Denjoy iMate-II User Manual

Rev. 02/01/18 VER SMS-IMATE-II 20140828-EN

USER MANUAL

iMate-II

*The unit must be installed by a qualified engineer.
*Only for user by dental professionals.
*Read this manual carefully before installation or operation.

Endo Motor

Rev. 02/01/18 VER SMS-IMATE-II 20140828-EN

CONTENTS

SECTION 1: GENERAL INTRODUCTION

SECTION 2: MAIN TECHNICAL INDEX

SECTION 3: SYMBOL

SECTION 4: PRODUCT STRUCTURE

SECTION 5: OPERATION PANEL AND LCD SCREEN

SECTION 6: OPERATION

SECTION 7: NOTICE

SECTION 8: TOUBLESHOOTING

SECTION 9: MANTENANCE & SERVICE

SECTION 10: STERILIZATION

SECTION 11: ENVIRONMENTAL REQUIREMENTS

SECTION 12: PACKING LIST

SECTION 13: WARRANTY

REMARKS:

The pictures here are for reference only

Real products shall prevail. The parameters and pictures in

this manual are subject to change without prior notice.

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Thank you for purchasing our device. Before operating the

device, please fully read the manual and this manual should be

saved for later use.

DENJOY DENTAL CO., LTD will take the responsibility for the
security, reliability, capability under the following conditions:

1. The installation, debugging, maintenance should be
adjusted by the approbatory technician by our company or
obtained related nation quality level license professions.

2. The power supply shall be in conformity with the relevant
provisions of the state and the use requirements of device
itself.

3. The device should be operated by licensed dental
professionals with medical applied skill. The whole operation
process should follow user’s manual strictly.

DENJOY DENTAL CO., LTD has right to improve shape and
structure of the device, change any information and technical
specification of this manual all the time, and no need to notice
the user in advance.

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Address: DORFSTRASSE 2/4, EMMENDINGEN, 79312

GERMANY

CONTACT INFORMATION

The device is manufactured by:
DENJOY DENTAL CO., LTD
Address: F4, Building A4, Lugu Medical Device Park, No.229
Guyuan Road, Changsha, 410205 P. R. China

Authorized European Representative:
Company name: LANDLINK GMBH

Please contact sales representative directly from whom
you have bought this device for user’s record and further
after-sale service.

SECTION 1: GENERAL INTRODUCTION

Cordless Endo Motor is an endodontic operation
instrument. Endo motor function is a kind of endodontic
micromotor to drive Ni-Ti instruments, which can assist the
dentists to shape more standard root-canal in the process of

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root-canal treatment based on the micro-electronic control
technology. Cordless endo motor can be held in hand to
operate and cordless charging. This unit contributes to
alleviate the dentist’s working intensity.

Product application and intended use

Cordless Endo Motor is applied to dental especially
endodontic treatment. It is used for treat the root canal pulp
necrosis, chronic pulpitis, chronic apical periodontitis
(including meat tooth apical swelling, periapical abscess,
periapical cyst), periodontal pulp syndrome and systemic
diseases should not be extract but urgent needed to be treat.

Unique advantages

Use endo rotary file to enlarge the root canal, not only
enlarges the root canal in straight situation, but also works for
curved root canal.

1. Compact design complies with standard of human
engineering, exquisite and ingenious of surface, easy to take.

2. Six different programs can be preset and saved according to
the requirement of the operator. P6 is special program for
reciprocating rotation mode and the mark “ ” can be seen
on the LCD. Under P6, 16:1 reciprocating manual file contra­angle can be used. Only speed can be changed and the torque

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and reverse mode can not be changed. Under P6, when the
torque exceeds 3.0N.cm, reciprocating rotation will stop.
(Remarks: Mini 16:1 contra-angle is a standard part of
iMate-II.)

3. Auto-reverse and auto-stop function: When torque exceeds
the upper limit, the motor will automatically reverse or stop.

4. Mini 16:1 contra-angle can be 135℃ autoclaved.

5. Build-in rechargeable battery, greatly resolved the
inconvenience of frequently replacement of the battery and
the cost of using our device. In order to extend the life-span
and working life of the battery, the device will turn off
automatically after 5 minutes of no-operation.

6. If low battery, the machine will alarm to indicate operator.

7. Beep can be heard when running out of battery.

8. For correct operation for each step, the sound of “DING”
once can be heard. When turn on/off the device, the sound of
“DING” twice can be heard. For incorrect or invalid operation,
the sound of “DING” three times can be heard.

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SECTION 2: MAIN TECHNICAL INDEX

Model Name: iMate-II
Trade Name: iM2
Type of protection against electric shock:

Class II equipment:
Degree of protection against electric shock:

Type B applied part:
Degree of protection against ingress of water: IPX0
Operation mode: Continuous Operation

Main Unit

Battery voltage: 3.7Vdc Battery capacity: 1050mAh
Net weight: 210 g

Adapter

Rated input voltage: AC100-240V 50HZ/60HZ
Output voltage: DC5V Output current: 1A

SECTION 3: SYMBOL

The following symbols may appear in this manual, on the label,
or on it’s accessories. Some of the symbols represent standards
and compliances associated with the endo motor and its use.

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Consult accompanying documents

Cautions

Authorized Representative in the European
Community

CE Mark: conforms to essential requirements
of the Medical Device Directive 93/42/EEC.

Date of manufacture.

Manufacturer

SN

Specifies serial number

Type B applied part

Refer to instruction manual / booklet

The device should not be used after the end
of the shown or the day

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DISPOSAL: Do not dispose this product as
unsorted municipal waste. Collection of such
waste separately for special treatment is
necessary.

alert indicator displayed on the LCD screen

Battery power sign displayed on the LCD
screen

AUTO REVERSE: If the load is removed after
auto reverse rotation, it returns to the normal
rotation again.

AUTO STOP

: I

f the load is removed after auto

reverse rotations, it stops.

AUTO REVERSE OFF: Auto reverse function is
not activated.

SECTION 4: PRODUCT STRUCTURE

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1

2

3

1. Mini 16:1 Contra-angle 2. Motor handpiece

3. Charging Base

SECTION 5: OPERATION PANEL AND LCD PANEL

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POWER

● Holding down the POWER key for more than one second
turns on the power and the LCD panel lights.

● Holding down the POWER key for more than one second
while the power is on turns off the power and the LCD display
turns off.

ON/OFF

When the power is on, press ON/OFF key and the device start

working, press this key again and the device stop working.

SELECT

To change Torque (TQ), Gear Ratio (GR), Speed (SP) and Auto

reserve setting. The speed and torque can be changed while

the file is in motion.

PROGRAM (MEMORIZE)

The present program number can be displayed.
The program number is available from P1 to P6.

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Speed（rpm）

Gear Ratio

Torque（N.CM）

140-600

16:1

0.3-3.0

Holding down the PROGRAM key for more than one second

choose program number.

The following parameters can be set.

Torque, Gear ratio, Speed and Auto reserve.

Press PROGRAM key can memorize the parameters setting.

UP/DOWN

To adjust the set value for each parameter

Speed: rpm, Torque: N.cm

Gear ratio is 16:1

Please use suitable contra-angle based on gear ratio.

LCD PANEL for PI to P5, LCD PANEL for P6,

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means program 1, 2, 3, 4,5, 6.

6 different programs can be preset and saved according to the

requirement of the operator.

P6 is special program for reciprocating rotation
mode and the mark “ ” can be seen on the LCD.
Under P6, 16:1 reciprocating manual file contra-angle can be
used. Only speed can be changed ,the torque and reverse
mode can not be changed. Under P6, when the torque
exceeds 3.0N.cm, reciprocating motion will stop.

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means speed of 550 rpm.

means torque of 2.0.

means reverse setting

means battery remaining

AUTO REVERSE

The present auto reverse mode mark is displayed.

AUTO REVERSING (If the load is removed after auto

：

reverse rotation, it returns to the normal rotation again.)

: AUTO STOP (If the load is removed after auto reverse

rotations, it stops.

AUTO REVERSE OFF: Auto reverse function is not

activated.

BATTERY REMAINING

The mark of the present remaining amount of the batteries is

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displayed regardless of the ON or OFF position of the power.
The mark will be animated when the batteries are being
charged.

:Means full charge

:Means appro. 30-80% remains

: Means less than 30%

: Means low voltage. Charge immediately

Initialization of Program (Factory-set configuration)

The program can be returned to the original state configured
at the time of factory shipment, if setup becomes confusing.

1. Turn on the power when the power is off.

2. Connect handpiece contra angle

3. Hold down the SELECT key for more than one second

4. Press ON/OFF key when the LCD panel indicates “ ”

5. Initialization is completed, when LCD panel display
normally.

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SECTION 6: OPERATION

1, Charge

A, connect the power adapter to the charging base.

B, Put the main unit on the charging base, during this period,

please confirm if a beep is heard and the power display is

flashing, and shows “ ”.

C, If the beep has been heard, and the Power display shows

“ ”, means the battery is full.

2, Contra-angle install and uninstall

Connect the contra-angle and motor handpiece, please target

the hole of motor handpiece and contra-angle until a sound

can be heard. When uninstall the contra-angle, please pull out

in vertical direction.

3, Inserting and Removing the file

Insert the file inside the contra angle and revolve lightly to find

the contra-angle right position, and then use stronger

strength to insert until a sound can be heard. When uninstall

the file, just press the pushbutton contra-angle to uninstall.

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Note:

While uninstall the file, please turn off the power.

While install the file, please double confirm the file has been

successfully loaded.

Please keep the file clean, dirty file can cause the vibration

during the operation.

4, Operation

Press the Power button to start the machine, press the engine

on/off button to start the rotation, press again the engine

on/off button to stop the rotation.

5, After the operation

Please press the power button to turn off the machine after

the operation.

Auto turn off function

The device will turn off automatically after 5 minutes of

no-operation.

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Program memory setting.

Because last time you already saved the program setting, this

program setting will remain the same until you change the

program and save again.

SECTION 7: NOTICE

Note: Please do not use improper file because it will cause

accident during operation.

Please use the speed according to the file manufacturer.

Please avoid putting the machine under high temperature

such as sun light, fire.

While insert the machine to the charging base, please make

sure to put in the correct position in order to avoid break.

Please do not lubricate our endo motor or autoclave it.

The endo motor is not water proof, please keep it away from

water or medicine liquid in order to avoid short circuit.

Please do not fall down the main unit and charging base.

Please use our power adapter for charge the machine.

Our endo motor usually will not make electromagnetic

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Problems

Cause & Solution

The device
can’t be
turned on.

The batteries are empty.
Charge the batteries or use the AC adapter.

The press of the power button is short.
Please long press the power button

The POWER button is broken. Contact with
your dealer.

interference other equipment

Forbidden

The cardiac pacemaker patient can not use this product. Do

not use with high-frequency surgical equipment and heart

disease in patients with caution!

The machine can only be used independently; please do not

connect the machine with other products.

Section 8: TOUBLESHOOTING GUIDE

When trouble is found, check the following again before
contacting your dealer. If none of these are applicable or the
trouble is not remedied even after action has been taken, the
product may have failed. Contact your dealer.

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The
battery
can’t be
charged.

The adapter didn’t connect well.
Please recheck the connection

The major machine didn’t put on the charger
base correctly. Please recheck the connection

The battery is broken. Contact with your
dealer

Fault
code

Function

Description

Overcurrent
Protection

The motor will shut off when
overcurrent happened during
the operation

Overheating
Protection

The motor will shut off when
overheating happened during
a long time of heavy operation

Energy
consumption
Protection

The motor will shut off in 15
minutes if the operation
situation without heavy change

Correcting
Protection

Fault Calibration. Exit
calibration directly When
current over theoretical value

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Relief Measures：For all the fault codes，please press any
button to eliminate fault code except the POWER.

SECTION 9: MANTENANCE

1) Please recharge the battery for 5 minutes each month and

check the machine everything in order too.

2) The machine has the life span for 5 years.

3) When the surface of main body is polluted, please rub the
surface with dry soft cloth ONLY by use Neutral cleanser.

REMARKS: Any liquid lotion like ethanol, banana oil and light
oil are not allowed.

SECTION 10: STERILIZATION

Please autoclave Mini16:1 contra-angle only.

Before autoclave contra-angle, please use AR spray for
cleaning the contra angle.
The mentioned above accessories we suggest use 135℃
autoclave for 15 minutes. 121°autoclave for 20 minutes.
If the cleaned contra-angle is not in use, please seal in the
sterilization bags and store it in a clean place.

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OPERATING CONDITIONS

Ambient temperature: 5℃~ 40

℃

Relative humidity range:≤80%

Atmospheric pressure: 70kPa~ 106kPa

STORAGE AND SHIPPING CONDITIONS

Ambient temperature: -40℃~ 55

℃

Relative humidity range:≤80%

Atmospheric pressure: 50kPa ~ 106kPa

Remarks:

Please autoclave Mini 16:1 contra-angle only.

Because the high temperature disinfection stand is close to
the bottom of the heat source, the local temperature will be
very high, so put the vessel in the middle or upper part of the
disinfection cabinet.
Oxidation potential water, (strongly acidic water super acidic
water) or sterilization liquid is strictly prohibited to wash,
impregnation the vessel.

Section 11: ENVIRONMENTAL REQUIREMENTS

Equipment is not suitable for storage in the presence of
sunlight, rain, dust, and corrosive gasoline and volatile

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without poor ventilation.
Transportation is applicable to all common method.

Section 12: Packing List

Endo Motor iMate-II includes:

Motor handpiece 1 pc

Charging base 1 pc

Mini 16:1 contra-angle 1 pc

Adapter 1 pc

Motor cover 1 pc

User manual 1 pc

SECTION 13: WARRANTY STATEMENT

The device is maintained free of charge and doesn't require
any routine maintenance within warranty period.
Do not modify and disassemble the device.
This device described below has been fully inspected and
confronts to the current products specification.
This instrument is guaranteed for its designated use, against
original defects in materials and workmanship for a period of
12 months from date of purchase.

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Products warranty or service will not be extended if (1) the
product is repaired, modified, misused, disassembled, or using
the parts are not provided by the manufacturer, (2) The serial
number of the product is defaced or missing.
The guarantee for accessories is 6 months. All accessories of
the device are damaged or needed to be renewed, the user
can purchase new accessories from the seller.

WARNING

The device is not repairable by user and contains no user
serviceable parts. No modification of this equipment is
allowed.

The user must check that the equipment functions safely and
see that it is in proper working condition before being used.
The manufacturer does not require such preventive
inspections by other persons.

Please contact sales representative directly from whom
you have bought this device for user’s record and further
after-sale service.

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Guidance and manufacturer’s declaration -

electromagnetic emissions

The [iMate-Ⅱ] is intended for use in the electromagnetic

environment specified below. The customer or the user of

the [iMate-Ⅱ] should assure that it is used in such an

environment

Emissions

test

Compliance

Electromagnetic

environment - guidance

RF
emissions
CISPR 11

Group 1

The [iMate-Ⅱ] uses RF

energy only for its internal
function. Therefore, its RF

emissions are very low and

are not likely to cause any

interference in nearby

electronic equipment.

RF
emissions
CISPR 11

Class [B]

The [iMate-Ⅱ] is suitable for

use in all establishments
other than domestic, and
may be used in domestic

establishments and those

directly connected to the
public low-voltage power

supply network that supplies

buildings used for domestic

purposes, provided the

following warning is heeded:

Warning: This

Harmonic

emissions

IEC

61000-3-2

Class A

Voltage

fluctuations/

flicker

emissions

IEC

Complies

Table 1

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equipment/system is

intended for use by

healthcare professionals

only. This equipment/ system

may cause radio

interference or may disrupt

the operation of nearby

equipment. It may be

necessary to take mitigation

measures, such as

re-orienting or relocating the

[iMate-Ⅱ] or shielding the

location.

61000-3-3

Guidance and manufacturer’s declaration -

electromagnetic emissions

The [iMate-Ⅱ] is intended for use in the electromagnetic

environment specified below. The customer or the user of

the [iMate-Ⅱ] should assure that it is used in such an

environment

Immunity

Test

IEC

60601

Test level

Complian

ce level

Electromagne

tic

environment -

guidance

Electrostatic
discharge

±6 kV
contact

±6 kV
contact

Floors should
be wood,

Table 2

26

(ESD)
IEC
61000-4-2

±8 kV air

±8 kV air

concrete or
ceramic tile. If
floors are
covered with
synthetic
material, the
relative
humidity
should be at
least 30 %

Electrical
fast
transient/bur
st
IEC
61000-4-4

±2 kV for
power
supply
lines
±1 kV for
input/outp
ut lines

±2 kV for
power
supply
lines

Mains
power quality
should be that
of a typical
commercial or
hospital
environment.

The electrical
fast transient

burst (EFT) is

generated by
the switching of
inductive loads.

Separation

between the

equipment and

other loads

shall be

considered

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before

installation.

Mains filter is

required, if
necessary.

Surge
IEC
61000-4-5

±1 kV
line(s) to
line(s)
±2 kV
line(s) to
earth

±1 kV
line(s) to
line(s)

Mains power

quality should

be that of a

typical

commercial or

hospital

environment.

Voltage
dips, short
interruptions
and voltage
variations
on power
supply input
lines
IEC
61000-4-11

<5% U

T

(>95% dip
in UT)
for 0.5
cycle

40% U

T

(60% dip
in UT)
for 5 cycle

70% U

T

(30% dip
in UT)
for 25
cycle

<5% U

T

(>95% dip
in UT)
for 0.5
cycle

40% U

T

(60% dip in
UT)
for 5 cycle

70% U

T

(30% dip in
UT)
for 25
cycle

Mains power

quality should

be that of a

typical

commercial or

hospital

environment. If

the user of the

[iMate-Ⅱ]

requires

continued

operation

during power

mains

interruptions, it

is

recommended

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<5% U

T

(>95% dip
in UT)
for 5s

<5% U

T

(>95% dip
in UT)
for 5s

the [iMate-Ⅱ]

be powered

from an

uninterruptible

power supply

or a battery.

Power
frequency
(50/60Hz)
magnetic
field
IEC
61000-4-8

3 A/m

3 A/m

Power

frequency

magnetic fields

should be at

levels

characteristic

of a typical

location in a

typical

commercial or

hospital

environment.

NOTE UTis the a.c. mians voltage prior to application of
the test level.

Guidance and manufacturer’s declaration -

electromagnetic emissions

The [iMate-Ⅱ] is intended for use in the electromagnetic

environment specified below. The customer or the user of

the [iMate-Ⅱ] should assure that it is used in such an

environment

Table 3

29

Immun
ity Test

IEC

6060

1

Test

level

Complia

nce

level

Electromagnetic

environment - guidance

Conduc
ted RF
IEC
61000­4-6

Radiate
d RF
IEC
61000­4-3

3Vrm
s
150K
Hz to
80M
Hz

3 V/m
80M
Hz to

2.5G
Hz

3V

3 V/m

Portable and mobile RF

communications

equipment should be

used no closer to any part

of the [iMate-Ⅱ],

including cables, than the

recommended separation

distance calculated from

the equation applicable to

the frequency of the

transmitter.

Recommended
separation distance

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where p is the maximum

output power rating of the

transmitter in watts (W)

according to the

transmitter manufacturer

and d is the

recommended separation

distance in metres (m)

Field strengths from fixed

RF transmitters, as

determined by an

electromagnetic site

survey,ashould be less

than the compliance level

in each frequency range.

b

Interference may occur in

the vicinity of equipment

marked with the following

symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency
range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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a

Field strengths from fixed transmitters, such as base
stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast
and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field
strength in the location in which the [iMate- Ⅱ ] is used
exceeds the applicable RF compliance level above, the
[iMate-Ⅱ] should be observed to verify normal operation.
If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or
relocating the [iMate-Ⅱ].

b

Over the frequency range 150 kHz to 80 MHz, field
strengths should be less than 3 V/m.

Recommended separation distances between portable

and mobile RF communications equipment and the

[iMate-Ⅱ]

The [iMate- Ⅱ ] is intended for use in an electromagnetic
environment in which radiated RF disturbances are
controlled. The customer or the user of the [iMate-Ⅱ ] can
help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF
communications equipment (transmitters) and the [iMate­Ⅱ ] as recommended below, according to the maximum

Table 4

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output power of the communications equipment.

Rated

maximum

output

power of

transmitte

r

W

Separation distance according to

frequency of transmitter

m

150 kHz to 80

MHz

d=1.2

80MHz to

800MHz

d=1.2

800MHz

to

2.5GHz

d=2.3

0,01/0.12

0.23

0,1/0.38

0.73

1/1.2

2.3

10/3.8

7.3

100/12

23

For transmitters rated at a maximum output power not
listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance
for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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WARRANTY REGISTRATION FORM

Item Name:
Model Name:
Serial No.:

Date of Purchase:
Name:
Address:

Phone:
Email:

Name of Distributor:
Authorized Distributors:
Stamp and Signature