Bien Air iOptima User manual

REF 2100279-0004/2018.06
iOptima
iOptimaINT
ENG INSTRUCTIONS FOR USE.
other languages available on www.bienair.com/ifu

REF 2100279-0004/2018.06 © Bien-Air Dental
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
Options
1x
REF 1600036-006

REF 2100279-0004/2018.06 © Bien-Air Dental

REF 2100279-0004/2018.06 © Bien-Air Dental
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

REF 2100279-0004/2018.06 © Bien-Air Dental
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
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 Warnings & Precautions of 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 ................................................................................................. 12
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................................................................................................. 13
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 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 Notation................................................................................................ 26
9 Warnings & Precautions of Use .................. 27
10 Description ..................................................... 28
10.1 iOptimaINT system overview ......................................................... 28
10.2 iOptimaINT system table ................................................................. 28
10.3 Set supplied........................................................................................ 29
10.4 Options ................................................................................................. 29
10.5 Technical data .................................................................................... 30
10.6 Environmental protection and information for disposal....... 31
10.7 Limitation of liability ........................................................................ 31
10.8 Electromagnetic compatibility (technical description) for
iOptimaINT ........................................................................................... 31
11 Installation...................................................... 34
11.1 Install the iOptima app .................................................................... 34
11.2 Install the iOptimaINT system ....................................................... 34
12 Interface overview......................................... 35
12.1 iOptima application........................................................................... 35
12.2 Sound alerts ....................................................................................... 35
12.3 iPod/iPad and iOptimaINT connection / disconnection
conditions............................................................................................ 36
Table of contents

2
iOptima/iOptimaINT operation .........38
13 Getting started ............................................... 39
13.1 Back up data....................................................................................... 39
13.2 Use of the Touch screen.................................................................. 39
13.3 Launch iOptima app ......................................................................... 40
13.4 Welcome screen and disclaimer .................................................. 41
13.5 Information ......................................................................................... 42
13.6 Settings ................................................................................................ 43
13.7 iOptima app update .......................................................................... 43
14 Operation - Restorative mode ..................... 45
14.1 Enter Restorative mode .................................................................. 45
14.2 Operative screen description......................................................... 45
14.3 Standard Use - Operating mode (Start) ..................................... 47
14.4 Customize default operations ....................................................... 47
14.5 Create new operations (user-defined)........................................ 49
15 Operation - Endodontics Mode.................... 51
15.1 Enter Endodontics mode................................................................. 51
15.2 Operative screen description......................................................... 51
15.3 Standard Use - Operating mode (Start) ..................................... 53
15.4 Customize settings ........................................................................... 53
15.5 Add, sort or remove files ................................................................ 55
15.6 Restore (default) and delete (user-defined) systems............. 56
15.7 Create new Brands and Systems................................................. 57
15.8 CA ENDO / Reciproq option............................................................. 58
16 List of errors & Troubleshooting ................ 59
16.1 Safety warning (operating)............................................................. 59
16.2 Device operating error..................................................................... 60
16.3 iOS compatibility errors (disclaimer screen),........................... 61
17 Maintenance ................................................... 63
17.1 Servicing.............................................................................................. 63
17.2 Cleaning-disinfection ....................................................................... 63
17.3 Important............................................................................................. 63
17.4 Replace 4VL seal............................................................................... 64
17.5 iOptimaINT ........................................................................................... 64
18 General information and guarantee........... 65
18.1 General information ......................................................................... 65
18.2 Terms of guarantee .......................................................................... 65

Rx Only
iOptima description

5
ENG
1Symbols
1.1 Description of symbols for iOptima unit
Symbol Description Symbol Description
CE Marking with number of the notified body. RF emitting device (Interference may occur in the
vicinity of equipment marked with this symbol).
Manufacturer. Alternating current.
Reference number. Main switch - Power OFF.
Serial number. Main switch - Power ON.
CAUTION! In accordance with federal law (USA),
this device is only available for sale upon recom-
mendation by an accredited practitioner.
Sound alerts
Separate collection of electric and electronic
equipment. Move fully to the stop, in the direction indicated.
Refer to the accompanying documents for the
correct use of the product.(www.bienair.com/ifu.) 4-hole connection and 4 electric (4VLM).
Recyclable materials. 4-hole connection (4way).
CAUTION! Consult accompanying documents.
Provides an instruction that should be observed
for safety reasons.
REF
SN
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 equip-
ment.
Manufacturer. Serial number.
Reference number. Electrical safety.
Applied part type B.
SN
REF

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 device as soon as it is
connected. Under normal use (power supply = 32Vdc), the unit
does not use any battery energy of the iPod.
The iOptima unit charges the iPod battery when connected.
The restorative, endodontics parameters are defined before
operation using the iOptima application installed on the iPod.
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 iOS operating system.
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 equipments are only intended for use in general
dentistry, restorative dentistry and endodontics procedure by
dentists and dental professionals in a dental office.
FIG. 1
iOptima system connected to an iPod 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.
• Interface device «iPod Touch®» is referred to as «iPod».
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 Warnings & Precautions of Use
CAUTION
The iOptima unit is not designed for use in an explosive
atmosphere (anesthetic gas).
CAUTION
To prevent any risk of electric shock, the iOptima unit must be
connected only to a power supply network provided with a
protective earth.
CAUTION
The power plug of the iOptima is the device used for
disconnection in case of problems, it must be easily accessible at
all times.
WARNING
Never connect a handpiece on a running micromotor.
CAUTION
Ensure that the micromotor hose is not bent.
WARNING
The iPod must never be disconnected from the iOptima dental
unit during operation!
WARNING
The parameters contained in the dental procedures are indicative
only.
Bien-Air Dental SA cannot be held liable for them.
Note 1
NOTES
1The predefined parameters may be subject to modification
without notice.

ENG
10
4 Description
4.1 iOptima system overview
The iOptima system consists of:
• iOptima unit (3) with docking station for iPod (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 [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) Label (under the unit)
(10) MX2 micromotor hose* (A)
(11) iOptima status light (green power on)
(12) MX2 micromotor*
(13) Handpiece* [not provided in set]
(14) 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
1011
12
13
14
iOpti
m
a
a
9

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 1700544-001
iOptima set REF 1700547-001
4.4 Options
Product Device Technology Motor Restorative Endodontics CA ENDO
option Surgery
iOptima iPod DMX2 MX2 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/Asia, 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/Asia, 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)..........................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 “16 List of errors & Troubleshooting” on page 59.
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 2002/96/EC).
4.7 Limitation of liability
Bien-Air Dental SA shall not be held liable for any non-compliant
use of the iPod.
The conditions for and restrictions on use set by Apple must be
respected (jailbreak, hardware modification, etc.).
To ensure optimum operation of iOptima the application, iOS
updates must be according to version used during validation of
the application.
4.8 Electromagnetic compatibility
(technical description) for iOptima
Precautions regarding Electromagnetic Compatibility (EMC)
Electro-medical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to
the EMC information provided in this document.
CAUTION
Dental professionals need to be aware of potential
electromagnetic interference between electronic dental devices
and active implantable medical devices, and should always
inquire about any devices implanted in the patient.
CAUTION
iOptima complies with the EMC requirements according to IEC
60601-1-2. Radio transmitting equipment, cellular phones, etc.
shall not be used in close proximity to the unit since they could
influence the performance of the unit. Special precautions must
be taken when using strong emission sources such as High
Frequency surgical equipment and similar equipment so that the
HF cables are not routed on or near the unit. If in doubt, please
contact a qualified technician or Bien-Air Dental SA.
iOptima should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, iOptima
should be monitored to verify normal operation in the
configuration in which it will be used.
CAUTION
The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by
Bien-Air Dental SA as replacements parts for internal
components, may result in increased emissions or decreased
immunity of iOptima.

ENG
14
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
iOptima uses RF energy only for its internal function.
CISPR 11 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
iOptima is suitable for use in all establishments including domestic establishments and those
directly connected to the public low-voltage power supply network that supplies buildings used
for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Compliant
Voltage fluctuations/flicker emis-
sions
IEC 61000-3-3
Not applicable
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 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 lines no
input/output
±2 kV for power
supply lines
±1 kV for lines no
input/output
Mains power quality should be that of a typical
commercial or hospital environment.
Shock waves
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 typical
commercial or hospital environment.
Voltage dips and
outages
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
iOptima requires continued operation during
power mains interruptions, it is recommended that
iOptima be powered from an uninterruptible power
supply or a battery.

15
Note 1 - 2
Power frequency (50/60 Hz)
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 typi-
cal commercial or hospital environment.
Note : UTis the a.c. mains voltage prior to application of the test level.
Essential performance: The essential performance is the maintaining of the visual lighting intensity of the LED and the maintaining of motor speed.
Maximum allowed speed deviation is ± 5%.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz 3 Vrms Portable and mobile RF communications equipment should be
used no closer to any part of iOptima, including cables, than the
recommended separation distance calculated from the equa-
tion applicable to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W) accor-
ding to the transmitter manufacturer and d
is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site surveyashould be less than the com-
pliance level in each frequency rangeb.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz 3 V/m
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 elec-
tromagnetic site survey should be considered. If the measured field strength in the location in which the iOptima is used exceeds the applicable RF compliance
level above, the iOptima should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the iOptima.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance