Related Manuals for Bien Air CA 20:1 L Micro Series
Summary of Contents for Bien Air CA 20:1 L Micro Series
- Page 1 CA 20:1, CA 20:1 L CA 20:1 L KM CA 20:1 L Micro-Series CA 20:1 L KM Micro-Series ENG INSTRUCTIONS FOR USE Other languages available on https://dental.bienair.com/IFU RX Only REF 2100209-0009/2024-08...
- Page 2 Devices REF 1600632-001 REF 1600598-001 REF 1600692-001 REF 1600785-001 REF 1600786-001 Optional accessories (REF) IRRIGATION LINE IRRIGATION LINE KM IRRIGATION LINE SYST KM 20:1 L (10/pkg) (10/pkg) (10/pkg) REF 1500984-010 REF 1501635-010 REF 1501621-010 MAINT SPRAYNET® MAINT LUBRIFLUID® MAINT AQUACARE (BOX of 6 CANS) (BOX of 6 CANS) (BOX of 6 CANS)
- Page 3 Table of content S S ymbols ymbols ............4 4 1.
- Page 4 ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Description of symbols used S S ymbol ymbol Description Description S S ymbol ymbol Description Description CE Marking with number of the notified Manufacturer. body. WARNING: hazard that could result in Consult instructions for use or consult serious injury or damage to the device electronic...
- Page 5 2 Identification & Intended Use 2.1 Identific Identification ation Medical devices manufactured by Bien-Air Dental SA. Type Dental contra-angles handpiece (CA), push-button bur locking, with or without light, speed reducing ratio and external irrigation. Description Bien-Air Dental contra-angles are designed to transmit and apply the mechanical energy produced by an electric micromotor.
- Page 6 2.8 In c In case of ac ase of accident cident If an accident occurs, the device must not be used until repairs have been completed by a qualified, authorized and trained technician in a repair center. If any serious incident occurs in relation to the device, report it to a competent authority of your country, as well as the manufacturer through your regional distributor.
- Page 7 3 User and Patient Safety: Warnings & Precautions for use WARNING The device must be used by qualified dental professionals in compliance with the current legal provisions concerning occupational safety, health and accident prevention measures, and these instructions for use. In accordance with such requirements, the operators: •...
- Page 8 To prevent any risk of device failure or malfunction the cautions below must be observed: CAUTION • Before performing any clinical application, always test your device without any load to ensure it is in perfect order. • Only use original Bien-Air Dental SA devices and accessories or those recommended by Bien-Air Dental SA.
- Page 9 FIG. 1 . 1 4 Description 4.1 Ov Overview erview FIG. 1 (1) Micromotor connection (2) Light output (if applicable) (3) Tool (not supplied) (4) Transmission (5) Push-button with a bur-locking system (6) Kirshner/Meyer irrigation system (7) Plastic holder for the Kirshner/Meyer irrigation system Note : Note : The technical specifications, illustrations and dimensions contained in these instructions are given merely as an indication.
- Page 10 4.2 T T echnic echnical Data al Data T T echnic echnical data al data CA 20:1 CA 20:1 Coupling according to ISO 3964 - MS & MICRO-SERIES can be coupled to short and extra short Motor Motor coupling compatibility coupling - Other CA &...
- Page 11 FIG. 2 . 2 Compatibility of the chuck mechanism Shaft diameter 2.35 mm (0.09 in), type 1 as per ISO 1797, max. length 34 mm (0.87 in), code 4-6 as per ISO 6360-1 FIG. In implantology, longer cutting tools (Min. shaft length 12 mm in accordance with ISO 1797) can be used under the responsibility of the practitioner.
- Page 12 4.3 Classific Classification ation Class IIa in accordance with European Medical Regulation (EU) 2017/745. 4.4 P P erf erformanc ormances es P P erf erformances ormances CA 20:1 CA 20:1 Speed transmission ratio 20:1 4.5 Oper Operating c ating conditions onditions Oper Operating conditions...
- Page 13 FIG. 3 . 3 5 Operation 5.1 Pictogr Pictograms used ams used Clamping system inspection S S ym ym Description Description S S ym ym Description Description Verify that the bur can be turned around smoothly and check that the bur remains in position when Movement in the Movement to the stop traction is applied...
- Page 14 6 Maintenance and Servicing 6.1 Maintenanc Maintenance - Gener e - General inf al information ormation WARNING • The device is supplied "nonsterile". Clean, dry, lubricate and sterilize the device prior to first use. • Follow your national directives, standards and guidelines for cleaning and sterilization recommendations.
- Page 15 FIG. 5 . 5 FIG. 4 . 4 6.2 Cleaning Cleaning Remove dirt / deposits • Do not use saline solution to keep the device 1. 1. Clean the exterior and interior of the device moist until it can be cleaned. under tap water at 15°C-38°C (59°F-100°F) •...
- Page 16 FIG. 6 . 6 6.3 Disinf Disinfection ection 6.3.2 Automatic disinfection Note : Note : The automatic cleaning-disinfection can 6.3.1 Manual cleaning and disinfection replace the previous steps 4 to 6. 1. 1. Dip the device in a bath containing a cleaning and disinfectant product (e.g.
- Page 17 Recommended specifications for the thermo-disinfection cycle. Phase Phase P P ar arameter ameters s Pre-cleaning <45°C (113°F); ≥ 2 minutes 45-55°C/113-131°F for enzymatic detergents and 45-65 °C/113-149°F for alkaline Cleaning detergents ≥ 5 minutes Neutralization ≥ 2 minutes Rinsing Tap water, ≤30°C (86°F), ≥ 2 minutes cold water Thermal Demineralized water, 90°C —...
- Page 18 FIG. 7 . 7 6.4 Lubric Lubrication ation Verifying cleanliness Visually inspect the device to ensure it is clean. Repeat the cleaning and disinfection procedure if necessary. Lubrication Lubricate before each sterilization or at least twice a day. Only the Lubrifluid® spray must be used. FIG.
- Page 19 The recommended parameters for the sterilization cycle are: • The maximum temperature in the autoclave chamber does not exceed 137°C (278°F), i.e. the nominal temperature of the autoclave is set between 132°C – 135.5°C (269.6°F – 275.9°F) taking into account the uncertainty of the sterilizer as regards temperature. •...
- Page 20 7 Transport and Disposal 7.1 T T r r ansport ansport T T r r ansport conditions ansport conditions [-20°C; +50°C] Temperature range: [-4°F; +122°F] Relative humidity range: [5%; 80%] Air pressure range: [650 hPa; 1060 hPa] Barometric pressure range: [490 mmHg;...
- Page 21 8 General Information 8.1 T T erms of guar erms of guarantee antee 8.2 R R ef efer erenc ences es Bien-Air Dental SA grants the user a guarantee Legend Legend covering all functional defect, or material or manufacturing faults. Contra-angle handpiece speed 1600598-001 reducing ratio CA 20:1 L with light,...
- Page 22 REF 2100209-0009/2024-08 CA 20:1 • © Bien-Air Dental SA...
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