Bien Air iOptima, 1700544-001, 1700704-001, iOptima INT, 1700547-001 Instructions For Use Manual

...

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REF 2100279-0004/2018.06

iOptima

INT

iOptima

ENG INSTRUCTIONS FOR USE.

other languages available on www.bienair.com/ifu

Set iOptima REF 1700544-001

1x REF 1600926-001

1x REF 1600677-001 1xREF 1600762-001 1xREF 1501938-001

Set iOptima REF 1700547-001

1x REF 1600926-001

1x REF 1600762-001 1xREF 1501938-001

Options

1x REF 1600036-006

REF 2100279-0004/2018.06 © Bien-Air Dental

Set iOptima

INT

REF 1700704-001

1x REF 1502475-001

Set iOptima

1x REF 1502475-001

1x REF 1600677-001 1xREF 1600809-001 1xREF 1601074-001 1xREF 1500666-0011xREF 1502568-0011xREF 1300067-001

INT

REF 1700705-001

2x REF 1600677-001 2xREF 1600809-001 1xREF 1601075-001 1xREF 1500666-0011xREF 1502568-0011xREF 1300067-001

REF 2100279-0004/2018.06 © Bien-Air Dental

Set iOptima

1x REF 1601074-001 1xREF 1500666-0011xREF 1600809-001 1xREF 1502568-0011xREF 1300067-001

INT

REF 1700730-001

Set iOptima

1x REF 1601075-001 1xREF 1500666-0012xREF 1600809-001 1xREF 1502568-0011xREF 1300067-001

INT

REF 1700731-001

Options

1x REF 1502620-0011xREF 1502621-0011xREF 1502622-0011xREF 1502623-0011xREF 1502567-001

REF 2100279-0004/2018.06 © Bien-Air Dental

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

iOptima

7 Symbols........................................................... 23

7.1 Description of symbols for iOptima

7.2 Description of symbols for iOptima

INT

description ..................... 22

INT

....................................... 23

INT

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 iOptima

10.2 iOptima

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

iOptima

INT

system overview ......................................................... 28

INT

system table ................................................................. 28

INT

........................................................................................... 31

11 Installation...................................................... 34

11.1 Install the iOptima app .................................................................... 34

11.2 Install the iOptima

INT

system ....................................................... 34

12 Interface overview......................................... 35

12.1 iOptima application........................................................................... 35

12.2 Sound alerts ....................................................................................... 35

12.3 iPod/iPad and iOptima

conditions............................................................................................ 36

INT

connection / disconnection

iOptima/iOptima

INT

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 iOptima

INT

........................................................................................... 64

18 General information and guarantee...........65

18.1 General information ......................................................................... 65

18.2 Terms of guarantee .......................................................................... 65

Rx Only

iOptima description

ENG

Rx Only



1Symbols

1.1 Description of symbols for iOptima unit

Symbol Description Symbol Description

REF

CE Marking with number of the notified body.

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 recommendation by an accredited practitioner.

Separate collection of electric and electronic equipment.

Refer to the accompanying documents for the correct use of the product.(www.bienair.com/ifu.)

Recyclable materials. 4-hole connection (4way).

CAUTION! Consult accompanying documents. Provides an instruction that should be observed for safety reasons.

RF emitting device (Interference may occur in the vicinity of equipment marked with this symbol).

Sound alerts

Move fully to the stop, in the direction indicated.

4-hole connection and 4 electric (4VLM).

ENG

1.2 Description of symbols for iOptima accessories

REF

Symbol Description Symbol Description

CE Marking with number of the notified body.

Manufacturer. Serial number.

Reference number.

Separate collection of electric and electronic equipment.

Electrical safety. Applied part type B.

FIG. 1

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

ENG

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

1 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.

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!

NOTES

1 The predefined parameters may be subject to modification without notice.

 WARNING

The parameters contained in the dental procedures are indicative only. Bien-Air Dental SA cannot be held liable for them.

Note 1

ENG

4 Description

5 6 7 8

A B C

1011

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).

(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

(7) Power input connector (with lock) (C)

pneumatic unit (B)

FIG. 1

(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)

4.2 iOptima system table

Summary of the iOptima functions and technological features. .

Product Device Technology Motor Restorative Endodontics

iOptima iPod DMX2 MX2 X X - -

4.3 Set supplied

4.3.1 iOptima system

iOptima set REF 1700544-001

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)

3P cable system, Europe, length 2.50 m (1x) 1300066-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

1300065-001

4.4 Options

Designation REF number

Spraynet, cleaning spray 500 ml, box of 6 cans

CA ENDO

option

1600036-006

Surgery

iOptima set REF 1700547-001

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)

3P cable system, Europe, length 2.50 m (1x) 1300066-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

1300065-001

ENG

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

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

Temperat ure

Relative humidity

Atmospheric pressure

Altitude

Operating

+10°C (50°F) to +25°C (77°F)

30% to 80% 30% to 80%

700 hPa to 1060 hPa

0 to 3'048 m (0 to 10'000 ft)

Transport and storage (max. 15 weeks)

-25°C (-13°F) to +70°C (158°F)

500 hPa to 1060 hPa

 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.

Product Micromotor IFU Hose IFU

iOptima MX2 LED 2100199 MX2 2100223

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

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

Harmonic emissions IEC 61000-3-2

Voltage fluctuations/flicker emissions IEC 61000-3-3

Group 1

Class B

Compliant

Not applicable

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.

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.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD)

IEC 61000-4-2

Electrical fast transient burst IEC 61000-4-4

Shock waves IEC 61000-4-5

Voltage dips and outages

IEC 61000-4-11

±6 kV contact

±8 kV air

±2 kV for power supply lines ±1 kV for lines no input/output

±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

<5% U

(>95% dip in UT) for 0.5 cycle 40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in U for 25 cycles

<5% U (>95% dip in UT) for 5 sec

)

±6 kV contact

±8 kV air

±2 kV for power supply lines ±1 kV for lines no input/output

±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

<5% U

(>95% dip in UT) for 0.5 cycle 40% U

(60% dip in UT) for 5 cycles

70% U

(30% dip in U for 25 cycles

<5% U (>95% dip in UT) for 5 sec

)

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

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

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.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

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

Note : UT is 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%.

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.

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 equation applicable to the frequency of the transmitter. Recommended separation distance

80 MHz to 800 MHz

800 MHz to 2.5 GHz

Radiated RF IEC 61000-4-3

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 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.

3 V/m 80 MHz to 2,5 GHz

3 V/m

is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey

pliance level in each frequency range Interference may occur in the vicinity of equipment marked

with the following symbol:

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d

should be less than the com-

Note 1 - 2

ENG

Recommended separation distances between portable and mobile RF communications equipment and the iOptima

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

Separation distance according to frequency of transmitter [m] Rated maximum output power of transmitter [W]

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

11.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (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 - 2

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

NOTES

1 At 80 MHz and 800 MHz, the higher frequency range applies.

2 These guidelines may not apply in all situations. Electro-

magnetic propagation is affected by absorption and reflection from structures, objects and people.

FIG. 1

1 2

5 Installation

FIG. 2 FIG. 3 FIG. 4

5.1 Install the iOptima app

A. Open the "App Store". B.

Search the iOptima application.

Install the iOptima application designed by Bien-Air Dental.

Note 1

5.2 Install the iOptima system

 CAUTION

Before installing, please read carefully this product instruction.

Note 2

FIG. 1

A. Place the iOptima on a flat surface capable of bearing its

weight.

 CAUTION

It may be positioned on a table, on a trolley or any another surface but in no circumstances on the floor. It is not designed to be placed on wet surfaces or to come in contact with liquids.

FIG. 2

Connect the power cord (2) to the power supply (1) and plug to

the mains.

Note 3

 CAUTION

The power plug is the device used for disconnection in case of problems, it must be easily accessible at all times.

FIG. 3

Connect the power supply cable (1) to the input connector (2) and

turn right to lock.

 CAUTION

Ensure that the power switch (3) is off «O».

 CAUTION

Before connecting the MX2 cable ensure that all o-rings are correctly fitted and connectors are clean of dust.

FIG. 4

Connect the MX2 cable plug (2) to the output connector (1):

• First sleeve up and carefully and firmly insert the cable plug, by guiding the connector and plug with the index pin on the connector;

• Sleeve down and tighten (CW).

ENG

FIG. 5 FIG. 6 FIG. 7

FIG. 5

Connect the MX2 cable (2) to the MX2 micromotor (1), by guiding

the connector and plug with the index pin on the connector and tighten (CW).

NOTES

 CAUTION

Never connect a handpiece on a running micromotor.

FIG. 6

Connect the 4-way hose (1) to the 4-way connector of the

iOptima unit (2):

• First guide the sleeve and carefully and firmly insert the hose sleeve, by matching the connector and the coupling;

•Tighten (CW).

FIG. 7

Switch on the water and power supply of the dental unit (refer to

your dental unit instructions).

Switch on the iOptima (1) («I» = ON).

 The led (4) turns green (power on).

Once it has been switched on, connect the interface device

«iPod» (2) to the iOptima carefully sliding it along the lightning adapter (3).

 The iOptima is ready for use.

See chapter “6 Interface overview” on page 19.

1 The iPod must be correctly connected to a Wi-Fi network before the App Store is opened; refer to Apple's user guide for appropriate use of the iPod.

2 In order to conform to the IEC 60601-1-2 standards, take into account the different routes of the wires through the system (bend, fold, section etc) (see chapter “4.1 iOptima system overview” on page 10 and only use the power supply provided with the iOptima. In order to maintain warranty, this unit must be installed with the greatest care. Follow all the necessary instructions. Protect the unit from direct sunlight and dust. Keep the original packaging for storage and shipment.

3 The equipment is powered by your mains power supply (100240 VAC).

FIG. 1 (iPod Touch®)

6 Interface overview

6.1 iOptima application

The iOptima application allows to carry out endodontics and restorative dentistry operations.

6.1.1 Compatibility

The iOptima application is compatible with iPod from 6th generation.

6.1.2 Notation

In order to simplify the notation, in this manual:

• iOptima application is referred to as «iOptima app»;

• Restorative and Endodontics modes are referred to as «RESTO» and «ENDO».

6.2 Sound alerts

Sound alert Description

Entering in endodontics or restorative

One long beep

Alternate short beeps

Alternate medium beeps

Alternate long beeps

mode

ENDO mode when selecting the first File

Warning notifications

Micromotor REVERSE running indicator

ENDO mode when the micromotor is running in reverse

System failure notification

ENG

6.3 iPod and iOptima connection / disconnection conditions

6.3.1 Disconnection

If the iPod is disconnected, the iOptima system is in standby mode (micromotor stopped).

 WARNING

The iPod must never be disconnected from the iOptima dental unit during operation! If the iPod is disconnected during an operation, the micromotor stops immediately.

6.3.2 Connection

The micromotor can start only when the iPod is connected and the application is in operative mode.

 CAUTION

If the footpedal is pressed before entering in operative mode, a warning message «Please release the pedal…» will be displayed. The micromotor will not start to run until the footpedal is released and pressed again.

6.3.3 iOptima unit switched ON

If the iOptima app is running and the iPod plugged to the iOptima (switch ON):

• The iPod will charge up (even if the app is not running);

• The sleep mode is deactivated;

• The micromotor can be operated with the pedal (iOptima app in operative mode).

iOptima

INT

description

7Symbols

ENG

7.1 Description of symbols for iOptima

Symbol Description Symbol Description

CE Marking with number of the notified body.

Manufacturer. Alternating current.

REF

Reference number. Main switch - Power OFF.

Serial number. Main switch - Power ON.

CAUTION! Consult accompanying documents. Provides an instruction that should be observed for safety reasons.

Separate collection of electric and electronic equipment.

Refer to the accompanying documents for the correct use of the product.(www.bienair.com/ifu.)

INT

RF emitting device (Interference may occur in the vicinity of equipment marked with this symbol).

Sound alerts

Move fully to the stop, in the direction indicated.

4-hole connection and 4 electric (4VLM).

Recyclable materials. 4-hole connection (4way).

ENG

7.2 Description of symbols for iOptima

REF

Symbol Description Symbol Description

INT

accessories

CE Marking with number of the notified body.

Manufacturer. Serial number.

Reference number.

Separate collection of electric and electronic equipment.

Electrical safety. Applied part type B.

FIG. 1

8 Identification, Intended use and Notation

8.1 Identification

iOptima

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.

The unit provides power to the iPod/iPad device as soon as it is connected. Under normal use (power supply = 32Vdc), the unit does not use any battery energy of the iPod/iPad.

The iOptima/iOptima connected. The restorative and endodontics parameters are defined before operation using the iOptima application installed on the iPod/ iPad. 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

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.

INT

unit charges the iPod/iPad battery when

8.2 Intended use

Product intended for professional use only.

The iOptima dentistry, restorative dentistry and endodontics procedure by dentists and dental professionals in a dental office.

FIG. 1

iOptima micromotor in holder 1 (endodontics + restorative). Any use other than that for which this product is intended is unauthorized and can be harmful.

Note 1

INT

systems are only intended for use in general

INT

system connected to an iPod/iPad that controls a MX2

ENG

8.3 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.

• Interface device «iPod Touch®/iPad Mini®» is referred to as «iPod/iPad».

 CAUTION

All illustrations and screenshots shown in this manual refer to the iPod and may differ from what is displayed on the iPad.

NOTES

9 Warnings & Precautions of Use

 CAUTION

The iOptima atmosphere (anesthetic gas).

 CAUTION

To prevent any risk of electric shock, the iOptima connected only to a power supply network provided with a protective earth.

 WARNING

Never connect a handpiece on a running micromotor.

 CAUTION

Ensure that the micromotor hose is not bent.

 WARNING

The iPod/iPad must never be disconnected from the iOptima dental unit during operation!

 WARNING

Never touch simultaneously the iPod/iPad and the patient.

INT

unit is not designed for use in an explosive

INT

unit must be

NOTES

1 The predefined parameters may be subject to modification without notice.

INT

 WARNING

The parameters contained in the dental procedures are indicative only. Bien-Air Dental SA cannot be held liable for them.

Note 1

ENG

10 Description

10.1 iOptima

The iOptima

• A unit as a docking station (2) for iPod/iPad device.

• The iPod/iPad provide the user interface to the iOptima

• The electronic board (1), integrated in the dental unit system, is in charge to drive the micromotor (MX2) and communicate with the interface through the Lightning connector.

• A dental micromotor and the related hose (MX2).

• A power supply 100-240 VAC.

INT

system overview

INT

system mainly consists of:

INT

system, except speed reference input.

FIG. 1

10.2 iOptima

Summary of the iOptima

Product Device Te chn ology Motor Restorative Endodontics

INT

iOptima

INT

system table

INT

functions and technological features.

iPod/iPadDMX3MX2XXX-

CA ENDO

option

Surgery

10.3 Set supplied

iOptima

INT

set REF 1700730-001

10.3.1 iOptima

iOptima

INT

set REF 1700704-001

Designation REF number

INT

iOptima

MX2 Micromotor (1x) 1600677-001

MX2 Micromotor hose (1x) 1600809-001

Power supply reset switchs 1502568-001

Power supply PMP90 (1x) 1500666-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

1 Motor Control Boards 1601074-001

Designation REF number

iOptima

MX2 Micromotor (2x) 1600677-001

MX2 Micromotor hose (2x) 1600809-001

Power supply reset switch 1502568-001

Power supply PMP90 (1x) 1500666-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

Dual Motor Control Boards 1601075-001

iDevice fixation (1x)

INT

set REF 1700705-001

INT

iDevice fixation (1x)

INT

system

1502475-001

Designation REF number

MX2 Micromotor hose (1x) 1600809-001

Power supply reset switch 1502568-001

Power supply PMP90 (1x) 1500666-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

1 Motor Control Boards 1601074-001

iOptima

INT

set REF 1700731-001

Designation REF number

MX2 Micromotor hose (2x) 1600809-001

Power supply reset switch 1502568-001

Power supply PMP90 (1x) 1500666-001

3P cable system, US/Asia, length 2.00 m (1x) 1300067-001

Dual Motor Control Boards 1601075-001

10.4 Options

Designation REF number

Mechanical interface iPod right mount

Mechanical interface iPod left mount

Mechanical interface iPad right mount

Mechanical interface iPad left mount

Mounting tools 1502567-001

1502620-001

1502621-001

1502622-001

1502623-001

ENG

10.5 Technical data

Dimensions L x W x H

MX2 hose ....................................................L 1.7 m

MX2 micromotor.......................................Ø 21 x L 73.5 mm

Weight

MX2 micromotor....................................... 94 g

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

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

Temperat ure

Relative humidity

Atmospheric pressure

Altitude

Operating

+10°C (50°F) to +35°C (77°F)

30% to 80% 30% to 80%

700 hPa to 1060 hPa

0 to 3'000 m (0 to 9842 ft)

Transport and storage (max. 15 weeks)

-25°C (-13°F) to +70°C (158°F)

500 hPa to 1060 hPa

 CAUTION

Do not use iOptima

INT

outside the range of operating temperature.

List of errors & Troubleshooting

See chapter “16 List of errors & Troubleshooting” on page 59.

Important: Consult the Instructions for Use of the following devices:

Product Micromotor IFU Hose IFU

INT

iOptima

MX2 LED 2100199 MX2 2100223

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).

10.6 Environmental protection and information for disposal

The disposal and/or recycling of materials must be performed in accordance with the legislation in force.

10.7 Limitation of liability

Bien-Air Dental SA shall not be held liable for any non-compliant use of the iPod/iPad. The conditions for and restrictions on use set by Apple must be respected (jailbreak, hardware modification, etc.).

To ensure optimum operation of iOptima

INT

the application, iOS updates must be according to version used during validation of the application.

10.8 Electromagnetic compatibility (technical description) for iOptima

INT

10.8.1 Electromagnetic compatibility warnings

The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional healthcare facility environment.

 CAUTION

The iOptima 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 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.

INT

complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc., should not be

INT

, including cables specified by the manufacturer. Otherwise, degradation of the

ENG

10.8.2 Electromagnetic compatibility – emissions & immunity

Guidance and manufacturer’s declaration - electromagnetic emissions

INT

iOptima

The customer or the user of iOptima

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Emissions due to voltage fluctuations IEC 61000-3-3

Guidance and manufacturer’s declaration – Electromagnetic immunity

The iOptima INT is intended for use in the electromagnetic environment specified below. The customer or the user of the iOptima INT 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

Electrical fast transient burst IEC 61000-4-4

Surge IEC 61000-4-5

is intended for use in the electromagnetic environment specified below.

INT

should ensure that it is used in such an environment.

The iOptima INT uses RF energy for its internal operation only. Therefore, its RF

Group 1

Class B

Class A

Conforming

±8 kV contact ±2 kV air ±4 kV air ±8 kV air ±15 kV air

±2 kV for power supply lines ±1 kV for other lines

±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

emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The iOptima INT 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.

±8 kV contact ±2 kV air ±4 kV air ±8 kV air ±15 kV air

±2 kV for power supply lines ±1 kV for lines no input/output

±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

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

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

Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

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

0% UT for 0.5 cycle, at 0°, 45°, 90°, 135°, 180°, 225°,

270° and 315°

for 1 cycle and

0% U

70% UT for 25/30 cycles at 0°

0% UT for 0.5 cycle, at 0°, 45°, 90°, 135°, 180°, 225°,

270° and 315°

for 1 cycle and

0% U

70% UT for 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

Conducted disturbances induced by RF fields IEC 61000-4-6

Radiated RF EM fields IEC 61000-4-3

Proximity fields from RF wireless communications equipment IEC 61000-4-3

30 A/m 30 A/m

3 V

RMS

0,15 MHz – 80 MHz

in ISM bands

6 V

RMS

0,15 MHz – 80 MHz 80% AM at 1 kHz

3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Test freq . [ MHz] Max. power [W]

RMS

0,15 MHz – 80 MHz

in ISM and ama-

6 V

RMS

teur bands 0,15 MHz – 80 MHz 80% AM at 1 kHz

3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Immunity test level [V/m]

385 1.8 27

450 2 28

710, 745, 780 0.2 9

810, 870, 930 2 28

1720, 1845, 1970

228

2450 2 28

Magnetic fields generated by the mains frequency should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site

should be less than the compliance

survey level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Distance: 0.3 m

5240, 5500, 5785

0.2 9

NOTE: UT is 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%.

a. 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 electromagnetic site survey should be considered. If the measured field strength in the location 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.

ENG

11 Installation

11.1 Install the iOptima app

A. Open the "App Store".

Search the iOptima application.

B. C.

Install the iOptima application designed by Bien-Air Dental.

Note 1

11.2 Install the iOptima

Refer to the iOptima

Note 2

INT

installation manual.

INT

system

NOTES

1 Th e iPo d/iPad mus t be correc tly c onnected t o a Wi-Fi ne twor k before the App Store is opened; refer to Apple's user guide for appropriate use of the iPod/iPad.

2 The iOptima neer certified by Bien-Air Dental SA.

INT

system must be installed by a service engi-

FIG. 1 (iPod Touch®)

12 Interface overview

12.1 iOptima application

The iOptima application allows to carry out endodontics and restorative dentistry operations.

12.1.1 Compatibility

The iOptima application is compatible with iPod from 6th generation and iPad from 4th generation.

12.1.2 Notation

In order to simplify the notation, in this manual:

• iOptima application is referred to as «iOptima app»;

• Restorative and Endodontics modes are referred to as «RESTO» and «ENDO».

12.2 Sound alerts

Sound alert Description

Entering in endodontics or restorative

One long beep

Alternate short beeps

Alternate medium beeps

Alternate long beeps

mode

ENDO mode when selecting the first File

Warning notifications

Micromotor REVERSE running indicator

ENDO mode when the micromotor is running in reverse

System failure notification

ENG

12.3 iPod/iPad and iOptima

INT

connection /

disconnection conditions

12.3.1 Disconnection

If the iPod/iPad is disconnected, the iOptima standby mode (micromotor stopped).

 WARNING

The iPod/iPad must never be disconnected from the iOptima dental unit during operation! If the iPod/iPad is disconnected during an operation, the micromotor stops immediately.

INT

system is in

INT

12.3.2 Connection

The micromotor can start only when the iPod/iPad is connected and the application is in operative mode.

 CAUTION

12.3.3 iOptima

If the iOptima app is running and the iPod/iPad plugged to the

INT

iOptima

(switch ON):

• The iPod/iPad will charge up (even if the app is not running);

• The sleep mode is deactivated;

• The micromotor can be operated with the pedal (iOptima app in operative mode).

12.3.4 iOptima

For iOptima the active motor. Memory of each operation set at last usage for each motor is kept (e.g. a user who has two motors can leave a blue CA on «motor 1» and a red CA on «motor 2» and, depending on which motor is activated, the corresponding modes are automatically activated).

INT

unit switched ON

INT

last set operation memory

, the operation displayed by default is associated to

iOptima/iOptima operation

INT

FIG. 1 FIG. 2 FIG. 3 FIG. 4 FIG. 5

13 Getting started

13.1 Back up data

Use iTunes or iCloud to automatically back up your iOptima application user-defined settings. Refer to Apple's user guide for appropriate use of the iPod/iPad, iTunes or iCloud.

13.2.1 Display onscreen keyboard

FIG. 5

• Tap a text field to display the onscreen keyboard;

• Type characters with the onscreen keyboard (tap to delete all characters).

13.2 Use of the Touch screen

The iOptima application is operated with the iPod Touch®/iPad Mini® screen with a few simple gestures:

FIG. 1

• Tap to click.

FIG. 2

• Slide to scroll and adjust parameters.

FIG. 3

• Swipe to restore or remove parameters.

Note 1

FIG. 4

• Long tap to access the drag and drop function;

• Drag and drop to sort files/operations.

ENG

FIG. 6

13.3 Launch iOptima app

FIG. 6

Make sure that the sound volume on your iPod/iPad is ON and set

to an appropriate level according to the ambient noise of the room:

• Volume down (1) and up (2). Close all other applications in order not to disrupt the operation:

• Double-click the home button (6) to show the multitasking display and drag the app up to close.

• Click the home button again to return to the main screen.

Deactivate all alerts. Refer to Apple's user guide for appropriate

use of the iPod/iPad.

Ensure that the latest application updates have been installed

(see chapter “13.7 iOptima app update” on page 43).

Tap the app icon (5) to launch the iOptima application.

Note 2

NOTES

1 The swipe gesture is only active in the delimited area (1).

2 If not using your iPod/iPad, press the Sleep/Wake button (3)

to lock it.

FIG. 7 FIG. 8 FIG. 9

13.4 Welcome screen and disclaimer

A. To ensure the appropriate working of the iOptima Dental unit, make sure to only use your iOptima application with the iOS version validated by Bien-Air Dental.

FIG. 7

 Refer to the current version of your device (1).

See also chapter “16.3 iOS compatibility errors (disclaimer screen),” on page 61.

For more information go to the App Store the selected application.

Tap OK (2) to acknowledge disclaimer message and access the

DISCLAIMER

message second screen (3).

FIG. 8

Make sure to have set all steps of disclaimer (3) and tap OK (4),

see chapter “13.3 Launch iOptima app” on page 40 for details.

 The Welcome screen is displayed.

FIG. 9

The Welcome screen differs whether using the iOptima or

INT

iOptima

system and depends on which type of micromotor is

connected.

See chapter “4.2 iOptima system table” on page 11 for more information.

Tap RO (5) to enter the restorative mode.

See chapter “14.1 Enter Restorative mode” on page 45.

Tap EN (6) to enter the endodontics mode.

See chapter “15.1 Enter Endodontics mode” on page 51 for details.

Tap i (7) to open the

Information

screen.

See chapter “13.5 Information” on page 42 for details.

Tap

Settings

(8) to open the

Settings

screen.

See chapter “13.5 Information” on page 42 for details.

ENG

FIG. 10 FIG. 11 FIG. 12 FIG. 13

2 3 4 5

13.5 Information

FIG. 10

A. Tap (1) to access Bien-Air (catalogue, new products, etc.)

and iOptima (User Manual and About) information screen.

FIG. 11

 The information screen allows to navigate to the following

pages:

• Latest news (2) (opens Bien-Air website latest news page);

• User manual (3) (application detects the language of the iPod/iPad and downloads the User Manual in the same language);

Note 3

• Catalogue (4) (opens online catalogue (pdf file));

• Web TV (5) (opens Bien-Air web TV);

• About (6) (displays About screen (FIG. 12, 8) with iOptima system and Bien-Air factory information);

• Contact us (opens email application with predefined email address iOptima@bienair.com).

Note 4

FIG. 13

• Chapter links and the table of contents By clicking on a chapter section in the table of contents or in the manual, the user can directly access it. The dedicated button (9) links the user directly to the table.

NOTES

3 If the User Manual is not available in the correct language, the English manual is downloaded.

4 Latest News, Catalogue, Web TV and Contact us functions are available only if the iPod/iPad is connected to a Wi-Fi network.

FIG. 14 FIG. 15 FIG. 16 FIG. 17 FIG. 18

3 4

13.6 Settings

FIG. 14

INT

A. Tap (1) to access iOptima/iOptima screen.

system Settings

 The Settings screen allows to set the torque unit for each

available mode.

FIG. 15

Tap

Tor qu e u ni t

FIG. 16

Tap ENDO (3) to access the endodontics screen.

FIG. 17

Tap your preferred torque unit.

D. E.

Select between;

to access its screen.

Ncm; mNm; gcm

and % (RESTO mode only).

13.6.1 Service engineer settings

With service engineer access (password protected), the settings screen also allows access to the micromotor holder configuration

(iOptima

INT

) and lock settings.

13.7 iOptima app update

FIG. 18

When the application is launched, it will check whether a new version is available on the App Store. If a new update is available, a message box will be displayed on Disclaimer screen to notify the user should download the application.

Note 6

• Download: user can automatically access App Store application page.

• Remind Me Later: user can delay the update and continue to work with currently installed app version (the message appears once a day).

• Ignore: User can ignore the update and continue to work with currently installed app version (the message reappears only if a new version is available).

Important: if Lock settings is set, it is not possible to save any user-defined data!

Note 5

ENG

NOTES

5 To modify service engineer settings, please contact a service engineer certified by Bien-Air Dental SA.

6 This function is active only when the iPod/iPad is connected to a Wi-Fi network.

FIG. 1 FIG. 2 FIG. 3 FIG. 4 FIG. 5

14 Operation - Restorative mode

14.1 Enter Restorative mode

FIG. 1

Tap to enter the restorative mode. Predefined restorative operations are available by default, it is possible to modify and restore them. It is possible to create and delete User-defined operations.

Note 1 - 2

14.2 Operative screen description

FIG. 2

The operative screen displays the selected operation type and settings:

(1) Settings (access to operation types and settings) (2) Selected operation type (3) Micromotor rotation mode: FORWARD and REVERSE (4) Save (customize settings) (5) Footpedal mode: PROGRESSIVE or ON/OFF mode (6) Light intensity (7) Handpiece ratio (8) Maximum micromotor torque in % (or according to set-

(9) Maximum micromotor speed in rpm (10) Back to the previous screen

tings, see chapter “13.6 Settings” on page 43)

Note 3

See chapter “14.3 Standard Use - Operating mode (Start)” on page 47.

14.2.1 Micromotor Speed & Torque

FIG. 3

Slide to adjust the maximum speed and torque values.

Or tap the icons to activate the wheel scroller.

FIG. 4

Slide to precisely adjust the motor speed and torque values and tap Cancel or Done to validate.

FIG. 5

When the power demand of the micromotor is excessive, the

operative screen displays the overheating symbol . In this case the iOptima unit automatically lowers the torque in order to avoid overheating of the micromotor. To restore 100% torque, allow the motor to idle or stop for a few seconds.

14.2.2 Handpiece ratio

FIG. 6

Tap and select the handpiece ratio.

ENG

FIG. 6 FIG. 7 FIG. 8 FIG. 9

 CAUTION

Verify that the handpiece corresponds to your selection.

Note 4 - 5

NOTES

14.2.3 Light intensity

FIG. 7

Slide or tap the appropriate dot to set up the light intensity of the micromotor. 11 levels of adjustment are possible:

• light OFF, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% and 100% of the max light intensity value.

Note 6 - 7

14.2.4 Footpedal mode

FIG. 8

Tap and select the footpedal mode:

• ON/OFF (1): The speed consign is equal to the maximum speed once the footpedal is pressed; whatever the pressure on it.

• Progressive (2): The speed consign value is (linear) function to the pressure on it.

Note 8

14.2.5 Micromotor rotation direction

FIG. 9

Tap and select the rotation mode of the micromotor:

• Forward (clockwise)

• Reverse (counterclockwise).

Note 9 - 10

1 In restorative mode, the air spray is always switched ON by

the help of the electro-valve integrated in the iOptima unit.

2 Save and create (

chapter “13.6 Settings” on page 43).

3 All parameters can be changed and saved directly in the op-

erative screen (except if a lock is set).

4 The handpiece ratio is red-colored for multiplication gears,

blue-colored for direct-drive, and green-colored for reduction gears.

5 The operative screen always displays the selected handpiece

ratio.

6 The light intensity value is set for each operation. The default

value of the light intensity is 100%.

7 The operative screen always displays the selected light inten-

sity value.

8 The operative screen always displays the selected footpedal

mode.

9 In reverse mode (CCW), the symbol flashes and there is a

sound alert (alternate medium beeps).

10 The operative screen always displays the selected rotation di-

rection.

) buttons

are disabled if a lock is set (see

FIG. 10 FIG. 11 FIG. 12 FIG. 13 FIG. 14

14.3 Standard Use - Operating mode (Start)

FIG. 10

Tap to enter the RESTO mode, the operative screen opens.

Note 11

FIG. 11

Tap

Settings

Note 12

FIG. 12

Tap to select an operation type.

 The app navigates back to the operative screen.

Press the dental unit pedal to switch on the micromotor.

to open the

Operations

screen.

Tap the operation type above (3) or below (4) the selected

operation type to navigate to the operation respectively preceding or following the current one in the predefined operation list.

See chapter “14.4.3 Sort operations” on page 48 to sort operations in the list.

14.4 Customize default operations

FIG. 14

From the operative screen, tap

screen.

FIG. 15

Tap to customize an operation type.

 The Operation screen opens.

Settings

to open the

Operations

 CAUTION

FIG. 13

Note 13 - 14

• Slide to adjust the micromotor speed and torque values of

• Adjust the handpiece ratio, light intensity, footpedal mode or

•Tap Save (5) to validate the new settings.

Note 15

the selected operation.

rotation direction of the selected operation.

FIG. 16

Customize the operation settings.

Tap

Cancel

(2) or

Save

(3) to validate custom settings and tap

back (1).

 If saved, the symbol (factory predefined settings) changes

to (custom settings).

Select an operation.

 The app navigates back to operative screen.

ENG

FIG. 15 FIG. 16 FIG. 17 FIG. 18 FIG. 19

2 31

14.4.1 Restore (default) and delete (userdefined) operations

FIG. 17

Swipe left to restore or delete.

Note 16 - 17

14.4.2 Default Operations

FIG. 18

 CAUTION

The parameters contained in the dental procedures are indicative only. Bien-Air Dental cannot be held liable for them.

Note 18

14.4.3 Sort operations

FIG. 19

NOTES

11 If using iOptima

holder, the operative mode previously used with that motor is displayed by default (only from Home page).

12 Each operation in the list is tagged with a colored dot to indi-

cate which type of gear ratio it is associated to: red for multiplication gears, blue for direct-drive, green for reduction gears.

13 When the micromotor is switched ON, the speed and torque

values displayed in the operative screen FIG. 13, toggle from predefined values to real time values. Once the motor stops running, the speed and torque values displayed toggle back to maximum predefined values.

14 All parameters can be directly modified in the operative

screen (only when the footpedal is released).

INT

system, each time you pull a motor from a

Do a long tap on an operation to activate the drag and drop

function and display the icons (2).

Tap the icon to drag and drop the operations.

Tap

Done

(1) to validate.

15 Modifications are discarded when leaving the operative

screen without saving.

16 Predefined RESTO operations can not be deleted. But it is pos-

sible to restore the default values if modified. Only user-defined operations can be deleted.

17 Custom and user-defined operations are represented by .

Default operations are represented by .

18 The predefined parameters may be subject to modification

without notice.

FIG. 20 FIG. 21 FIG. 22 FIG. 23

1 2

14.5 Create new operations (user-defined)

FIG. 20

From the operative screen, tap

screen.

FIG. 21

Tap to create a new operation type.

 The Operations screen opens.

Note 19

Settings

to open the

Operations

FIG. 22

Tap in t he

Operation name

text field (1) to display the onscreen

keyboard.

FIG. 23

Type the ne w

D. E.

Set handpiece ratio and operation settings.

Tap

Cancel

Operation name

Save

(2) to validate user-defined operation and tap

(3) and tap

Done

(4).

back, FIG. 22.

 If saved, the new operation is displayed in the Operations

screen (5) with the symbol (user-defined) beside it, FIG. 21.

Select an operation.

 The app navigates back to operative screen.

ENG

NOTES

19 Maximum storage of 20 user-defined operations, if reached

the icon disappears.

FIG. 1 FIG. 2 FIG. 3 FIG. 4 FIG. 5

15 Operation - Endodontics Mode

15.1 Enter Endodontics mode

FIG. 1

Tap to enter the endodontics mode. Predefined endodontics systems are available by default, it is possible to modify and restore them. It is possible to create and delete User-defined endodontics brands, systems and files.

Note 1 - 2

(9) Maximum micromotor speed in rpm (10) Figure of the file (11) File system name (12) File brand (13) Back to the previous screen

Note 3

15.2.1 Micromotor Speed & Torque

FIG. 3

Slide to adjust the maximum speed and torque values.

15.2 Operative screen description

Or tap the icons to activate the wheel scroller.

FIG. 2

The operative screen displays the selected operation brand, system type and file settings:

(1) Access to brands, systems and file settings (2) File name and color designation of file according to ISO

3630-1 standard

(3) Micromotor rotation mode: FORWARD, AUTO-REVERSE,

AUTO-FORWARD

(4) Save (to customize settings) (5) Footpedal mode: PROGRESSIVE or ON/OFF mode (6) Light intensity (7) Handpiece ratio (8) Maximum micromotor torque in Ncm (or according to set-

tings, see chapter “13.6 Settings” on page 43)

FIG. 4

Slide to precisely adjust the motor speed and torque values and tap Cancel or Done to validate.

FIG. 5

When the power demand of the micromotor is excessive, the

operative screen displays the overheating symbol . In this case the iOptima unit lowers the torque automatically in order to avoid overheating of the micromotor. To restore 100% torque, allow the motor to idle or stop for a few seconds.

ENG

FIG. 6 FIG. 7 FIG. 8

15.2.2 Handpiece ratio

FIG. 6

Tap and select to modify the handpiece ratio.

 CAUTION

Verify that the handpiece corresponds to your selection.

Note 4 - 5 - 6

15.2.3 Light intensity

FIG. 7

Slide or tap the appropriate dot to set up the light intensity of the micromotor. 11 levels of adjustment are possible:

• light OFF, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% and 100% of the max light intensity value.

Note 7 - 8

15.2.4 Footpedal mode

FIG. 8

Tap and select the footpedal mode:

• ON/OFF (1): the speed consign is equal to the maximum speed once the footpedal is pressed; whatever the pressure on it.

• Progressive (2): The speed consign value is (linear) function to the pressure on it.

Note 9

NOTES

1 In endodontics mode, the air spray is always switched OFF by

the help of the electro-valve integrated in the iOptima/iOptima unit.

)

2 Save and create (

chapter “13.6 Settings” on page 43).

3 All parameters can be changed and saved directly in the op-

erative screen (except if a lock is set).

The operative screen always displays the selected handpiece ratio.

If a different ratio than 8:1 Bien-Air or 1:1 Bien-Air is chosen, a disclaimer is displayed on the handpiece ratio popup: «IMPORTANT WARNING: If instruments other than the 8:1 Bien-Air or the 1:1 Bien-Air Dental are used with the iOptima, please note that the displayed torque values cannot be guaranteed any longer (they represent a purely indicative information). In such case, Bien-Air Dental declines all responsabilities in case of any injury or any damage resulting of the inappropriate use of the equipment.».

The handpiece ratio is red-colored for multiplication gears, bluecolored for direct-drive, and green-colored for reduction gears.

The light intensity value is set for each operation. The default value of the light intensity is 100%.

The operative screen always displays the selected light intensity value.

The operative screen always displays the selected footpedal mode.

buttons are disabled if a lock is set (see

INT

FIG. 9 FIG. 10 FIG. 11 FIG. 12 FIG. 13

15.2.5 Micromotor rotation direction

FIG. 9

Tap to select the rotation mode of the micromotor:

• Forward (clockwise) (1)

• Auto-reverse (2): the direction of rotation reverses automatically once the maximum torque set is reached (clockwise to counterclockwise).

• Auto-forward (3): the direction of rotation reverses automatically once the maximum torque set is reached (clockwise to counterclockwise). In Auto-forward mode (reverse), the motor stops and reverses automatically after the time set (4): 0.5 to 3.0 seconds counterclockwise to clockwise).

Note 10 - 11

15.3 Standard Use - Operating mode (Start)

FIG. 10

Tap to enter the ENDO mode, the operative screen opens.

Note 12

FIG. 11

Tap

Settings

FIG. 12

Tap to choose a brand, the

FIG. 13

Tap to select a file system.

Note 13

to open the

Brands

Systems

screen,

screen opens.

 The app navigates back to the operative screen, FIG. 14.

Press the dental unit pedal to switch on the micromotor.

 CAUTION

FIG. 14

Tap the file figure area to jump to the next file, parameters of the

file system previously selected are automatically loaded (or directly tap the required file (3)).

Note 14 - 15

15.4 Customize settings

15.4.1 Customize default settings (operative screen)

FIG. 15

Note 15

Slide to adjust the micromotor speed and torque values of the

selected file.

Adjust the handpiece ratio, light intensity, footpedal mode or

rotation direction to customize settings for the selected file system.

Tap

Save

to validate the new settings.

Note 16

ENG

FIG. 14 FIG. 15 FIG. 16 FIG. 17 FIG. 18

15.4.2 Customize system settings

FIG. 16

Tap

Settings

to open the

Brands

screen.

FIG. 17

Tap a

Brand

to open the

Tap to customize a file system, the

Systems

screen.

Settings

screen opens.

FIG. 18

Customize the file system settings:

• tap any file (4) to open the File screen and modify motor speed and torque values (tap (3) to go back);

• tap the icons (5) to modify the handpiece ratio, etc...;

•tap in the Add new file field (6) to create a new file, make a long tap to sort the files, or swipe left to remove existing files. See chapter “15.5 Add, sort or remove files” on page 55, for details.

Tap

Cancel

(1) or

Save

(2) to validate custom settings.

 If saved, the symbol (factory predefined settings) changes

to (custom settings).

Note 17

See chapter “15.7 Create new Brands and Systems” on page 57, for details

NOTES

10 The operative screen always displays the selected rotation

direction.

11 In reverse mode (CCW), the symbol flashes and there is a

sound alert (alternate medium beeps).

12 If using iOptima

holder, the operative mode previously used with that motor is displayed by default (only from Home page).

13 If an ENDO file systems foresee

ment is selected, speed, torque, motor direction, light, pedal mode disappear and the gear ratio is fixed.

See chapter “15.8 CA ENDO

14 When the micromotor is switched ON, the speed and torque

values displayed toggle from predefined values to real time values. Once the motor stops running, the speed and torque values displayed toggle back to maximum predefined values.

15 All parameters can be directly modified in the operative

screen (only when the footpedal is released). See chapter “15.4.1 Customize default settings (operative screen)” on page 53.

16 Modifications are discarded when leaving the operative

screen without saving.

17 From the Systems screen it is also possible to chose a differ-

ent brand and create a new system or a new brand with the

symbol.

INT

system, each time you pull a motor from a

ing the reciprocating move-

/ Recipro

q option” on page 58.

FIG. 19 FIG. 20 FIG. 21 FIG. 22 FIG. 23

15.5 Add, sort or remove files

Note 18

15.5.1 Add new files

FIG. 19

Tap in t he

FIG. 20 - FIG. 21

Tap in t he

type the new

Add new file

File name

(5) and tap

field to open the

File

field (3) to display the onscreen keyboard,

Done

(onscreen keyboard).

screen.

FIG. 22

Tap the file figure (4) to display the

Color designation

select a color for the new file and tap back (6) (color designat file is according to ISO 3630-1 standard).

Adjust the micromotor speed and torque values (7), FIG. 20.

See “15.2 Operative screen description” on page 51, for details.

Tap back (2) and

Save

(1), FIG. 19.

15.5.2 Sort files

FIG. 23

Do a long tap on a file to activate the drag and drop function and

display the icons (2).

Tap the icon to drag and drop the files.

Tap

Done

(1) to validate.

screen,

ion of

ENG

FIG. 24 FIG. 25 FIG. 26 FIG. 27 FIG. 28

15.5.3 Remove files

FIG. 24

Swipe left to remove existing files and tap

Save

Cancel

15.6 Restore (default) and delete (userdefined) systems

FIG. 25

Swipe left to restore or delete.

Note 19 - 20

15.6.1 Default Systems

FIG. 26

Dentsply Sirona

Note 21

FIG. 27

FKG swiss endo

FIG. 28

VDW

 CAUTION

The parameters contained in the dental procedures are indicative only. Bien-Air Dental cannot be held liable for them.

Note 22

NOTES

18 New files can be

user-defined files.

19 Predefined ENDO systems can not be deleted. But it is possi-

ble to restore the default values if modified. Only user-defined systems can be deleted.

20 Custom and user-defined systems are represented with the

symbol .

Default manufacturer files are represented by the symbol .

21 Predefined endo file systems foreseeing the reciprocating

movement need activation on the iOptima movement wasn’t previosuly activated, taping it leads to the acti-

vation page.

See chapter “15

22 The predefined parameters may be subject to modification

without notice.

added, sorted or removed in default and

INT

system. In case the

CA ENDO

/ Recipr

oq option” on page 58.

1 2 43

FIG. 29 FIG. 30 FIG. 31 FIG. 32 FIG. 33

15.7 Create new Brands and Systems

FIG. 29

Tap to add a new brand or a new system, the

opens.

Note 23 - 24

FIG. 30

Tap in t he

FIG. 31

Type the new

drop-down list box and tap

FIG. 30

Tap in

(onscreen keyboard).

Tap

page 55.

Tap the icons (6) to set the iOptima unit parameters:

• Handpiece ratio

• Light intensity

• Footpedal mode: PROGRESSIVE or ON/OFF mode

• Micromotor rotation mode: FORWARD, AUTO-REVERSE,

See chapter “15.2 Operative screen description” on page 51, for details.

Tap

Brand

text field (1) to display the onscreen keyboard.

Brand name

System

field (2), type the

Add new file

AUTO-FORWARD

Save

(3).

(4), refer to chapter “15.5.1 Add new files” on

(5) or select an existing brand from the

Done

(onscreen keyboard).

System name

Settings

and tap

screen

Done

15.7.1 Restore (custom) and delete (userdefined) brand

Note 25 - 26

Restore default brands (factory settings)

FIG. 32

Swipe left on a default brand.

 A message box opens: Restore factory brand.

Tap Cancel or Restore to acknowledge.

Delete user-defined brands

FIG. 33

Swipe left on a user-defined brand.

 A message box opens: Delete user brand.

Tap

Cancel

Delete

to acknowledge.

ENG

FIG. 34 FIG. 35 FIG. 36

3 4

15.8 CA ENDO / Reciproq option

Predefined endo file systems foreseeing the reciprocating

INT

movement need activation on the iOptima

system. In case the movement wasn’t previously activated, tapping it leads to the activation page.

15.8.1 Activation page

FIG. 34

Tap

More information

FIG. 35

Input the code obtained and tap

 A message box displays either:

License not Activated. License Activated.

FIG. 36

If activated the app navigates back to the operative screen.

Note 27 - 29

Press the dental unit pedal to switch on the micromotor.

and follow the instructions displayed.

Activate

(2)

NOTES

23 New systems and brands can also be created directly from

the system screen.

24 Maximum storage of 10 user-defined brands and 10 systems

per brand, if reached the icon disappears.

25 Restore ALL default system settings from the Brands screen.

26 It is only possible to delete user-defined brands

27 If an ENDO file systems foreseeing the reciprocating move-

ment is selected, speed, torque, motor direction, light, pedal mode disappear and the gear ratio is fixed.

cessive, the operative screen displays the overheating symbol (3). In this case the iOptima/iOptima matically in order to avoid overheating of the MX2 micromotor. To restore 100% torque, allow the motor to idle or stop for a few seconds.

displays

When the power demand of the MX2 micromotor is ex-

INT

unit lowers the torque auto-

If stress is excessive on the file, the file stress warning

(4).

 CAUTION

• Valid only with Bien-Air CA ENDO.

• CA ENDO must be used only with specific tools.

16 List of errors & Troubleshooting

16.1 Safety warning (operating)

Warning description Message Cause of warning Action

Pedal is pressed when accessing operative page. Pedal remains pressed when

Footpedal to be released Please release pedal …

Motor torque limitation active

Please switch ON sound volume on your iPod/iPad and

iPod/iPad speaker OFF

set it to an appropriate level according to the ambient noise level in your practice room.

acknowledging any system notification. Motor is jammed for more than 2 seconds.

Motor drive limits delivered torque to prevent motor overheating.

iPod

/iPad

speaker was switched OFF, or sound volume was disabled by user. It is necessary to have iPod

/iPad

speaker turned ON so that system sound notifications and alarms may be heard distinctly.

Release footpedal and press it again.

Avoid extended use. Let system cool down.

Turn iPod/iPad speaker ON and set sound volume to an appropriate level.

Non-verified iOS version in use

User Manual has been updated

Motor torque threshold limit reached, file stress condition encountered

User Manual has been updated, and may be consulted in the Information page.

iOS version installed on the iPod

/iPad

has not been verified according to Bien-Air validation protocols. Therefore it is NOT recommended to use the system with this configuration.

As an update of the User Manual was available on Bien-Air website, it has been automatically downloaded and updated on the iPod

System detects that motor torque threshold limit is reached.

/iPad

Do NOT update iPod/iPad with new iOS versions unless Bien-Air recommends to do so. If the iPod/iPad has been updated with a new iOS version despite everything, do not use the system until Bien-Air has verified and approved the new iOS version.

It is highly recommended to consult the updated User Manual before using the system.

Release file pressure. Slow down treatment.

ENG

16.2 Device operating error

Error description Message Cause of error Action

ERROR 4

Motor connection missing

ERROR 5

Motor cable failure

ERROR 6

Motor drive over temperature

GEN ERROR [FailCode]

System electrical failure.

Motor is not connected ! Please check motor connection.

Motor cable fault ! Please replace motor cable.

Overall system overheating ! Please wait until cool.

Electrical system fault ! Please contact Bien-Air Dental SA.

Motor phase missing failure. Motor is not properly connected.

Motor drive power protection failure. Motor cable may be defect.

Motor drive over temperature failure.

[FailCode] = EC100 : Motor drive communication failure [FailCode] = EC101 : Motor drive under voltage failure [FailCode] = EC102 : Motor drive over voltage failure [FailCode] = EC120 : Motor drive other failure

1. Check motor connection.

2. If problem persists, contact Bien-Air Dental SA.

1. Replace motor cable.

2. If problem persists, contact Bien-Air Dental SA.

1. Wait for system cooling.

2. If problem persists, contact Bien-Air Dental SA.

1. Switch OFF unit

2. Disconnect iPod/iPad device from unit

3. Close iOptima application

4. Switch unit back ON

5. Reconnect iPod/iPad device to unit

6. Restart iOptima application

7. If problem persists, contact Bien-Air Dental SA.

16.3 iOS compatibility errors (disclaimer screen),

Color iOS version (identifier digit change) Text version Restriction (recommendations)

Green

Orange

Red

Note 1

•None.

• Currently installed iOS is identical to iOS verified during app validation.

• Last digit is different: iOS x.y.Z.

• Currently installed iOS was updated for a minor change compared to iOS verified during app validation.

• First and/or second digit are/is different: iOS X.y.z, or iOS X.Y.z.

• Currently installed iOS was updated for major or at least significant changes compared to iOS verified during app validation

Currently installed iOS x.y.z text section is displayed in green color.

Currently installed iOS x.y.z text section is displayed in orange color. User must be aware that the configuration he is using is slightly different from the recommended configuration.

Currently installed iOS x.y.z text section is displayed in red color.

No restrictions

• Configuration in use is slightly different from recommended configuration.

•No restrictions

• Configuration in use is significantly different from recommended configuration.

 CAUTION

The current configuration should NOT be used!

ENG

NOTES

1 It is imperative to read and understand this IFU before carry-

ing out any troubleshooting on the iOptima. In case of unclear information or for any error message that is not listed in the following tables contact Bien-Air Dental SA.

FIG. 1

17 Maintenance

 CAUTION

Only use original Bien-Air Dental maintenance products and parts or those recommended by Bien-Air Dental. Using other products or parts may cause operational failure and/or void the guarantee.

17.1 Servicing

Never disassemble the device. For any modification and repair, we recommend to contact your regular supplier or

directly at the address indicated on the back cover.

Note 1

Bien-Air Dental

17.3 Important

For maintenance of micromotors and hoses: See IFU

Product Micromotor IFU Hose IFU

iOptima MX2 LED 2100199 MX2 2100223

INT

iOptima

MX2 LED 2100199 MX2 2100223

17.2 Cleaning-disinfection

• Disinfect the surfaces of the iOptima unit / iOptima in and footpedal by gently rubbing for about 15 seconds with a clean cloth soaked in a suitable product (i.e. Bien-Air Dental Spraynet or isopropyl alcohol) or with an appropriate disinfectant wipe.

• Do not immerse in disinfectant solution.

• Do not immerse in an ultrasonic bath.

INT

dock-

ENG

17.4 Replace 4VL seal

FIG. 1

 CAUTION

Immediately replace any damaged or leaking O-rings and seals. Never use sharp tools!

A. Switch off the water and the dental unit power supply.

Switch OFF the iOptima unit «O».

B. C.

Unscrew and unplug the 4VL hose (1).

Remove the damaged 4VL seal (2).

Replace with a new 4VL seal (REF 1302403-010).

 Refit hose, switch ON units and water.

See chapter “5.1 Install the iOptima app” on page 17 for details.

17.5 iOptima

Refer to the iOptima

INT

installation manual

 CAUTION

Only a qualified Bien-Air Dental service engineer is permitted to

open the dental unit and repair the iOptima

INT

system.

NOTES

1 Bien-Air Dental SA recommends the user to have its dynamic instruments regularly checked or inspected (at least once a year).

18 General information and guarantee

18.1 General information

The device must be used by qualified professionals in compliance with the current legal provisions concerning occupational safety, health and accident prevention measures, and these instructions for use. In accordance with such requirements, the operators:

• must only use devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other signs that may indicate malfunction of the device, the work must be stopped immediately; in this case, contact a repair center that is approved by Bien-Air Dental SA;

• must ensure that the device is used only for the purpose for which it is intended, must protect themselves, their patients and third parties from any danger, and must avoid contamination through the use of the product.

18.2 Terms of guarantee

Bien-Air Dental SA grants the user a guarantee covering all functional defects, material or production faults.

The device is covered by this guarantee for:

• 12 months for the hose

• 12 months for the power supply

• 12months for integrable electronic boards

• 24 months for the iOptima/iOptima

• 36 months for series MX2 LED electric micromotors

from the date of invoicing.

INT

unit

Bien-Air Dental SA shall not be held responsible for damage or injury and the consequences thereof, resulting from:

• excessive wear and tear

•improper use

• non-observance of the instructions for installation, operation and maintenance

• unusual chemical, electrical or electrolytic influences

• poor connections, whether of the air, water or electricity supply.

The guarantee does not cover flexible “fiber optic” type light conductors, or any parts made of synthetic materials. The guarantee shall become null and void if the damage and its consequences are due to improper manipulation of the product, or modifications to the product carried out by persons not authorized by Bien-Air Dental SA.

Claims under the terms of the guarantee will be considered only on presentation, together with the product, of the invoice or the consignment note, on which the date of purchase, the product reference and the serial no. should be clearly indicated.

In case of justified claim, Bien-Air Dental SA or its authorized representative will fulfill the company’s obligations under this guarantee by repairing or replacing the product free of charge. Any other claims, of whatever nature, in particular in the form of a claim for damages and interest, are excluded.

Bien-Air Dental SA

Länggasse 60 Case postale 2500 Bienne 6, Switzerland Tel. +41 (0)32 344 64 64 Fax +41 (0)32 344 64 91 oce@bienair.com

Bien-Air Deutschland GmbH

Jechtinger Strasse 11 79111 Freiburg, Germany Tel. +49 (0)761 45 57 40 Fax +49 (0)761 47 47 28 ba-d@bienair.com

Bien-Air España, SAU

Entença, 169 Bajos 08029 Barcelona, Spain Tel. +34 934 25 30 40 Fax +34 934 23 98 60 ba-e@bienair.com

Bien-Air USA, Inc.

5 Corporate Park Suite 160 Irvine, CA 92606 USA Phone +1 800-433-2436 Phone +1 949-477-6050 Fax +1 949-477-6051 ba-usa@bienair.com

Bien-Air France Sàrl

19-21, rue du 8 Mai 1945 CS 30310 94113 Arcueil, France Tel. +33 (0)1 49 08 02 60 Fax +33 (0)1 46 64 86 58 ba-f@bienair.com

Bien-Air Italia S.r.l.

Via Vaina 3 20122 Milano, Italy Tel. +39 (02) 58 32 12 51 Fax +39 (02) 58 32 12 53 ba-i@bienair.com

Bien-Air UK Ltd

Arundel House Unit 1 - Ground Floor Amberley Court, Whitworth Road Crawley, RH11 7XL, England Tel. +44 (0)1293 550 200 Fax +44 (0)1293 520 481 ba-uk@bienair.com

Bien-Air Asia Ltd.

Nishi-Ikebukuro Daiichi-Seimei Bldg. 10F 2-40-12 Ikebukuro, Toshimaku Tokyo, 171-0014, Japan

Tel. +81 (3) 5954-7661 Fax +81 (3) 5954-7660 ba-asia@bienair.com

Beijing Bien-Air

Medical Instrument Technology Service Co. Ltd. Room 1415, Block B Lucky Tower, No 3 Dongsanhuan Beilu, Chaoyang District, Beijing 100027, China

Tel. +86 10 6567 0651 Fax +86 10 6567 8047 ba-beijing@bienair.com

▦℻ゑ㦬棂◉₫ₘ▦℻ゑ㦬棂◉₫ₘ 䘾▦恾⚆ㄇ䰞⮶䘾▦恾⚆ㄇ䰞⮶☵ %ㄶ⸳

%ㄶ⸳

REF 2100279-0004/2018.06 iOptima/iOptima

INT

Bien Air iOptima, 1700544-001, 1700704-001, iOptima INT, 1700547-001 Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

ENG INSTRUCTIONS FOR USE.

Table of contents

1Symbols

1.1 Description of symbols for iOptima unit

1.2 Description of symbols for iOptima accessories

2 Identification, Intended use and Notation

2.1 Identification

iOptima

2.2 Intended use

2.3 Notation

3 Warnings & Precautions of Use

4 Description

4.1 iOptima system overview

4.2 iOptima system table

4.3 Set supplied

4.3.1 iOptima system

iOptima set REF 1700544-001

4.4 Options

iOptima set REF 1700547-001

4.5 Technical data

Dimensions L x W x H

Weight

Electrical and pressure data

Electric insulation class

Degree of protection

Memory

List of errors & Troubleshooting

Environmental conditions

Classification

4.6 Environmental protection and information for disposal

4.7 Limitation of liability

4.8 Electromagnetic compatibility (technical description) for iOptima

Precautions regarding Electromagnetic Compatibility (EMC)

Guidance and manufacturer’s declaration - electromagnetic emissions

Recommended separation distances between portable and mobile RF communications equipment and the iOptima

5 Installation

5.1 Install the iOptima app

5.2 Install the iOptima system

6 Interface overview

6.1 iOptima application

6.1.1 Compatibility

6.1.2 Notation

6.2 Sound alerts

6.3 iPod and iOptima connection / disconnection conditions

6.3.1 Disconnection

6.3.2 Connection

6.3.3 iOptima unit switched ON

7Symbols

8 Identification, Intended use and Notation

8.1 Identification

8.2 Intended use

8.3 Notation

9 Warnings & Precautions of Use

10 Description

10.3 Set supplied

10.4 Options

10.5 Technical data

Dimensions L x W x H

Weight

Memory

Electrical and pressure data

Environmental conditions

List of errors & Troubleshooting

Classification

Electric insulation class

10.6 Environmental protection and information for disposal

10.7 Limitation of liability

10.8.1 Electromagnetic compatibility warnings

10.8.2 Electromagnetic compatibility – emissions & immunity

Guidance and manufacturer’s declaration - electromagnetic emissions

Guidance and manufacturer’s declaration – Electromagnetic immunity

11 Installation

11.1 Install the iOptima app

12 Interface overview

12.1 iOptima application

12.1.1 Compatibility