling the counter-angle to the micromotor, pull it lightly to confirm that it is correctly fastened.- Use the reverse spinning mode carefully. Since this mode was designed to free the fastened files, its spinning is fast and powerful, being able to break the file easily.

Warning The equipment is not indicated for patients and dentist-surgeons bearers of a cardiac pacemaker.

Precautions and warnings “after” the use of the equipment- Turn off the main switch of the dental set when it is not in use for an extended period of time.- Always maintain the equipment clean for the next operation.- Do not modify any part of the equipment. Do not disconnect the cable or other connections without need.- If you are not going to use the equipment for an extended period of time, we recommend you that the battery is removed in order to avoid fluid leakage. Please contact your Saevo representative.

Precautions and warnings during the “cleaning and disinfection” of the equipmento- Avoid spilling water or other liquids inside the equipment which could cause shortcircuits.- Do not use microabrasive material or steel wool during cleaning, do not use organic solvents or detergents which contain solvents such as ether, stain removers, etc.- For the cleaning of the LCD Display use a soft and dry cloth.- Do not sterilize other than in autoclave (humid vapor), the parts suitable for this process are: Counter-angle, labial clip and file support.

Precautions in case of alteration in the functioning of equipment- If the equipment has any abnormality, check if the problem is related to any item listed in the topic of unforeseen events (failures, causes and solutions). If it is not possible to resolve the problem, turn off the equipment, remove the power supply cable from the socket and contact your representative (Saevo).

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Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation and abandoning of equipmentIn order to avoid environmental contamination or undue use of the Equipment after it has become useless, it should be discarded in the suitable place (as per the local legislation of the country).- Pay attention to the local legislation of the country for the conditions of installation and disposal of residue.

CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION

Attention - In order to prevent risks and damages to equipment, make sure that the liquid does notenter into the equipment.- To cleaning the equipment, using the damp cloth with a mild soap. The application of other solvent-based cleaning products or sodium hypochloride isn’t recommended, becausethey may damage the equipment.

CleaningImportant: In order to execute cleaning or any type of maintenance, ensure that the equipment isdisconnected from the electrical network.

Additional procedures for reuseThe equipment can be reused in undetermined, i.e. unlimited, quantities, only needing to be cleanedand disinfected.

Disinfection

WARNING For preventing contamination, use gloves and other protection systems during disinfection.Even that, during the procedures, gloves are used, after removing gloves the hands mustbe washed out.

These processes shall be used on handpieces.- Uncouple the part from the fitting terminal.- Remove the drill or diamond tip.- Clean the external part using 70% alcohol or other disinfectant that does not have acid, ammonia or chlorine.

ATTENTION - Never immerse the instrument in a disinfection bath.- Never use microabrasive material or steel wool during cleaning.


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Sterilization

WARNINGS - The accessories that get in contact with the patient’s mouth during the use of the equipment shall be sterilized in autoclave, between two patients, to avoid cross contamination.- For the counter-angle, clean, lubricate and remove the excess of oil from the instrument, put it on the package surgical degree paper type (not provided with the product) and sterilize in autoclave until 135ºC (275ºF) during one cycleo.- Sterilize before first use, sterilized product not provided. Complete this process every time you’re about to sterilize;- The sterilization process is not valid or recommended by ethilene oxide;- Do not sterilize in a greenhouse;- Before sterilization, connect the equipment and activate it for a few seconds to eliminate the excess of oil;- In case the excess of oil is not eliminated, it might cause burned residues on the bearings.

Spray lubricationFor lubrication of your equipment, we recommend the use of the Lubs product.Lubrication should be done through the back hole of the Contra Angle. Insert the adapter into the hole as shown in figure (a). Firmly insert the oil applicator nozzle into the adapter hole (b) and apply the spray for 1 or 2 seconds observing the lubrication to the instrument head.Cover the piece with absorbent paper to remove excess oil.

Adapter for lubrication

Warning Before lubricating Handpieces, remove the drill.

figure a figure b

The lubricant does not accompany the product.

ATTENTION:Failure to use the lubricant will result in loss of product warranty.

NOTE: Handpieces not subjected to a sterilization process should be lubricated at least twice a day.

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Preventive MaintenanceThe equipment must suffer routinely measurements, following the current legislation of the country.But, never with a period superior to 3 years.For protecting your equipment, look for a Saevo’ technical assistance for periodic reviews as preventive maintenances.

Attention In case of the equipment presents any abnormality; check if the problem is related to someof the listed items under the item Unpredictable (situation, cause and solution).If it’s not possible to solve the problem, shutdown the equipment and demand the presenceof a Saevo’ technician from the nearest resale, or ask through the Attendance Service Saevo: + 55 (16) 3512-1212.

Corrective MaintenanceSaevo states that the supplying of the circuits’ diagram, Part lists or any other information that permits the technical assistance by the user, can be requested, since previously agreed between the buyer and Saevo.


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Upon coming across any problem in operation, follow the instructions below to check and repair the problem, and/or get in touch with your representative.

UNFORESEEN EVENTS – SOLUTION OF PROBLEMS

Imprevistos Provável Causa SoluçõesProblem Probable cause Solution- Non operative equipment. - Battery without charge.

- Charger connected.- Recharge the battery.- Disconnect the charger.

- Micromotor won’t start. - Pedal / Micromotor badly connected.- Equipment out of mode (M2).- Damaged counter-angle.

- Check the cable(s) and resta-blish the connection.- Select the mode.- Substitute counter-angle.

- Micromotor retrocedes con-tinually.

- Excessive resistance inside the canal.

- Raise the torque adjusting it manually.

- The Apex locator can’t make any measurement because it can’t close the circuit of the measurement current.

- The root canal is calcified orobliterated.

- The root canal is excessivelydry.

- Measurement instrument very thin for a large root canal.

- The labial clip is not correctlyapplied to the patient’s mouth.- The measurement instrumentis incorrectly connected to the tip, i.e., in reality it’s in contact with the metallic shaft .

- Connecting cable damaged.

- Make a comparison with a radiographic image, in order to obtain more indications.- Wash with a NaOCl solution, and dry the access cavity with an air syringe, or a cotton pellet.- If you can’t make contact with the tip, choose a larger instrument.- Apply again the labial clip to the patient.- Check again the cables and connections.- Check if there is a good con-tact between the tip and the instrument.- Check if the cables and the connections present any visible damage.

- Reduced battery capacity. - It hasn’t been fully charged.

- The battery is not keeping its charge.

- Charge the battery for 4 hours at the minimum.- Contact Saevo Technical As-sistance.

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FINAL CONSIDERATIONSAmong the care you have to take with your equipment, the most important is regarding of the spare parts replacement.To ensure the lifetime of your device, only replace original spare parts from Saevo. They have the assurance of the standards and technical specifications required by the Saevo representative.We call your attention to our authorized resellers’ chain. Only this chain will keep your equipment constantly new, because it has trained technical assistant and specific tools for the correct maintenanceof your device.Whenever you need, demand the presence of a Saevo’ technician from the nearest resale, or ask throughthe Attendance Service Saevo: + 55 (16) 3512-1212.

EQUIPMENT’S WARRANTYThis equipment is covered by the warranty terms and norms contained in the Warranty Certificatethat accompany the product.

PRESENTATION OF MANUAL - Saevo · 2020. 8. 28. · ABNT NBR IEC CISPR 11 Group 1 This Endus Duo R...

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Transcript of PRESENTATION OF MANUAL - Saevo · 2020. 8. 28. · ABNT NBR IEC CISPR 11 Group 1 This Endus Duo R...