Related Manuals for Bien Air CA 15:1 PROPHY
Summary of Contents for Bien Air CA 15:1 PROPHY
- Page 1 CA 15:1 PROPHY PM 10:1 PROPHY ENG INSTRUCTIONS FOR USE Other languages available on https://dental.bienair.com/IFU RX Only REF 2100050-0002/2024-04...
- Page 2 SCREW-TYPE MANDRE HEAD PM PROPHY MAINT SPRAYNET MAINT LUBRIFLUID (10/pkg) DISPOSABLE (100/pkg) (BOX 6 CANS) (BOX 6 CANS) REF 033.41.11-010 REF 1100056-100 REF 1600036-006 REF REF 1600064-006 REF 2100050-0002/2024-04 CA 15:1 PROPHY - PM 10:1 PROPHY • © Bien-Air Dental SA...
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Page 3: Table Of Contents
Table of content S S ymbols ymbols ............4 4 1. -
Page 4: Ymbols
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: Ation & Intended Use
E-type connection (ISO 3964) Ratio With light Without light Standard Short ● ● ● CA 15:1 PROPHY ● ● ● PM 10:1 PROPHY 2.2 Intended Use Intended Use Devices intended for use in general dentistry for dental prophylaxis. 2.3 Intended patient population... -
Page 6: Patient Contra-Indication And Side Effects
2.7 P P atient c atient contr ontra-indic a-indication and side effects ation and side effects No specific patient contra indication, side effects nor warnings exist for the contra-angle devices when the devices are used as intended. 2.8 In c In case of ac ase of accident cident... -
Page 7: Or Use
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.
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Page 9: Description
FIG. 1 . 1 4 Description 4.1 Ov Overview erview FIG. 1 (1) Screw-type mandrel for fixing Snap-On prophy tool (2) Micromotor connection (3) Handpiece head for prophy head insertion Note : Note : The technical specifications, illustrations and dimensions contained in these instructions are given merely as an indication. -
Page 10: Technical Data
4.2 T T echnic echnical Data al Data T T echnic echnical data al data CA 15:1 PR CA 15:1 PROPHY OPHY PM 10:1 PR PM 10:1 PROPHY OPHY Motor coupling Coupling according to ISO 3964 compatibility Transmission ratio Speed increasing ratio 15:1 (green color) -
Page 11: Ation
FIG. 2 . 2 FIG. 3 . 3 5 Operation 5.1 Pictogr Pictograms used ams used S S ym Description Description S S ym Description Description Movement in the direction Movement to the stop in the direction indicated. indicated. 5.2 Changing the pr Changing the proph ophy tool y tool... - Page 12 FIG. 4 . 4 For PM 10:1 Before connecting the handpiece to the motor, fit the disposable head in the handpiece chuck, by simply pushing it to the stop (FIG. 4, step 1). Disassembling the head Disconnect the handpiece from the motor. Then, disassemble the disposable head, by simply pulling it (FIG.
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Page 13: Maintenance And Servicing
6 Maintenance and Servicing 6.1 Maintenanc Maintenance - Gener e - General inf al information ormation Immediately after the treatment, disconnect and eliminate the prophy disposable tool. WARNING • The device is supplied "nonsterile". Clean, dry, lubricate and sterilize the device prior to first use. •... -
Page 14: Cleaning
FIG. 5 . 5 6.2 Cleaning Cleaning Remove dirt / deposits • Do not use saline solution to keep the device Clean the exterior and interior of the device under moist until it can be cleaned. tap water at 15°C-38°C (59°F-100°F) provided •... -
Page 15: Disinfection
FIG. 6 . 6 6.3.2 Automatic disinfection 6.3 Disinf Disinfection ection 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 Washer-disinfector and disinfectant product (e.g. - Page 16 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 —...
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Page 17: Lubrication
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 18: Packing And Storage
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 19: T T R R Ansport And Disposal Ansport And Disposal
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 20: General Information
8 General 8.2 R R ef efer erenc ences es Information Legend Legend Contra-angle handpiece decreasing 1600290-001 ratio 15:1 without light nor spray 8.1 T T erms of guar erms of guarantee antee Straight handpiece decreasing ratio 1600289-001 Bien-Air Dental SA grants the user a guarantee 10:1 without light nor spray covering all functional defect, or material or manufacturing faults. - Page 21 REF 2100050-0002/2024-04 CA 15:1 PROPHY - PM 10:1 PROPHY • © Bien-Air Dental SA...
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