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Summary of Contents for Bien Air RECIPROCATING MICROSAW
- Page 1 RECIPROCATING MICROSAW ENG INSTRUCTIONS FOR USE RX ONLY REF: 2100358-0002/2024.06...
- Page 2 Set supplied (REF) RECIPROCATING MICROSAW RECIPROCATING MICROSAW Irrigation ring REF 1601098-001 1502918-001 O-rings REF 1308430-001 Optional accessories (REF) Spraynet® Lubrifluid® Aquacare REF 1600036-006 REF 1600064-006 REF 1600617-0006 Irrigation line Irrigation ring REF 1500984-010 REF 1502918-003 REF 2100358-0002/2024.06 Reciprocating Microsaw • © Bien-Air Dental SA...
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Page 3: Table Of Contents
Table of contents 1 Symbols ..............................5 1.1 Description of Symbols used ......................5 2 Identification & Intended Use ......................6 2.1 Identification ..........................6 2.2 Intended use ..........................6 2.3 Intended patient population ......................6 2.4 Intended User ..........................6 2.5 Intended medical condition ...................... - Page 4 6.3.2 Automatic disinfection (optional) ..................17 6.4 Lubrication ........................... 19 6.4.1. Verifying cleanliness ......................19 6.4.2 Lubrication with Lubrifluid® ....................19 6.5 Sterilization ..........................20 6.5.1 Procedure ..........................20 6.6 Packing and storage ........................21 6.7 Servicing ............................21 7 Transport & disposal .......................... 22 7.1 Transport .............................
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Page 5: Symbols
1 Symbols 1.1 Description of Symbols used Symbol Description Symbol Description Manufacturer. Catalogue number. Sterilizable in a steam sterilizer Serial number. (autoclave) up to the specified temperature. RX ONLY Caution: in accordance with federal Data Matrix code for product law (USA), this device is only available information including for sale upon recommendation by an UDI (Unique Device Identification). -
Page 6: Identification & Intended Use
2 Identification & Intended Use 2.1 Identification Medical device manufactured by Bien-Air Dental SA. Type Reciprocating Microsaw* handpiece, with internal irrigation, without light, to be connected to a E type short micromotor (ISO 3964). *Hereafter: Microsaw Classification Class I according to FDA Code of Federal Regulations 21 CFR 878.4820 relating to medical devices. -
Page 7: In Case Of Accidents
2.7 In case of accidents The Microsaw system (microsaw and cutting tools) must not be used until repairs of the microsaw have been completed by a qualified and trained technician authorized by the manufacturer. Damaged or deformed cutting tools must be disposed of. 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 8: Warnings & Precautions Of Use
3 Warnings & Precautions of use 3.1 General information The device must be used by qualified 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 9: Description
(4) Irrigation ring (5) Reciprocating microsaw (6) Clamping ring 4.2 Technical data The following technical data and performances apply to the reciprocating microsaw device (the dispersion affecting these quantities is below or equal to 5%). Technical data Reciprocating microsaw Irrigation ring 1502918-001... -
Page 10: Performances
4.3 Performances Performances Reciprocating microsaw ≥ 5.5 mm/s (***) Cutting speed ≥ 100 ml/min (**) Maximum distribution of physiological liquid ≥ 50 ml/min (**) Minimum distribution of physiological liquid Noise in no-load (at 1 meter) < 75 dBA (*) Hand-transmitted vibrations in <... -
Page 11: Operation
Movement to the stop in the direction indicated. Movement in the direction indicated. Description of pictograms used 5 Operation 5.1 Operating conditions and procedure Before operating the device, follow this procedure: 1) Check that the ambient temperature ranges between +10°C to +35°C (+50°F to +95°F) and that it is under standard humidity conditions (relative humidity below 80%, without condensation). -
Page 12: Changing The Cutting Tool
CAUTION Depending on the angular position of the clamping ring, a difference of flow rate may be noticed for high flow rate. CAUTION Before each use, always check that the physiological solution flows freely and without leak out of the cutting tool. CAUTION Perform a test run during 5 seconds before each use. -
Page 13: Changing The Irrigation Line
Never touch a cutting tool on a microsaw in motion. FIG. 3 FIG. 4 5.3 Changing the irrigation line WARNING Irrigation lines are single use. The irrigation ring is reusable. CAUTION Prior to changing the irrigation line and ring, always remove the cutting tool, as it may damage the irrigation ring O-rings. -
Page 14: Changing The O-Rings
5.4 Changing the O-rings 5.4.1 Missing or damaged O-rings In case of insufficient irrigation and leakage: • Make sure that all O-rings are on the irrigation ring and are undamaged. • If at least one O-ring is missing on the irrigation ring or damaged: Replace the O-rings. 5.4.2 Replacing the O-rings 1. -
Page 15: Cleaning And Servicing
6 Cleaning and Servicing 6.1 Maintenance – general information WARNING The microsaw and the ring are supplied "non sterile". Clean, dry and sterilize the device prior to first use. 6.1.1 Precautions for maintenance • Within a maximum of 30 minutes after each treatment, clean and disinfect the instrument (lubrication and sterilization can be done later). -
Page 16: Microsaw And Irrigation Ring
6.1.3 Microsaw and irrigation ring • For cleaning, disinfection, and sterilization, if present, the irrigation ring may be either cleaned separately or left on the microsaw. For the last case, after a maximal amount of 25 uses, the irrigation ring must be disconnected, checked, and the microsaw with the irrigation ring must be cleaned, disinfected, and sterilized separately. -
Page 17: Disinfection
6.3 Disinfection 6.3.1 Manual disinfection 1) Dip the devices (both the microsaw and the irrigation ring) separately or assembled in a bath containing a disinfectant product (e.g. didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral enzymatic product which are allowable chemical agents). Follow the concentration and duration recommended by the fabricant of the disinfection product. - Page 18 Washer-disinfector Carry out automatic cleaning-disinfection using an approved washer disinfector which complies with ISO standard 15883-1. Detergent and washing cycle Use an alkaline or enzymatic detergent recommended for cleaning in a washer-disinfector for dental or surgical instruments (pH 8-11). Recommended specifications of the thermo-disinfection cycle: Phase Parameters <45°C (113°F);...
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Page 19: Lubrication
6.4 Lubrication 6.4.1. Verifying cleanliness Before lubrication, visually inspect the device to ensure it is clean. Repeat the cleaning and disinfection procedure if necessary. 6.4.2 Lubrication with Lubrifluid® Before each sterilization lubricate with Lubrifluid®. Never lubricate after sterilization. If the irrigation ring is left on the microsaw during cleaning-disinfection, it should be left on the microsaw during lubrication as well. -
Page 20: Sterilization
6.5 Sterilization WARNING The quality of the sterilization is highly dependent on how clean the instrument is. Only perfectly clean instruments may be sterilized. To improve the effectiveness of the sterilization, make sure the Microsaw is completely dry before and after the sterilization. CAUTION Do not use a sterilization procedure other than the one described below. -
Page 21: Packing And Storage
6.6 Packing and storage The device must be stored inside the sterilization pouch in a dry and dust free environment. The temperature must not exceed 55°C (131°F). If the device will not be used for 7 days or more after the sterilization, extract the device from the sterilization pouch and store it in the original package. -
Page 22: Transport & Disposal
7 Transport & disposal 7.1 Transport There are no particular transport conditions required. 7.2 Disposal The disposal and/or recycling of materials must be performed in accordance with the legislation in force. This device must be recycled. In order to avoid any risk of contamination, the user must return the device sterilized to his dealer or contact an authorized body for the treatment and recovery of this type of equipment. -
Page 23: General Information
8 General information 8.1 Terms of guarantee Bien-Air Dental SA grants the user a warranty covering all functional defects, material or production faults. The warranty period for this medical device is 12 months from the date of invoicing. In the event of a justified claim, Bien-Air Dental SA or its authorised representative will repair or replace the product free of charge. -
Page 24: References
8.2 References 8.2.1 Set supplied (see cover) Legend 1601098-001 RECIPROCATING MICROSAW 1502918-001 Irrigation ring 1308430-001 O-rings 8.2.2 Optional accessories (see cover) Legend Legend Short Microsaw Blade Short Bullnose Blade 1502671-001 1502731-001 22x0.4mm 22x0.4mm Short Microsaw Blade Short Bullnose Blade 1502672-001 1502732-001 27x0.4mm... - Page 25 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 addresses available www.bienair.com REF 2100358-0002/2024.06 RECIPROCATING MICROSAW © Bien-Air Dental...
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