Maintenance; Preamble; Procedure; Main Technical Data - Micro-Mega Dual-Move Manual De Instrucciones

Fig. 13.F Reference point (RP) defined Fig. 13.G New position for RP
through the apex locator interface
• Use the original data transfer cable only, otherwise the devices may be damaged.
• Carefully manipulate the devices.
• Do not throw, shake or shock the devices. Do not splash devices with liquids.
• Make sure the two devices are connected in the right way.
• After connecting the two devices, gently push and pull the wire plugs to ensure a stable connection and
an accurate data transmission.
• In some cases, the determination of the file position may be impossible (blocked canal), or not accurate
(abnormal or unusual root canal morphology). An x-ray may be required to confirm results.
• If the displayed file position does not move when the file penetrates the root canal, the device may not
work properly. Stop using it and contact your after-sales service.

14. Maintenance

14. 1. Preamble

• Wear gloves and follow carefully the instructions to avoid cross contamination when performing
maintenance.
• Refer to your national guidelines, standards and requirements for cleaning, disinfection and
sterilization.
• The device and its components have not been disinfected or sterilized before first use. Please
follow the necessary steps before the first treatment.
• Cleaning and disinfection protocols to be applied are specific to each component. Be sure to
follow the right procedure below when performing daily maintenance.

14. 2. Procedure

• The procedure below shall be followed from step 1 to 6 before the first treatment and after every
subsequent treatment.
Operation Concerned parts
All
1 Cleaning
Handpiece (1.B)
Handpiece base (1.C)
2 Disinfection
Data transfer cable (1.D)
Mains adapter (1E)
Contra-angle (1.A)
3 Lubrication
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Fig. 13.H RP is reached
Processing Warning
Remove debris under running water Remove the file and disconnect the contra-
(except electronic parts), and then wipe angle before cleaning it.
off all components. Do not use an ultra-sonic cleaning device
for the contra-angle.
Wipe the components with a piece If use of washer-disinfectors, use only
of gauze impregnated with Ethanol approved devices according to EN ISO
(Ethanol 70 to 80% vol.). Make sure the 15883 and refer to their manufacturer's
components are dry before next step. instructions for use.
Attach the spray nozzle to the oil can Before autoclaving, the contra angle must
(slight screwing) and the contra angle, be lubricated.
press the oil can button more than 3 Use qualified spray and refer to its
seconds, till all the black oil flow out instructions for use.
from the head of the contra angle. Do not lubricate the motor handpiece.
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 20cm x 17.5cm x7cm (package) - 700g
Contra-angle Compatible with rotary and reciprocating instruments, equipped with a 2.35 mm shaft
conforming to EN ISO 1797, Type 1
Power supply Lithium ion battery 3.7V -1600mAh
Charger AC 100-240V - 50/60Hz - 5.5VA
Torque range 0.5 N.cm - 4 N.cm
Speed range 120 - 650 rpm
Electrical safety class - Applied part Class II - BF
Operating conditions Indoor use only - 10°C / 40 °C - Relative humidity <80% non-condensing at 0 °C
Altitude < 2000 m above sea level
Transport and storage conditions -20 °C / +50 °C - Relative humidity 20% - 80%, non-condensing at > 40 °C
Atmospheric pressure 50 kPa - 106 kPa
16. Electromagnetic Compatibility (EMC) – Declaration of conformity
Guidance and manufacturer's declaration
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 Compliance
RF emissions - CISPR 11 Group 1
Class B
Harmonic emissions IEC61000-3-2 Not applicable
Voltage fluctuations/flicker emissions - IEC61000-3-3 Not applicable
Processing Warning
Pack components in sterilization Use pouches which resist to a
pouches. temperature up to 141°C and
compliant with EN ISO 11607.
Steam sterilization at 135°C at least Use only approved autoclave devices
4 minutes, or at 121°C at least 35 according to EN 13060 or EN 285
minutes. The sterilization procedure must
Minimum drying time after sterilization: comply with ISO 17665.
10 minutes. Waiting for cooling before touching.
Keep the components in sterilization Check the packaging before using it
packaging in a dry and clean (packaging integrity, no humidity and
environment. 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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