Related Manuals for Bien Air CA 1:2.5 L
Summary of Contents for Bien Air 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 REF 2100439-0000/2023.06...
- Page 2 Optional accessories (REF) IRRIGATION LINE MAINT SPRAYNET® MAINT LUBRIFLUID® MAINT AQUACARE (10/pkg) (BOX 6 CANS) (BOX 6 CANS) (BOX 6 CANS) REF 1500984-010 REF 1600036-006 REF 1600064-006 REF 1600617-006 REF 2100439-0000/2023.06 CA 1:2.5 L - CA 1:2.5 L MS • © Bien-Air Dental SA...
-
Page 3: Table Of Contents
Table of content 6.3 Disinfection 1 Symbols 6.3.1 Manual cleaning and disinfection 16 1.1 Description of symbols used 6.3.2 Automatic disinfection 2 Identification & Intended Use 5 6.4 Lubrification 2.1 Identification 6.5 Sterilization 2.2 Intended Use 6.6 Packing and storage 2.3 Intended patient population 6.7 Servicing 2.4 Intended user... -
Page 4: Symbols
ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Symbol Description Symbol Description CE Marking with number of the notified body. Manufacturer.. WARNING: hazard that could result in serious injury Consult instructions for use or consult electronic or damage to the device if the safety instructions instructions for use. -
Page 5: Identification & Intended Use
Short ● CA 1:2.5 L ● ● ● CA 1:2.5 L MS ● ● 2.2 Intended Use Devices intended for use in oral surgery and maxillofacial surgery. 2.3 Intended patient population The intended patient population for the contra-angles includes any person visiting a medical practitioners’... -
Page 6: In Case Of Accident
2.8 In case of accident If an accident occurs, the device must not be used until repairs have been com- pleted 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 au- thority of your country, as well as the manufacturer through your regional distributor. -
Page 7: User And Patient Safety: Warnings & Precautions For 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 pre- vention measures, and these instructions for use. In accordance with such requirements, the operators: Must only use devices that are in perfect working order;... - Page 8 away using a retractor or dental mirror to avoid the risk of burns if the push- button is inadvertently pressed while the instrument is running. To prevent any risk of device overheating, the cautions below must be ob- served: CAUTION The device must not be started without a bur inserted into the chuck.
-
Page 9: Description
FIG. 1 4 Description 4.1 Overview FIG. 1 (1) Push-button with a bur-locking system (2) Transmission ratio (3) Bur (not supplied) (4) Light output (5) Micromotor connection (6) External irrigation connection 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. -
Page 10: Technical Data
4.2 Technical Data Contra-angle Information Coupling according to ISO 3964 Motor coupling - Microseries (MS) CA & PM can be coupled to short and extra short Motor couplings compatibility - Standard CA & PM can be coupled to all coupling types “L”... - Page 11 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) FIG. 2. (*) 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.
-
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 [+10°C; +35°C] Temperature range: [+50°F; +95°F] Relative humidity range: [30%;... -
Page 13: Operation
FIG. 3 5 Operation WARNING Never insert or remove a bur 5.1 Pictograms used while the device is rotating. Never partially insert a bur to in- Description Description crease its active length. Do not touch the bur while the Movement in Movement to the device is rotating. -
Page 14: Maintenance And Servicing
6 Maintenance and Servicing 6.1 Maintenance - General information 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. Rest the device on a cleanable support to avoid risks of infection for yourself, the patient or third parties. -
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 of the the device moist until it can be device under tap water at 15°C-38°C cleaned. (59°F-100°F) provided that the local Clean using manual cleaning or tap water has a pH within the range automated... -
Page 16: Disinfection
FIG. 6 6.3 Disinfection 6. Dry the external surfaces with sterile non-woven compresses (low linting 6.3.1 Manual cleaning and dis- textiles), preferably impregnated infection with Spraynet® or other blends of 1. Dip the device in a bath containing a drying alcohols, like ethanol or iso- cleaning and disinfectant product propyl alcohol suitable for metals (e.g. - Page 17 Recommended specifications for the thermo-disinfection cycle. Phase Parameters 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 de- Cleaning tergents ≥ 5 minutes Neutralization ≥ 2 minutes Rinsing Tap water, ≤30°C (86°F), ≥ 2 minutes cold water Thermal Disin- Demineralized water, 90°C —...
-
Page 18: Lubrification
FIG. 7 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. 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 jur- isdictions where sterilization for prions is required, sterilize at 135°C (275°F) for 18 minutes. -
Page 20: Servicing
sterilization pouch and store it in the original package. If the device is not stored in a sterilization pouch or if the pouch is no longer sterile, clean, lubricate and ster- ilize the device before using it. CAUTION If the medical device has been stored refrigerated, allow it to warm up to room tem- perature prior to removal from its packaging and use. -
Page 21: General Information
Information Legend Contra-angle handpiece speed in- 8.1 Terms of guarantee 1601163-001 creasing ratio CA 1:2.5 L with light, Bien- Air Dental SA grants the user a push-button grip, external irrigation guarantee covering all functional de- Micro-series contra-angle handpiece fect, or material or manufacturing speed increasing ratio CA 1:2.5 L MS... - 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 REF 2100439-0000/2023.06 CA 1:2.5 L - CA 1:2.5 L MS • © Bien-Air Dental SA...
Need help?
Do you have a question about the CA 1:2.5 L and is the answer not in the manual?
Questions and answers