Bien Air Micromotor MX2, MCX, MCX LED Instruction

Micromotor MX2

0120

Instruction

REF 2100199-0004/2014.05/ENG

English

Medical devices entirely made in Switzerland
by Bien-Air Dental SA.

Identification

Brushless electric micromotor.
The most commonly used coupling in the world as
per ISO Standard 3964 with internalspray and light
with LED light.

Sterilisable motor

USA Caution: Federal law restricts this device to sale
by or on the order of a dentist.

Intended use

Product intended for professional use only. Use in
dentistry for prophylaxis, general dentistry and
endodontics work and in the field of body care and
health treatment. Thedevice is not designed for use
in an explosive atmosphere (anaesthetic gas).
The device is intended for medical treatment only;
any use other than that for which this product is
intended is unauthorised and may be dangerous.
The medical device meets all the current legal
requirements.

Technical data

Classification

Class IIa in accordance with European Directive
93/42/EEC concerning medical devices. This med­ical device is in compliance with the legislation in
force.

Electrical safety

According to IEC 60601-1 standard (General safety
for Medical Electrical Equipement), the device shall
be classified as a class II type B device.

fig. 1a

Associated terminology is defined in sections 3.14
(3.13 if Class I) & 3.132 of the same standard.
The following requirements as specified in IEC
60601-1 apply:

• Protection against electrical shock

• Ingress of liquids

• Protection against excessive temperatures and
other safety hazards

Electromagnetic compatibility

Corresponds to the electromagnetic compatibility
in accordance with IEC 60601-1-2. Declaration
by the manufacturer regarding electromagnetic
compatibility.

Hose Junction

Hose with connector type MX2.
Brushless type, 3-phase. Effective power according
to the type of electronic power supply used.
Synchronous motor with permanent magnets.
Body of chromium and nickel-plated brass.
Stainless steel nose.

Rphase

0.8 Ohm (included hose MX2 resistance).

Lphase

55 μH

Torque constant

6 mNm/ A rms

Back emf constant

6.5 mV/(rad/s).

Permanent
I max.

Cooling

Through compressed air from the unit. Place the
flowmeter on the connector and set 10 to normliter/
min.

1.25 A rms

5.0 A rms [10s]

fig. 2

.

fig. 1

Air consumption output

10 Nl/min (+/-10%).

Dimensions

Ø 21.2 x 73.5 mm (0.83 x 2.90 inches) including
the nose attachment.

Coupling

Nose in accordance with ISO 3964, with internal
spray and light.

Weight

94 g (3.18 oz) without the cable.

Operating times

According to the type of electronics used.

Noise level

In accordance with ISO 11498, less than 53 dBA
at 45 cm (17.72 in).

Recommanded rotation speed

Max. 40.000 rpm.

Direction of rotation

Clockwise and anticlockwise.

Torque

Depending on the type of electronic controller used.

Light

LED, variable from 10 klux to 38 klux.

Assembly

Important
Never connect an instrument on a running
micromotor.
Changing the seals,

Disposal

This device must to be recycled.Electrical and

electronicequipment may containdangerous
substances which constitute health and environ­mental hazards. The user must return the device 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).

Maintenance

Important

• The instrument is delivered "non sterile".

• Before using for the first time and within a

maximum of 30 minutes after each treatment,
clean, disinfect the attachment, then sterilise.
Observing this procedure eliminates any blood,
saliva or saline solution residues.

• Do not immerse in an ultrasonic bath.

• Do not clean in a washer-disinfectant

unit

fig. 8

• 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.

In the event of prolonged disuse, the instrument
must be stored in a dry environment. Clean and
sterilise the instrument before reuse.

fig. 3

.

Precautions of use

The standard precautions in particular wearing
individual protection equipment (gloves,
glasses…), must be complied with by healthcare
personnelworkingwith contaminated or potentially
contaminated medical instruments. Pointed and
sharp instruments should be handled with great
caution.
Check that the steriliser and the water that is used
are clean. After each sterilisation cycle, remove the
device from the sterilising apparatus immediately,
in order to reduce the risk of corrosion.

We recommend that the motor is cleaned
and sterilised as described below before the
initial first use and subsequently after each
treatment.

0 Cleaning

The external surface of the motor must be cleaned
to remove impurities as follows

• Hold the motor by the nose under running
water (< 25ºC) as shown in the diagram below

• With the aid of a soft bristled brush, clean the
external surface of the motor.

• Avoid allowing water to enter internally into the
motor either by the the nose or hose connector.

1 Disinfection

Carefully rub the external surfaces of the motor,
for approximately one minute, with a soft bristle
brush impregnated with a detergent or disinfectant
solution

fig. 5

.

The motor must be rinsed as follows

• Hold the motor by the nose under running
water (< 25ºC) as shown in the diagram below

• Avoid allowing water to enter internally into the
motor either by the the nose or hose connector.

Suitable detergents

• Detergent or detergent-disinfectant (pH 6- 9.5)
recommended for cleaning-disinfection of den­tal or surgical instruments.

• Quaternary ammonium- and/or enzyme-based
surfactants.

• Do not use solutions that are corrosive or con­tain chlorine, acetone aldehydes or bleaches.

• Do not soak in physiological liquid (NaCl).

2 Sterilisation

Do not use a sterilisation procedure other than the
one described below.

Procedure:

ilisation, Class B cycle acc. to EN13060. The proce­dure has been validated according to ISO 17664.All
Bien-Air Dental straight handpieces are sterilisable
in an autoclave up to 135°C (273.2°F).Duration:
3 or 18 min., depending to the national require­ments in force.

Important

The quality of the sterilisation depends very much
on the cleanliness of the device.Only perfectlyclean
devices may be sterilised
The instrument will function in excess of
500 sterilisations.

Fractionated pre-vacuum steam ster-

Do not lubricate!!!

or Spray internally!!!

fig. 6

.

Warning

fig. 4

.

fig. 4

fig. 3

Sterilization

2

fig. 6

fig. 7

fig. 8

fig. 4

fig. 2

1

Disinfect

fig. 5

fig. 1b

0

Wash

REF 2100199-0004/2014.05/ENG 1/2

0120

3 Lubrication

essential to maintain the quality of the cooling
air and water utilised.

Important
The Bien-Air Dental motor MX2 is mainte­nance free. Do not spray any lubricant or
cleaning solution into the motor

fig. 7

!

The compressed air should be dry and purified and
the compressor should be regularly maintained.
Toavoid the tubing and connectors from blocking,
the water should be filtered and purified to avoid

Servicing

Never disassemble the device. For all modification

impurities and build-up of high levels of calcium

deposits.
and repair, we recommend that you contact your
regular supplier or Bien-Air Dental directly. Bien-Air

Guarantee

Dental asks the user to have its dynamic instru­ments checked or inspected at least once a year.

Terms of guarantee

Bien-Air Dental grants the operator a guarantee

Transportation and storage conditions

Temperature between -40°C (-40°F) and 70°C
(158°F), relative humidity between 10% and 100%,

covering all functional defects, material or pro-

duction faults. The device is covered by this guar-

antee for 36 months from the date of invoicing.
atmospheric pressure 50 kPa to 106 kPa (7.3 to

15.3 psi).

In the event of justified claim, Bien-Air Dental or

its authorised representative will fulfil the com-

Information

The technical specifications, illustrations and

pany’s obligations under this guarantee by repair-

ing or replacing the product free of charge.
dimensions contained in these instructions are
given only as a guide. They may not be the subject
of any claim. The manufacturerreserves the right to
make technical improvements to its equipment,

Any other claims, of whatever nature, in particular

in the form of a claim for damages and interest, are

excluded.
without amending these instructions. For all addi­tional information, please contact Bien-Air Dental
SA at the address indicated on the back cover.

Bien-Air Dental shall not be held responsible for

damage or injury and the consequences thereof,

resulting from:

Other precautions for use

• excessive wear and tear

• improper use
The device must be used by a qualified professional
in compliance with the current legalprovisions con­cerning workplace safety, health and accident pre­vention measures, and these working instructions.
In accordance with these requirements, the opera­tors:

• non-observance of the instructions for installa-

tion, operation and maintenance

• unusual chemical, electrical or electrolytic

influences

• poor connections, whether of the air, water or

electricity supply.

• must only use operating devices that are in per-

fect working order; in the event of irregular
functioning, excessive vibration, abnormal
heating or other signs indicating malfunction

The guarantee does not cover flexible “fibre optic”
type conductors, or any parts made of synthetic

materials.
of the device, the work must be stopped immedi­ately; in this case, contact a repair centre that is
approved by Bien-Air Dental;

• 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

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 personsnot authorised by

Bien-Air Dental.
any danger, and must avoid contamination
through the use of the product.

Claims under the terms of the guarantee will be

considered only on presentation, together with the

Rest the device on a suitable support to avoid risks
of infection for yourself, the patient or third parties.

• To ensure the lifetime of the instrument, it is

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.

This product may be covered by one or more of the following patents:

EP Europe: 745358 / 688539 / 948294 / 1145688 / 1563800 / 1563801 / 1675523 / 1753360 DE Germany: 29616023.7
DK Denmark: 9600315 FR France: 2722972 CH Switzerland: 693922 CN China: 100528099 / 100522100 / 100522099 /
100553584 JP Japan: 3892485 / 4298933 / 7000419 US United-States: 5453008 / 6033220 / 6319003 / 7214060 / 7448870
RU Russia: 2361540 / 2361541 / 2372046

REF 1600677-001 MOT MX2

Set supplied

MX2

REF 1600677-001 REF 1300967-010

REF Legend

1600677-001 Micromotor MX2, with internal spray and LED
1600678-001 Hose MX2 Grey, fixed connector, with air flow return
1300967-010 O-Ring for the motor MX2
1501393-001 Electronic DMX2 Plus
1501384-001 Electronic DMX2 Pro
1600307-001 Flow-meter for micromotors MX2

List of Bien-Air Dental SA registered trade mark products ®:

Aquilon

®

Bora
Boralina
ChiroPro

®

®

®

®

Eolia

®

Gyro
Gyrolina
Isolite

®

Lubrifluid

®

Lubrimed

®

®

®

MX
PowerCare

®

Prestilina
Spraynet

®

®

In these instructions, “Device” corresponds to the product described in the
heading “Identification”. For example, turbine, contra-angle, handpiece,
micromotor,tube, electronics, connectors, station etc.

Symbols

CE Marking with number
of the notified body.

Attention.

Wear rubber gloves.

Sterilisable at the
specified temperature.

Light.

Manufacturer.

Recyclable electrical and
electronic material.

Electrical security.
Applied part type B.

Move in the
direction indicated.

Move fully to the stop,
in the direction
indicated.

Bien-Air Dental SA

Länggasse 60
Case postale
2500 Bienne 6, Switzerland
Tel. [phone]
Fax [phone]

Bien-Air Italia s.r.l.

Via Vaina 3
20122 Milano, Italia
Tel. [phone]/54
Fax [phone]
[e-mail]

[e-mail]

Bien-Air UK Ltd
Bien-Air
Deutschland GmbH

Jechtinger Strasse 11
79111 Freiburg, Deutschland
Tel. [phone]
Fax [phone]
[e-mail]

Bien-Air España, SA

Entença, 169 Bajos
08029 Barcelona, España
Tel.[phone]
Fax [phone]

Arundel House

Unit 1 - Ground Floor

Amberley Court, Whitworth Road

Crawley,West Sussex, RH11 7XL

Telephone [phone]

Fax: [phone]

[e-mail]

Bien-Air Asia Ltd.

Nishi-Ikebukuro

Daiichi-Seimei Bldg. 10F

2-40-12 Ikebukuro, Toshimaku

Tokyo,171-0014, Japan
[e-mail]

Bien-Air USA, Inc.

Medical Technologies
5 Corporate Park
Suite 160

Tel. [phone]

Fax [phone]

[e-mail]
Irvine, CA 92606 USA
Phone [phone]-BIEN
Phone [phone]
Fax [phone]
[e-mail]

Beijing Bien-Air

Medical Instrument

Technology Service Co. Ltd.

Room 907, The Exchange Beijing,

No 118 Jian Guo Lu Yi,

Optional accessories

Bien-Air France Sàrl

55-57, avenue Jean Lolive

Chao Yang District,

Beijing 100022, China
93508 Pantin Cedex, France
Tel.[phone]
Fax [phone]
[e-mail]

10x

REF 1501393-001

REF 1600678-001

REF 2100199-0004/2014.05/ENG 2/2

REF 1300967-010

REF 1501384-001

REF 1600307-001

Tel. [phone]

Fax [phone]
[e-mail]