U.N.I Contra-Angle Handpiece User Manual

This document is an English translation of the original French version. Reference J28200 version V2 and drawing number NF32FR010B.

Assortment supplied (REF) CA 1:5

F28201

F28204

Assortment supplied (REF) CA 1:1

F28200

F28203

Accessories (REF)

1600036-006

1600064-006

1000001-010

Contents 1 1.1.

Symbols...2 Description of the symbols used... 2

2 2.1. 2.2.

Identification and indication for use...3 Identification...3 Indication for use...3

3

Precautions for use...4

4 4.1. 4.2.

Description...5 Overview...5 Technical data...5

5 5.1.

Assembly...6 Replacing the drill...6

6

Operation...6

9 General information...12 9.1. Manufacturer responsibility...12 9.2. References...12 9.2.1. Assortment supplied (see cover)...12 9.2.2. Accessories (see cover)...12

7 Retreatment and service...7 7.1. Maintenance...7 7.1.1. Precautions for maintenance ...7 7.1.2. Suitable maintenance products...7 7.2. Pre-cleaning ...8 7.2.1. Manual pre-cleaning...8 7.2.2. Pre-cleaning in a bath...8 7.3. Cleaning-disinfection...9 7.3.1. Manual cleaning-disinfection...9 7.3.2. Automatic cleaning-disinfection...9 7.4. Checks...10 7.5. Lubrication...10 7.6. Sterilisation...10 7.7. Service...10 8 8.1.

Packaging and disposal...11 Transportation and storage conditions...11 8.1.1. Packaging...11 8.2. Recycling...11 8.3. Disposal...11

1

1 Symbols 1.1. Description of the symbols used Sign

Description

Sign

Always wear protective gloves

134°C

Rx only

Description Year of manufacture

Manufacturer

SN

Serial number

CE marking

REF

Reference number

Caution

Washer-disinfector for thermal disinfection

Biohazard

After the first mechanical resistance, fully tighten in the indicated direction

Light

Back-and-forth movement

Sterilisation at 134 °C in an autoclave

Movement in the indicated direction

Under United States Federal Law, this medical device must only be sold by or under the orders of a qualified doctor

Movement to end of travel in the indicated direction

Page 2 - User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B

2 Identification and indication for use 2.1. Identification Medical devices made in France by SATELEC, a company of Acteon group.

2.2. Indication for use Product for professional use only. The indications for use are as follows, in part or in full: • U.N.I CA 1:1 and U.N.I CA 1:1 LED. Prophylaxis, endodontics and restoration dentistry treatments. • U.N.I CA 1:5 and U.N.I CA 1:5 LED. Restoration dentistry treatments.

Type Dental contra-angles (CA) with pushbutton-operated clamp, three sprays in the range without lights (U.N.I CA 1:1 and U.N.I CA 1:5) and four mixed sprays in the range with lights (U.N.I CA 1:1 LED and U.N.I CA 1:5 LED).

Classification Class IIa according to the European Directive 93/42/EEC concerning medical devices. This medical device complies with the legislation in force.

Caution All uses that do not comply with the indication for use of this device are forbidden and may be dangerous. Caution 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 into wounds, causing infection and the risk of embolism.

User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B - Page 3

3 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. Caution Place the device on a suitable support to prevent risks of injury and infection.

Caution Excess maintenance products (lubricant, cleaning and disinfection products) from the contra-angle 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. Caution 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. Note: Using hard and unfiltered water will cause premature clogging of the pipes, couplings and spray dispensers. Note: The technical specifications, illustrations and dimensions contained in these instructions are for reference only. They shall not give rise to any complaints. For more information, please contact SATELEC, a company of Acteon group (see address on the back).

Caution Universal precautions, and in particular the wearing of personal protective equipment, such as gloves and goggles, must be taken by the medical personnel using or maintaining contaminated or potentially contaminated medical devices. Pointed or sharp instruments must be handled with great care.

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5

134°C

4 3

2

1 FIG. 1

4 Description 4.1. Overview FIG. 1

(1) Micromotor centring (2) Light outputs (3) Drill (not included) (4) Transmission ratio marking (5) Pushbutton

4.2. Technical data Transmission ratio

1:1

1:5

Typical coupling

According to standard ISO 3964

According to standard ISO 3964

Transmission ratio

Direct ratio, blue mark

x multiplier, red mark

Drive speed

40,000 rpm max.

40,000 rpm max.

Speed of rotation. Weight

40,000 rpm max.

200,000 rpm max.

86 g (U.N.I CA 1:1)

89 g (U.N.I CA 1:5)

84 g (U.N.I CA 1:1 LED)

88 g (U.N.I CA 1:5 LED)

Length

97 mm

97 mm

Air consumption

8 - 10 Nl/min

8 - 10 Nl/min

User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B - Page 5

min. 12 mm

max. 22 mm

max. 21 mm

Ø 1.60 mm

min. 12 mm

Type 3 / ISO 1797 Code 4-5 / ISO 6360-1

Ø 2.35 mm

Type 1 / ISO 1797 Code 4 / ISO 6360-1

FIG. 2 Drill FIG. 2

• Stem diameter 2.35 mm, type 1 according to ISO 1797-1. Max. length 22 mm, code 4 according to ISO 6360-1, for the 1:1 range. • Stem diameter 1.60 mm, type 3 according to ISO 1797-1. Max. length 21 mm, code 4/5 according to ISO 6360-1, for the 1:5 range.

Caution 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.

5 Assembly 5.1. Replacing the drill FIG. 3

Pushbutton-operated clamp. 1. Press the pushbutton and simultaneously pull on the drill. 2. Press the pushbutton, insert the new drill fully home and release the pushbutton.

1

2

3

FIG. 3 3. Gently push/pull the drill to check that it is secure. Caution Always check that the drill is in position and turns freely. If this is not the case, contact your usual supplier or SATELEC, a company of Acteon group, for repairs.

6 Operation Caution Do not start the device without a drill inserted. To avoid overheating of the pushbutton, which could result in burns, make sure that it is not inadvertently pressed when the device is rotating. Soft tissue, such as the tongue, cheeks and lips, must be protected by distension using a retractor or a dental mirror. Caution Never engage a device on a rotating micromotor. Caution Always check that the spray outlets are not blocked.

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7 Retreatment and service 7.1. Maintenance Clean, lubricate and sterilise the device separately before each patient. Caution The device is not sterile when delivered.

7.1.1. Precautions for maintenance • Clean, disinfect and lubricate the device, then sterilise it, before first use and IMMEDIATELY after each treatment. Following this procedure will eliminate residues of blood, saliva or saline solution and prevent the transmission system from jamming. • Only instruments with the pictogram can be put in a washerdisinfector. • Do not immerse in an ultrasonic bath. • SATELEC, a company of Acteon group, recommends Bien-Air Dental maintenance products. Using other products or parts may result in faulty operation and/or render the warranty null and void.

7.1.2. Suitable maintenance products Automatic cleaning-disinfection: • Slightly alkaline or enzymatic detergents are recommended for cleaning dental or surgical instruments in a washer-disinfector (pH 6 - 9.5).

Manual cleaning-disinfection • Spraynet. • Detergents or detergentdisinfectants (pH 6 - 9.5) are recommended to clean and disinfect dental or surgical instruments. Surface-active enzymatic/quaternary ammoniumtype detergents. Caution • Do not use detergents that are corrosive or contain chlorine, acetone, aldehydes or bleach. • Do not immerse in physiological liquids (NaCl). • Check that the steriliser and the water are clean. After each sterilisation cycle, immediately remove the device from the steriliser to reduce the risk of corrosion.

Drill clamping system (cutting tool) Clean, disinfect and sterilise without the drill in the clamping system.

User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B - Page 7

U.N.I CA 1:1 LED U.N.I CA 1:5 LED

1

2

U.N.I CA 1:1, 1:5

3

FIG. 4

FIG. 5

7.2. Pre-cleaning

7.2.2. Pre-cleaning in a bath

Preparation FIG. 4

Caution Pre-cleaning in a bath must be followed by automatic cleaningdisinfection. 1. Totally immerse the device in a cleaning bath containing a suitable detergent and follow the instructions of the detergent manufacturer in terms of duration, concentration, temperature and renewal. 2. Rinse the inside and the outside of the device in demineralised water (<38 °C) for 30 seconds. 3. Allow to drip and wipe the ourside surface with absorbent paper or proceed immediately to automatic cleaning-disinfection (see 7.3.2, page 9).

1. Disconnect the device from the coupling and remove the drill (Fig. 3, step 1.). Caution If severely soiled, clean the outside of the device with disinfecting wipes. 2. Unblock the spray channels with the cleaning wire. 3. Perform a manual pre-clean (see 7.2.1, page 8) or a pre-clean in a bath (see 7.2.2, page 8).

7.2.1. Manual pre-cleaning FIG. 5

1. Disconnect the device from its coupling and remove the drill. 2. Spray the inside and the outside of the device with Spraynet for 1 second. Carefully clean the surfaces with a soft cloth. Disinfecting wipes can also be used. 3. Allow any liquid residue to drain off and wipe the outside with absorbent paper, or immediately proceed to the cleaning-disinfecting step (see 7.3, page 9).

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FIG. 6

7.3. Cleaning-disinfection 7.3.1. Manual cleaningdisinfection

1. Immerse the device in a tank containing a suitable detergent and clean the outside of the device with a clean and disinfected soft brush, by following the detergent manufacturer’s instructions (duration, concentration, temperature, renewal, etc.). 2. Rinse the inside and the outside of the device in demineralised water (<38 °C) for 30 seconds.

FIG. 6 3. Spray the inside of the device with Spraynet to immediately evacuate the rinse water and to avoid damaging and jamming the internal parts, then dry the outside surfaces with absorbent paper.

7.3.2. Automatic cleaningdisinfection Caution Only for devices etched with .

Washer-disinfector Automatically clean and disinfect with a validated washer-disinfector that complies with the standard ISO 15883-1 (e.g., Miele G 7781 / G 7881 or Steris Hamo LM-25).

Detergent and wash cycle Slightly alkaline or enzymatic detergents are recommended for cleaning dental or surgical instruments in a washer-disinfector (pH 6 - 9.5). Select the wash cycle that is recommended for the device and is compatible with the detergent manufacturer’s indications. Caution Never cool down the devices by rinsing.

User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B - Page 9

3

4

1

2

FIG. 7

7.4. Checks Visually check that the device is clean. If necessary, clean again with a soft brush.

7.5. Lubrication Lubricate before each sterilisation or at least twice a day. Only use the Lubrifluid spray.

FIG. 7 1. Remove the drill from the device and wrap the device in a cloth to absorb any excess lubricant. 2. Take the appropriate endpiece and remove the protective cap. 3. Introduce the endpiece of the spray into the rear of the handle of the device. 4. Spray for 1 second and wipe off any excess oil from the outside.

7.6. Sterilisation Caution The quality of sterilisation depends very much on the cleanliness of the device. Only sterilise perfectly clean instruments. Caution Only sterilise according to the process below.

FIG. 8 Process

Enclose the device and its accessories in sufficiently large sterilisation bags, such that they are not stretched, and that comply with the applicable standards (e.g., EN 868-5). Steam sterilise, following the class B cycle as per EN 13060 / ISO 17665-1. Note: All the contra-angles from SATELEC, a company of Acteon group, can be sterilised in an autoclave at up to 134 °C. Duration: 3 or 18 minutes, depending on the national requirements in force.

FIG. 8

After cleaning, disinfecting and sterilising the device, turn the device before use at a moderate speed with a drill in the clamp (FIG. 3, step 2) for 10 to 15 seconds in order to spread out and remove any excess lubricant.

7.7. 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.

Page 10 - User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B

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] 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. Note: SATELEC, a company of Acteon group, invites users to regularly check or service their moving devices.

8.2. 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).

8.3. Disposal A medical device that has reached the end of its service life must be disposed of in infectious clinical waste containers.

8 Packaging and disposal 8.1. Transportation and storage conditions Temperature between -40 °C et 70 °C, relative humidity between 10 % and 100 %, atmospheric pressure between 50 kPa and 106 kPa.

8.1.1. Packaging Pack the instrument in packaging approved for sterilisation by steam. Caution If the device remains unused for a lengthy period, store it in a dry place. Clean, lubricate and sterilise before using again.

User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B - Page 11

9 General information

9.2. References

9.1. Manufacturer responsibility

REF

Key

F28200

U.N.I CA 1:1 LED

F28203

U.N.I CA 1:1

F28201

U.N.I CA 1:5 LED

F28204

U.N.I CA 1:5

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 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. • non-compliance with the instructions contained in this document. Note: the manufacturer reserves the right to modify the medical device and/ or any documentation without notice.

9.2.1. Assortment supplied (see cover)

9.2.2. Accessories (see cover) REF

Key

1600036-006

Spraynet, 500 ml cleaning spray, box of six

1600064-006

Lubrifluid, 500 ml lubricating spray, box of six

1000001-010

Cleaning wire, box of ten

Caution 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.

Page 12 - User manual | U.N.I CA contra-angle | J28201 | V2 | (17) | 05/2017 | NF32EN010B

SATELEC

MIDDLE LATIN AMERICA LATIN AMERICA MIDDLE EAST EAST ACTEON MIDDLE EAST EAST ACTEON LATINA AMERICA ACTEON MIDDLE ACTEON LATINA AMERIC 247 Wasfi Al Tal str. Bogotà COLOMBIA 247 Wasfi Al Tal str. Bogotà - COLOMBIA 401 AMMAN - JORDAN 312 377 +57 8209312 377 820 401 AMMAN - JORDAN Celular: +57Celular: Tel. +962 6 553 4401 [email protected] Tel. +962 6 553 4401 info.latam@acteongrou Fax. +962 6 553 7833 Fax. +962 6 553 7833 [email protected] RUSSIA [email protected] RUSSIA ACTEON RUSSIA ACTEON RUSSIA CHINA [email protected] group.com CHINA [email protected] ACTEON CHINA OfficeACTEON 401 - 12 Xinyuanxili U.S.A. & Canada www.acteongroup.com CHINA AUSTRALIA/NEW ZEALAND ZhongOffice Street 401 ACTEON North America - 12 Xinyuanxili AUSTRALIA/NEW ZEALAN ACTEON AUTRALIA/NEW Chaoyang District - BEIJING 124 Gaither Drive, Suite 140 ZEALAND ACTEON AUTRALIA/NEW U.S.A. & Canada Zhong Street 100027 - CHINA District - BEIJING Mount Laurel, NJ 08054 - USA Suite 119, 30-40 Harcourt ACTEON North America Chaoyang ZEALAND Tel. +86 10 646 570 11 / 2 / 3 Tel. +1 856 222 9988 Parade 124 Gaither Drive, Suite 140 100027 - CHINA Suite 119, 30-40 Harcou Fax. +86 10 646 580 15 Fax. +1 856 222 4726 NSW 2018 Mount Laurel, NJ 08054 - USA Tel. +86 10 646 570 11 / Rosebery 2/3 Parade [email protected] [email protected] Australia AACompany ofof ACTEON Company ACTEON 17, Gustave Eiffel 17,avenue avenue Gustave Eiffel BP BP30216 30216 France France Tel. +33 (0) 556.34.06.07 Tel. +33 (0) 556.34.06.07 Fax. +33 (0) 556.34.92.92 Fax. +33 (0) 556.34.92.92 E.mail : [email protected] E.mail : [email protected]

Tel. +1 856 222 9988

Fax. +86 10 646 580 15

Rosebery NSW 2018

Tel. +612 9669 2292 [email protected] Australia THAILAND Fax. +612 9669 2204 Tel. +612 9669 2292 ACTEON (THAILAND) LTD [email protected] 23/45THAILAND Sorachai Building 16th Fax. +612 9669 2204 floor -ACTEON Sukumvit(THAILAND) 63 LTD TAIWAN [email protected] Road,23/45 Klongton Nua Sorachai BuildingACTEON 16th TAIWAN Wattana, BANGKOK 10110 floor - Sukumvit 63 TAIWANRd. 11F., No.1, Songzhi - THAILAND Xinyi Dist., Taipei City TAIWAN 11047 METTMANN - GERMANY Road, Klongton Nua ACTEON Tel. +66 2 714 3295 TAIWAN (R.O.C.) Tel. +49 21 04 95 65 10 Wattana, BANGKOK 10110 11F., No.1, Songzhi Rd. Fax. +66 2 714 3296 SPAIN + 886 2 8729 2103Dist., Taipei City 11 Fax. +49MEDICO-DENTAL 21 04 95 65 11 - THAILAND Xinyi [email protected] ACTEON [email protected] [email protected] Tel. +66 2 714 3295 TAIWAN (R.O.C.) IBERICA, S.A.U. Hong Fax. Kong+66 Re. Office Avda Principal n°11 H 2 714 3296 + 886 2 8729 2103 21/F, On Hing Building Poligono SPAIN Industrial Can [email protected] [email protected] Central Hong Kong Clapers ACTEON MEDICO-DENTAL Tel. +852 66 962 134 08181 SENTMENAT IBERICA, S.A.U. Hong Kong Re. Office [email protected] (BARCELONA) - SPAIN Avda Principal n°11 H 21/F, On Hing Building Tel. +34 93 715 45 20 Poligono Industrial Can INDIACentral - Hong Kong Fax. +34 93 715 32 29 Clapers Tel.INDIA +852 66 962 134 ACTEON [email protected] 08181 SENTMENAT 1202, vianney.ruellan@acteonPLOT NO. D-9 (BARCELONA) - SPAIN group.com GOPAL HEIGHTS, NETAJI U.K. SUBASH PLACE ACTEON Tel. +34UK 93 715 45 20 PITAMPURA, Phoenix Eaton Fax. +34Park– 93 715 32Socon, 29 INDIA DELHI - 110034 INDIAACTEON INDIA St Neots [email protected] Tel. +91 11 47 018 291 / 47 CAMBS PE19 8EP - UK 1202, PLOT NO. D-9 058 291 / 45 618 291 Tel. +44 1480 477 307 U.K. GOPAL HEIGHTS, NETAJI Fax. +91 79 2328 7480 Fax. +44 1480 477 381 ACTEON UK SUBASH PLACE [email protected] [email protected]

Fax. +1 856 222 4726 GERMANY [email protected] ACTEON GERMANY GmbH Industriestrasse 9 – 40822 METTMANN GERMANY - GERMANY Tel. +49 21GERMANY 04 95 65 10 GmbH ACTEON Fax. +49 21 04 95 65 11 Industriestrasse 9 – 40822 [email protected]

Phoenix Park– Eaton Socon, St PITAMPURA, DELHI - 110034 Neots INDIA CAMBS PE19 8EP - UK Tel. +91 11 47 018 291 / 47 Tel. +44 1480 477 307 058 291 / 45 618 291 J28201 | V2 | (17) | 05/2017 | NF32EN010B Fax. +44 1480 477 381 Fax. +91 79 2328 7480 [email protected] [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