Coltene MicroMega Dual-move Instrucciones página 11

15. Main Technical Data
Dimensions - Weight
Contra-angle
Power supply
Charger
Torque range
Speed range
Electrical safety class - Applied part
Operating conditions
Transport and storage conditions
16. Electromagnetic Compatibility (EMC) – Declaration of conformity
The medical device is intended for use in the electromagnetic environment specifi e d below. The customer or the user of Dual Move
should assure that it is used in such an environment.
Electromagnetic emission
Emissions test
RF emissions - CISPR 11
Harmonic emissions IEC61000-3-2
Voltage fl uctuations/fl icker emissions - IEC61000-3-3
Electromagnetic immunity
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2
Electrical fast transients/bursts
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions
and voltage variations on power
supply lines
IEC 61000-4-11
20cm x 17.5cm x7cm (package) - 700g
Compatible with rotary and reciprocating instruments, equipped with Ø2.35 mm nickel
titanium root canal file conforming to ISO 1797:2017, Type 1, Files length 11-31mm.
Lithium ion battery 3.7V -1500mAh
AC 100-240V - 50/60Hz - 0.2A
0.5 N.cm - 4 N.cm
120 - 1000 rpm
Class II - B
Indoor use only 10°C / 40 °C - Relative humidity 30% ~75% non-condensing at 0 °C
Altitude < 2000 m above sea level
-20 °C / +55 °C - Relative humidity 20% - 80%, non-condensing at > 40 °C
Atmospheric pressure 70 kPa - 106 kPa
Guidance and manufacturer's declaration
Compliance
Group 1
Class B
Class A
Complies
IEC 60601 test level
±8 kV contact
±2, 4, 8, 15 kV air
±2 kV
100kHz repetition frequency
Line to line: ±0.5kV, ±1 kV
Line to earth: ±0.5kV, ±1 kV, ±2 kV
0% UT; 0.5 cycleat 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°
0% UT; 1 cycle and 70% UT; 25/30 cycles sine phase at 0°
0% UT; 250/300 cycle
Electromagnetic environment - Guidance
Professional healthcare facility environment and Home
healthcare environment.
Professional healthcare facility environment.
Compliance level Electromagnetic environment -
guidance
±8 kV contact Floors should be in wood, concrete or
±2, 4, 8, 15 kV air
ceramic tile. If covered by synthetic
material, the relative humidity should
be at least 30 %.
Mains power quality should be that
±2 kV
of a typical commercial or hospital
100kHz repetition
environment.
frequency
Line to line: ±0.5kV, ±1 kV
Mains power quality should be that of a
Line to earth: ±0.5kV, ±1 kV,
typical commercial or hospital environment.
±2 kV
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
devices require continued operation during power
mains interruptions, it is recommended that devices be
powered form an uninterruptible power supply or a
battery.
11