Bien Air Micromotor MX User manual

Coupling
Nose in accordance with ISO 3964, with internal
spray and light.
Weight
115 g (4.05 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
According to the type of electronics used.
Changing the bulb fig. 3
Box of 5 bulbs. Wear rubber gloves when carrying
out this changing operation.
Changing the seals fig. 4
Maintenance
The instrument is delivered “non sterile”. Before
first use, lubricate and sterilize the instrument.
Please comply with these instructions.
Important
•After each surgical intervention, the instrument
should be cleaned, disinfected and lubricated as
soon as possible (within max. 2hours),
then sterilized. Observing this procedure elimi-
nates any blood, saliva or saline solution residu-
es and prevents the transmission system from
being blocked.
•Only instruments bearing a pictogram
can be placed in the washer/disinfectant
unit.
•Do not immerse in an ultrasonic bath.
•The sleeves and clipped tubes follow the same
procedure as the instrument.
Detergent
•Use a PH-neutral to alkaline (max. pH11),
enzyme-based detergent specifically designed
for the cleaning and disinfection of dental
instruments.
•Do not use detergents which are corrosive or
which contain chlorine, acetone or Javel water.
Only use maintenance products and components
from Bien-Air. The use of other products and com-
ponentscan lead to annulment of the guarantee.
Check that the sterilizer and the water that is used
are clean. After each sterilization cycle, remove the
device from the sterilizing apparatus immediately,
in order to reduce the risk of corrosion.
In the event of prolonged disuse, the instru-
ment must be stored in a dry environment. Lubri-
cate and sterilize the instrument before reuse.
REF 2100062-ENG/07.08
Micromotor MX
ENG Instruction
REF 2100062-ENG/07.08 1/2
English
Fully Swiss-manufactured devices.
Type
Brushless electric micromotor, The most common-
ly used coupling in the world as per ISO Standard
3964 with internal spray and light with bulb and
switch integral with the motor. Sterilizable motor.
Body of chromium and nickel-plated brass. Stain-
less steel nose. Brushless type, 3-phase. Effective
power according to the type of electronic power
supply used. Synchronous motor with permanent
magnets. USA Caution: Federal law restricts this
device to sale by or on the order of a dentist.
Planned use
Product intended for professional use only. Use in
dentistry for prophylaxis, general dentistry and en-
dodontics work.
Technical data and assembly
Classification
Class IIa in accordance with European Directive
93/42/EC concerning medical devices.
Junction fig. 1
Tube supply 4VX or B4VX type.
Important
Never connect an instrument with a micromotor
that is running.
Safety
According to IEC 60601-1 standard (General sa-
fety for Medical Electrical Equipement), the device
shall be classified as a class II type BF device. As-
sociated terminology is defined in section 2.1.7 &
2.2.5 of the same document. The following regula-
tions as specified in IEC 60601-1 must be observer:
•“Protection against electrical shock”
•“Ingress of liquids”
•“Protection against excessive temperatures and
other safety hasard”
Rphase 1.2 Ohm (included 4VX resistance).
Lphase 120 µH
Torque constant
8.18 mNm/ A rms
Back emf constant
6.67 mV/(rad/s).
Permanent 2.5 A rms
Imax.
4.2 A rms [10s]
Cooling
Via compressed air from the unit. Place the flow-
meter on the connector and set 10 normliter/min.
fig. 1 .
Air consumption output
10 Nl/min (+/-10%).
Dimensions
Ø21.2 x 100.5 mm (0.83 x 3.95 in) including the
nose attachment.
No Yes No Yes without picto
Yes Yes Yes Yes with picto
0Pre-disinfection (at place of operation)
Preparation
•Disconnect the micromotor from the cable (fig. 1a)
•Perform manual pre-cleaning or pre-cleaning in a bath.
Manual pre-cleaning
Use the Spraynet cleaning product from Bien-Air.
•Spray the exterior of the instrument
(fig. 5) to remove residue and carefully clean all
surfaces with a cloth impregnated with Spraynet.
•Wipe down the external surfaces with an absorbent paper towel.
•Perform a manual or automatic cleaning-disinfection process.
or
Pre-cleaning by bath
Attention : Pre-cleaning by bath must be followed by automatic cleaning-disinfection.
•Immerse the instrument completely in a cleaning bath containing a sufficient amount of
detergent.
•
Asit leaves the bath, rinse the interior and exterior of the instrument under cold running water.
•Dry the interior and exterior of the instrument to remove all traces of detergent and rinsing
water immediately to prevent any adverse impact on the internal components, e.g. which
might cause them to seize.
•Perform an automatic cleaning-disinfection process.
1Cleaning-disinfection
Manual cleaning-disinfection
Cleaning and disinfection:
Clean and disinfect the exterior of the instrument with a suitable detergent.
Rinsing: Rinse the exterior of the instrument under cold running water.
Drying : Spray the exterior of the instrument with Spraynet product
(fig. 5) immediately to
removeall traces of detergent and rinsing water to prevent any adverse impact on the internal
components, e.g. which might cause them to seize.
or
Automatic cleaning-disinfection
Note : only for engraved instruments
Cleaner - disinfectant:
Use an approved cleaner-disinfectant with a suitable amount and type of detergent.
Washing cycle: Select the specified washing cycle for these instruments which should be
compatible with the detergent manufacturer's instructions
Temperatures recommended for these instruments:
Water: cold to max 95°C (203°F) Air : Max. ambient temperatureof 100°C (212°F)
0120
fig. 1a
fig. 1b
fig. 2
fig. 4
fig. 3
fig. 5
A
B
fig. 6
0,5 – 1 sec.
3

Bien-Air Dental SA
Länggasse 60
Case postale 6008
2500 Bienne 6, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
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]
[e-mail]
Bien-Air USA, Inc.
Medical Technologies
5Corporate Park
Suite 160
Irvine, CA 92606 USA
Phone [phone]-BIEN
Phone [phone]
Fax [phone]
[e-mail]
Bien-Air France Sarl
131, BoulevardPéreire
75017 Paris, France
Tel. [phone]
Fax [phone]
[e-mail]
Bien-Air Italia s.r.l.
Via Vaina 3
20122 Milano, Italia
Tel. [phone]/54
Fax [phone]
[e-mail]
Bien-Air UK Limited
63, The Street Capel,
Surrey RH5 5JZ, England
Tel. [phone]
[phone]
Fax [phone]
[e-mail]
Bien-Air Asia Ltd.
Nishi-Ikebukuro
Daiichi-Seimei Bldg. 10F
2-40-12 Ikebukuro, Toshimaku
Tokyo, 171-0014, Japan
Tel. [phone]
Fax [phone]
[e-mail]
Beijing Bien-Air
Medical Instruments
Technology Service Co. Ltd.
Room 2106,
The Exchange Beijing
Yi 118 Jianguo Road
Chaoyang District
Beijing 100022, China
Tel. [phone]
Fax [phone]
[e-mail]
REF 2100062-ENG/07.08 2/2
Optional accessories
Set supplied
REF Legend
1600375-001 Electric micromotor MX, with
internal spray and light
1600387-001 4VX hose, grey silicone, with
revolving 4-hole connector
1600428-001 B4VX hose, grey silicone, with
revolving 4-hole connector,
bayonet connection to unit
1300967-010 Attachment ‘O’ Rings for
micromotors MX
1300922-001 Outer Sleeve for micromotor MX
1500007-005 Pack of 5 bulbs, for micromotors
MX
1600307-001 Flow-meter for micromotor MX
1600036-006 Spraynet, cleaning spray 500 ml,
box of 6 cans
1600064-006 Lubrifluid, lubricant 500 ml,
box of 6 cans
This product may be covered by one or moreof the following patents:
EP Europe: 0497 139 / 0 526 783 / 0 745 358 / 0 688 539 / 0 894 879 / 1 145 688 / 1 109 301 DE Germany: 296 16 023.7
DK Denmark: 96 00315 FR France: 2679 804 /2 722 972 /2 733 680 /2 692 621 / 2 720 263 /2 757 763 /2 766 697 /2 781 318
CH Switzerland: 693 922 CN China: 129343 JP Japan: 2037 611 / 1 991 770 US United-States: 5.059.122 / 4.773.856 /
6.033.220 /6.337.554 / 5.453.008 / 6.319.003 / 6.495.937
REF 1600375-001 MOT MX
In these instructions, “Device” corresponds to the
product described in the heading “Type”. For ex-
ample, turbine, contra-angle, handpiece, micro-
motor, tube, electronics, connectors, station etc.
List of Bien-Air registered trade mark
products ®:
Aquilon®
Bora®
Boralina®
Eolia®
Gyro®
Gyrolina®
Isolite®
Lubrifluid®
Lubrimed®
MX®
Prestilina®
Spraynet®
2Lubrication and conditioning process
Check for cleanliness
Visually inspect the cleanliness of the instrument,
the sleeve and the clipped tube (if fitted).
Lubrication
Use Lubrifluid lubricant spray from Bien-Air.
•Place the instrument in a cloth to collect all
surplus lubricant.
• Insert the plastic nozzle 3of the Lubrifluid
fully into the nose of the motor
(fig. 6) .
•Operate the spray for 1 second.
Conditioning process
Immediately wrap the instrument in approved
packaging for steam sterilization.
3Sterilization
Procedure : With steam after fractioned initial va-
cuum phase acc. to EN285 or with Class B cycle
acc. to EN13060.
Nominal temperature : 134°C (273°F)
Duration : From 3 to 18 minutes depending on
local directives in force.
Overhaul
Never disassemble the device. For all modifications
and repairs, we recommend that you contact your
regular supplier or Bien-Air direct. Bien-Air asks
the user to have its dynamic instruments checked
or inspected at least once a year thereafter.
Environment
Temperature between -40°C (-40°F) and 70°C
(158°F), relative humidity between 10% and
100%, atmospheric pressure 50 kPa to 106 kPa
(7.3 to 15.3 psi).
Sterilization in USA
Process: Steam autoclave up to 134°C (273°F) for
12 minutes. The required time for sterilization of
our products must comply with the prevailing
local regulations for this type of instrument.
Information
The technical specifications, illustrations and di-
mensions 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. The French
original of this text conforms to the legal stan-
dards. For all additional information, please
contact Bien-Air at the address indicated on the
back cover.
General information
The device must be used by a competent person in
accordance with the current legal provisions con-
cerning industrial safety, health and accident pre-
vention regulations, and these working instruc-
tions. In accordance with these requirements, the
operators:
•must only use operating devices that are in per-
fect working order; in the event of irregular fun-
ctioning, excessive vibration, abnormal heating
or other signs indicating malfunction of the
device, the work must be stopped immediately;
in this case, contact a repair centre that is
approved by Bien-Air;
•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.
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 European
legal requirements.
The device is not authorised for use in an explosi-
ve atmosphere (anaesthetic gas).
Rest the device on a suitable support to avoid risks
of infection for yourself,the patient or third parties.
This equipment needs to be recycled. The user
must be return the equipment to its dealer or
Symbols
0120
CE Marking with number of the notified
body
Movement in the direction indicated
Movement fully to the stop, in the
direction indicated
Wear rubber
gloves
Recyclable electrical
and electronic material
Attention
In Thermal
washer
MX
REF 16000375-001
REF 1600064-006
REF 1600036-006
REF 1300922-001
REF 1300967-010
REF 1600307-001
REF 1500007-005
6x 6x
5x
10x
establish direct contact with an approved body for
treatment and recycling of this type of equipment
(European Directive 2002/96/EC).
Guarantee
Terms of guarantee
Bien-Air grants the operator a guarantee covering
all functional defects, material or production
faults. The device is covered by this guarantee for
24 months from the date of invoicing.
In the event of justified claims, Bien-Air or its aut-
horised representative will fulfil the company’s ob-
ligations under this guarantee by repairing or re-
placing 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 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.
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.