Related Manuals for Bien-Air Dental CA NOVA 1:1L
Summary of Contents for Bien-Air Dental CA NOVA 1:1L
- Page 1 CA NOVA 1:1L CA NOVA 1:5L CA 1:1 L EVO15 CA 1:5 L EVO15 CA 1:1 CA 1:5 CA 10:1 HP 1:1 ENG INSTRUCTIONS FOR USE. Other languages available on www.bienair.com/ifu Rx Only REF 2100294-0003/2020.03...
- Page 2 Set supplied (REF) CA 10:1 Set supplied (REF) HP 1:1 CA 10:1 L CA 10:1 HP 1:1 HP 1:1 MS 1600385-001 1600425-001 1600383-001 1600693-001 Optional accessories (REF) 1600036-006 1600064-006 1000001-010 REF 2100294-0003/2020.03 CA 1:1,CA 1:5,CA 10:1,EVO15,NOVA,HP 1:1 • © Bien-Air Dental...
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Page 3: Table Of Contents
Table of contents 1 Symbols 7 Transport& disposal 1.1 Description of symbols used 7.1 Transport and storage con- ditions after first use 2 Identification & Intended Use 5 7.2 Disposal 2.1 Identification 8 General information 2.2 Classification 2.3 Intended use 8.1 Terms of guarantee 8.2 References 3 Precautions for use... -
Page 4: Symbols
ENG INSTRUCTIONS FOR USE 1 Symbols Description of symbols used Description Description Manufacturer. Reference number. CE Marking with number of the notified Serial number. body. WARNING:hazard that could result in ser- ious injury or damage to the device if the Medical Device. -
Page 5: Identification & Intended Use
2 Identification & Intended Use 2.1 Identification Medical devices manufactured in Switzerland by Bien-Air Dental SA. Type Dental contra-angles handpieces (CA), push-button bur locking, with or without light, with 3 internal sprays (CA 1:1, CA 10:1, CA 1:5), 4 mixed sprays on the EVO15 range and NOVA 1:5, 1 separated spray on the NOVA 1:1. -
Page 6: Classification
2.2 Classification Class IIa according to European Dir- ective 93/42/EEC relating to medical devices. Those medical devices comply with the legislation in force. 2.3 Intended use Products intended for professional use only. Used in general dentistry: NOVA 1:1L, EVO15 1:1, CA 1:1 and CA 10:1 for prophylaxis, res- toration endodontics... -
Page 7: Precautions For Use
For any further information, please con- tact Bien-Air Dental SA at the address In the event of irregular operation, ex- given on the back cover. cessive vibrations, abnormal heating,... -
Page 8: Description
FIG. 1 4 Description 4.1 Overview FIG. 1 (1) Centering for the micromotor (2) Light output (3) Bur (not supplied) (4) Transmission ratio marking clip (5) Push-button... -
Page 9: Technical Data
CA NOVA 1:5L MS, CA NOVA 1:1L MS, CA 1:5 L EVO15 MICRO-SERIES, CA 1:1 L EVO15 MICRO-SERIES, CA 1:5 L MICRO-SERIES, CA 1:1 L MICRO-SERIES and HP 1:1 MICRO-SERIES can only be operated on dental motors with an ISO coupling measuring no longer than 23 mm. - Page 10 FIG. 2 FIG. 3 Bur chuck FIG. 2 Shaft diameter 2.35 mm, type 1 as per ISO 1797-1, max length 22 mm, code 4 as per ISO 6360-1 for the CA 1:1 and the CA 10:1 range (max. working dia- meter 3 mm). Shaft diameter 1.60 mm, type 3 as per ISO 1797- 1, max length 21 mm, code 4-5 as per ISO 6360-1 for the CA 1:5 range (max.
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Page 11: Operation
FIG. 4 FIG. 5 5 Operation forced and the sleeve meets the mechanical abutment. 3. Check that the bur rotates freely and 5.1 Changing the bur that it is locked by gently pushing and CA NOVA 1:1L, CA NOVA 1:5L, CA 1:1, pulling the bur. CA 1:5, CA 10:1, CA 1:1 L EVO15 and CA 1:5 L EVO15 FIG. 4... - Page 12 CAUTION Never insert or remove a device while the micromotor is rotating. WARNING Do not touch the dental bur while it is ro- tating. WARNING Never push the push-button while the CA is in operation. Never rotate the lock- ing ring on an operating HP. CAUTION Always check that the bur is in place and rotates freely.
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Page 13: Cleaning And Servicing
(deionized) water instead. mission system from being blocked. Manual cleaning-disinfection: Only use original Bien-Air Dental Alkaline detergent or detergent- SA maintenance products and disinfectant (pH 8-11) re- parts or those recommended by commended for cleaning- Bien-Air Dental SA.For suitable... -
Page 14: Cleaning
EVO15 NOVA 1:1 CA 1:1, 1:5, 10:1 HP 1:1 FIG. 6 FIG. 7 6.2 Cleaning Preparation 1. Disconnect the device from the elec- trical motor and remove the bur (FIG. 4 step 1). CAUTION If there is a large amount of debris, clean the exterior of the device with dis- infectant wipes. -
Page 15: Disinfection
FIG. 8 6.3 Disinfection 6. Dry the external surfaces with sterile non-woven compresses (low linting textiles). 6.3.1 Manual cleaning / disinfection 1. Dip the device in a bath containing a 6.3.2 Automatic disinfection disinfectant product (e.g. di- decyldimethylammonium chloride, CAUTION quaternary ammonium carbonate or neutral enzymatic product which are Only for device engraved with allowable chemical agents). - Page 16 Recommended specifications for the thermo-disinfection cycle. Phase Parameters Pre-cleaning <45°C (113°F); ≥ 2 minutes Cleaning 55°C-65°C (131°F-149°F); ≥ 5 minutes Neutralization ≥ 2 minutes Rinsing Tap water, ≤30°C (86°F), ≥ 2 minutes cold water Thermal Disinfection Demineralized water, 90°C-95°C (194°F-203°F), 5-10 minutes Drying 18-22 minutes CAUTION...
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Page 17: Lubrication
FIG. 9 6.4 Lubrication Procedure 6.4.1 Verifying cleanliness CAUTION Visually inspect the device to ensure it is clean. Repeat the cleaning and dis- Pack the device in a packaging ap- infection procedure if necessary. proved for steam sterilisation. 6.4.2 Lubrication CAUTION Lubricate before each sterilisation or at Only use dynamic air removal cycles: least twice a day. -
Page 18: Packing
6.7 Servicing temperature of 137°C is in ac- cordance with national Note : Bien-Air Dental SA recommends requirements for moist heat ster- that the user has his or her dynamic ilization and does not exceed 30 devices checked or serviced every minutes. -
Page 19: General Information
8 General 8.2 References information 8.2.1 Set supplied (see cover) Legend 8.1 Terms of guarantee Ratio Bien-Air Dental SA grants the user a ● 1601139-001 CA NOVA 1:5L* warranty covering any operating fault, ● 1601138-001 CA NOVA 1:5L MS* or material or manufacturing defect. -
Page 20: Set Supplied For Students
8.2.2 Set supplied for students 8.2.3 Optional accessories (see cover) SET 1700793 Legend Ratio Legend ● 1600052-001 PM 1:1 EXT SPRAY Spraynet, 500ml cleaning spray, 1600036-006 1600677-001 MC MX2 box of 6 CA 1:1 L Lubrifluid, 500ml spray lub- ● 1600691-001 1600064-006 MICRO-SERIES*... - Page 21 Bien-Air Dental SA Länggasse 60 Case postale 2500 Bienne 6 Switzerland Tel. +41 (0)32 344 64 64 Fax +41 (0)32 344 64 91 dental@bienair.com Other adresses available at www.bienair.com REF 2100294-0003/2020.03 CA 1:1,CA 1:5,CA 10:1,EVO15,NOVA,HP 1:1 • © Bien-Air Dental...
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