Main Technical Data; Electromagnetic Compatibility (Emc) - Declaration Of Conformity - MICRO MEGA Dual-Move Instructions

Operation Concerned parts
4 Packing
Contra-angle (1.A)
Silicon sleeve (1.G)
5 Sterilization
6 Storage
• Use only Ethanol for disinfection (Ethanol 70 to 80% vol.). Do not use too much ethanol to avoid
penetration inside the device that may damage internal components.

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 specified below. The customer or the user of Dual Move shall
make sure it is used in such an environment.
Electromagnetic emission
Emissions test
RF emissions - CISPR 11
Harmonic emissions IEC61000-3-2
Voltage fluctuations/flicker emissions - IEC61000-3-3
Processing
Pack components in sterilization
pouches.
Steam sterilization at 135°C at least
4 minutes, or at 121°C at least 35
minutes.
Minimum drying time after sterilization:
10 minutes.
Keep the components in sterilization
packaging in a dry and clean
environment.
20cm x 17.5cm x7cm (package) - 700g
Compatible with rotary and reciprocating instruments, equipped with a 2.35 mm shaft
conforming to EN ISO 1797, Type 1
Lithium ion battery 3.7V -1600mAh
AC 100-240V - 50/60Hz - 5.5VA
0.5 N.cm - 4 N.cm
120 - 650 rpm
Class II - BF
Indoor use only - 10°C / 40 °C - Relative humidity <80% non-condensing at 0 °C
Altitude < 2000 m above sea level
-20 °C / +50 °C - Relative humidity 20% - 80%, non-condensing at > 40 °C
Atmospheric pressure 50 kPa - 106 kPa
Guidance and manufacturer's declaration
Compliance
Group 1
Class B
Not applicable
Not applicable
Warning
Use pouches which resist to a
temperature up to 141°C and
compliant with EN ISO 11607.
Use only approved autoclave devices
according to EN 13060 or EN 285
The sterilization procedure must
comply with ISO 17665.
Waiting for cooling before touching.
Check the packaging before using it
(packaging integrity, no humidity and
validity period), otherwise sterilize
again.
Electromagnetic environment - Guidance
The medical device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
The medical device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
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