Table of Contents
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Table of Contents
Summary of Contents for nobel biocare OsseoCare Pro
- Page 1 Manufactured OsseoCare™ Pro Instructions for use - drilling unit...
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Page 2: Disclaimer
Nobel Biocare. Non-recommended use of products made by third parties in conjunction with Nobel Biocare products will void any warranty or other obligation, express or implied, of Nobel Biocare. The user of Nobel Biocare products has the duty to determine whether or not any product is suitable for the particular patient and circumstances. -
Page 3: Table Of Contents
Table of contents Disclaimer Table of contents Description Identification Intended use Indications Contraindications Compatibility Limitation of liability Hardware keys and elements Explanation of symbols Environment Working Transport and storage Environmental protection and information for disposal Technical description Technical data Electromagnetic compatibility Precautions regarding Electromagnetic Compatibility (EMC) Guidance &... -
Page 4: Description
Description Identification Electronically controlled tabletop device for dentistry allowing the operation of an MX-i LED micromotor with variable speed control by means of a pedal. A peristaltic pump conveys the physiological liquid via a disposable irrigation line without being contaminated. It is essential to connect a supported iPad®... -
Page 5: Explanation Of Symbols
Explanation of symbols CEMarkingwithnumberofthenotifiedbody 0120 Protective earth (ground) Main switch - Power OFF. Main switch - Power ON. Fuse Ø 5 x 20 mm Alternating current Electrical security. Applied part type B. CAUTION! Dangerous voltage. Element sensitive to electrostatic discharges WARNING! Refer to the accompanying documents Dangerofpinching.Donotputyourfingersinrotatingparts. -
Page 6: Environment
Environment Warning! The device is not designed for use in an explosive atmosphere (anaesthetic gas). Working Temperature: +10°C (50°F) to +25°C (77°F) Relative humidity: 30% to 80%, including condensation Atmospheric pressure: 700 hPa to 1060 hPa Transport and storage Environmental conditions for a period of maximum 15 weeks Temperature: -25°C (-13°F) to +70°C (158°F) Relative humidity:... -
Page 7: Technical Description
Technical description Technical data Voltage 100 – 240 VAC, 50 / 60 Hz Fuses 2 fuses T4.0A L 250 VAC, breaking capacity 40A Power demand – 100 V / 300 VA – 240 V / 300 VA Classification Class IIa in accordance with European Directive 93/42/EEC concerning medical devices. Electric insulation class Class I, per IEC 60601-1 (apparatus protected against electric shocks). - Page 8 Peristaltic pump Pump delivery: From 30 to 150 ml/min. (5 levels) Hose for pump: External Ø 5.60 mm Internal Ø 2.40 mm Wall thickness 1.60 mm Foot control REF 1600631-001 Dimensions (LxWxH) 250 x 205 x 54 mm With handle: 250 x 205 x 144 mm The pedal is waterproof (IP X8 in accordance with CEI 529).
- Page 9 Set OsseoCare Pro CA 20:1 L MS REF 1700470-001 ™ CA 20:1 L Micro-Series 1 x REF 1600870-001 1 x REF 1306205-001 1 x REF 1600875-001 1 x REF 1600873-001 1 x REF 1303393-001 1 x REF 1305949-001 1 x REF 1301575-001 1 x REF 1501746-010 10 x 10 x...
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Page 10: Electromagnetic Compatibility
Electromagnetic compatibility Precautions regarding Electromagnetic Compatibility (EMC) Electro-medical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document. OsseoCare Pro complies with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. ™... -
Page 11: Recommended Separation Distances
OsseoCare Proisintendedforuseintheelectromagneticenvironmentspecifiedbelow. ™ The customer or the user of OsseoCare Pro should ensure that it is used in such an environment. ™ Immunity test IEC 60601 test Compliance Electromagnetic environment - guidance level level Portable and mobile RF communications should be used no closer to any part of OsseoCare™... -
Page 12: Installation
Installation Installing the OsseoCare™ Pro application on the iPad® q Open the App Store by tapping on the App Store icon on the iPad®. w Find the OsseoCare™ Pro application using the search window at the top right-hand side of the screen. e Tapon‘Free’. r Thentapon‘Install’toinstalltheOsseoCare™Proapplication. -
Page 13: Installation Of The Ipad® On The Osseocare™ Pro Unit
YYYY/MM i Check the packaging integrity, as well as the expiry date of the irrigation line on the label. Warning! Only lines supplied by Bien-Air Dental ensure trouble-free operation. These lines are sterile and for single use. Reuse may result in microbiological contamination of the patient. o Remove the single-use sterile irrigation line from its pouch. -
Page 14: Operating The Drilling Unit
Operating the drilling unit When the iPad® is installed on the OsseoCare™ Pro and everything is set up and connected correctly, the drilling unit can be operated. The OsseoCare™ Pro device is equipped with an ergonomic foot pedal with three colored buttons. These give you full control over speed, rotation direction and drill selection. -
Page 15: List Of Errors And Troubleshooting
List of errors and troubleshooting Message Cause of error Action Release the pedal The pedal is pressed when starting Safety Release the pedal and press again. the device. The motor is blocked for more than 2 sec. The motor control card limits the Safety Avoid extended use power supplied to the motor to... -
Page 16: Maintenance
Maintenance Only use original Bien-Air Dental maintenance products and parts or those recommended by Bien-Air Dental. Using other products or parts may cause operational failure and/or void the guarantee. Servicing Neverdisassemblethedevice.Foranymodificationandrepair,werecommendthatyoucontactyourregularsupplierorBien-AirDental directly. Bien-Air Dental asks the user to have its dynamic instruments checked or inspected at least once a year. Information Thetechnicalspecifications,illustrationsanddimensionscontainedintheseinstructionsaregivenonlyasaguide.Theymaynotbethe subject of any claim.