REF 2100199-0004/2014.05/ENG
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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 Spray internally!!!
fig. 8
Instruction
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 internal spray 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. 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.
0
Cleaning
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.
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 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.
Suitable 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).
2
Sterilisation
Do not use a sterilisation procedure other than the
one described below.
Procedure:
Fractionated 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°F). 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.
