SAEVO Endus Duo R User manual

2
PRESENTATION OF MANUAL
INSTRUCTIONS FOR USE
CAUTION
Technical Name: Micromotor Dental
Trade Name: Electric Micromotor With Apex Locator
Model: Endus Duo R
Brand: Saevo
Manufacturer / Distribuitor:
Alliage S/A Indústrias Médico Odontológica
C.N.P.J. 55.979.736/0001-45 - Insc. Est. 582.002.897.114
Rod. Abrão Assed, Km 53+450m - Cx. Postal 782 CEP 14097-500
Ribeirão Preto - S.P. - Brasil
Phone [phone]
Technical Duties: Ricardo J. Ravaneli
CREA-SP: 5060714523
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.

3
INDEX
02 PRESENTATION OF MANUAL
04 IDENTIFICATION OF EQUIPMENT
06 MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CONSUMPTION
10 TECHNICAL SPECIFICATIONS
10 General features
11 Electromagnetic emission
15 Packing symbols
15 Product symbols
17 INSTALLATION OF EQUIPMENT
20 EQUIPMENT OPERATION
26 PRECAUTIONS, RESTRICTIONS AND WARNINGS
26 Recommendations for preserving the equipment
26 Transportation, storage and operation
26 Sensitivity to predictable environmental conditions in ordinary situations of use
27 Precaution and warnings “during the installation” of the equipment
27 Precautions and warnings “during the use” of equipment
28 Precautions and warnings “after” the use of equipment
28 Precautions and warnings during the “cleaning and disinfection” of equipment
28 Precautions in case of alteration in the functioning of equipment
29 Precautions to be adopted against foreseeable or uncommon risks, related to the deactivation
and abandoning of equipment
29 CORRECTIVE AND PREVENTIVE MAINTENANCE AND PRESERVATION
29 Additional procedures for reuse
29 Cleaning
29 Disinfection
30 Lubrication of the counter-angle
31 Preventive Maintenance
31 Corrective Maintenance
32 UNFORESEEN EVENTS – SOLUTION OF PROBLEMS
33 EQUIPMENT’S WARRANTY
33 FINAL CONSIDERATIONS

4
IDENTIFICATION OF EQUIPMENT
Dear Customer
Congratulations. You have made a good choice when you decided to buy a SAEVO QUALITY product
comparable 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 indication
This equipment is for exclusive odontological use, and it should be handled and used by an expert
professional (professional properly certied, 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 PRODUCT
Technical Name: Micromotor Dental
Trade Name: Electric Micromotor With Apex Locator
Model: Endus Duo R
Brand: 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.

5
Equipment description
The 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 lling
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-dened programmings;
- Double-frequency apex locator;
- Four modes of operation;
- It allows the use of diverse types of drills and les;
- 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 o;
- Low noise and vibration level.
Principles and foundations applied to the proper functioning of the product
Apex 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 dierence 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, le, would touch the tissue uid, indicating the most apical portion
of the radicular canal, “the apical foramen”.
Electric micromotor: Its functioning principle is based on the magnetic eld, which will induce the
rotor to spin when a direct current is applied to its poles.
IDENTIFICATION OF EQUIPMENT

6
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
01 - Connection of the apex meter
02 - Connection of the micromotor
03 - LCD Panel
04 - Support for the micromotor
05 - Battery charger input
06 - Pedal input
07 - Control panel
08 - On/O Key
09 - Reverse mode (it changes the direction of spinning)
10 - Pre-programmed modes
11 - Adjustment (+/-)
12 - Personalized conguration
13 - Operation mode
Main Unit
04
07
01
06
05
02
03
a
b
Rear view a
b
08 09 10
11
12
13
The contents of this page are of an informative nature, the equipment being able to dier
from that illustrated. So, upon acquiring the product check the technical compatibilty
between equipment, coupling and accessories.

7
LCD Panel
Micromotor
03 02 01 01 - Micromotor Body
02 - Button activation/stop
03 - Counter angle
01 - Operation modes
02 - Reverse mode
(changes the direction of spinning)
03 - OVER (apex exceeding area)
04 - APEX (ideal level of the root apex)
05 - Program Selection
06 - Torque intensity value
07 - Torque indicator (N.cm)
08 - Power level indicator (battery)
09 - Speed indicator (rpm)
10 - Advancement on the canal indicator
11 - Manual functions, the le 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.cm
4.0
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

8
Accessories that come with the product
01
04
02 03
05
08
11
06
09
12
07
10
Drill xing system
- Lock Blade *
- Push Button *
*
*Optional items
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION

9
01 - Main unit
02 - Cable for measurement Apex locator (main unit)
03 - Cable for measurement apex locator (micromotor)
04 - Stainless steel labial Clip (04 units)
05 - Pedal
06 - Power supply
07 - File support (02 units)
08 - Contra Angle*
09 - Micromotor
10 - Adapter for lubrication*
11 - Support for micromotor
12 - Battery
Accessories that come with the product
Attention
The use of any part, accessory or material neither specied nor foreseen in those
use operation instructions and it is of the user’s entire responsibility.
MODULES, ACCESSORIES, OPTIONS AND MATERIALS OF CON-
SUMPTION
*Optional items

10
TECHNICAL SPECIFICATIONS
Technical characteristics of the equipment and its accessories
Model
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 ammable 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 o
After 3 minutes without a signal, automatic turning o
Gross Weight (Main Unit and Micromotor)
1,610 kg
Net Weight (Main Unit)
0,360 kg

11
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 les
Ø2,334-2,35mm
Stem length
9-12mm
Drill attachment system
*Lock blade / *Push Button
*Optional items
TECHNICAL SPECIFICATIONS
Electromagnetic Emissions
The Endus Duo R is made to be used in the electromagnetic environments specied 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 emissions
ABNT 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 11
Class B
Emissions of harmonics
IEC 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 icker
IEC 61000-3-3
As per

12
TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration - electromagnetic immunity
The Endus Duo R is made to be used in the electromagnetic environments specied below. The
client or the user of the Endus Duo R must be sure that it is used in such environment.
Immunity
test
ABNT Test level
NBR IEC 60601
Level of
compliance
Electromagnetic
environment Directives
Electrostatic
discharge (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 electric
transitory phases
/ train of pulses
(”Burst”)
IEC 61000-4-4
± 2 kV in power
supply lines
± 1 kV in input /
output lines
± 2 kV in power
supply lines
± 1 kV in input /
output lines
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Surges
IEC 61000-4-5
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
± 1 kV lines (s) to
lines (s)
± 2kV lines (s) to
ground
It is advisable that the
quality of the power supply
should be that of hospital
or typical commercial
environment.
Reduction,
i n t e r r u p t i o n
and variance of
voltage in power
supply input lines
IEC 61000-4-11
< 5% Ut
(>95% drop in Ut)
for 0,5 cycle
40% Ut
(60% drop in Ut)
for 5 cycles
70% 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 cycles
40% Ut
(60% drop in Ut)
for 5 cycles
70% 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 recommended
that the Endus Duo R be
feed by an uninterruptible
power supply or a battery.
Magnetic eld in
f re q u e n c y o f
power 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
eld 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

13
TECHNICAL SPECIFICATIONS
Guidelines and manufacturer's declaration - electromagnetic immunity
The Endus Duo R is made to be used in the electromagnetic environments specied below. The
client or the user of the Endus Duo R must be sure that it is used in such environment.
Immunity
test
ABNT test level
NBR IEC 60601
Level of
compliance
Electromagnetic Environment
Directives
RF conducted
IEC 61000-4-6
RF radiated
IEC 61000-4-3
3 vrms
150 kHz up to 80 MHz
3 V/m
80MHz up to 2,5 GHz
3 Vrms
3 V/m
It is advisable that portable and mobile RF
communication 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 800MHz
d = 2,3√P 800 MHz thru 2,5MHz
Where P is the nominal maximum power of
output 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 el 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
equipment
marked 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 aected by the absorption and reection of structures, objects and people.
a - The eld intensities set by the xed transmitters, such as radio base stations, telephones
(mobile phone, wireless) land mobile radio, amateur radio, AM and FM radio transmissions and TV
transmissions can not be predicted with accuracy. Due to the RF xed transmitters is recommended
to 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 eld 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 eld intensity
below than 3 V/m.

14
Attention
The materials used to produce the equipment are Biocompatible.
TECHNICAL SPECIFICATIONS
Recommended 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 Rmay help preventing electromagnetic
interference by keeping a minimal distance between mobile and portable RF communication
equipment (transmitters) and the Endus Duo Ras recommended below, in accordance with the
maximal voltage output of the communication equipment.
Transmitter Maximum
Output (W)
Separation distance according to transmitter frequency (M)
150 kHz to 80 MHz
d= 1,2√p
80 kHz to 800 MHz
d= 1,2√p
800 kHz to 2,5 GHz
d= 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 frequency
of the transmitter, where Pis 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 reection from
structures, objects and people aect the electromagnetic propagation.

15
Packing symbols
Product symbols
It determines the maximum
quantity of boxes which can be
stacked during transportation and
storage “as per packaging”
Packing to be transported and /
or stored avoiding humidity, rains
and wet oor
Packing to be transported and / or
stored with the harrows up
The packing must be stored and
transported away from direct sun
light exposure
Packing to be transported and / or
stored with care (should not suer
drop and neither receive impact)
Temperature limit for the packing
to be stored or transported
General warning:
If the instructions are not properly
followed, the use can lead to
damage to the product, user or
patient
Attention:
Check the functioning instructions
Note:
It indicates useful information for
operation of the product
B type equipment
On / O Button Power level indicator (battery)
TECHNICAL SPECIFICATIONS

16
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 conguration key Battery charger connection
Adjustment Key (lesser)
Adjustment Key (higher) Torque intensity scale
Micromotor connection Apex locator connection
TECHNICAL SPECIFICATIONS

17
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 rm and leveled place.
- Connect the plug of the battery charger in the main unit –
only for recharge (g.01).
The battery comes already installed, even though it needs an
initial charge.
Main unit
01
NOTE
Charge the battery for 08 hours before using the
equipment for the rst time.
- Leave the battery charging for at least 4 hours.
Connect the measurement cable
to the main unit (g.02).
Conguring for the MODE M1 – Apex Locator
03
Connect the labial clip (A) and file support (B) to the
measurement cable (g.03).
ATTENTION
Always hold by the connectors to connect or
disconnect the cables.
a
b

18
06
Place the handpiece, correctly connected, at
rest on the support of the main unit (g.06)
or over the detached support provided with
the equipment.
04
05
Connect the pedal on the rear part of the
main unit (g.04).
Connect the micromotor cable at the main
unit (g.05).
Couple the counter-angle to the micromotor.
Conguring for the M2/M3/M4 MODE- Micromotor
INSTALLATION OF EQUIPMENT

19
08
09
10
Counter-angle type lock-blade* - Fixation of the le/drill
- Couple the counter-angle on the micromotor.
- Turn the lever counterclockwise (g.08).
- Introduce the drill on the orice and turn untill it locks on the limiter (g.09).
- By touching the limiter with the drill, turn the lever to the initial direction to lock the drill (g.10).
12 13
11
Counter-Angle Push Button type* - Fixation of the le/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 (g.12).
- Make sure that the drill is placed until the bottom
for a deep xation (g.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-angle
Connecting
The 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 g.07).
Disconnecting
When removing the counter-angle, pull it
rectilinearly (g.07).
a b
Attention
Before connecting or disconnecting the
counter angle, turn o the motor. Check
if the counter-angles is well placed on
the handpiece.
*Optional items
INSTALLATION OF EQUIPMENT

20
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’s
lip and fasten the le to its support.
Introduce the file to the canal,
according to the gure.
Functions and programmings
The equipment has 4 operation modes and 4 function options according to the table below.
MODE
FUNCTIONS
Inversion
of the
automatic
spinning
Reciprocating
Movement 1
(VDW Standard)
Reciprocating
Movement 2
(DENTSPLY Standard)
Apex
Locator
M1 - - - √
M2 √- - -
M3 -√- -
M4 - - √-
WARNING
In order to assure a precise measurement,
you shouldn’t continue the procedure while
you don’t hear the orientation beeps.
Apex
Locator
On/O Switch
Lip
File Support
Tooth Stainless
steel labial clip