OsseoCare Pro. Instructions for use - drilling unit. Manufactured by

Transcription

1 OsseoCare Pro Instructions for use - drilling unit Manufactured by

2 Disclaimer English Limitations of liability This product is part of an overall concept and may only be used in conjunction with the associated original products according to the instructions and recommendation of 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. Nobel Biocare disclaims any liability, express or implied, and shall have no responsibility for any direct, indirect, punitive or other damages, arising out of or in connection with any errors in professional judgment or practice in the use of Nobel Biocare products. The user is also obliged to study the latest developments in regard to this Nobel Biocare product and its applications regularly. In cases of doubt, the user has to contact Nobel Biocare. Since the utilization of this product is under the control of the user, they are his/her responsibility. Nobel Biocare does not assume any liability whatsoever for damage arising thereof. Please note that some products detailed in this Instruction for Use may not be regulatory cleared, released or licensed for sale in all markets. Please note that not all products may have been licensed in accordance with Canadian law. For additional information on surgical procedures please consult the Procedures & products treatment guidelines available at nobelbiocare.com or request the latest printed version from a Nobel Biocare representative. Bien-Air Dental SA Länggasse 60 Case postale 2500 Bienne 6, Switzerland Tel. +41 (0) Fax +41 (0) Caution: The caution text Federal (USA) law restricts the sale of this device to, or on the order of, a licensed physician or dentist is shown on labels with Rx Only GMT Date of issue All rights reserved. Nobel Biocare, the Nobel Biocare logotype and all other trademarks used in this document are, if nothing else is stated or is evident from the context in a certain case, trademarks of Nobel Biocare. ipad and icloud are registered trademarks of Apple Inc. Product images in this document are not necessarily to scale. 2

3 English Table of contents Disclaimer 2 Table of contents 3 Description 4 Identification 4 Intended use 4 Indications 4 Contraindications 4 Compatibility 4 Limitation of liability 4 Hardware keys and elements 4 Explanation of symbols 5 Environment 6 Working 6 Transport and storage 6 Environmental protection and information for disposal 6 Technical description 7 Technical data 7 Electromagnetic compatibility 10 Precautions regarding Electromagnetic Compatibility (EMC) 10 Guidance & manufacturer s declaration 10 Electromagnetic emission 10 Electromagnetic immunity 10 Recommended separation distances 11 Installation 12 Installing the OsseoCare Pro application on the ipad 12 Installation of the OsseoCare Pro drilling unit 12 Installation of the ipad on the OsseoCare Pro unit 13 On/off procedure 13 Operating the drilling unit 14 Blue button 14 Orange button 14 Grey button 14 Speed drive 14 List of errors and troubleshooting 15 Device operating error 15 Maintenance 16 Servicing 16 Information 16 Cleaning and disinfection 16 Important 16 General information and guarantee 16 Terms of guarantee 16 3

4 English 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 to the device using the connector provided for this purpose. The implant fitting parameters are defined before the operation using the OsseoCare Pro application installed on the ipad. Intended use The OsseoCare Pro system is intended for use in dental surgery, endodontics and implantology by dentists and surgeons in dental offices and hospitals to cut hard and soft tissue with appropriate tools. The OsseoCare Pro system is designed to control a dental micromotor which can drive a dental handpiece fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants. Indications The OsseoCare Pro system does not specify a disease, condition or population and therefore the Indications for use are the same as the Intended use. Contraindications None identified. Compatibility The OsseoCare Pro drilling unit is compatible with ipad devices ipad 2, ipad 3, ipad 4, ipad Air and ipad Air 2. Please note that no other ipad devices can be used than the ones indicated here. Limitation of liability Bien-Air Dental shall not be held liable for any non-compliant use of the ipad. The conditions for and restrictions on use set by Apple must be respected (jailbreak, hardware modification, etc.). Hardware keys and elements w e r u i o a q y t q Adapter for ipad w Bracket support e Pedal connector r Peristaltic pump LID t Micromotor connector y Micromotor u Irrigation ON/OFF control button on pedal i Configurable Program button on pedal o Button to reverse the rotation of the micromotor on pedal a Variable speed drive on pedal s ( VAC) Mains connector d Fuse holder f Main switch g Label r e g w f d s 4

5 English Explanation of symbols 0120 CE Marking with number of the notified body 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 Danger of pinching. Do not put your fingers in rotating parts. Machine washable Recyclable materials Recyclable electrical and electronic materials 135 C Sterilizable in autoclave up to the specified temperature. Manufacturer (acc. 93/42/EEC article 1.2 (f)) Light Use by date DEHP Product containing phthalates Do not re-use Sterilise with Ethylene Oxyde Caution: Federal law (USA) restricts this device to sale by or on the order of a licensed healthcare practitioner. 5

6 Environment English Working Warning! The device is not designed for use in an explosive atmosphere (anaesthetic gas). 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: 10% to 100%, including condensation Atmospheric pressure: 500 hpa to 1060 hpa Environmental protection and information for disposal The disposal and/or recycling of materials must be performed in accordance with the legislation in force. This device and its accessories must be recycled. Electrical and electronic equipment may contain dangerous substances which constitute health and environmental hazards. The user must return the device to its dealer or establish direct contact with an approved body for treatment and recovery of this type of equipment (European Directive 2002/96/EC). 6

7 English Technical description Technical data Voltage 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 (apparatus protected against electric shocks). Degree of protection IP 40 (protection against insertion of objects larger than 1 mm). Dimensions L x W x H 242 x 244 x 102 mm. Height with bracket 482 mm Weight Housing 2.8 kg Pedal 830 g Cable 105 g Bracket 115 g Languages English List of errors & troubleshooting Turn to page 15. Bracket for physiological liquid flask Stainless steel Intended for use with MX-i LED micromotor REF Cable for micromotor REF Contra-angle CA 20:1 L Micro-Series, light REF Contra-angle CA 20:1 L KM Micro-Series, light REF Warning! The use of the system with other handpieces, motors or cables has not been validated / certified. 7

8 Peristaltic pump English Pump delivery: Hose for pump: From 30 to 150 ml/min. (5 levels) External Ø 5.60 mm Internal Ø 2.40 mm Wall thickness 1.60 mm Foot control REF Dimensions (LxWxH) With handle: 250 x 205 x 54 mm 250 x 205 x 144 mm The pedal is waterproof (IP X8 in accordance with CEI 529). Cables Length of cables: Pedal cable 2.90 m Motor cable 2.00 m Warning! To prevent any risk of electric shock, this device must be connected only to a power supply network provided with protective earth. Modification of the device is forbidden. The system is not adapted for use in the presence of inflammable gases (e.g. anesthetic gas). Do not attempt to open the apparatus when it is connected to the electric mains. Beware of electric shocks. Parts applied (per IEC ) MX-i LED micromotor REF Cable for MX-i LED micromotor REF CA 20:1 L Micro-Series REF CA 20:1 L KM Micro-Series REF Irrigation lines REF KM Irrigation lines REF

9 English Set OsseoCare Pro CA 20:1 L MS REF CA 20:1 L Micro-Series 1 x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF Set OsseoCare Pro CA 20:1 L MS KM REF CA 20:1 L KM Micro-Series 1 x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF Optional CA 20:1 L Micro-Series CA 20:1 L KM Micro-Series 1 x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF x REF

10 Electromagnetic compatibility English 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 Radio transmitting equipment, cellular phones, etc. shall not be used in close proximity to the device since they could influence the performance of the device. Particular precaution is required when using strong emission sources such as High Frequency surgical equipment and similar equipment so that the HF cables are not routed on or near the device. If in doubt, please contact your local service and repair center (see the contacting details on www. nobelbiocare.com/osseocare). OsseoCare Pro should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, OsseoCare Pro should be monitored to verify normal operation in the configuration in which it will be used. Warning! The use of accessories, transducers and ca bles other than those specified, with the exception of transducers and cables sold by Bien-Air Dental as replacements parts for internal components, may result in increased emissions or decreased immunity of OsseoCare Pro. Dental professionals need to be aware of potential electromagnetic interference between electronic dental devices and active implantable medical devices, and should always inquire about any devices implanted in the patient. Guidance & manufacturer s declaration Electromagnetic emission OsseoCare Pro is intended for use in the electromagnetic environment specified below. The customer or the user of OsseoCare Pro should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions CISPR 11 Group 1 OsseoCare Pro uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 Harmonic emissions Compliant OsseoCare Pro is suitable for use in all establishments, including domestic establishments IEC Voltage fluctuations/flicker emissions IEC Not applicable and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. Electromagnetic immunity OsseoCare Pro is intended for use in the electromagnetic environment specified below. The customer or the user of OsseoCare Pro should ensure that it is used in such an environment. Immunity test IEC test level Compliance Electromagnetic environment - guidance Electrostatic discharge (ESD) IEC ±6 kv contact ±8 kv air ±6 kv contact ±8 kv air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient burst IEC ±2 kv for power supply lines ±1 kv for lines no input/output ±2 kv for power supply lines ±1 kv for lines no input/output Mains power quality should be that of a typical commercial or hospital environment. Shock waves IEC Voltage dips and outages IEC Power frequency (50 Hz) magnetic field IEC ±0.5 kv line to line ±1 kv line to line ±0.5 kv line to earth ±1 kv line to earth ±2 kv line to earth <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec 3 A/m 3 A/m ±0.5 kv line to line ±1 kv line to line ±0.5 kv line to earth ±1 kv line to earth ±2 kv line to earth <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of OsseoCare Pro requires continued operation during power mains interruptions, it is recommended that OsseoCare Pro be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level. Essential performance: The essential performance is the maintaining of the visual lighting intensity of the LED and the maintaining of motor speed. Maximum allowed speed deviation is ± 5%. 10

11 English OsseoCare Pro is intended for use in the electromagnetic environment specified below. The customer or the user of OsseoCare Pro should ensure that it is used in such an environment. Immunity test IEC test level Compliance level Electromagnetic environment - guidance Portable and mobile RF communications should be used no closer to any part of OsseoCare Pro, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC Vrms 150 khz to 80 MHz 3V radiated RF IEC V/m 80 MHz to 2,5 GHz 3 V/m 80 MHz to 800 MHz 800 MHZ to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be less than the compliance level in each frequency range (b). Interference may occur in the vicinity of equipment marked with this symbol. NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the OsseoCare Pro is used exceeds the applicable RF compliance level above, the OsseoCare Pro should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the OsseoCare Pro. (b) Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances (between portable and mobile RF communications equipment and the OsseoCare Pro) The OsseoCare Pro is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OsseoCare Pro can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the OsseoCare Pro as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 11

12 Installation English Installing the OsseoCare Pro application on the ipad q Open the App Store SM by tapping on the App Store SM icon on the ipad. w Find the OsseoCare Pro application using the search window at the top right-hand side of the screen. e Tap on Free. r Then tap on Install to install the OsseoCare Pro application. Caution! The ipad must be connected to the Internet correctly before the App Store is opened. Refer to Apple s instructions for directions regarding appropriate use of the ipad. Installation of the OsseoCare Pro drilling unit q If necessary, use the screwdriver to change the adapter for the ipad model being used. Please ensure that, during this action, the OsseoCare Pro drilling unit is not connected to the electrical outlet. w OsseoCare Pro may be positioned on a table, on a trolley or another surface, but in no circumstances on the floor. The power plug is the device for disconnection in case of problems, and it must be easily accessible at all times. r e ON/OFF e The fuse box may be opened with a screwdriver Vac = fuse T-4.0 A L 250 VAC (REF ) r The equipment is powered by your line voltage ( Vac). Connect the power cable to the plug. t t Connect the pedal cable to the output provided on the rear panel, guiding the connector and plug by means of the index pin on the connector. Warning! Do not raise the pedal using the connection cable. y y Connect the micromotor cable to the motor output, guiding the connector and plug by means of the index pin on the connector. u u Align and attach the bracket to the housing provided on the console s rear and suspend the flask or bottle. 12

13 English YYYY/MM i Check the packaging integrity, as well as the expiry date of the irrigation line on the label. Warning! i 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. o a a Connect the flexible hose of the irrigation line to the spray tube of the handpiece or contra-angle. s Install the plastic cassette in the peristaltic pump. Check that the cassette is clipped correctly. Close the pump lid. If there is any resistance when closing, open the lid again and check the correct positioning of the cassette. Caution! Do not run the pump when the lid is open. Danger of pinching REF s d d Perforate the cap of the physiological liquid flask with the pointed end of the irrigation line after removing the protective cap. Attach the irrigation line onto the motor cable using the attachment collars (REF ). Installation of the ipad on the OsseoCare Pro unit q Remove the single-use sterile protection sheet for ipad from its pouch and stick it on the screen. Refer to the instructions on the back of the pouch. w w Connect the ipad to the OsseoCare Pro by sliding it carefully along the adapter. Drape the back of the ipad with appropriate material (e.g. ipad protective film) to prevent contamination. On/off procedure The device can be switched on and off safely using the main switch on the ipad and OsseoCare Pro. 13

14 Operating the drilling unit English 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. They also allow you to switch irrigation on and off easily, or to jump between drilling and implant insertion without touching the ipad screen. Blue button The blue button is the control button to switch between the irrigation level statuses On and Off. When tapping the blue button a beeping sound is made: A single beep means irrigation is switched ON. A double beep means irrigation is switched OFF. Orange button A short press on the orange button takes you one step further when moving between different values in the quick select bar or drills in a drill set. When you press and hold down the orange button, the app switches between the drilling page and the implant insertion page. Another press and hold switches back to the other page. Three short beeps (two low and one higher beep) can be heard whenever you switch between these two pages by means of the orange button. Grey button Press the grey button to reverse the rotation of the micromotor. A beeping sound is made to indicate the rotation direction. A single beep means the drill is rotating forward. A double beep means it is rotating in reverse. When pressing down the foot pedal, the Drill Direction indicator in the application will blink. Speed drive The large central pedal button is the variable speed drive on the device for both drilling speed and implant insertion speed. 14

15 List of errors and troubleshooting English Message Cause of error Action Release the pedal The pedal is pressed when starting the device. The motor is blocked for more than 2 sec. Safety Release the pedal and press again. The motor control card limits the power supplied to the motor to prevent motor overheating. Safety Avoid extended use Device operating error The following errors may occur during operation of the device ERROR 1 Pedal connection is missing ERROR 3 Irrigation pump general failure ERROR 4 Motor connection is missing. The pedal is not connected! Please check the pedal connection. Irrigation pump fault! Please contact Bien-Air Dental SA. The motor is not connected! Please check the motor connection. The pedal is not properly connected. Irrigation pump electrical failure. Irrigation pump motor overheats. Motor phase missing failure. Motor is not properly connected. ERROR 5 Motor cable failure Motor cable failure. Motor drive power protection failure. The motor cable may be defective. ERROR 6 Motor drive Overall system overheating! Motor drive overtemperature failure. overtemperature Please wait until cool. GEN ERROR [FailCode] GEN ERROR [FailCode] Electrical system fault! [FailCode] = EC100: Motor drive System electrical failure Bien-Air Dental SA. communication failure [FailCode] = EC101: Motor drive under voltage failure [FailCode] = EC102: Motor drive over voltage failure [FailCode] = EC120: Motor drive other failure 1. Check pedal connection. 2. If the problem persists, contact Bien-Air Dental SA. Contact Bien-Air Dental SA. 1. Check motor connection. 2. If the problem persists, contact Bien-Air Dental SA. 1. Replace motor cable. 2. If the problem persists, contact Bien-Air Dental SA. 1. Wait for the system to cool down. 2. If the problem persists, contact Bien-Air Dental SA. 1. Switch OFF the unit. 2. Disconnect the ipad device from the drilling unit. 3. Close the OsseoCare Pro app. 4. Switch the drilling unit back ON. 5. Reconnect the ipad device to the drilling unit. 6. Restart the OsseoCare Pro app. 7. If the problem persists, contact Bien-Air Dental SA. 15

16 English 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 Never disassemble the device. For any modification and repair, we recommend that you contact your regular supplier or Bien-Air Dental directly. Bien-Air Dental asks the user to have its dynamic instruments checked or inspected at least once a year. Information The technical specifications, illustrations and dimensions contained in these instructions are given only as a guide. They may not be the subject of any claim. For all additional information, please contact Bien-Air Dental SA at the address indicated on the back cover. Cleaning and disinfection Disinfect the surfaces of the console by rubbing with a clean cloth soaked in a suitable disinfectant (e.g. isopropyl alcohol) for about 15 seconds. Do not immerse in disinfectant solution. Not designed for an ultrasonic bath. Use a new sterile irrigation line for each patient. Use a new sterile protective sheet for each patient. Important For maintenance of: MX-i LED micromotor REF Cable for micromotor REF Contra-angle CA 20:1 L Micro-Series REF Contra-angle CA 20:1 L KM Micro-Series REF see instructions General information and guarantee The device must be used by qualified professionals in compliance with the current legal provisions concerning workplace safety, health and accident prevention measures, and these working instructions. In accordance with such requirements, the operators: must only use devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other signs that may indicate malfunction of the device, the work must be stopped immediately; in this case, contact a repair center that is approved by Bien-Air Dental. 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, and must avoid contamination through the use of the product. Terms of guarantee Bien-Air Dental grants the user a guarantee covering all functional defects, material or production faults. The device is covered by this guarantee for 24 months from the date of invoicing. In case of a justified claim, Bien-Air Dental or its authorised representative will fulfil the company s obligations under this guarantee by repairing or replacing the product free of charge. Any other claims, of whatever nature, in particular in the form of a claim for damages and interest, are excluded. Bien-Air Dental shall not be held responsible for damage or injury and the consequences thereof, resulting from: excessive wear and tear improper use non-observance of the instructions for installation, operation and maintenance unusual chemical, electrical or electrolytic influences poor connections, whether of the air, water or electricity supply. The guarantee does not cover flexible fibre optic type light conductors, or any parts made of synthetic materials. The guarantee shall become null and void if the damage and its consequences are due to improper manipulation of the product, or modifications to the product carried out by persons not authorised by Bien-Air Dental. Claims under the terms of the guarantee will be considered only on presentation, together with the product, of the invoice or the consignment note, on which the date of purchase, the product reference and the Serial No. should be clearly indicated. 16