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Summary of Contents for Bien Air CA 1:1
- Page 1 CA 1:1 EVO.15 1:1 CA 1:5 EVO.15 1:5 CA 10:1 HP 1:1 ENG INSTRUCTIONS FOR USE. Other languages available on www.bienair.com/ifu REF 2100294-0002/2020.01 Rx Only...
- Page 2 Set supplied (REF) CA 1:1 1600384-001 1600424-001 1600691-001 1600939-001 1600938-001 Set supplied (REF) CA 10:1 Set supplied (REF) HP 1:1 1600385-001 1600425-001 1600383-001 1600693-001 Optional accessories (REF) 1600036-006 1600064-006 1000001-010 REF 2100294-0002/2020.01 CA 1:1,CA 1:5,CA 10:1,EVO.15,HP 1:1 • © Bien-Air Dental SA...
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Page 3: Table Of Contents
Table of contents 7.1 Transport and storage condi- 1 Symbols tions 1.1 Description of symbols used 7.2 Disposal 2 Identification & Intended Use 5 8 General information 2.1 Identification 8.1 Terms of guarantee 2.2 Classification 8.2 References 2.3 Intended use 8.2.1 Set supplied (see cover) 3 Precautions for use 8.2.2 Optional accessories (see cover) 15... -
Page 4: Symbols
ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Description Description Manufacturer. Reference number. CE Marking with number of the no- Serial number. tified body. Separate collection of electric and electronic equip- CAUTION! ment. Refer to the accompanying Recyclable materials. -
Page 5: Identification & Intended Use
93/42/EEC relating to medical prove dangerous. devices. This medical device complies CA 1:1, CA 10:1and EVO.15 1:1 for with the legislation in force. prophylaxis, restoration and en- dodontic procedures. CA 1:5, EVO.15 1:5 and HP 1:1 for general dentistry and restoration procedures. -
Page 6: Precautions For Use
3 Precautions for use This medical device accessory must be operation. Always observe the main- used by a competent person, in par- tenance instructions provided with each ticular in compliance with the legal product. Never lubricate the electric provisions in force regarding oc- brush motor. -
Page 7: Description
135°C FIG. 1 4 Description 4.1 Overview Electric power supply VDC or VAC: 3.4 ±0.3 V. The power sup- FIG. 1 ply systems must be in compliance with (1) Centering for the micromotor IEC 60601-1 and IEC 60601-1-2 stan- (2) Light output dards. - Page 8 Type 1 / ISO 1797 Type 2 / ISO 1797 min. 12 mm Code 4 / ISO 6360-1 Code 4 / ISO 6360-1 min. 30 mm max. 22 mm ø 2,35 mm Type 3 / ISO 1797 min. 12 mm Code 4-5 / ISO 6360-1 max.
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Page 9: Operation
FIG. 5 5 Operation CAUTION Never insert a device on a rotating mi- 5.1 Changing the bur cromotor. CA 1:1, CA 1:5, CA 10:1, EVO.15 1:1 and CAUTION EVO.15 1:5 Always ensure that the spray outlets are not obstructed. FIG. 4 CAUTION Push-button bur locking. -
Page 10: Cleaning And Servicing
6 Cleaning and 6.1.2 Suitable maintenance products servicing Automatic cleaning-disinfection: Low alkaline or enzymatic detergent re- 6.1 Maintenance commended for cleaning in a washer- Clean, lubricate and sterilise the device disinfector for dental or surgical ins- separately between patients. truments (pH 6 - 9.5). Manual cleaning-disinfection: CAUTION Spraynet. -
Page 11: Preliminary Cleaning
EVO.15 CA 1:1, 1:5, 10:1 HP 1:1 FIG. 6 FIG. 7 6.2 Preliminary cleaning 6.2.1 Manual preliminary cleaning 1. Spray the exterior and interior of the Preparation device for 1 second with Spraynet. 1. Disconnect the device from the cou- Carefully clean the surfaces using a pling and remove the bur (FIG. 3... -
Page 12: Cleaning-Disinfection
FIG. 8 6.3 Cleaning-disinfection 6.3.2 Automatic cleaning-disinfection 6.3.1 Manual cleaning/disinfection CAUTION FIG. 8 Only for device engraved with 1. Dip the device in a tank containing ap- propriate detergent and, using a soft Washer-disinfector brush, clean and disinfect the device, Carry automatic cleaning- di- clean the exterior of the device in ac- sinfection using an approved washer-... -
Page 13: Lubrication
FIG. 9 FIG. 10 6.4 Lubrication Procedure Enclose the device and its accessories in 6.4.1 Verifying cleanliness sterilisation bags which are large en- Visually inspect the device to ensure it is ough to ensure the items can move clean. If necessary, clean again using a around, and which comply with the stan- soft brush. -
Page 14: Packing & Disposal
The warranty period is: Packing 12 months for the CA 10:1 range Pack the device in packaging approved 24 months for the CA 1:1, CA 1:5, for steam sterilisation. HP 1:1 and EVO.15 ranges from the date of invoicing. CAUTION... -
Page 15: References
8.2.2 Optional accessories CAUTION (see cover) The warranty becomes null and void if damage and its consequences result from incorrect servicing or modification Legend by third parties not authorised Spraynet, 500ml cleaning spray, by Bien-Air Dental SA. 1600036-006 box of 6 Warranty requests will only be taken in- to consideration if the product is Lubrifluid, 500ml... - Page 16 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 2100294-0002/2020.01 CA 1:1,CA 1:5,CA 10:1,EVO.15,HP 1:1 • © Bien-Air Dental SA...
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