10
TABLE OF CONTENTS
I.
MEANING OF SYMBOLS
II.
SCOPE OF USE
III.
GENERAL SAFETY INFORMATION
IV.
TECHNICAL CHARACTERISTICS
V.
INSTALLATION OF MD
VI.
HYGIENE AND MAINTENANCE
VII.
RÉPAIR
VIII.
GUARANTEES
IX.
ACCESSORIES
X.
CONDITIONS OF STORAGE & TRANSPORT
XI.
DISPOSAL
I. MEANING OF SYMBOLS
II. SCOPE OF USE
Dental care in the field of endodontology (for cleaning, preparation
and obturation of the root canal).
Inappropriate or indirect use could damage this device and be a
risk to the user and third parties.
These MDs are for professional use only in the dental surgery field.
According to these instructions, the MD must only be used by a
user with dental medicine experience, for the stated use, and in
compliance with current guidelines regarding the prevention of
accidents at work and work protection and the instructions in this
leaflet. MDs must be prepared and maintained only by individuals
who have been trained in preventing infections, auto-protection and
patient protection.
According to these instructions, users must:
• Only use non-defective work instruments,
• Only use the MD in a unit that complies with the guidelines of the
EN 60601 standard,
• Follow the correct use instructions,
• Protect oneself and patients and third parties against all dangers,
• Avoid all contamination by the product.
The following situations:
• Inappropriate use,
• Lack of maintenance,
• Use of removable accessories or parts not approved by Anthogyr,
• Using accessories from other devices on this MD,
• Change or addition to a MD not validated by Anthogyr.
Relieve Anthogyr of all guarantee obligations or other claims.
These MDs comply with the Community Directive 93/42/CEE as
amended by the 2007/47/CEE directive.
III. GENERAL SAFETY INFORMATION
Prior to use, check that the device has not been damaged in
any way and that no parts are missing.
Wear appropriate protection, especially gloves, a mask and
glasses.
Do not use the MD and inform your distributor or Anthogyr After-
Sales (AS) in the following situations : • visible failure or damage.
Risk of damage to the device and injury, wait until the motor has
completely stopped to:
• connect/disconnect the MD from the motor,
• turn the locking/unlocking system for the rotary instrument on,
DANGER !
Visual inspection
General information
Non sterile device
Sterilisable up to 135°C
Thermo-disinfectable
Wear gloves
Device reference
Device serial number
Date of manufacture
Nom of manufacturer
Medical device (Contra-
angle, hand piece, etc.)
E
x
D
F
g
e
r
A
B
MD
N
P
x
F
ra
n
ça
is
En
g
li
sh
(U
K
)
D
e
u
tsch
Esp
a
ñ
o
l
It
al
iano
P
o
rt
u
g
u
ê
s
N
e
d
e
rla
n
d
s
中国的
11
ر
ع
En
g
li
sh
(U
S
)
• handle the rotary instrument.
Assess the risk of septic substances penetrating tissue if used with
a central air cooling motor (refer to the motor manufacturer’s
leaflet).
Risk of burning and injury :
• Apply pressure to the MD with a rotary instrument (refer to the
manufacturer’s instructions).
Risk of electrical discharge due to MD being badly connected to an
Anthogyr non-compatible system:
• In the event of the MD being assembled and used in other manu-
facturer’s treatment devices and installations, refer to “Protection
against the risk of electrocution”, “Leaking current” and “Non-
earthing of use part” according to the IEC 60601-1 standard.
Do not use in explosive atmospheres.
IV. TECHNICAL CHARACTERISTICS
4.1 – Description of
MD
(Fig.1)
4.2 - Characteristics of
MD
s
V. INSTALLATION OF MD
The MD is supplied non-sterile.
Before first use, the MD must be cleaned, decontaminated and
sterilised (see § VI).
5.1 – Connection to the motor
Check that the MD is completely dry before connecting it to the
motor.
MICRO NITI®
NITI CONTROL®
Code
Name
Code
Name
A
Head
E
Head
B
Push button
F
Push button
C
Latch
G
Torque adjusting ting
D
Body
H
Body
M
IC
RO
N
ITI®
N
ITI
c
o
n
t
r
o
l
®
R
ef
er
en
ce
s
10
60
8
10
60
8M
B
P
10
61
6
10
61
6M
B
P
10
63
2
10
63
2M
B
P
10
66
4
10
66
4M
B
P
10
62
8
10
62
8M
B
P
10
66
4M
B
P
-DA
10
62
8M
B
P
-DA
R
at
io
8:
1
16
:1
32
:1
64
:1
12
8:
1
64
:1
12
8:
1
Co
lo
ur
c
od
e
G
re
en
Li
gh
t
N
o
M
ot
or
c
on
ne
ct
io
n
st
an
da
rd
IS
O
3
96
4
M
ax
im
al
s
pe
ed
o
f m
ot
or
40
0
00
r
pm
R
ot
ar
y
in
st
ru
m
en
ts
ac
co
rd
in
g
to
E
N
IS
O
1
79
7-
1
Ø
2
.3
5
m
m
R
ot
ar
y
in
st
ru
m
en
ts
ac
co
rd
in
g
to
E
N
IS
O
3
63
0-
1
In
st
ru
m
en
ts
fo
r
ro
o
t
ca
n
al
s
M
A
X
m
ot
or
s
pe
ed
w
he
n
to
ol
at
3
00
r
pm
1
(r
pm
)
25
00
50
00
10
00
0
20
00
0
40
00
0
20
00
0
40
00
0
M
A
X
m
ot
or
s
pe
ed
w
he
n
to
ol
at
6
00
r
pm
1
(r
pm
)
50
00
10
00
0
20
00
0
40
00
0
-
40
00
0
-
1
: Indicative values. In the event of the use of longer or bigger rotary tools, the user is responsible for
choosing the right operational conditions that avoids all risks to patients or third parties. Follow the
instructions for use, in accordance with the tools manufacturer’s instructions.
F
