Bien Air iOptima User manual

iOptimaINT
ENG INSTALLATION INSTRUCTIONS.
REF 2100320-0000/2018.06

REF 2100320-0000/2018.06 iOptimaINT • © Bien-Air Dental SA
Set iOptimaINT REF 1700704-001
1x
REF 1502475-001
1x REF
1600677-001
1x REF
1600809-001
1x REF
1601074-001
1x REF
1500666-001
1x REF
1502568-001
1x REF
1300067-001
Set iOptimaINT REF 1700705-001
1x
REF 1502475-001
2x REF
1600677-001
2x REF
1600809-001
1x REF
1601075-001
1x REF
1500666-001
1x REF
1502568-001
1x REF
1300067-001
Set iOptimaINT REF 1700730-001
1x
REF 1600809-001
1x
REF 1601074-001
1x
REF 1600666-001
1x
REF 1502568-001
1x
REF 1300067-001
Set iOptimaINT REF 1700731-001
2x
REF 1600809-001
1x
REF 1601075-001
1x
REF 1600666-001
1x
REF 1502568-001
1x
REF 1300067-001

REF 2100320-0000/2018.06 iOptimaINT • © Bien-Air Dental SA
Options
1x
REF 1502620-001
1x
REF 1502621-001
1x
REF 1502622-001
1x
REF 1502623-001
1x
REF 3300409-001
1x
REF 3300404-001
1x
REF 3300403-001
1x
REF 1000031-001
1x
REF 1502567-001
1x
REF 1307467-001

REF 2100320-0000/2018.06 iOptimaINT • © Bien-Air Dental SA

ENG
1
1 Symbols.................................. 2
2 Identification and Intended
use ........................................... 2
2.1 Identification .................................2
2.2 Intended use .................................2
2.3 Notation .........................................2
3Electromagnetic
compatibility for
iOptima INT ............................ 3
3.1 Electromagnetic compatibility
warnings .......................................3
3.2 Electromagnetic compatibility –
emissions & immunity ..............4
4 Description............................. 7
4.1 System overview ........................7
4.2 Technical data ..............................7
4.3 Environmental protection and
information for disposal ...........8
5 Installation ............................. 9
5.1 Docking and bracket ..................9
5.2 Dental unit pedal connection 10
5.3 DMX3 wiring .............................. 10
5.3.1 DMX3 with 1 MX2 motor
procedure ................................... 10
5.3.2 DMX3 with 1 MX2 motor
diagram ...................................... 12
5.3.3 DMX3 with 2 MX2 motors
procedure ................................... 14
5.3.4 DMX3 with 2 MX2 motors
diagram ...................................... 16
6 iOptima application
settings................................. 18
6.1 Display integrator's menus ...18
6.2 Board configuration .................18
6.2.1 Change motor ............................ 19
6.3 Lock settings .............................19
7 Integration checklist .......... 20
8 Maintenance ........................ 21
9 General information,
guarantee and references 21
9.1 General information ................21
9.2 Terms of guarantee .................21
9.3 References .................................22
9.3.1 Set supplied
(see cover page) ........................ 22
9.3.2 Optional accessories
(see cover page) ........................ 22
Table of contents

2
ENG Installation instructions
1Symbols
2 Identification and Intended use
2.1 Identification
Electronic control for Bien-Air Dental SA MX2 brushless and sensorless micromotor.
2.2 Intended use
This product is intended solely for professional use. It is intended for use in
dentistry for restorative and endodontics procedures. Any use other than that for
which this product is intended is prohibited and may prove dangerous.
2.3 Notation
• A , B , C , etc.
Text preceded by a letter indicates a procedure to be carried out step-by-step.
•
(1) , (2) , (3) , etc.
Text preceded by a number indicates text used in conjunction with an illustration.
Sign Description Sign Description
CE Marking with number of the
notified body.
Refer to the accompanying
documents for the correct use of the
product.(www.bienair.com/ifu.)
Manufacturer. Serial number.
Reference number. Separate collection of electric and
electronic equipment.
CAUTION! Consult accompanying
documents. Provides an instruction
that should be observed for safety
reasons.
Light.
RF emitting device (Interference may
occur in the vicinity of equipment
marked with this symbol).
Recyclable materials.
SN
REF


ENG
3
3 Electromagnetic compatibility
for iOptima INT
3.1 Electromagnetic compatibility warnings
The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional
healthcare facility environment.
CAUTION
The iOptima INT complies with the EMC requirements according to IEC 60601-1-2.
Radio transmitting equipment, cellular phones, etc., should not be used in the
immediate vicinity of the device, since this could affect its operation. The device is
not suitable for being used close to high-frequency surgical equipment, magnetic
resonance imaging (MRI) and other similar devices where the intensity of
electromagnetic disturbances is high. In any case, ensure that no high frequency
cables are routed above or near the device. If in doubt, contact a qualified
technician or Bien-Air Dental SA.
Special precautions should be taken when using strong emission sources such as
high-frequency surgical equipment and other similar devices, to ensure that HF
cables are not routed above or near the device. If in doubt, please contact a
qualified technician or Bien-Air.
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the iOptima INT, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
CAUTION
The use of accessories, transducers and cables other than those specified, with
the exception of transducers and cables sold by Bien-Air as spare parts for
internal components, may result in increased emissions or decreased immunity.
CAUTION
Since this device is intended to be used adjacent to or stacked with other
equipment, the responsibility of verifying normal operation in the configuration in
which it will be used falls onto the dental unit manufacturer.

4
3.2 Electromagnetic compatibility – emissions & immunity
Guidance and manufacturer’s declaration – Electromagnetic emissions
iOptimaINT is intended for use in the electromagnetic environment specified below.
The customer or the user of iOptimaINT should ensure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The iOptimaINT uses RF energy for its internal
operation only. 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 iOptimaINT is suitable for use in any building,
including residential buildings and those directly
connected to the public low-voltage power supply
network that supplies buildings used for
residential purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Emissions due to
voltage fluctuations IEC
61000-3-3
Conforming

ENG
5
Guidance and manufacturer’s declaration – Electromagnetic immunity
The iOptimaINT is intended for use in the electromagnetic environment specified
below. The customer or the user of the iOptimaINT must ensure that it is actually
used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient
burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for other lines
±2 kV for power
supply lines
±1 kV for lines no
input/output
Mains power quality should be
that of a commercial or
hospital environment.
Surge
IEC 61000-4-5
±0.5 kV line to line
±1 kV line to line
±0.5 kV line to earth
±1 kV line to earth
±2 kV line to earth
±0.5 kV line to line
±1 kV line to line
±0.5 kV line to earth
±1 kV line to earth
±2 kV line to earth
??.
Mains power quality should be
that of a commercial or
hospital environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-
11
?
0% UTfor 0.5 cycle,
at 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% UTfor 1 cycle
and
70% UTfor 25/30
cycles at 0°
0% UTfor 0.5 cycle,
at 0°, 45°, 90°, 135°,
180°, 225°, 270°
and 315°
0% UTfor 1 cycle
and
70% UTfor 25/30
cycles at 0°
Mains power quality should be
that of a commercial or
hospital environment. If the
user of the iOptima INT
requires continued operation
during mains power
interruptions, it is
recommended that the iOptima
INT be powered from an
uninterruptible power supply
or a battery.
Magnetic field
due to mains
frequency (50/
60 Hz)
IEC 61000-4-8
30 A/m 30 A/m
Magnetic fields generated by
the mains frequency should be
at levels characteristic of a
typical location in a typical
commercial or hospital
environment.

6
Conducted
disturbances
induced by RF
fields
IEC 61000-4-6
3 VRMS
0,15 MHz – 80 MHz
6 VRMS in ISM bands
0,15 MHz – 80 MHz
80% AM at 1 kHz
3 VRMS
0,15 MHz – 80 MHz
6 VRMS in ISM and
amateur bands
0,15 MHz – 80 MHz
80% AM at 1 kHz
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site
survey1should be less than the
compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Radiated RF
EM fields
IEC 61000-4-3
?
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximity
fields from RF
wireless
communicatio
ns equipment
IEC 61000-4-3
Test freq.
[MHz]
Max. power
[W]
Immunity
test level [V/
m]
Distance: 0.3 m
385 1.8 27
450 228
710, 745,
780 0.2 9
810, 870,
930 228
1720, 1845,
1970 228
2450 228
5240, 5500,
5785 09
NOTE: UTis the AC mains voltage prior to application of the test level.
Essential performance per IEC 60601-1: The essential performance is to maintain the visual
luminous intensity of the LED and the motor speed. The maximum speed deviation is ±5%.
1. Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones and mobile field radios, amateur radios, AM and FM radio
broadcasts and TV broadcasts cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an electro-
magnetic site survey should be considered. If the measured field strength in the lo-
cation in which the iOptima INT is used exceeds the RF compliance level mentioned
above, the iOptima INT should be observed to verify that it is operating normally. If
abnormal operation is observed, additional measures may be necessary, such as
reorienting or relocating the iOptima INT.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance

ENG
7
4Description
4.1 System overview
Electronically controlled integrated unit for dentistry allowing operation of multiple
micromotors (MX2) with variable speed using the dental unit pedal.
It is essential to connect a compatible iPod Touch® or iPad Mini® using the lighting
connector with the provided docking station.
4.2 Technical data
CAUTION
The technical specifications, illustrations and dimensions contained in these
instructions are given only as a guide.
They may not be the subject of any claim The manufacturer reserves the right to
make technical improvements to its equipment, without amending these
instructions. For all additional information, please contact Bien-Air Dental SA at
the address indicated on the back cover.
Electrical and pressure data
Voltage ............................................................................. 100-240 VAC
Frequency ....................................................................... 47-63 Hz
Nominal power.............................................................. 90 W
Max. input power .......................................................... 160 W
Operating voltage ......................................................... + 32 Vdc
Operating current ......................................................... Max 4.6 A
Max. input pneumatic pressure................................5 bar / 72.5 psi
Min. input pneumatic pressure................................. 3 bar / 43.5 psi
Environmental conditions
Classification
Class IIa in accordance with European Directive 93/42/EEC concerning medical
devices.
Environmental
conditions Operating Transport and storage (max. 15 weeks)
Temperature +10°C (50°F) to
+35°C (77°F)
-25°C (-13°F) to
+70°C (158°F)
Relative humidity 30% to 80% 30% to 80%
Atmospheric pressure 700 hPa to 1060 hPa 500 hPa to 1060 hPa
Altitude 0 to 3'000 m (0 to 9'842 ft) -

8
Electric insulation class
Class I per IEC 60601-1 (apparatus protected against electric shocks).
Important: Consult the Instructions for Use of the following devices:
4.3 Environmental protection and information for disposal
This device must be recycled. Electrical and electronic equipment may contain
dangerous substances which constitute health and environmental hazards. The
user can return the device to its dealer or directly enlist the services of a firm
accredited for the processing and recovery of this type of equipment (European
Directive 2002/96/EC).
Device IFU REF
Motor MX2 LED 2100199 1600677-001
Hose MX2 2100223 1600809-001
Control DMX3 set 2100278 1600903-001

ENG
9
5Installation
CAUTION
Before use, please read these installation instructions and the iOptima
INT
operating
instructions (2100279) carefully. Switch ON only when the system is ready for use.
To conform with IEC 60601-1-2 standards, take into account the different routes of the
wires through the unit (bend, fold, section etc) and only use the transformer provided
with the kit or the unit’s power supply (Refer to “5.3 DMX3 wiring” on page 10).
To maintain warranty, this device must be installed with the greatest care. Follow
all the necessary instructions.
5.1 Docking and bracket
A. Center the docking (1) into the bracket (2) and tighten both screws (3) using
socket wrench REF 1000031-001 and M3 TORX-S Screw Head REF 3300404-001.
B. Fix the bracket onto the left or right connection bracket (4), adjust the desired
angle for the device and tighten both bolts (5) using socket wrench REF 1000031-
001 and M4 TORX-S Screw Head REF 1307307-001.
C. Add the caps (6) to hide the screws and the nuts.
D. Drill 2 x Ø 3.5 to 4 mm holes in the dental unit.
E. Fix the connection bracket onto the dental unit and tighten the two nuts (7).
Depending on the desired distance from the unit to the iPod/iPad, fix the connec-
tion bracket onto the dental unit using the position (7.1) or (7.2).
F. Fit the iPod/iPad (8).
G. Insert the lock (9) and tighten the screw (10) using socket wrench REF
1000031-001 and M3 TORX-S Screw Head REF 3300404-001.
Note: It is possible to fit the docking station on both sides of the dental unit.
FIG. 1 FIG. 2

10
5.2 Dental unit pedal connection
Connect either a pneumatic (0–3 bar / 0-43.5 psi) (1) or an electrical (0–5 Vdc) (2)
dental unit pedal according to the following:
5.3 DMX3 wiring
Note: Refer to the corresponding diagram on the following pages.
THE POWER MUST NOT BE CONNECTED DURING THE WHOLE INSTALLATION
PROCEDURE.
5.3.1 DMX3 with 1 MX2 motor procedure
A. Drill a hole of diameter 12 mm in the unit to install the Power supply reset
switch (1502568) (1).
B. Connect together: Power supply reset switch (1502568), Power Supply PMP90
(1500666) (2) and Power Outlet Cable (1300067).
C. Drill two holes of diameter 3.5 mm in the unit to fix the electrovalve (1502523)
to the dental unit using screws and nuts (1502564).
FIG. 3
FIG. 4 FIG. 5
FIG. 6
1 2
1
2

ENG
11
D. Fix the whiteboxes (1601015 and 1502569) to the dental unit using Velcros
(1502565).
E. Connect the pneumatic circuit (1502566) to the delivery unit and to the motors
according to the “5.3.2 DMX3 with 1 MX2 motor diagram” on page 12.
Note: Please use pneumatic pipes with an internal diameter of 2.8 mm.
F. Connect the electrovalves (1502523) to the DMX3 Whitebox (1601015) (1).
G. Connect the DMX3 Whitebox (1601015) to the motor hose following the color
code (2) on the connector.
H. Connect the Power supply reset switch to the DMX3 Whitebox (1601015) (3).
I.
Connect the Apple USB Cable (not provided in the set) to the DMX3 Whitebox (1601015).
J. Drill a hole of diameter 19 mm in the unit with the hole saw (3300409). Pass the
Apple USB cable through the opening on the dental unit. To protect and avoid any
USB cable movement:
• fix it inside the unit with the provided cable zip tie (1) and its Self-adhesive
cable tie mount (1502535) (2),
• protect the opening with cable pass-through protection.
K. Connect the Lightning cable to the Apple device.
L. Connect the power supply cable.
M. Configure the board through the App according to the iOptima application set-
tings chapter.
FIG. 7 FIG. 8
FIG. 9 FIG. 10
1
32
1 2

12
5.3.2 DMX3 with 1 MX2 motor diagram
+32Vdc
Gnd
Phase A / blue
Phase B / red
Phase C / black
L - / orange
L + / brown
Gnd
VDC
Gnd
Air Drive MX2
Power Supply PMP90-16-k24
REF 1500666
iOptima Int 1 EV directe
REF 1502523 +
Kit de fixation 1502564
USB / Lightning
cable
5()
iOptima Int wiring diagram 1 MX2 motor ref. 160
80 - 230VAC
Kit fixation lightning
REF 1502535
300-500kPa
Cable 230 VAC
REF1300067
(Drill hole 19 mm)
Pneumatic 1x valve
MX2 REF 1502566
Kit fixation iPod/iPad
REF1502475
DMX3 REF 1601015
Top box REF 1307249
Bottom box REF 1307248
Kit fixation box REF 1502565

ENG
13
Phase A / blue
Phase B / red
Phase C / black
BIEN-AIR Dental SA / 28.05.2018
MX2 REF 1600677
Hose MX2 REF 1600700
wiring diagram 1 MX2 motor ref. 1601074
+32Vdc
Gnd
Drill hole
12.5 mm
iOptima Int
connexion alim
REF 1502568
Note:
The iOptima INT system is only compliant
to the IEC60601-1 standard when used with
the power supply ref. 1500666 provided
by Bien-Air and mounted inside the dental
unit.
The use of any other power supply type is
prohibited and may prove dangerous and
mounted inside the dental unit.

14
5.3.3 DMX3 with 2 MX2 motors procedure
A. Drill a hole of diameter 12 mm in the unit to install the Power supply reset
switch (1502568).
B. Connect together: Power supply reset switch (1502568), Power Supply PMP90
(1500666) (1) and Power Outlet Cable (1300067).
C. Drill four holes of diameter 3.5 mm in the unit to fix the electrovalves (1502528)
to the dental unit using screws and nuts (1502574).
D. Fix the whiteboxes (1601015 and 1502569) to the dental unit using Velcros
(1502572).
E. Connect the pneumatic circuit (1502573) to the delivery unit and to the motors
according to the “5.3.4 DMX3 with 2 MX2 motors diagram” on page 16.
Note: Please use pneumatic pipes with an internal diameter of 2.8mm.
F. Connect the air switches to the motor holders.
G. Connect the air switches to the DMX3 board (1).
H. Connect the electrovalves (1502528) to the dual motor whitebox (1502569) (2).
FIG. 11
FIG. 12
FIG. 13 FIG. 14
2
1
2

ENG
15
I. Connect the dual motor whitebox (1502569) to the motor hoses following the color code
on the connectors. Motor 1 shall be connected to (1.1), motor 2 shall be connected to (1.2).
J. Connect the Power supply reset switch to the DMX3 Whitebox (1601015) (2).
K. Connect the DMX3 Whitebox (1601015) to the dual motor whitebox (1502569)
with the DMS connection (1502525) (1).
L.
Connect the Apple USB Cable (not provided in the set) to the DMX3 Whitebox (1601015).
M. Drill a hole of diameter 19 mm in the unit with the hole saw (3300409). Pass the
Apple USB cable through the opening on the dental unit. To protect and avoid any
USB cable movement:
• fix it inside the unit with the provided cable zip tie (1) and its Self-adhesive
cable tie mount (1502535) (2),
• protect the opening with cable pass-through protection.
N. Connect the Lightning cable to the Apple device.
O. Connect the power supply cable.
P. Configure the board through the App according to the iOptima application set-
tings chapter.
FIG. 15 FIG. 16
FIG. 17
FIG. 18 FIG. 19
1.2 1.1
32
1
1.1
1.2
1.3
1.4
1 2

16
5.3.4 DMX3 with 2 MX2 motors diagram
iOptima Int
DMS connexion
REF 1502525
+32Vdc
Gnd
DMX3 REF 1601015
Top box REF 1307249
Bottom box REF 1307248
Kit fixation box REF 1502572
Phase A / blue
Phase B / red
Phase C / black
L - / orange
L + / brown
Gnd
Air Drive
MX2 N°1
Power Supply PMP90-16-k24
REF 1500666
Kit Pneumatic
2x MX2
REF 1502573
USB / Lightning
cable
5()
iOptima Int wiring diagram 2 MX2 motors REF 1
M 2
80 - 230VAC
Kit fixation iPod/iPad
REF1502475
M 1
Air Drive
MX2 N°2
Cable 230 VAC
REF 1300067
Assembly DMS + air switches
in box REF 1502569
300-500kPa
M 1
M 2
EV1
EV2
EV1
EV2
Air MX2 N°1
Air MX2 N°2
(Drill hole 19 mm)
Free flow
Free flow
Kit fixation lightning
REF 1502535