Intended Use; Technical Data - Bien Air MCX Mode D'emploi

English
Identification
MCX LED & MCX are brushless, steriliz-
able, electric micromotor.
Description MCX LED
With internal spray and LED light.
Description MCX
With internal spray without 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. Asso-
ciated terminology is defined in sec-
tions 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 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 fig. 1
Hose with connector type MCX.
Supply voltage / Max admisible cur-
rent
32 VDC / 5A
Idle current
0.3 A at 40000 rpm
Recommended rotation speed
100 – 40000 rpm ± 5%, clockwise and
anticlockwise ; Depending on the elec-
tronics used.
Torque (limited electronically)
25 mNm until 25,000 rpm
20 mNm at 40,000 rpm
Mechanical Power (limited electron-
ically)
Max. 150 W at 25000 rpm
Effective power according to the type
of electronic power supply used.
Noise level
In accordance with ISO 14457, less
than 53 dBA at 45 cm (17.72 in).
Dimensions
Ø 21 x 64 mm (0.82 x 2.51 inches) in-
cluding the nose attachment.
Weight
76 g (2.68 oz) without the cable.
Rphase
0.9 Ohm
(included hose MCX resistance).
Lphase
60 μH
Torque constant
5.20 mNm/ Arms
Luminous intensity MCX LED
LED, variable from 10 klux to 38 klux.
Coupling
Nose in accordance with ISO 3964.
Cooling
Through compressed air from the unit.
Place the flowmeter on the nose at-
tachment and set it to 10 normliter/
min. fig. 2.
2 2