Intended Use; Technical Data - Bien Air MX2 Instrucciones De Uso

English
Identification
Brushless, sterilizable electric micro-
motor with internal spray and Led
light.

Intended use

Product intended for use in general
dentistry.
The device is intended for medical
treatment only.
WARNING
Any use other than that for which this
product is intended is unauthorised
and may be dangerous.
The medical device meets all the cur-
rent legal requirements.
Intended user
Product intended for professional use
only. All of Bien-Air Dental SA's electric
micromotors are intended to be used
by qualified dentistry staff.
The intended EM environment (per IEC
60601-1-2) is a Professional health-
care facility environment.
Classification
Class IIa in accordance with European
Directive 93/42/EEC concerning medi-
cal devices. This medical device is in
compliance with the legislation in
force.
USA Caution: Federal law restricts this
device to sale by or on the order of a
dentist.

Technical data

Electrical safety
According to IEC 60601-1 standard
(General safety for Medical Electrical
Equipement), the device shall be clas-
sified 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 must be respected:
• Protection against electrical shock
• Leakage currents
• Protection against excessive tem-
peratures and other safety hazards
Electromagnetic compatibility
Corresponds to the electromagnetic
compatibility in accordance with IEC
60601-1-2. Declaration by the manu-
facturer regarding electromagnetic
compatibility.
WARNING
Magnetic disturbance can occur from
other electromedical devices.
Hose Junction fig. 1
Hose with connector type MX2.
Rphase
0.8 Ohm (included hose MX2 resis-
tance).
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 nose at-
tachment and set it to 10 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.
Weight
94 g (3.18 oz) without the cable.
Operating times
According to the type of electronics
used.
Noise level
In accordance with ISO 11457, less
than 53 dBA at 45 cm (17 in).
Rotation speed
Max. 40.000 rpm.
Direction of rotation
Clockwise and anticlockwise.
Torque
Depending on the type of electronic
controller used (max 35 mNm).
Luminous intensity
LED, variable from 10 klux to 38 klux.
Assembly
CAUTION
Never connect an instrument on a run-
ning micromotor.
Changing the seals, fig. 3.
Disposal
The disposal and/or recycling of
materials must be performed in
accordance with the legislation in
force.
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