Bien Air Micromotor MX2 User manual

REF 2100199-0004/2014.05/ENG 1/2
REF 2100199-0004/2014.05/ENG
Micromotor MX2
0120
fig. 1a
fig. 1b fig. 2 fig. 3
fig. 6
2
Sterilization
fig. 4 fig. 5
0
Wash
1
Disinfect
fig. 7
Warning
Do not lubricate!!!
or S ray internally!!!
fig. 8
Instruction
English
Medical devices entirely made in witzerland
by Bien-Air Dental A.
Identification
Brushless electric micromotor.
The most commonly used coupling in the world as
per ISO Standard 3964 with internal spray and light
with LED light.
terilisable motor
USA Caution: ederal 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. The device 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 med-
ical 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.
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 fig. 1
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 1.25 A rms
I max. 5.0 A rms [10s]
Cooling
Through compressed air from the unit. Place the
flowmeter on the connector and set 10 to normliter/
min.
fig. 2 .
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,
fig. 3
Disposal
This device must to be recycled.Electrical and
electronic equipment may contain dangerous
substances which constitute health and environ-
mental 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.
Precautions of use
The standard precautions in particular wearing
individual protection equipment (gloves,
glasses…), must be complied with by healthcare
personnel working with 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.
0Cleaning
The external surface of the motor must be cleaned
to remove impurities as follows
fig. 4 .
• 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.
1Disinfection
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 fig. 4
• 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.
uitable detergents
• Detergent or detergent-disinfectant (pH 6- 9.5)
recommended for cleaning-disinfection of den-
tal or surgical instruments.
• Quaternary ammonium- and/or enzyme-based
surfactants.
• Do not use solutions that are corrosive or con-
tain chlorine, acetone aldehydes or bleaches.
• Do not soak in physiological liquid (NaCl).
2terilisation
Do not use a sterilisation procedure other than the
one described below.
Procedure: ractionated pre-vacuum steam ster-
ilisation, Class B cycle acc. to EN13060. The proce-
dure has been validated according to ISO 17664.All
Bien-Air Dental straight handpieces are sterilisable
in an autoclave up to 135°C (273.2° ). Duration:
3 or 18 min., depending to the national require-
ments in force.
Important
The quality of the sterilisation depends very much
on the cleanliness of the device.Only perfectly clean
devices may be sterilised
fig. 6 .
The instrument will function in excess of
500 sterilisations.

0120
CE Marking with number
of the notified body.
REF 2100199-0004/2014.05/ENG 2/2
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 witzerland: 693922 CN China: 100528099 / 100522100 / 100522099 /
100553584 JP Japan: 3892485 / 4298933 / 7000419 U United- tates: 5453008 / 6033220 / 6319003 / 7214060 / 7448870
RU Russia: 2361540 / 2361541 / 2372046
RE 1600677-001 MOT MX2
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 low-meter for micromotors MX2
ymbols
Move in the
direction indicated.
In these instructions, “Device” corresponds to the product described in the
heading “Identification”. or example, turbine, contra-angle, handpiece,
micromotor, tube, electronics, connectors, station etc.
Move fully to the stop,
in the direction
indicated.
List of Bien-Air Dental A registered trade mark products ®:
Wear rubber gloves.
Sterilisable at the
specified temperature.
Aquilon®
Bora®
Boralina®
ChiroPro®
Eolia®
Gyro®
Gyrolina®
Isolite®
Lubrifluid®
Lubrimed®
MX®
PowerCare®
Prestilina®
Spraynet®
Recyclable electrical and
electronic material.
Attention.
essential to maintain the quality of the cooling
air and water utilised.
The compressed air should be dry and purified and
the compressor should be regularly maintained.
To avoid the tubing and connectors from blocking,
the water should be filtered and purified to avoid
impurities and build-up of high levels of calcium
deposits.
Guarantee
Terms of guarantee
Bien-Air Dental grants the operator a guarantee
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.
In the event of justified claim, Bien-Air Dental or
its authorised representative will fulfil the com-
pany’s obligations under this guarantee by repair-
ing 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 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 installa-
tion, 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 “fibre optic”
type 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 authorised by
Bien-Air Dental.
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.
Manufacturer.
Bien-Air Dental A
Länggasse 60
Case postale
2500 Bienne 6, Switzerland
Tel. [phone]
ax [phone]
[e-mail]
Bien-Air
Deutschland GmbH
Jechtinger Strasse 11
79111 reiburg, Deutschland
Tel. [phone]
ax [phone]
[e-mail]
Bien-Air España, A
Entença, 169 Bajos
08029 Barcelona, España
Tel. [phone]
ax [phone]
[e-mail]
Bien-Air U A, Inc.
Medical Technologies
5 Corporate Park
Suite 160
Irvine, CA 92606 USA
Phone [phone]-BIEN
Phone [phone]
ax 949-477-6051
[e-mail]
Bien-Air France àrl
55-57, avenue Jean Lolive
93508 Pantin Cedex, rance
Tel. [phone]
ax [phone]
[e-mail]
Bien-Air Italia s.r.l.
Via Vaina 3
20122 Milano, Italia
Tel. [phone]/54
ax [phone]
[e-mail]
Bien-Air UK Ltd
Arundel House
Unit 1 - Ground loor
Amberley Court, Whitworth Road
Crawley, West Sussex, RH11 7XL
Telephone [phone]
ax: [phone]
[e-mail]
Bien-Air Asia Ltd.
Nishi-Ikebukuro
Daiichi-Seimei Bldg. 10
2-40-12 Ikebukuro, Toshimaku
Tokyo, 171-0014, Japan
Tel. [phone]
ax [phone]
[e-mail]
Beijing Bien-Air
Medical Instrument
Technology Service Co. Ltd.
Room 907, The Exchange Beijing,
No 118 Jian Guo Lu Yi,
Chao Yang District,
Beijing 100022, China
Tel. [phone]
ax [phone]
[e-mail]
Set su lied
MX2
REF 1600677-001 REF 1300967-010
REF 1300967-010
REF 1600678-001
10x
REF 1600307-001
REF 1501393-001
REF 1501384-001
Electrical security.
Applied part type B.
O tional accessories
3Lubrication
Important
The Bien-Air Dental motor MX2 is mainte-
nance free. Do not spray any lubricant or
cleaning solution into the motor
fig. 7 !
ervicing
Never disassemble the device. or all modification
and repair, we recommend that you contact your
regular supplier or Bien-Air Dental directly.Bien-Air
Dental asks the user to have its dynamic instru-
ments checked or inspected at least once a year.
Transportation and storage conditions
Temperature between -40°C (-40° ) and 70°C
(158° ), relative humidity between 10% and 100%,
atmospheric pressure 50 kPa to 106 kPa (7.3 to
15.3 psi).
Information
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. or all addi-
tional information, please contact Bien-Air Dental
SA at the address indicated on the back cover.
Other precautions for use
The device must be used by a qualified professional
in compliance with the current legal provisions con-
cerning workplace safety, health and accident pre-
vention measures, and these working instructions.
In accordance with these requirements, the opera-
tors:
• 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
of the device, the work must be stopped immedi-
ately; 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
any danger, and must avoid contamination
through the use of the product.
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
Light.