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Summary of Contents for Bien Air CA 1:2.5 L MS
- Page 1 CA 1: 2.5 L MS ENG INSTRUCTIONS FOR USE Other languages available on www.bienair.com/ifu REF 2100337-0003/2020.09 Rx Only...
- Page 2 Set supplied (REF) CA 1:2.5 L MS 1601055-001 Optional accessories (REF) 1600617-006 1600036-006 1600064-006 1000001-010 REF 2100337-0003/2020.09 CA 1:2.5 L MS • © Bien-Air Dental SA...
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Page 3: Table Of Contents
Table of contents 6.7 Servicing 1 Symbols 1.1 Description of symbols used 7 Transport& disposal 2 Identification & Intended Use 6 7.1 Transport 7.2 Disposal 2.1 Identification 2.2 Classification 8 General information 2.3 Intended use 8.1 Terms of guarantee 8.2 References 3 Precautions for use 8.2.1 Set supplied (see cover) 4 Description... -
Page 4: Symbols
ENG INSTRUCTIONS FOR USE 1 Symbols Description of symbols used Description Description Manufacturer. Catalogue number. CE Marking with number of the notified Serial number. body. WARNING:hazard that could result in ser- ious injury or damage to the device if the Medical Device. -
Page 5: Identification & Intended Use
2 Identification & Intended Use 2.1 Identification 2.3 Intended use Medical devices manufactured by Bien- Product intended for professional use Air Dental SA. only. Used in general dentistry and oral surgery. Type Contra-angle handpiece (CA) speed mul- tiplier ratio with light and external WARNING irrigation. -
Page 6: Precautions For Use
3 Precautions for use Those medical devices must be used by CAUTION professionals in compliance with the It is essential to use dry, purified com- legal provisions in force regarding oc- pressed air in order to ensure the long cupational safety, health and accident working life of the device. -
Page 7: Description
FIG. 1 (CA 1:2.5 L MS) 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 4.2 Technical data Contra-angle 1:2.5 Standard coupling As per ISO standard 3964* Drive speed 40’000 rpm max. - Page 8 FIG. 2 FIG. 3 Bur chuck FIG. 2 Shaft diameter 1.60 mm, type 3 as per ISO 1797-1, recommended length 21 mm* code 4/5 as per ISO 6360-1 for the 1:2.5 range (Maximum working dia- meter 2 mm). (*) When using longer rotary in- struments (e.g.
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Page 9: Operation
5 Operation WARNING The use of a coolant while the in- 5.1 Changing the bur strument is in operation is mandatory, failure comply with this FIG. 3 commendation result Push-button bur locking. overheating and burns or product fail- 1. Press the push-button and sim- ure. -
Page 10: Cleaning And Servicing
6 Cleaning and Only instruments marked with the logo can be cleaned in a servicing washer-disinfector machine. As with all instruments, following 6.1 Maintenance - General in- each sterilization cycle, including drying, remove the device to avoid formation excess exposure to heat which can result in corrosion. -
Page 11: Cleaning
FIG. 4 FIG. 5 6.2 Cleaning outside of the device and inside the ir- rigation tube (see FIG. 5). Preparation 1. Disconnect the device from the elec- trical motor and remove the bur (FIG. 3 step 1). CAUTION If there is a large amount of debris, clean the exterior of the device with dis- infectant wipes. -
Page 12: Disinfection
FIG. 6 6.3 Disinfection 5. After selecting the appropriate nozzle, spray inside the device with Spraynet (FIG. 6). 6.3.1 Manual disinfection 1. Dip the device in a bath containing a 6. Dry the external surfaces with sterile disinfectant product (e.g. di- non-woven compresses (low linting decyldimethylammonium chloride, textiles). - Page 13 Recommended specifications for the thermo-disinfection cycle. Phase Parameters Pre-cleaning <45°C (113°F); ≥ 2 minutes Cleaning 55°C-65°C (131°F-149°F); ≥ 5 minutes Neutralization ≥ 2 minutes Rinsing Tap water, ≤30°C (86°F), ≥ 2 minutes cold water Thermal Disinfection 90°C-95°C (194°F-203°F), 5-10 minutes Drying 18-22 minutes CAUTION...
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Page 14: Lubrication
FIG. 7 6.4 Lubrication 6.5.1 Procedure 6.4.1 Verifying cleanliness 1. Pack the device in a packaging ap- Visually inspect the device to ensure it is proved for steam sterilization. clean. Repeat the cleaning and dis- 2. Sterilize using steam, following dy- infection procedure if necessary. - Page 15 The recommended parameters for the sterilization cycle are: The maximum temperature in the autoclave chamber does not exceed 137°C, i.e. the nominal temperature of the autoclave is set at 134°C, 135°C or 135.5°C taking into account the uncertainty of the sterilizer as regards tem- perature.
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Page 16: Packing And Storage
7 Transport 6.6 Packing and storage The device must be stored inside the & disposal sterilization pouch in a dry and dust- free environment. The temperature 7.1 Transport must not exceed 55°C (131°F). If the device will not be used for 7 days or There are no particular transport and more after the sterilization, extract the storage conditions required. -
Page 17: General Information
8.2 References information 8.2.1 Set supplied (see cover) Legend 8.1 Terms of guarantee 1601055-001 CA 1:2.5 L MS contra-angle Bien-Air Dental SA grants the user a warranty covering any operating fault, 8.2.2 Optional accessories or material or manufacturing defect. (see cover) - Page 18 NOTES...
- Page 19 NOTES...
- Page 20 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 adresses available at www.bienair.com REF 2100337-0003/2020.09 CA 1:2.5 L MS • © Bien-Air Dental SA...
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