Related Manuals for Bien-Air Dental CA 1:2.5 L
Summary of Contents for Bien-Air Dental CA 1:2.5 L
- Page 1 CA 1:2.5 L CA 1:2.5 L MS ENG Instructions for use Other languages available on https:// dental.bienair.com/ifu RX Only 2100439-0000/2023.06...
- Page 2 MAINT LUBRIFLUID MAINT AQUA CARE REF 1500984-010 (BOX of 6 CANS) (BOX of 6 CANS) (BOX of 6 CANS) REF 1600036-006 REF 1600064-006 REF 1600617-006 2100439-0000 /2023.06 CA 1:2.5 L - CA 1 :2.5 L MS Bien-Air Dental SA © ●...
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Page 3: Table Of Contents
Table of content 1. Symbol ..........................3 Description of symbols used......................3 2. Identification & Intended Use ....................4 Identification ............................ 4 Intended Use ............................ 4 Intended patient population ......................4 Intended user ........................... 4 Use Environment ..........................4 Intended Medical Conditions ...................... -
Page 4: Symbol
1. Symbol 1.1 Description of symbols used. Symbol Description Symbol Description CE Marking with number of the Manufacturer. notified body. WARNING! hazard that could result Consult instructions for use or in serious injury or damage to the consult electronic instructions for device if the safety instructions are use. -
Page 5: Identification & Intended Use
Surgical contra-angles handpiece (CA), push-button bur locking, with light, speed increasing ratio and external irrigation. Description Bien-Air Dental contra-angles and straight handpieces (PM) are designed to transmit and apply the mechanical energy produced by an electric micromotor. E-type connection (ISO 3964) -
Page 6: Patient Contra-Indication And Side Effects
2.7 Patient contra-indication 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 case of accident 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. -
Page 7: User And Patient Safety: Warnings & Precautions For Use
Bien-Air Dental SA and have the service personnel carry out repair work. • Must ensure that the device is used only for the purpose for which it is intended, must protect themselves, their patients and third parties from any danger. - Page 8 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. • Respect the cleaning, sterilization and maintenance procedure detailed in section 6.
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Page 9: Description
They may not give rise to any claim. The original language of these instructions for use is English. For any further information, please contact Bien-Air Dental SA at the address given on the back cover. -
Page 10: Technical Data
4.2 Technical Data Contra-angle Information Motor coupling compatibility Coupling according to ISO 3964 - Microseries (MS) CA & PM can be coupled to short and extra short Motor couplings - Standard CA & PM can be coupled to all coupling types Lighting “L”... - Page 11 Shaft Length Length FIG 2 Compatibility of the chuck mechanism Shaft diameter 2.35 mm, type 1 as per ISO 1797, recommended length 26mm* code 4/5 as per ISO 6360-1 (Maximum working diameter 2.3 mm) (*) When using longer rotary instruments (e.g. 34 mm surgical burs) the user must ensure, by selecting the correct operating conditions, that there is no danger to the user, patient or third parties.
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Page 12: Classification
4.3 Classification Class IIa in accordance with European Medical Regulation (EU) 2017/745. 4.4 Performances Performances CA 1:2.5 L & CA 1:2.5 L MS Speed transmission ratio 1:2.5 4.5 Operating conditions Operating conditions Temperature range: [+10°C; +35°C] [+50°F; +95°F] Relative humidity range: [30%;... -
Page 13: Operation
• Never partially insert a bur to increase its contact your usual supplier or Bien-Air Dental SA for repair. active length. • Test your device without any • Do not touch the bur while the device is load to ensure the bur rotates rotating. -
Page 14: Maintenance And Servicing
Observing this procedure eliminates any blood, saliva or residues and prevents the transmission system from being blocked. • Only use original Bien-Air Dental SA maintenance products and parts or those recommended by Bien-Air Dental SA. For suitable maintenance products refer to section 6.1.2 Suitable maintenance... -
Page 15: Cleaning
FIG 4 FIG 5 6.2 Cleaning Remove dirt / deposits • Do not use saline solution to keep 1. Clean the exterior and interior the device moist until it can be of the device under tap water at cleaned. 15°C-38°C (59°F-100°F) •... -
Page 16: Disinfection
FIG. 7 6.3 Disinfection 5. After selecting the appropriate 6.3.1 Manual cleaning and disinfection nozzle, spray inside the device 1. Dip the device in a bath with Spraynet® (FIG 6). containing a cleaning and 6. Dry the external surfaces with disinfectant product (e.g. - Page 17 Recommended specifications for the thermo-disinfection cycle. Phase Parameters Pre-cleaning <45°C (113°F); ≥ 2 minutes Cleaning 45-55°C/113-131°F for enzymatic detergents and 45-65 °C/113- 149°F for alkaline detergents ≥ 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...
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Page 18: Lubrication
FIG. 7 6.4 Lubrication 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 7 1. -
Page 19: Packing And Storage
Procedure 1. Pack the device in a packaging approved for steam sterilization. 2. Sterilize using steam, following dynamic air removal cycle (ANSI/AAMI ST79, Section 2.19), i.e. air removal via forced evacuation (ISO 17665- 1, ISO/TS 17665- 2) at 135°C (275°F), for 3 minutes or 132°C (269.6°F) for 4 minutes. In jurisdictions where sterilization for prions is required, sterilize at 135°C (275°F) for 18 minutes. -
Page 20: Servicing
CAUTION 6.7 Servicing If the medical device has been stored Bien-Air Dental SA recommends a regular refrigerated, allow it to warm up to room service for the handpiece after 2000 temperature prior to removal from its processing cycles or 2 years. Never packaging and use. -
Page 21: General Information
LEGEND guarantee covering all functional defect, or material or manufacturing faults. Contra-angle handpiece speed 1601163-001 increasing ratio CA 1:2.5 L with light, The guarantee period is 12 months from push-button grip, external irrigation the date of invoicing. 1601164-001 Micro-series contra-angle handpie ce speed increasing ratio CA 1:2.5... - Page 22 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 2100439-0000/2023.06 CA 1:2.5 L - CA 1 :2.5 L MS Bien-Air Dental SA © ●...
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