Bien Air iOptima User manual

Rx Only
REF 2100279-0012/2022.03
iOptima
iOptimaINT
ENG INSTRUCTIONS FOR USE.
Other languages available on www.bienair.com/ifu

REF 2100279-0012/2022.03© Bien-Air Dental
Set iOptima REF 1700563-001
1x
REF 1600926-001
1x
REF 1600677-001
1x
REF 1600762-001
1x
REF 1501938-001
1x
REF 1501988-001
Set iOptima REF 1700544-001
1x
REF 1600926-001
1x
REF 1600677-001
1x
REF 1600762-001
1x
REF 1501938-001
Set iOptima REF 1700547-001
1x
REF 1600926-001
1x
REF 1600762-001
1x
REF 1501938-001

REF 2100279-0012/2022.03© Bien-Air Dental
Options
1x
REF 1600036-006
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
1x
REF
3300404-001
1x
REF
3300403-001
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
1x
REF
3300404-001
1x
REF
3300403-001

REF 2100279-0012/2022.03© Bien-Air Dental
Set iOptimaINT REF 1700563-001
1x
REF
1502475-001
1x
REF
1600677-001
1x
REF
1600809-001
1x
REF
1600755-001
1x
REF
1600606-001
1x
REF
1601076-001
1x
REF
1500666-001
1x
REF
1502568-001
1x
REF
1300067-001
1x
REF
3300404-001
1x
REF
3300403-001
1x
REF
1303711-010
Set iOptimaINT REF 1700730-001
1x
REF 1601074-001
1x
REF 1500666-001
1x
REF 1600809-001
1x
REF 1502568-001
1x
REF 1300067-001
Set iOptimaINT REF 1700731-001
1x
REF 1601075-001
1x
REF 1500666-001
2x
REF 1600809-001
1x
REF 1502568-001
1x
REF 1300067-001
PLUS

REF 2100279-0012/2022.03© Bien-Air Dental
Set iOptimaINT REF 1700732-001
1x
REF 1601076-001
1x
REF 1500666-001
1x
REF 1600809-001
1x
REF 1600606-001
1x
REF 1502568-001
1x
REF 1300067-001
1x
REF 1303711-010
Options
1x
REF 1502620-001
1x
REF 1502621-001
1x
REF 1502622-001
1x
REF 1502623-001
1x
REF 1502567-001

1
iOptima description ...........................4
1 Symbols ............................................................ 5
1.1 Description of symbols for iOptima unit .......................................5
1.2 Description of symbols for iOptima accessories........................6
2 Identification, Intended use and Notation .. 7
2.1 Identification..........................................................................................7
2.2 Intended use..........................................................................................7
2.3 Notation...................................................................................................8
3 User and Patient safety: Warnings &
Precautions for Use ....................................... 9
4 Description ..................................................... 10
4.1 iOptima system overview ............................................................... 10
4.2 iOptima system table....................................................................... 11
4.3 Set supplied........................................................................................ 11
4.4 Options ................................................................................................. 11
4.5 Technical data .................................................................................... 12
4.6 Environmental protection and information for disposal....... 13
4.7 Limitation of liability ........................................................................ 13
4.8 Electromagnetic compatibility (technical description) for
iOptima................................................................................................. 14
5 Installation ..................................................... 17
5.1 Install the iOptima app .................................................................... 17
5.2 Install the iOptima system ............................................................. 17
6 Interface overview ........................................ 19
6.1 iOptima application........................................................................... 19
6.2 Sound alerts ....................................................................................... 19
6.3 iPod touch® and iOptima connection / disconnection
conditions............................................................................................ 20
iOptimaINT description .................. 22
7 Symbols .......................................................... 23
7.1 Description of symbols for iOptimaINT....................................... 23
7.2 Description of symbols for iOptimaINT accessories............... 24
8 Identification, Intended use and Notation 25
8.1 Identification....................................................................................... 25
8.2 Intended use....................................................................................... 25
8.3 Intended patient population........................................................... 26
8.4 Intended User..................................................................................... 26
8.5 Intended medical conditions ......................................................... 26
8.6 Patient contra-indications and Side-effects ............................. 27
8.7 In case of accidents.......................................................................... 27
8.8 Notation................................................................................................ 28
9 User and Patient safety: Warnings &
Precautions for Use ..................................... 29
10 Description .................................................... 31
10.1 iOptimaINT system overview ......................................................... 31
10.2 iOptimaINT system table ................................................................. 31
10.3 Technical data .................................................................................... 32
10.4 Performances .................................................................................... 33
10.5 Environmental protection and information for disposal....... 33
10.6 Limitation of liability ........................................................................ 33
10.7 Electromagnetic compatibility (technical description) for
iOptimaINT ........................................................................................... 34
11 Installation ..................................................... 37
11.1 Install the iOptima app .................................................................... 37
11.2 Install the iOptimaINT system ....................................................... 37
12 Interface overview ....................................... 38
12.1 iOptima application........................................................................... 38
12.2 Sound alerts ....................................................................................... 38
12.3 iPod touch®/iPad mini® and iOptimaINT connection /
disconnection conditions................................................................ 39
Table of contents

2
iOptima/iOptimaINT operation .....40
13 Getting started .............................................. 41
13.1 Back up data....................................................................................... 41
13.2 Use of the Touch screen.................................................................. 41
13.3 Launch iOptima app ......................................................................... 42
13.4 Quit iOptima app................................................................................ 42
13.5 Welcome screen and disclaimer .................................................. 43
13.6 Information ......................................................................................... 44
13.7 Settings ................................................................................................ 45
13.8 iOptima app update .......................................................................... 45
13.9 Software update................................................................................ 46
14 Operation - Restorative mode .................... 47
14.1 Enter Restorative mode .................................................................. 47
14.2 Operative screen description......................................................... 47
14.3 Standard Use - Operating mode (Start) ..................................... 49
14.4 Customize default operations ....................................................... 49
14.5 Create new operations (user-defined)........................................ 51
15 Operation - Endodontics mode .................. 53
15.1 Enter Endodontics mode................................................................. 53
15.2 Operative screen description......................................................... 53
15.3 Standard Use - Operating mode (Start) ..................................... 55
15.4 Customize settings ........................................................................... 55
15.5 Add, sort or remove files ................................................................ 57
15.6 Restore (default) and delete (user-defined) systems............. 58
15.7 Create new Brands and Systems................................................. 59
15.8 CA ENDO / Reciproc option ............................................................ 60
16 Operation - Surgery mode .......................... 61
16.1 Enter Surgery mode......................................................................... 61
16.2 Operative screen description......................................................... 61
16.3 Standard Use - Operating mode (Start) ..................................... 63
16.4 Customize default operations ....................................................... 64
16.5 Create new operations (user-defined)........................................ 65
17 Operation - Piezo scaling mode ................. 67
17.1 Enter Piezo scaling mode............................................................... 67
17.2 Operative screen description......................................................... 67
17.3 Standard Use - Operating mode (Start) ..................................... 67
17.4 Customize default operations ....................................................... 68
17.5 Create new operations (user-defined)........................................ 70
18 List of errors & Troubleshooting ...............71
18.1 Alert messages (operating)............................................................ 71
18.2 Device operating error..................................................................... 72
18.3 iOS compatibility errors (disclaimer screen),........................... 73
19 Maintenance .................................................. 75
19.1 Servicing.............................................................................................. 75
19.2 Cleaning ............................................................................................... 75
19.3 Important............................................................................................. 75
19.4 Replace 4VL seal............................................................................... 76
19.5 iOptimaINT ........................................................................................... 76
20 Legal and general ......................................... 77
20.1 General information ......................................................................... 77
20.2 Trademarks......................................................................................... 77
20.3 Terms of guarantee .......................................................................... 77

3

Rx Only
iOptima description

5
1Symbols
1.1 Description of symbols for iOptima unit
Symbol Description Symbol Description
CE Marking with number of the notified body. Non-ionizing electromagnetic radiation.
Manufacturer. Alternating current.
Catalogue number. OFF (power).
Serial number. ON (power).
Medical device. Data Matrix code for product information including
UDI (Unique Device Identification).
Warning: In accordance with federal law (USA),
this device is only available for sale upon recom-
mendation by an accredited practitioner.
Sound alerts.
WARNING: hazard that could result in serious
injury or damage to the device if the safety
instructions are not correctly followed.
CAUTION: hazard that could result in light or moder-
ate injury or damage to the device if the safety
instructions are not correctly followed.
Separate collection of electric and electronic
equipment. Movement to the stop, in the direction indicated.
Refer to instruction manual/booklet (https://den-
tal.bienair.com/en_ch/support/download-center). 4-hole connection and 4 electric (4VLM).
General symbol for recovery/recyclable. Authorized EC Representative in the European
Community.
REF
SN
MD
MD
Rx Only

ENG
6
1.2 Description of symbols for iOptima accessories
Symbol Description Symbol Description
CE Marking with number of the notified body. Separate collection of electric and electronic
equipment.
Manufacturer. Serial number.
Catalogue number. Electrical safety.
Applied part type B.
Medical device. Data Matrix code for product information including
UDI (Unique Device Identification).
Authorized EC Representative in the European
Community.
Warning: In accordance with federal law (USA), this
device is only available for sale upon
recommendation by an accredited practitioner.
Sterilization up to the specified temperature.
XXXX
SN
REF
MD
MD
Rx Only
135°C

7
2 Identification, Intended use and Notation
2.1 Identification
iOptima
Electronically controlled unit for dentistry allowing operation of a
single MX2 micromotor with variable speed using the dental unit
pedal.
It is essential to connect a compatible iPod touch® using the
lightning connector.
The unit provides power to the iPod touch® device as soon as it is
connected. Under normal use (power supply = 32Vdc), the unit
does not use any battery energy of the iPod touch®.
The iOptima unit charges the iPod touch® battery when
connected.
The restorative, endodontics parameters are defined before
operation using the iOptima application installed on the iPod
touch®.
The iOptima application indicates the operation steps, the ratio of
the handpiece, tool speed, torque value, light intensity, footpedal
mode and the micromotor rotation direction. iOptima application
is compatible with Apple operating systems (iOS & iPadOS).
⚠CAUTION
In endodontic mode, the predefined torque and speed values are
only intended as a guide. The file values used must be adapted
according to the manufacturer instructions of the files.
2.2 Intended use
Product intended for professional use only.
The iOptima systems are intended for use in restorative dentistry,
endodontics, dental prophylaxis, and orthodontics by dentists and
dental professionals in a dental office.
FIG. 1
iOptima system connected to an iPod touch® that controls a MX2
motor.
Any use other than that for which this product is intended is
unauthorized and can be harmful.
Note 1
FIG. 1

ENG
8
2.3 Notation
•A, B, C, etc.
Text preceded by a letter indicates a procedure to be carried
out step-by-step.
•
Indicates a procedure result.
•(1),(2),(3), etc.
Text preceded by a number indicates text used in
conjunction with an illustration.
•OK,Save,Settings, etc.
Text in bold italic font style indicates, on-screen elements
such as buttons, menus, menu items, screen areas, values,
fields when they are named and screen names.
Tap Settings to open the Settings screen, change parameters
and tap Done.
NOTES
1The 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, with-
out amending these instructions. For all additional information,
please contact Bien-Air Dental SA at the address indicated on the
back cover.

9
3 User and Patient safety: Warnings &
Precautions for Use
To prevent any risk of explosion, the warning below must be
observed:
⚠WARNING
According to IEC 60601-1:2005+A12012/AnnexG, electrified
devices (motors, control units, couplers and attachments), can be
safely used in a medical environment in which potentially
explosive or flammable mixtures of anaesthetic substances are
delivered to the patient only if:
(1) The distance between the motor and the anaesthetic
breathing circuit exceeds 25 cm.
(2) The motor is not used simultaneously to the administra-
tion of the anaesthetic substances to the patient.
To prevent any risk of electric shock, the warning below must
be observed:
⚠WARNING
• The iOptima unit must be connected only to a power supply
network provided with a protective earth.
To prevent any risk of motor overheating, the cautions below
must be observed:
⚠CAUTION
• Ensure that the micromotor hose is not bent.
• The iPod touch® must never be disconnected from the
iOptima dental unit during operation.
To prevent any risk of injury (damage to bone, teeth, tissue) the
caution below must be observed:
⚠CAUTION
• The parameters contained in the dental procedures are
indicative only. Bien-Air Dental SA cannot be held liable for
them.
NOTES
1The predefined parameters may be subject to modification
without notice.
• The iPod touch® must never be disconnected from the
iOptima dental unit during operation. If the iPod touch® is
disconnected during an operation, the micromotor stops
immediately.
To prevent any risk of injury and/or material damage the
cautions below must be observed:
⚠CAUTION
• Never connect a handpiece on a running micromotor.
• The power plug of the iOptima is the device used for
disconnection in case of problems, it must be easily accessible at
all times
Note 1

ENG
10
4 Description
4.1 iOptima system overview
The iOptima system consists of:
• iOptima unit (3) with docking station for iPod touch® (4);
• A MX2 micromotor (12) and MX2 hose (10, A);
• A pneumatic 4-way connection input (6, B);
• A power supply (2) and plug cord (C).
FIG. 1
(1) Power supply cord
(2) Power Supply (C)
(3) iOptima unit
(4) iPod touch® [not provided in set]
(5) MX2 micromotor hose output (A)
(6) 4-way connector input, air and water inlet from your
pneumatic unit (B)
(7) Power input connector (with lock) (C)
(8) Main power switch
(9) MX2 micromotor hose* (A)
(10) iOptima status light (green power on)
(11) MX2 micromotor*
(12) Handpiece* [not provided in set]
(13) Dental unit with pedal (B) [not provided in set]
*Applied parts (per IEC 60601-1)
5 6 7 8
A B C
A
B
C
1234
910
11
12
13
iOpti
m
a
a

11
4.2 iOptima system table
Summary of the iOptima functions and technological features. .
4.3 Set supplied
4.3.1 iOptima system
iOptima set REF 1700563-001
iOptima set REF 1700544-001
iOptima set REF 1700547-001
4.4 Options
Product Device Technology Motor Restorative Endodontics Oral surgery Implantology Prophylaxis
iOptima iPod touch® DMX2 MX2 X X - - X
Designation REF number
iOptima unit (1x) 1600926-001
MX2 Micromotor (1x) 1600677-001
MX2 Micromotor hose (1x) 1600762-001
Power supply (1x) 1501938-001
3P cable system, Switzerland, length
2.00 m (1x) 1300065-001
3P cable system, Europe, length 2.50 m (1x) 1300066-001
3P cable system, US, length 2.00 m (1x) 1300067-001
iOptima bracket 1501988-001
Designation REF number
iOptima unit (1x) 1600926-001
MX2 Micromotor (1x) 1600677-001
MX2 Micromotor hose (1x) 1600762-001
Power supply (1x) 1501938-001
3P cable system, Switzerland, length
2.00 m (1x) 1300065-001
3P cable system, Europe, length 2.50 m (1x) 1300066-001
3P cable system, US, length 2.00 m (1x) 1300067-001
Designation REF number
iOptima unit (1x) 1600926-001
MX2 Micromotor hose (1x) 1600762-001
Power supply (1x) 1501938-001
3P cable system, Switzerland, length
2.00 m (1x) 1300065-001
3P cable system, Europe, length 2.50 m (1x) 1300066-001
3P cable system, US, length 2.00 m (1x) 1300067-001
Designation REF number
Spraynet, cleaning spray 500 ml, box of 6 cans 1600036-006

ENG
12
4.5 Technical data
Dimensions L x W x H
iOptima unit................................................125 x 145 x 75 mm
iOptima unit (with iPod touch®)............125 x 145 x 160 mm
MX2 hose ....................................................L 1.7 m
MX2 micromotor.......................................Ø 21 x L 73.5 mm
Power Supply ............................................130 x 75 x 45 mm
Weight
iOptima unit................................................ 0.4 kg
Power Supply ............................................ 650 g
MX2 micromotor....................................... 94 g
Electrical and pressure data
Voltage.........................................................100-240 VAC
Frequency ..................................................47-63 Hz
Nominal power .........................................90 W
Max. input power......................................160 W
Max. input pneumatic pressure ..........5 bar / 72.5 psi
Min. input pneumatic pressure ...........3 bar / 43.5 psi
Environmental conditions
⚠CAUTION
Do not use iOptima outside the range of operating temperature.
Classification
Class IIa in accordance with European Directive 93/42/EEC
concerning medical devices.
Electric insulation class
Class I per IEC 60601-1 (apparatus protected against electric
shocks).
Degree of protection
IP 40 (protection against insertion of objects larger than 1 mm)
Memory
•Restorative
Storage of 20 user-defined Operations
•Endodontics
Storage of 10 user-defined Brands
Storage of 10 user-defined Systems
Storage of 8 Files per System including adjustment of speed
and torque values for each file
List of errors & Troubleshooting
See chapter “18 List of errors & Troubleshooting” on page 71.
Important: Consult the Instructions for Use of the following
devices:
Environmental
conditions Operating Transport and storage (max. 15 weeks)
Temperature +10°C (50°F) to
+25°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 3'048 m
(0 to 10'000 ft) -
Product Micromotor IFU Hose IFU
iOptima MX2 LED 2100199 MX2 2100223

13
4.6 Environmental protection and
information for disposal
The disposal and/or recycling of materials must be performed in
accordance with the legislation in force.
This unit and its accessories must be recycled.
Electrical and electronic equipment may contain dangerous substances
which constitute health and environmental hazards. The user must
return the unit to its dealer or establish direct contact with an approved
body for treatment and recovery of this type of equipment (European
Directive 2012/19/EU).
4.7 Limitation of liability
Bien-Air Dental SA shall not be held liable for any non-compliant
use of the iPod touch®.
The conditions for and restrictions on use set by Apple must be
respected (jailbreak, hardware modification, etc.).
To ensure optimum operation of the iOptima application, iOS
updates must be according to version used during validation of
the application.

ENG
14
4.8 Electromagnetic compatibility (technical description) for iOptima
4.8.1 Electromagnetic compatibility warnings
The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional healthcare facility environment.
⚠CAUTION
The iOptima 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, 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.
4.8.2 Electromagnetic compatibility – emissions & immunity
Guidance and manufacturer’s declaration - electromagnetic emissions
iOptima is intended for use in the electromagnetic environment specified below.
The customer or the user of iOptima should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
The iOptima uses RF energy for its internal operation only. Therefore, its RF emis-
sions are very low and are not likely to cause any interference in nearby electronic
equipment.
RF emissions
CISPR 11 Class B
The iOptima is suitable for use in any building, including residential buildings and
those directly connected to the public low-voltage power supply network that sup-
plies buildings used for residential purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Emissions due to voltage
fluctuations IEC 61000-3-3 Conforming

15
Guidance and manufacturer’s declaration – Electromagnetic immunity
The iOptima is intended for use in the electromagnetic environment specified below. The customer or the user of the iOptima 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 mate-
rial, 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 com-
mercial 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 com-
mercial or hospital environment.
Voltage dips, short inter-
ruptions and voltage
variations on power sup-
ply 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% U
T
for 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% U
T
for 25/30 cycles at 0°
Mains power quality should be that of a com-
mercial or hospital environment. If the user of
the iOptima INT requires continued operation
during mains power interruptions, it is recom-
mended that the iOptima 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 fre-
quency should be at levels characteristic of a
typical location in a typical commercial or
hospital environment.
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 ama-
teur bands
0,15 MHz – 80 MHz
80% AM at 1 kHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveyashould be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
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