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Suitable detergent For automatic cleaning-disinfection:
User Manual U.N.I HP 1:1
•
Mildly alkaline enzymatic detergents are recommended for cleaning dental or surgical instruments in a washer-disinfector.
For manual cleaning-disinfection: •
Spraynet
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Detergents or detergent-disinfectants (pH 6-9.5) are recommended for the cleaning and disinfection of dental or surgical instruments.
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Surface-active enzymatic/quaternary ammonium-type detergents.
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Do not use detergents that are corrosive or contain chlorine, acetone, aldehydes or bleach.
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If the device remains unused for a lengthy period, store it in a dry place. Clean, lubricate and sterilise
This document is an English translation of the original French version. Reference J28210 version V2 and drawing number NF32FR020B.
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Type Straight dental handpiece with an internal spray, without a light, direct ratio, ring-clamped.
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Technical data Classification Class IIa as per the European Directive 93/42/EEC on medical devices. Typical coupling According to standard ISO 3964, internal spray, no light. Transmission ratio Blue ring, direct ratio.
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Information The technical specifications, illustrations and dimensions contained in these instructions are for reference only. They shall not give rise to any complaints. The manufacturer reserves the right to make technical improvements to its devices without modifying these instructions. For more information, please contact SATELEC, a company of Acteon group (see address on the back).
Using the handpiece Drill Stem diameter 2.35 mm, type 2 according to ISO 1797, code 4, min. length 30 mm and max. length 44.5 mm according to ISO 6360-1, fig. 1.
After cleaning, disinfecting and sterilising the instrument, and before use, turn the instrument at a moderate speed with a tool in the clamp for 10 to 15 seconds, to distribute the lubricant and remove any excess.
Never actuate the locking/unlocking ring when
Recommended temperatures for the devices: Pre-washing Water: from cold to a maximum of 35 °C – Duration 2 min. Washing Water: 50 to 65 °C – Duration 5 min.
the device from the steriliser to reduce the risk of
when checking and using the device.
corrosion.
Rinsing Water: from cold to a maximum of 35 °C – Duration 2 min.
1 Pre-disinfection (in the place of use)
Thermal disinfection Water: 80 to 97 °C – Duration 5 min.
Preparation
Drying Air: 65 to 75 °C – Duration 25 min.
Always fully insert the drill in the clamp to
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Never exceed the maximum speed of rotation permitted by the drill manufacturer. Only use drills that are in perfect condition and concentric.
Disconnect the instrument from the drive motor, turn the ring, remove the drill and leave
break the drill.
the ring loose fig. 2. •
Unblock the spray channels with the cleaning
optimally, it must be cooled by an air flow rate of 8 to 10 Nl/min at the nose of the micromotor.
wire fig. 6. •
3 Lubrication, checks and packaging
Perform a manual pre-clean or a pre-clean
Manual pre-cleaning •
Use the cleaning spray Spraynet.
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Spray the inside and the outside of the instrument fig. 4 to expel any residue, then
Maintenance
thoroughly clean the surfaces.
Clean, lubricate and sterilise the device separately before each patient.
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Wipe the outside surfaces with absorbent paper.
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Clean-disinfect manually or automatically.
or
Caution •
The device is not sterile when delivered.
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Before first use, and no later than 30 minutes
Pre-cleaning in a bath
after each surgical treatment, clean, disinfect Caution
and lubricate the instrument, then sterilise it. Following this procedure will eliminate
Pre-cleaning in a bath must be followed by
residues of blood, saliva or saline solution
automatic cleaning-disinfection.
and prevent the transmission system from
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jamming. Only instruments with the
Caution Never cool down the devices by rinsing.
in a bath .
For the handpiece-micromotor assembly to work
pictogram can
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Do not immerse in an ultrasonic bath.
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SATELEC, a company of Acteon group, recommends the maintenance products Bien-Air Dental. Using other products or parts may result in faulty operation and/or render the warranty null and void.
Precautions for maintenance: Universal precautions, and in particular the
Replacing the drill Turn the ring and remove the drill fig. 2. Insert the drill fully home fig. 3, step 1. Lock the clamp by fully turning the ring. The clamp is fully locked after the first mechanical resistance fig. 3, step 2. A: loosen fig. 2 B: tighten fig. 3
wearing of personal protective equipment, such
Whenever inserting the drill, check that the clamping ring abuts by making a back-and-forth movement on the drill fig. 3, step 3.
Drill clamping system (cutting tool)
as gloves and goggles, must be taken by the medical personnel maintaining contaminated or potentially contaminated medical appliances. Pointed or sharp instruments must be handled with great care.
Totally immerse the instrument in a cleaning bath containing a suitable detergent.
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Remove from the bath, then rinse the inside and the outside of the instrument in cold
be put in a washer-disinfector.
running water (<35 °C) for 30 seconds. •
Allow to drain, then wipe the outside surfaces with absorbent paper.
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Clean-disinfect automatically.
2 Cleaning-disinfection Manual cleaning-disinfection Immerse the instrument in a tank containing a suitable detergent and clean the outside of the instrument with a clean and disinfected soft brush, following the detergent manufacturer’s instructions regarding the duration, concentration, temperature and renewal. Rinsing: Rinse the inside and the outside of the instrument
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Wash cycle: Select the wash cycle recommended for the instruments and compatible with the detergent manufacturer’s indications.
After each sterilisation cycle, immediately remove
produce enough centrifugal force to bend or
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Washer-disinfector: Use an approved washer-disinfector with a suitable detergent.
Always wear gloves or suitable protective gear
shown above), high speeds of rotation can
•
.
damage the mechanism or destroy the motor.
clamp or with a length greater than the values
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Caution Only for devices etched with
Check that the steriliser and the water are clean.
drill is off-centre (not fully inserted in the
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Automatic cleaning-disinfection
the instrument is rotating, as doing so can
avoid exceeding the maximum length. If the
Drive and rotation speed 40,000 rpm maximum Length and weight: 85 mm and 80 g
Never engage an instrument on a rotating micromotor.
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Product for professional use only. Use in dentistry for restorative dental treatments. All uses that do not comply with the indication for use of this device are forbidden and may be dangerous.
Do not start the device without a drill inserted in the clamp.
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Medical devices made in France by SATELEC, a company of Acteon group.
Indication for use
before using again.
Caution
or
Do not immerse in physiological liquids (NaCl). Caution
Identification
Drying: Spray the inside of the instrument with Spraynet fig. 4 to immediately evacuate the rinsing water to avoid damage to the inside parts and to prevent them from jamming. If necessary, wipe with absorbent paper.
Checking that the instrument is clean Visually check that the instrument is clean. If necessary, clean again with a soft brush. Lubricate before each sterilisation or at least twice a day. Only use the Lubrifluid spray. • Remove the tool from the clamp. • Wrap the instrument in a cloth to remove any debris and foreign bodies expelled by the jet of the spray. • Remove the protective cap and introduce the spray endpiece in the rear of the handle of the instrument. • Spray for 1 second fig. 5 and wipe off any excess oil from the outside. Checking the clamp Insert the drill fully home fig. 7A, step 1. Check the clamp by fully turning the ring. The clamp is fully locked after the first mechanical resistance fig. 7A, step 2. Every time a drill is inserted, check that the ring is fully tightened by making a back-and-forth movement on the drill fig. 7B. • Hold the handpiece vertically by the drill between the thumb and index finger fig. 7C, and turn the handpiece. The handpiece must turn freely through more than three turns. • Turn the ring and remove the drill ready for sterilisation fig. 7D. Warning: If the handpiece does not turn freely, there is a risk of burning the patient. If this is the case, send the handpiece to your usual dealer or directly to SATELEC, a company of Acteon group, for repair. •
Packaging Pack the instrument in packaging approved for sterilisation by steam.
in cold running water (<35 °C) for ~ 30 seconds.
Clean, disinfect and sterilise without the drill in the clamping system.
User Manual | U.N.I HP 1:1 straight handpiece | J28211 | V2 | (17) | 05/2017 | NF32EN020B
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4 Sterilisation
At the request of technical personnel working for the network of approved dealers, SATELEC, a company of Acteon group, will provide any information required to repair defective parts on which they may perform repairs.
Caution The quality of sterilisation highly depends on the cleanliness of the instrument. Only sterilise perfectly clean instruments. Only sterilise according to the process below.
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Process With steam in a fractionated pre-vacuum, class B cycle, according to EN 13060. The process has been validated according to ISO 17664. Sterilisable in an autoclave at up to 134 °C. Duration: 3 or 18 minutes, depending on the national requirements in force. Service Contact the supplier of your device. Using the services of an unapproved repairer could render your device dangerous for you and your patients. Caution Do not repair or modify the device without seeking the prior permission of SATELEC, a company of Acteon group. If the device is modified or repaired, specific checks and tests must be carried out to ensure that the medical device is still safe to use. In the event of doubt, please contact an approved dealer or the Customer Service team at SATELEC, a company of Acteon group. www.acteongroup.com [email protected]
Transportation and storage conditions Temperature between -40 °C and 70 °C, relative humidity between 10 % and 100 %, atmospheric pressure between 50 kPa and 106 kPa. Recycling When your medical device has reached the end of its service life, contact your nearest dental equipment dealer, or Acteon head office or one of the company branches to find out how to proceed (see relevant contact details on the back). Caution A medical device that has reached the end of its service life must be disposed of in infectious clinical waste containers.
Other precautions for use The device must be used by a competent person, especially with regard to the legal requirements applying to safety at work, hygiene measures and accident prevention, and these operating instructions. In accordance with these provisions, the user must: • only use devices that are in perfect working order. In the event of irregular operation,
excessive vibrations, overheating or any other signs that the device is malfunctioning, stop working immediately. In this case, contact a repair service approved by SATELEC, a company of Acteon group. make sure that the device is used only for the intended purposes, protect themselves, patients and third parties against any danger and avoid contamination by the device.
into wounds, causing infection and the risk of embolism. Follow the instructions for use, in compliance with the tool manufacturer’s instructions. Never use a tool with a non-compliant stem, as it may become detached during treatment, causing injury to yourself, the patient and third parties. The device is intended for medical treatments only. All uses that do not comply with the intended use of this device are forbidden and may be dangerous This medical device complies with the legal provisions in force.
Put the device on a suitable support to avoid risk of injury or infection to yourself, the patient and third parties. Excess maintenance products (lubricant, cleaning and disinfection products) from the device can enter the electric brush motor and interfere with its operation. It is imperative to follow the maintenance instructions for each product. Never lubricate the electric brush motor. Recommendations Only use dry and purified compressed air to guarantee a long lifespan of the device. Maintain the quality of the air and water supplied by regularly maintaining the compressor and the filtration systems. Using hard and unfiltered water will cause premature clogging of the pipes, couplings and spray dispensers. The device must not be used in the case of open lesions, injured soft tissue or fresh extractions. The evacuated air may propel infected materials
Type 2 / ISO 1797 Code 4 / ISO 6360-1
A min. min.30 30mm mm
1
ø mm Ø 2,35 2.35 mm
max. max.44.5 44.5mm mm
3 fig. 1
fig. 2
B
2
fig. 3 1 sec.
fig. 4
fig. 5
A
fig. 6
C
D
1 2
B
Turn
Turn three or more times
fig. 7 User Manual | U.N.I HP 1:1 straight handpiece | J28211 | V2 | (17) | 05/2017 | NF32EN020B
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Manufacturer responsibility The manufacturer shall under no circumstances be liable for: • non-compliance with manufacturer recommendations during installation, whether this is the network voltage or the electromagnetic environment, • maintenance or repair procedures performed by people who are unauthorised by the manufacturer, • use on an electrical fixture that is not compliant with the regulations in force, • uses other than those specified in this manual, • use of accessories or handpieces not supplied by SATELEC, a company of Acteon group, and • non-compliance with the instructions contained in this document.
REF
Key
F28202
U.N.I HP 1:1, direct ratio, no light, ring-clamped, tool stem Ø 2.35 mm
Symbols
1000001-010
Cleaning wire, box of ten
CE marking
1600036-006
Spraynet, 500 ml cleaning spray, box of six
Always wear protective gloves
1600064-006
Lubrifluid, 500 ml lubricating spray, box of six
Light
Washer-disinfector for thermal disinfection 134°C
Sterilisation at 134°C in an autoclave Caution
Biohazard
Back-and-forth movement Movement in the indicated direction Movement to end of travel in the indicated direction After the first mechanical resistance, fully tighten in the indicated direction
Accessories SATELEC
AA Company CompanyofofACTEON ACTEON 17, 17,avenue avenueGustave GustaveEiffel Eiffel BP 30216 BP 30216 France France Tel. Tel.+33 +33(0) (0)556.34.06.07 556.34.06.07 Fax. Fax.+33 +33(0) (0)556.34.92.92 556.34.92.92 E.mail : [email protected] E.mail : [email protected] group.com
10x REF 1000001-010
6x REF F28202
Year of manufacture
Four-channel coupling
The warranty is annulled when the damage and its consequences are the result of unsuitable interventions or modifications on the product, made by third parties that have not been authorised by SATELEC, a company of Acteon group. Warranty claims will only be considered if the product is accompanied by a copy of the invoice or the delivery documents. These documents must clearly show the date of purchase, the product reference and the serial number.
Assortment supplied
Manufacturer
REF 1600036-006
6x REF 1600064-006
MIDDLE EAST MIDDLE EAST ACTEON MIDDLE EAST ACTEON MIDDLE EAST 247 Wasfi Al str.str. 247 Wasfi Tal Al Tal 401 AMMAN JORDAN 401 AMMAN - JORDAN Tel. +962 6 553 4401 Tel. +962 6 553 4401 Fax. +962 6 553 7833 Fax. +962 6 553 7833 [email protected] [email protected]
LATIN AMERICA LATIN AMERICA ACTEON LATINA AMERICA ACTEON LATINA AMERICA Bogotà COLOMBIA Bogotà - COLOMBIA Celular: +57 312 377 8209 Celular: +57 312 377 8209 [email protected] [email protected]
RUSSIA RUSSIA ACTEON RUSSIA ACTEON RUSSIA CHINA [email protected] CHINA [email protected] ACTEON CHINA www.acteongroup.com ACTEON CHINA U.S.A. & Canada Office 401 - 12 Xinyuanxili AUSTRALIA/NEW ZEALAND Office 401 - 12 Xinyuanxili AUSTRALIA/NEW ZEALAND ACTEON North America Zhong Street ACTEON AUTRALIA/NEW U.S.A. & Canada Zhong Street ACTEON AUTRALIA/NEW 124 Gaither Drive, Suite 140 Chaoyang District - BEIJING ZEALAND ACTEON North Chaoyang District - BEIJING Suite ZEALAND Mount Laurel, NJAmerica 08054 - USA 100027 - CHINA 119, 30-40 Harcourt 124 Gaither Drive, Suite 140 100027 CHINA Suite 119, 30-40 Harcourt Tel. +1 856 222 9988 Tel. +86 10 646 570 11 / 2 / 3 Parade Mount Laurel, NJ 08054 USA Tel. +86 10 646 570 11 / 2 / 3 Parade Fax. +1 856 222 4726 Fax. +86 10 646 580 15 Rosebery NSW 2018 Tel. +1 856 222 9988 Fax. +86 10 646 580 15 Rosebery NSW 2018 [email protected] [email protected] Australia Fax. +1 856 222 4726 [email protected] Tel. Australia +612 9669 2292 [email protected] +612 9669 GERMANY THAILAND Fax.Tel. +612 9669 22042292 THAILAND Fax. +612 9669 2204 ACTEON GERMANY GmbH ACTEON (THAILAND) LTD [email protected] GERMANY ACTEON (THAILAND) LTD [email protected] Industriestrasse 9 – 40822 23/45 Sorachai Building 16th METTMANN - GERMANY floor - Sukumvit 63Building 16th TAIWAN ACTEON GERMANY GmbH 23/45 Sorachai Tel. +49 21 04 95 65 10 Road, Klongton Nua ACTEON TAIWAN Industriestrasse 9 – 40822 floor - Sukumvit 63 TAIWAN Fax. +49 21 04- 95 65 11 Wattana, BANGKOKNua 10110 11F.,ACTEON No.1, Songzhi Rd. METTMANN GERMANY Road, Klongton TAIWAN [email protected] - THAILAND Dist.,No.1, Taipei City 11047 Tel. +49 21 04 95 65 10 Wattana, BANGKOK 10110 Xinyi11F., Songzhi Rd. Tel. +66 2 714 3295 TAIWAN Fax. +49 21 04 95 65 11 - THAILAND Xinyi(R.O.C.) Dist., Taipei City 11047 SPAIN Fax. +66 2 714 3296 + 886 2 8729 (R.O.C.) 2103 [email protected] Tel. +66 2 714 3295 TAIWAN ACTEON MEDICO-DENTAL [email protected] [email protected] Fax. +66 2 714 3296 + 886 2 8729 2103 IBERICA, S.A.U. SPAIN [email protected] [email protected] Avda Principal n°11 H Hong Kong Re. Office ACTEON MEDICO-DENTAL Poligono Industrial Can 21/F, On Hing Building IBERICA, S.A.U. Hong Kong Re. Office Clapers Central - Hong Kong Avda Principal n°11 H 21/F, On Hing Building 08181 SENTMENAT Tel. +852 66 962 134 Poligono Industrial Can Central - Hong Kong (BARCELONA) - SPAIN [email protected] Clapers Tel. +852 66 962 134 Tel. +34 93 715 45 20 08181 SENTMENAT vianney.ruellan@acteonFax. +34 93 715 32 29 INDIA (BARCELONA) - SPAIN group.com [email protected] ACTEON INDIA Tel. +34 93 715 45 20 1202, PLOT NO. D-9 Fax. +34 93 715 32 29 INDIAHEIGHTS, NETAJI U.K. GOPAL [email protected] ACTEON INDIA ACTEON UK SUBASH PLACE 1202, PLOTDELHI NO. D-9 Phoenix Park– Eaton Socon, PITAMPURA, - 110034 U.K. GOPAL HEIGHTS, NETAJI St Neots INDIA CAMBS PE19 8EP UK Tel. +91 11 47 018 291 / 47 ACTEON UK SUBASH PLACE Tel. +44 1480 477 307 Socon, St 058 291 / 45 618DELHI 291 - 110034 Phoenix Park– Eaton PITAMPURA, Fax. +44 1480 477 381 Fax. +91 79 2328 7480 Neots INDIA [email protected] [email protected] CAMBS PE19 8EP - UK Tel. +91 11 47 018 291 / 47
Tel. +44 1480 477 307 Fax. +44 1480 477 381 [email protected]
058 291 / 45 618 291 Fax. +91 79 2328 7480 [email protected]
SATELEC S.A.S.|A company of ACTEON group 17 av. Gustave Eiffel|BP 30216|33708 MERIGNAC cedex|FRANCE Tel. +33 (0) 556 34 06 07|Fax. +33 (0) 556 34 92 92 Email: [email protected]|www.acteongroup.com
SATELEC S.A.S. |A Company of ACTEON Group
User Manual | U.N.I HP 1:1 straight handpiece | J28211 | V2 | (17) | 05/2017 | NF32EN020B17 av. Gustave Eiffel |BP 30216|33708 MERIGNAC cedex|FRANCE Tel. +33 (0) 556 34 06 07 |Fax. +33 (0) 556 34 92 92 E-mail : [email protected]|www.acteongroup.com
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