Bien-Air Dental Optima MCX User manual

Rx Only
REF 2100289-0003/2021.11
Optima MCX
ENG INSTRUCTIONS FOR USE
other languages available on www.bienair.com/ifu

REF 2100289-0003/2021.11 © Bien-Air Dental
Set Optima MCX REF 1700588-001
REF 1600959-001 (White) REF 1600751-001 REF 1501938-001
Set Optima MCX REF 1700589-001
REF 1600965-001 (Light Blue) REF 1600751-001 REF 1501938-001
Set Optima MCX REF 1700590-001
REF 1600966-001 (Pastel Orange) REF 1600751-001 REF 1501938-001
Set Optima MCX REF 1700591-001
REF 1600967-001 (Limetree Green) REF 1600751-001 REF 1501938-001
Set Optima MCX REF 1700592-001
REF 1600968-001 (Pink) REF 1600751-001 REF 1501938-001
Options
REF 1600036-006
REF 1501988-001
REF 1502056-001

ENG
1
1 Symbols ............................................................ 2
1.1 Description of symbols.......................................................................2
1.2 Description of symbols for Optima accessories.........................3
2 Identification, intended use and notation ... 4
2.1 Identification ..........................................................................................4
2.2 Intended use ..........................................................................................4
2.3 Intended patient population..............................................................4
2.4 Intended User........................................................................................4
2.5 Intended medical conditions.............................................................5
2.6 Patient contra-indications and warnings......................................5
2.7 In case of accidents.............................................................................5
2.8 Notation...................................................................................................5
3 Warnings & Precautions of Use ................... 6
4 Description ....................................................... 7
4.1 Optima MCX system overview..........................................................7
4.2 Set supplied...........................................................................................8
4.3 Options ....................................................................................................8
4.4 Technical data .......................................................................................8
4.5 Performances .......................................................................................9
4.6 Environmental protection and information for disposal..........9
4.7 Electromagnetic compatibility (technical description) .......... 10
4.7.1 Electromagnetic compatibility warnings .................... 10
4.7.2 Electromagnetic compatibility – emissions &
immunity .................................................................................. 11
5 Installation ..................................................... 14
5.1 Install the Optima MCX system ..................................................... 14
6 Operation ........................................................ 16
6.1 MCX micromotor speed................................................................... 16
6.2 MCX micromotor rotation direction ............................................. 16
6.3 Standard Use...................................................................................... 16
7 List of errors & Troubleshooting ............... 17
7.1 Device operating error..................................................................... 17
8 Maintenance ................................................. 18
8.1 Servicing.............................................................................................. 18
8.2 Cleaning-disinfection ....................................................................... 18
8.3 Important............................................................................................. 18
8.4 Replace 4VL seal............................................................................... 18
9 General information and guarantee ......... 20
9.1 General information ......................................................................... 20
9.2 Terms of guarantee.......................................................................... 20
Table of contents

2
1Symbols
1.1 Description of symbols
Symbol Description Symbol Description
CE Marking with number of the notified body. Non-ionizing electromagnetic radiation.
Manufacturer. Alternating current.
Catalogue number. OFF (power).
Serial number. ON (power).
Medical Device. Data Matrix code for product information including
UDI (Unique Device Identification).
Warning: in accordance with federal law (USA),
this device is only available for sale upon
recommendation by an accredited practitioner.
Electrical safety. Type B applied part.
CAUTION: hazard that could result in light or
moderate injury or damage to the device if the
safety instructions are not correctly followed.
WARNING: hazard that could result in serious injury
or damage to the device if the safety instructions are
not correctly followed.
Separate collection of electric and electronic
equipment.
Authorized EC Representative in the European
Community.
Refer to instruction manual/booklet
(https://dental.bienair.com/fr_ch/support/download-center/). General symbol for recovery/recyclable.
REF
SN
Rx Only

3
1.2 Description of symbols for Optima accessories
Symbol Description Symbol Description
CE Marking with number of the notified body. Separate collection of electric and electronic
equipment.
Manufacturer. Serial number.
Catalogue number. Electrical safety. Type B applied part.
Medical Device. Data Matrix code for product information including
UDI (Unique Device Identification).
Authorized EC Representative in the European
Community.
Warning: in accordance with federal law (USA), this
device is only available for sale upon recommenda-
tion by an accredited practitioner.
Sterilizable in autoclave up to the specified
temperature.
SN
REF
Rx Only
135°C
ENG

4
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.
2 Identification, intended use and notation
2.1 Identification
Electronically controlled unit for dentistry allowing operation of
an MCX micromotor with variable speed using the dental unit
pedal.
2.2 Intended use
Product intended for professional use only.
The system fitted with a MCX micromotor is intended for use in
general dentistry which includes restorative dentistry, dental
prophylaxis and orthodontics.
The system is designed to control a dental MCX micromotor
which can drive a dental handpiece (gear ratio 1:1 or 1:5) fitted
with appropriate burs.
Any use other than that for which this product is intended is
unauthorized and may be dangerous. The medical device meets
all the current legal requirements.
The intended EM environment (per IEC 60601-1-2 ed. 4.0) is
Professional healthcare facility environment.
Note 1
2.3 Intended patient population
The intended patient population of the Optima system includes
any person visiting a dental practitioners’ office to receive
treatment in line with the intended medical condition. There is no
restriction concerning subject age, race, or culture. The intended
user is responsible to select the adequate device for the patient
according to the specific clinical application.
2.4 Intended User
The Optima MCX is meant to be used only by dentists and dental
professionals in dental offices.

ENG
5
2.5 Intended medical conditions
General dentistry which includes restorative dentistry, dental
prophylaxis and orthodontics.
2.6 Patient contra-indications and
warnings
No specific patient contra-indication nor warning exist for the
Optima MCX device when the device is used as intended.
2.7 In case of accidents
If an accident occurs, the Optima MCX must not be used until
repairs have been completed by a qualified and trained technician
authorized by the manufacturer.
If any serious incident occurs in relation to the device, report it to
a competent authority of your country, as well as the
manufacturer through your regional distributor. Observe relevant
national regulations for detailed procedures.
2.8 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, 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.

6
3 Warnings & Precautions of Use
⚠CAUTION
According to IEC 60601-1:2005+A12012/AnnexG, electrified devices (motors, control units, couplers and attachments), can be safely used in
a medical environment in which potentially explosive or flammable mixtures of anaesthetic substances are delivered to the patient only if:
1. The distance between the motor and the anaesthetic breathing circuit exceeds 25 cm.
2. The motor is not used simultaneously to the administration of the anaesthetic substances to the patient.
⚠CAUTION
To prevent any risk of electric shock, the Optima MCX unit must be connected only to a power supply network provided with a protective
earth.
⚠CAUTION
The power plug is the device used for disconnection in case of problems, it must be easily accessible at all times.
⚠CAUTION
Ensure that the micromotor hose is not bent.
⚠WARNING
Never connect a handpiece on a running micromotor.
⚠WARNING
Do not attempt to open the device when it is connected to the electric mains. Risk of electrocution.
⚠WARNING
Modification of the device is forbidden.

ENG
7
4 Description
4.1 Optima MCX system overview
The Optima MCX connections (cables and hoses) consist of:
• Micromotor MCX hose (A);
• A pneumatic 4-way connection input (B);
• A power supply and plug cord (C).
Pictogram used
4-hole connection and 4 electric (4VLM).
FIG. 1
(1) Power supply cord
(2) Power Supply and plug cord (C)
(3) Optima MCX unit
(4) Micromotor MCX hose output (A)
(5) 4-way connector input, air and water inlet from your
pneumatic unit (B)
(6) Power input connector (with lock) (C)
(7) Main power switch
(8) Micromotor MCX connector (A)
(9) Optima MCX status light (green power on)
(10) MCX micromotor*
(11) Handpiece* [not provided in set]
(12) Dental unit with pedal (B) [not provided in set]
*Applied parts (per IEC 60601-1)
567
ABC
B
C
12
89
10
11
12
3
A
4

8
4.2 Set supplied
Optima MCX set REF 1700588-001
* The reference may vary depending on the colour set chosen.
** Common to all the sets
Optima MCX Color sets
4.3 Options
4.4 Technical data
Dimensions L x W x H
Optima MCX unit.......................................125 x 125 x 75 mm
Power Supply ............................................130 x 75 x 45 mm
Weight
Optima MCX unit.......................................600 g
Power Supply ............................................650 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
Maximum air spray flow rate
according to ISO 14457: .........................6 Nl/min at 2.5 bar
Maximum water spray flow rate
according to ISO 14457: .........................150 ml/min at 2.5 bar
*Compatible with generic footpedals working within the pressure
range of 3-5 bar and providing an output signal of 0-5V
⚠CAUTION
If the input pneumatic pressure is below the minimum threshold
indicated above, the motor could not reach the setpoint speed.
Designation REF number
* CONSOLE OPTIMA MCX WHITE (1x) 1600959-001
** MOT MCX LED (1x) 1600751-001
** TRANSFORMER IOPTIMA (1x) 1501938-001
** CABLE MAINS 3 POLE EU
(length 2.50 m) (1x) 1300066-001
** CABLE MAINS 3 POLE US
(length 2.00 m) (1x) 1300067-001
Set Unit REF
1700589-001 (Light Blue)
- CONSOLE OPTIMA MCX BLUE 1600965-001
1700590-001 (Pastel Orange)
- CONSOLE OPTIMA MCX ORANGE 1600966-001
1700591-001 (Limetree Green)
- CONSOLE OPTIMA MCX GREEN 1600967-001
1700592-001 (Pink)
- CONSOLE OPTIMA MCX PINK 1600968-001
Designation REF number
MAINT SPRAYNET (BOX 6 CANS) 1600036-006
BRACKET FOR iOPTIMA 1501988-001
SUPPORT OPTIMA MCX 1502056-001

ENG
9
Environmental conditions
⚠CAUTION
Do not use Optima MCX outside the range of operating
temperature.
Classification
Class IIa in accordance with European Regulation 2017/745
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).
List of errors & Troubleshooting
See chapter “7 List of errors & Troubleshooting” on page 17.
Important: Consult the Instructions for Use of the following
devices:
4.5 Performances
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).
Operating conditions
Temperature limitation: +10°C / +35°C
Relative humidity limitation: 30% - 80%
Air pressure limitation: 700 hPa - 1060 hPa
Storage
Temperature limitation: +0°C / +40°C
Relative humidity limitation: 10% - 80%
Air pressure limitation: 650 hPa - 1060 hPa
Transport
Temperature limitation: -20°C / + 50°C
Relative humidity limitation: 5% - 80%
Air pressure limitation: 650 hPa - 1060 hPa
Designation IFU
Micromoteur MCX LED 2100231
Performances
Speed accuracy 5% (in the range 1000-40000
RPM)
Light
Light ON when motor is
running and for 10s after
motor stops
Motor direction CW and CCW

10
4.7 Electromagnetic compatibility (technical description)
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.
4.7.1 Electromagnetic compatibility warnings
The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional healthcare facility environment.
⚠CAUTION
Optima MCX complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. should
not be used in the immediate vicinity of the device, since this could affect its operation. The device is not suitable for being used close to
high-frequency surgical equipment, magnetic resonance imaging (MRI) and other similar devices where the intensity of electromagnetic
disturbances is high. In any case, ensure that no high frequency cables are routed above or near the device. If in doubt, please contact a
qualified technician or Bien-Air Dental SA.
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 device, including cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
⚠CAUTION
The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air
as spare parts for internal components, may result in increased emissions or decreased immunity.
⚠CAUTION
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such
use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

ENG
11
4.7.2 Electromagnetic compatibility – emissions & immunity
Guidance and manufacturer’s declaration - electromagnetic emissions
Optima MCX is intended for use in the electromagnetic environment specified below.
The customer or the user of Optima MCX should ensure that it is used in such an environment.
Guidance and manufacturer’s declaration - electromagnetic immunity
Optima MCX is intended for use in the electromagnetic environment specified below.
The customer or the user of Optima MCX must ensure that it is actually used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1
Optima MCX uses RF energy only for its internal function.
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
Optima MCX is suitable for use in all establishments including domestic establishments and
those directly connected to the public low-voltage power supply network that supplies buil-
dings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
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
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
±8 kV contact
±2 kV air
±4 kV air
±8 kV air
±15 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic mate-
rial, the relative humidity should be at least
30%.
Electrical fast
transient burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for other lines
±2 kV for power
supply lines
N.A.
Mains power quality should be that of a com-
mercial or hospital environment.
Surge
IEC 61000-4-5
±0.5 kV line to line
±1 kV line to line
±0.5 kV line to earth
±1 kV line to earth
±2 kV line to earth
±0.5 kV line to line
±1 kV line to line
±0.5 kV line to earth
±1 kV line to earth
±2 kV line to earth
Mains power quality should be that of a com-
mercial or hospital environment.

12 Note 1 - 2
Voltage dips, short inter-
ruptions and voltage
variations on power sup-
ply input lines
IEC 61000-4-11
0% UTfor 0.5 cycle, at 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°
0% UTfor 1 cycle and
70% U
T
for 25/30 cycles at 0°
0% UTfor 250 cycle, at 0°
0% UTfor 0.5 cycle, at 0°,
45°, 90°, 135°, 180°, 225°,
270° and 315°
0% UTfor 1 cycle and
70% U
T
for 25/30 cycles at 0°
0% UTfor 250 cycle, at 0 °
Mains power quality should be that of a com-
mercial or hospital environment. If the user of
the Optima MCX requires continued operation
during mains power interruptions, it is recom-
mended that the Optima MCX be powered
from an uninterruptible power supply or a
battery.
Magnetic field due to
mains frequency (50/60
Hz)
IEC 61000-4-8
30 A/m 30 A/m
Magnetic fields generated by the mains fre-
quency should be at levels characteristic of a
typical location in a typical commercial or
hospital environment.
Conducted disturbances
induced by RF fields
IEC 61000-4-6
3 VRMS
0,15 MHz – 80 MHz
6 VRMS in ISM bands
0,15 MHz – 80 MHz
80% AM at 1 kHz
3 VRMS
0,15 MHz – 80 MHz
6 VRMS in ISM bands
0,15 MHz – 80 MHz
80% AM at 1 kHz
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
surveyashould be less than the compliance
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
Radiated RF EM fields
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
3 V/m
80 MHz – 2,7 GHz
80 % AM at 1 kHz
Proximity fields from RF
wireless communications
equipment
IEC 61000-4-3
Test freq. [MHz] Max. power [W] Immunity test
level [V/m]
Distance: 0.3 m
385 1.8 27
450 228
710, 745, 780 0.2 9
810, 870, 930 228
1720, 1845, 1970 228
2450 228
5240, 5500, 5785 0.2 9
NOTE: UTis the AC mains voltage prior to application of the test level.Essential performance per IEC 60601-1: The essential perfor-
mance 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 consid-
ered. If the measured field strength in the location in which the Optima MCX is used exceeds the RF compliance level mentioned above, the Optima MCX 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 Optima MCX.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance

ENG
13
NOTES
1At 80 MHz and 800 MHz, the higher frequency range applies.
2These guidelines may not apply in all situations. Electromag-
netic propagation is affected by absorption and reflection from
structures, objects and people.

14
5.1 Install the Optima MCX system
⚠CAUTION
Before installing, please read carefully this product instruction.
Note 1
FIG. 1
A. Place the Optima MCX 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
B.
Connect the power cord (2) to the power supply (1) and plug to
the mains.
Note 2
FIG. 3
C. 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».
FIG. 4
D.
Connect the MCX cable (2) to the MCX micromotor (1), by guiding
the connector and plug with the index pin on the connector and
tighten (CW).
⚠CAUTION
Always ensure the device is used with its proprietary accessories.
Pictogram used
Movement to the stop in the
direction indicated.
FIG. 1 FIG. 2 FIG. 3 FIG. 4
2
1
1
2
3
12
5 Installation

ENG
15
NOTES
1In 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 Optima MCX system
overview” on page 7) and only use the power supply provided with
the Optima MCX. In order to maintain warranty, this unit must be
installed with the greatest care. Follow all the necessary instruc-
tions. Protect the unit from direct sunlight and dust. Keep the ori-
ginal packaging for storage and shipment.
2The equipment is powered by your mains power supply (100-
240 VAC).
FIG. 5 FIG. 6
1
2
2
1
FIG. 5
E.
Connect the 4-way hose (1) to the 4-way connector of the Optima
MCX unit (2):
• First guide the sleeve and carefully and firmly insert the
hose sleeve, by matching the connector and the coupling.
•Tighten(CW)
FIG. 6
F.
Switch on the water and power supply of the dental unit (refer to
your dental unit instructions).
G. Switch on the Optima MCX (1) (« I » = ON).
The led (2) turns green (power on).
The Optima MCX is ready for use.
See chapter “6 Operation” on page 16.

16
FIG. 1 FIG. 2
1
1
6 Operation
6.1 MCX micromotor speed
FIG. 1
Set the maximum speed by turning the speed knob (1)
CW to increase the speed.
The maximum speed can be set any value between
1000 rpm and 40000 rpm (for the 1:1 gear ratio and
between 5000 rpm and 200000rpm for the 1:5 gear ratio).
The speed knob display corresponds to rotation per minute
(RPM) x 1’000.
6.2 MCX micromotor rotation direction
FIG. 2
Change rotation direction by pressing the button (1).
• Pressed = Reverse (CounterClockWise - CCW)
• Unpressed (or normal status) = Forward (ClockWise - CW)
⚠CAUTION
Always check the instrument rotation direction (CW or CCW)
before using it.
6.3 Standard Use
A. Connect a handpiece.
B.
Set the maximum speed.
C. Select the rotation direction to Forward or Reverse
D. Press the dental unit pedal to start the MCX micromotor (pedal
mode is progressive).
⚠CAUTION
If the footpedal is pressed before switching on the unit, the MCX
micromotor will not start to run until the footpedal is released
and pressed again.
⚠CAUTION
Verify that the handpiece gear ratio corresponds to one of those
displayed on the speed knob.
Pictogram used
Forward (ClockWise - CW).
Reverse (CounterClockWise - CCW).

ENG
17
7 List of errors & Troubleshooting
7.1 Device operating error
Error Cause of error Action
The motor doesn’t start
The pedal is already pressed when starting the device. Release the footpedal and press again.
The motor is not connected. Check motor connection. Contact Bien-Air Dental SA.
The motor cable may be defective. Check motor cable. Contact Bien-Air Dental SA.
System electrical fault. Contact Bien-Air Dental SA.
The motor stops
The motor is blocked for more than 2 seconds. Release the footpedal and press again.
The motor control card limits the power supplied to the motor
to prevent motor overheating. Avoid extended use.
Overheating of motor control card (electrical control of motor). Wait until the system cools. Contact Bien-Air Dental SA.
System electrical fault. Contact Bien-Air Dental SA.

18
8 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.
8.1 Servicing
Never disassemble the device. For any modification and repair,
we recommend to contact your regular supplier or Bien-Air Dental
SA
directly at the address indicated on the back cover.
Service period
The device was tested by simulating more than 6,000 clinical
procedures (corresponding to a service period of 4 to 6 years).
Note 1
8.2 Cleaning-disinfection
• Clean the surfaces of the Optima MCX unit 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).
• Do not immerse in disinfectant solution.
• Do not immerse in an ultrasonic bath.
8.3 Important
For maintenance of micromotors: see IFU
8.4 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.
B.
Switch OFF the Optima MCX unit « O ».
C. Unscrew and unplug the 4VL hose (1).
D. Remove the damaged 4VL seal (2).
E. Replace with a new 4VL seal (REF 1302403-010).
Refit hose, switch ON units and water.
See chapter “5.1 Install the Optima MCX system” on page 14 for
details.
Designation IFU
Micromoteur MCX LED 2100231
FIG. 1
1
2