Related Manuals for Bien Air PM
Summary of Contents for Bien Air PM
- Page 1 CA NOVA CA EVO CA CLASSIC ENG INSTRUCTIONS FOR USE. Other languages available on https://dental.bienair.com/IFU Rx Only REF 2100294-0007/2022.09...
- Page 2 Contra-angles (REF) CA 1:5 CA 1:5 L EVO15 CA 1:5 L CA NOVA 1:5L CA NOVA 1:5L MS CA 1:5 L EVO15 MICRO-SERIES CA 1:5 L CA 1:5 MICRO-SERIES 1601139-001 1601138-001 1600941-001 1600940-001 1600386-001 1600325-001 1600690-001 Contra-angles (REF) CA 1:1 CA 1:1 L EVO15 CA 1:1 L CA NOVA 1:1L...
- Page 3 Optional accessories (REF) MAINT SPRAYNET® (BOX 6 CANS) MAINT LUBRIFLUID® (BOX 6 CANS) 1600036-006 1600064-006...
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Page 4: Table Of Contents
Table of contents 6.2 Cleaning 1 Symbols 6.3 Disinfection 1.1 Description of symbols used 6.4 Lubrification 2 Identification & Intended Use 6 6.5 Sterilization 2.1 Identification 6.5.1 Procedure 2.2 Intended use 6.6 Packing and storage 2.3 Intended patientpopulation 6.7 Servicing 2.4 Intended user 7 Transport &... -
Page 5: Symbols
ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Symbol Description Symbol Description Manufacturer.. Catalogue number. CE Marking with number of the notified body. Serialnumber. WARNING: hazard that could result in serious injury or damage to the device if the safety instructions MedicalDevice. -
Page 6: Identification & Intended Use
● ● ● ● CA NOVA 1:5L ● ● ● ● CA NOVA 1:5L MS ● ● ● ● CA 1:5 L EVO15 CA 1:5 L EVO15 MICRO- ● ● ● ● SERIES ● ● ●... -
Page 7: Intended Use
2.2 Intended use 2.7 Patient contra -indications and side effects Devices intended for use in general dentistry: No specific patient contra- indication, NOVA 1:5L, EVO15 1:5, CA 1:5, PM side effects nor warning exist for the device when it is used as intended. Devices intended for use in general 2.8 In case of accident dentistry and in endodontics:... -
Page 8: User And Patient Safety: Warnings And Precautions For Use
3 User and Patient sharp instruments should be handled with great care. Safety: Warnings and Precautions for use To prevent any risk of contra- angle/handpiece overheating, the cau- This medical device must be used by tion below must be observed: professionals in compliance with the legal provisions in force regarding oc- CAUTION... - Page 9 locked by gently pushing and To prevent any risk of device mal- pulling the bur. function the cautions below must be Always check that the clamping observed: sleeve (or locking ring) is fully tightened, passing the initial mech- CAUTION anical resistance to meet the Before performing any clinical ap- abutment.
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Page 10: Description
FIG. 1 4 Description 4.1 Overview FIG. 1 (1) Micromotor connection (2) Light output (3) Bur (not supplied) (4) Transmission ratio (5) Push-button with a bur-locking system Note : The technical specifications, illustrations and dimensions contained in these instructions are given merely as an indication. They may not give rise to any claim. The original language of those instructions for use is English. -
Page 11: Technical Data
4.2 Technical data CA 1:1 CA 1:1 L CA 1:5 L MICRO-SERIES PM 1:1 CA NOVA 1:5L MS Technical data CA NOVA 1:1L CA 1:5 L PM 1:1 MICRO-SERIES CA NOVA 1:5L CA 1:1 L MICRO-SERIES CA 1:5 CA NOVA 1:1L MS... - Page 12 FIG. 2 FIG. 3 Cutting tool compatibility Shaft diameter 2.35 mm (Type 1) 2.35 mm (Type 2) 1.60 mm (Type 3) ISO 1797-1 Shaft length ≥ 11 mm ≥ 30 mm ≥ 11 mm ISO 1797-1 Cutting tool diameter ≤ 3 mm ≤...
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Page 13: Classification
4.3 Classification Class IIa in accordance with European Medical Regulation (EU) 2017/745. 4.4 Performances Performances Spray water flow at 200 kPa Min. 60 ml/min Spray air flow at 200 kPa Min. 2 Nl/min 4.5 Operating conditions Operating conditions Temperature range: +10°C —... -
Page 14: Operation
FIG. 4 5 Operation CAUTION It is essential to use dry, purified 5.1 Changing the bur compressed air in order to en- sure the long working life of the Pictograms used device. Maintain the quality of the air and the water by regular main- Description Description tenance of the compressor and... - Page 15 FIG. 5 FIG. 6 PM 1:1 FIG. 5 & FIG. 6 1. Rotate the sleeve and remove the bur. 2. Fully insert the new bur in the chuck system. Lock the bur changing mech- anism by fully rotating the sleeve, it will only be fully tightened if the initial mechanical resistance is forced and the sleeve meets the mechanical abutment.
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Page 16: Maintenance And Servicing
6 Maintenance and servicing 6.1 Maintenance - General information Clean, disinfect, dry and sterilize the device prior to first use. Within a maximum of 30 minutes after each treatment, clean, disinfect and lub- ricate the instrument. Observing this procedure eliminates any blood or saliva residues and prevents the transmission system from being blocked. -
Page 17: Cleaning
FIG. 7 6.2 Cleaning Remove dirt / deposits FIG. 7 CAUTION 1. Clean the exterior and interior of the Do not submerge in physiological device under tap water at 15°C-38°C liquid (NaCI) nor use saline solu- (59°F-100°F) provided that the local tion to keep the device moist until tap water has a pH within the range it can be cleaned. -
Page 18: Disinfection
6.3 Disinfection Detergent and washing cycle: Use an alkaline or detergent re- Manual cleaning and disinfection commended for cleaning in a washer- 1. Dip the device in a bath containing a disinfector for dental or surgical in- cleaning and disinfectant product (di- struments (pH 8-11). -
Page 19: Lubrification
FIG. 8 6.4 Lubrification Verifying cleanliness Visually inspect the device to ensure it is clean. Repeat the cleaning and dis- infection procedure if necessary. Lubrication Lubricate before each sterilization or at least twice a day. Only the Lubrifluid® spray must be used. FIG. 8 1. -
Page 20: Sterilization
6.5 Sterilization CAUTION The quality of the sterilization is highly dependent on how clean the device is. Only perfectly clean devices may be sterilized. To improve the effectiveness of the sterilization, make sure the device is com- pletely dry. Do not use a sterilization procedure other than the one described below. Only use dynamic air removal cycles: pre-vacuum or steam flush pressure pulse (SFPP) cycles. -
Page 21: Packing And Storage
6.6 Packing and storage Storage conditions Temperature range: 0°C — +40°C (+32°F — +104°F) Relative humidity range: 10% — 80% Air pressure range: 650 hPa — 1060 hPa Keep away from rain The device must be stored inside the sterilization pouch in a dry and dust free en- vironment. -
Page 22: Transport & Disposal
7 Transport & disposal 7.1 Transport Transport conditions Temperature range: -20°C — +50°C (-4°F — +122°F) Relative humidity range: 5% — 80% Air pressure range: 650 hPa — 1060 hPa Keep away from rain 7.2 Disposal The disposal and/or recycling of materials must be performed in accordance with the legislation in force. -
Page 23: General Information
8.1 Terms of guarantee ● 1601139-001 CA NOVA 1:5L* Bien-Air Dental SA grants the operator ● 1601138-001 CA NOVA 1:5L MS* a guarantee covering all functional de- ● fects, material or production faults. 1600941-001 CA 1:5 L EVO15* CA 1:5 L EVO15 The warranty period is 24 months from ●... - Page 24 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 addresses available at www.bienair.com Bien-Air France Sàrl 19-21 rue du 8 mai 1945 94110 Arcueil France REF 2100294-0007/2022.09 CA 1:1, CA 1:5, CA 10:1, EVO15, NOVA, PM 1:1 •...
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