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implantor LED / handy power /
handy power LED
97050841
Rev. 00
15.04
ENGLISH………………………………………………...2
EN
ENGLISH
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INTENDED USE ....................................................................................................................................................... 3
IMPORTANT WARNINGS ........................................................................................................................................ 3
SYMBOLS ................................................................................................................................................................. 4
TECHNICAL SPECIFICATIONS .............................................................................................................................. 4
CONNECTION TO THE POWER SUPPLY INSTRUMENT TUBING ...................................................................... 4
CONNECTION AND DISCONNECTION OF THE HANDPIECE ............................................................................. 4
SETTING OPERATIONAL PARAMETERS .............................................................................................................. 5
ILLUMINATION DEVICE .......................................................................................................................................... 5
MAINTENANCE ........................................................................................................................................................ 5
CLEANING, DISINFECTION AND STERILISATION ............................................................................................... 5
REPAIRS AND OVERHAULS .................................................................................................................................. 5
MODE OF USE ......................................................................................................................................................... 5
ENVIRONMENTAL CONDITIONS FOR USE .......................................................................................................... 5
ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING ................................ 6
TROUBLESHOOTING .............................................................................................................................................. 6
SCRAPPING ............................................................................................................................................................. 6
GUARANTEE CONDITIONS .................................................................................................................................... 7
MANUFACTURER .................................................................................................................................................... 7
2
OPERATOR'S MANUAL
EN
1. INTENDED USE
This is a Medical device, or a medical device accessory for professional use by Dentists, assisted by authorised
office personnel.
The device is intended for use on Dental Units complying with the 93/42/EEC Directive and subsequent additions and
amendments, complying with the IEC 60601-1 standard (III ed.) and installed in locations meeting the standards in
force for locations for medical purposes and with an electrical plant system that complies with the IEC 60364-7-710
standard.
2. IMPORTANT WARNINGS
Before using the device read the instructions in this manual carefully. The use of the device must respect the
instructions provided.
For the correct interpretation of the indications in this manual the Italian text is binding.
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The device is not suitable for use with blends of inflammable anaesthetics and oxygen or nitrous oxide.
The instrument is provided in a non-sterile state. Before use, see to its suitable cleaning and disinfection. If the
device may be sterilised, lubricate it before performing the autoclave sterilisation.
Use of electrically-powered devices may interfere with the operation of active implantable devices such as
pacemakers or other active devices. In case of doubt regarding the treatment of patients with such devices,
consult a cardiology expert or another competent medical institute.
During use of the device dust and fragments from the patient’s oral cavity or from the same device may be
projected into the environment (organic and inorganic dust and metal dust, fragments of the device or its tips and
potentially infected biological material).
Protect the patient, when possible, using a dental dam.
Instruct the patient to breathe through the nose in cases where the dam is not applicable.
Medical personnel must put on suitable personal protection equipment.
Suitably cool the surgical field during use.
Use only handpieces and counter angles with the CE mark of compliance with the 93/42/EEC Directive and
subsequent additions and amendments.
Use only burrs (or other similar tools) with CE Mark of compliance with Directive 93/42/EEC and subsequent
additions and amendments, made with biocompatible materials complying with ISO 10993-1 and whose
dimensions comply with EN ISO 1797-1 standards.
Before each use, verify the proper locking of the handpiece onto the micro-motor and of the burr onto the
handpiece chuck.
Do not use damaged or worn handpieces.
Make sure that during operation of the motor there is full flow of cooling air. In the absence of cooling stop using
the device and call authorised technical service assistance.
In case of visible damage, the emission of unusual noises and/or vibrations or if overheating is noticed, do not
use the device and call authorised technical service assistance.
LED radiation: do not stare into beam or view directly with optical instruments.
The manufacturer will not be held responsible regarding safety, reliability or performance of the device if:
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The essential requirements for the location, detailed in the Dental Unit User Manual are not respected;
The assembly, the additions, the adjustments, the calibrations and/or the repairs are not performed by authorised
technical service personnel;
If modifications, tampering, incorrect maintenance have been performed, or incompatible and/or non-original
spare parts have been used on the device;
The device is not used in compliance with the use instructions and its intended use.
EN
OPERATOR'S MANUAL
3
3. SYMBOLS
Symbol to call the attention to other information found in the equipment User Manual.
Symbol corresponding to “TYPE B PART APPLIED” according to IEC 60601-1.
Indicates a protection grade against direct and indirect contacts.
Part that may be sterilised in an autoclave.
Mark of Compliance with the 93/42/EEC Directive “MEDICAL DEVICES” and subsequent additions and
amendments.
Symbol for disposal pursuant to the 2002/95/EC, 2002/96/EC, 2003/108/EC Directives.
4. TECHNICAL SPECIFICATIONS
implantor LED
Power supply
Max absorption
Max Electrical power absorbed
Max speed
Min speed
Max torque
Cooling
Intermittent Operation
Pneumatic supply
Water Supply
Consumption
Classification
Handpiece Connection
LED Illumination
Applicable regulations
Dimensions
Weight
6A
170 W
40.000 ± 10% revs/min
100 ± 10% revs/min
5,3 Ncm
32 VDC
handy power
handy power LED
6A
170 W
40.000 ± 10% revs/min
100 ± 10% revs/min
3,3 Ncm
Forced Air
5 min of work - 5 min of rest
300 ± 20 kPa (3 ± 0,2 bar)
250 ± 20 kPa (2,5 ± 0,2 bar)
Cooling air ~ 25 Nl/min
Air Spray~ 5 Nl/min
Water Spray 35 cc/min
Class IIa (Directive 93/42 EEC and subsequent additions and
amendments)
Class II type B (IEC 60601-1)
Compliant with ISO 3964 and compatible with INTRAmatic® Lux.
5000 K - 20000 mlm
IEC 60601-1 – IEC 60601-1-2 – IEC 60825-1
ISO 10993-1 – EN ISO 14457
47,5 mm
35 mm
79 g
66,5 g
For the correct operation of the device it must be connected to the specific power supply and electronic control
circuits, designed by the manufacturer, by way of suitable connection supply tubing.
The manufacturer promises to provide, upon request, wiring diagrams, component parts lists, calibration instructions
or any other information that may be needed by authorised technical service assistance personnel.
The manufacturer reserves the right to bring about modifications at any moment without notice.
5. CONNECTION TO THE POWER SUPPLY INSTRUMENT TUBING
Bring the motor next to the instrument tubing and rotate it, on the connector itself until the coupling point is found.
Insert the motor completely and then fully tighten the ring nut.
6. CONNECTION AND DISCONNECTION OF THE HANDPIECE
Handpieces complying with ISO 3964 and with the INTRAmatic ® Lux. type may be used. Insert the handpiece on the
coupling until the connection “click” is heard.
Never mount a handpiece onto a motor that is running.
To detach the handpiece from the motor pull lightly.
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OPERATOR'S MANUAL
EN
7. SETTING OPERATIONAL PARAMETERS
Operational modes, speed adjustment, inversion of the rotation direction, torque adjustment, spray and LED lighting
activation (if available) are to be made through the Dental Unit command panel. Refer to the Dental Unit instruction
manual for the setting of the operational parameters.
8. ILLUMINATION DEVICE
In the micro-motors set up with LEDs for lighting of the surgical field, these light up automatically when the micromotor is running.
After the motor stops, the LED remains lighted for a pre-set time. Lighting depends on settings made on the Dental
Unit.
9. MAINTENANCE
At least once a week lubricate the O-Ring seals found in the handpiece coupling with silicone lubricating grease.
Wearing disposable gloves, apply a film of grease on the fingertips and lubricate with the fingers.
If liquids that potentially leave incrustations are used to supply the spray, it is recommended that the circuit be
flushed well with water at the end of each use.
The manufacturer requires an annual check or overhaul of the device by authorised service assistance personnel.
10. CLEANING, DISINFECTION AND STERILISATION
Before sanitisation operations, detach the handpiece from the micro-motor and the motor from the instrument tubing.
To maintain a level of hygienic security, at the end of each use and within a short time, clean, disinfect and, if
applicable, sterilise the micro-motor.
Micro-motors that may be sterilised are identified by the specific symbol found in the “Symbols” paragraph.
For cleaning and/or disinfection of the outside of the micro-motor, use gauze or cotton soaked in ethyl alcohol 70%
v/v.
Sterilise in a steam autoclave max 135 °C 220 kPa (2.2 bar) for 5 minutes (250 cycles tested – EN ISO 14457).
Before each autoclave cycle lubricate the micro-motor using the specific spray lubricant “DAILY OIL”, applying a
quick squirt. Reconnect the motor onto the instrument tubing and activate it so as to expel the excess lubricant. Dry
the outside of the micro-motor with gauze or cotton wool before proceeding on with sterilisation.
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Do not use ultrasound cleaners.
Do not immerse the handpiece in disinfectant or sanitizing solution.
Never sterilise the handpiece in a dry heat steriliser.
Do not leave the handpiece in the autoclave, but remove it immediately after the cycle.
Periodically check the autoclave according to the requirements of the manufacturer.
Temperatures higher than the indicated limit may damage the micro-motor.
11. REPAIRS AND OVERHAULS
Installation, overhaul, calibration and repair of the device must be performed exclusively by technical service
assistance personnel authorised by the manufacturer.
12. MODE OF USE
The method of application of the device is intermittent. The operational cycle indicated respects the following times:
Type of Instrument
implantor LED
handy power
handy power LED
Operation (minutes)
5
5
5
Pause (minutes)
5
5
5
13. ENVIRONMENTAL CONDITIONS FOR USE
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Ambient Temperature 10 ÷ 40 °C
Relative Humidity 30 ÷ 75 %
Atmospheric Pressure 700 ÷ 1060 hPa (700 ÷ 1060 mBar)
EN
OPERATOR'S MANUAL
5
14. ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING
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Ambient Temperature between -20 ÷ +70 °C
Relative Humidity 10 ÷ 100 %
Atmospheric Pressure 500 ÷ 1060 hPa (500 ÷ 1060 mBar)
15. TROUBLESHOOTING
FAULTS
PROBABLE CAUSES
O-ring seals worn or damaged.
INTERVENTION SUGGESTED
Request
technical
service
assistance.
Lubricate the handpiece.
Send the handpiece to technical
service assistance.
Request
technical
service
assistance.
Request
technical
service
assistance.
Request
technical
service
assistance.
Request
technical
service
assistance.
Substitute the instrument tubing.
Request
technical
service
assistance.
Recover the proper adjustment.
Recover the proper adjustment.
Request
technical
service
assistance.
Request
technical
service
assistance.
Lubricate the handpiece.
Send the handpiece to technical
service assistance.
Slide the handpiece out and reinsert
it properly.
Send the handpiece to technical
service assistance.
Request
technical
service
assistance.
Send the handpiece to technical
service assistance.
Substitute the handpiece.
Request
technical
service
assistance.
Substitute the O-rings.
O-ring seals worn or damaged.
Substitute the O-rings.
Motor blocked.
Blocked handpiece.
The motor does not turn.
Electronic control board broken.
Instrument tubing broken.
The motor runs but its speed is not
adjustable.
The motor functions sporadically.
The motor does
sufficient torque.
not
Adjustment command broken.
Electronic
control
malfunction.
Instrument tubing defective.
board
Bearings damaged.
provide
Torque set to its minimum.
Endodontics mode selected.
Power supply / motor malfunction.
Insufficient cooling air.
The motor overheats.
Handpiece with strong friction.
Handpiece not connected properly.
The motor turns regularly.
The burr does not turn.
Handpiece broken.
Defective transmission coupling.
The handpiece
coupling.
rotates
on
its
The handpiece does not remain
inserted on the micro-motor.
Water leakage at the handpiece.
Water leakage at the instrument
tubing coupling.
Blocked handpiece.
Handpiece damaged.
Motor hook ring damaged.
16. SCRAPPING
Scrapping the device must be carried out with respect for the laws in force for electrical and electronic equipment,
according to the individual national laws.
The materials used for the manufacture are not harmful for human beings or animals that come into contact with or
are exposed to them.
6
OPERATOR'S MANUAL
EN
17. GUARANTEE CONDITIONS
The manufacturer provides the end user with a 12-month warranty, starting from the date of installation and, in any
case, not exceeding 18 months from the invoice date, covering all operational faults, defects of materials or
manufacture.
In case of justified complaints the manufacturer or the Authorised Repair Centre will proceed with the repair or
substitution of the product free of charge.
To be able to make use of the free repair or substitution, it is an indispensable condition that, shipped together with
the device, there is a proof of user's purchase document for the same device, which must include clearly legible
references to the product, its serial number and date of purchase.
The guarantee expires when any damages and/or their consequences may be attributed to unsuitable procedures or
modifications of the product performed by third parties not authorised by the manufacturer: that is, if non-original
spare parts or components are used.
The recognition of any other claims from any origin whatsoever, in particular any requests for indemnification for
damages or interest are excluded.
The manufacturer may not be held responsible for damages, or injuries and their respective consequences derived:
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From excessive wear.
From connection of the instrument not compliant with the CE regulations.
From improper tampering or maintenance performed by unauthorised personnel.
From use of non-original accessories or spare parts.
From the lack of observance of the instructions for use, for assembly or maintenance, or from improper use of the
product.
From unusual chemical, electrical or electronic influxes.
From faulty connections (air water, electricity).
The guarantee does not cover the conductors such as the flexible “fibre optics”, nor any other elements made of
synthetic materials.
18. MANUFACTURER
Manufactured by
Sede Legale ed Amministrativa / Head Quarter
CEFLA sc - Via Selice Provinciale, 23/a - 40026 Imola (BO) Italy
Tel. +39/0542 653111 Fax +39 0542 653344
Stabilimento / Plant
CEFLA DENTAL GROUP - Via Bicocca, 14/c - 40026 Imola (BO) Italy
Tel. +39 0542 653441 Fax. +39 0542 653555
EN
OPERATOR'S MANUAL
7
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