ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols f Description of symbols for Console CHIR or Console CHIROPR OPRO L PREMIUM O L PREMIUM S S ym Description Description S S ym Description Description CE Marking with number of the notified General symbol recovery/...
1.2 Description of symbols f Description of symbols for Console CHIR or Console CHIROPR OPRO L PREMIUM O L PREMIUM ac acc c essories essories S S ym Description Description S S ym Description Description CE Marking with number of the notified Thermo washer disinfectable.
• The main maxillofacial surgery includes 2.2 Intended use Intended use procedures such as Orthognathic surgery, CHIROPRO L PREMIUM devices are intended to be genioplasty and rhinoplasty. used in dental implantology, periodontology, oral surgery and maxillo-facial surgery. 2.7 P P atient c...
3 User and patient safety: Warnings & Precautions of Use To prevent any risk of electric shock, the WARNING The device must be used by qualified dental warnings below must be observed: professionals in compliance with the current legal provisions concerning occupational safety, health WARNING and accident prevention measures, and these •...
Page 9
To prevent any risk of bone overheating, To prevent any risk of adverse tissue the warnings below must be observed: reaction, the caution below must be observed: WARNING • If the irrigation pump is used and regulated CAUTION by the device, verify that the pump is working •...
Page 10
To avoid any risk of electromagnetic To avoid any risk of electromagnetic interference that could affect active interference that could affect the implantable medical devices, and performance of the device the warnings sustainable life devices, the warnings below must be observed: below must be observed: WARNING •...
4 Description 4.1 Console CHIR Console CHIROPR OPRO L PREMIUM sy O L PREMIUM system o stem ov v erview erview FIG. 1 . 1 DEVICE SCREEN IRRIGATION ON/OFF CONTROL BUTTON ON PEDAL COMMAND TO REVERSE THE ROTATION “PROGRAM” BUTTON ON PEDAL - Short press OF THE MOTOR MX-i LED = next stage - Long press = previous stage “SETUP”...
4.2 Sets supplied Sets supplied Set CHIROPRO L US PREMIUM REF 1700463-001 Designation Designation REF number REF number Console CHIROPRO L PREMIUM 1600855-001 MOT MX-i LED 1600755-001 Cable MX LED 3m 1600881-001 FOOTCTRL 1600631-001 Irrigation line 3.5m (10/pkg) 1501738-010 Set CHIROPRO L US PREMIUM WL REF 1700889-001...
Dimensions L x W x H Dimensions L x W x H Console CHIROPRO L PREMIUM unit 209 x 220 x 123 mm CHIROPRO L PREMIUM unit height (with bracket) 506 mm Foot control (without handle) 206 x 180 x 60 mm...
Page 14
Applied parts (per IEC 60601-1): Applied parts (per IEC 60601-1): MX-i LED micromotor REF 1600755-001 Contra-angles (CA) & Straight handpieces (HP) ISO 3964 compatible CA&HP Degr Degree of ingr ee of ingress pr ess protection otection IP 41 (protection against insertion of Unit objects larger than 1 mm and dripping water (vertically falling drops)).
Memory Implantology mode: Storage in memory of 8 implant fitting sequences of 10 steps each. Surgery mode: Storage in memory of 4 separate programs. Languages French, German, English, Italian, Spanish, Portuguese and Russian Bracket for physiological liquid flask Stainless steel. P P eristaltic pump eristaltic pump Pump delivery...
4.6 P P erf erformanc ormance e P P erf erformance ormance REF 1600855-001 REF 1600855-001 Motor speed regulation Accuracy ± 5% in the speed range 100 - 40'000 rpm (*) Torque adjustable from 10% to 100% of the maximum Motor torque regulation torque Maximum motor torque...
Guidance and manufacturer’s declaration – Electromagnetic emissions The CHIROPRO L PREMIUM is intended for use in the electromagnetic environment specified below. The customer or the user of the CHIROPRO L PREMIUM must ensure that it is actually used in such an environment.
Page 18
Guidance and manufacturer’s declaration – Electromagnetic immunity The CHIROPRO L PREMIUM is intended for use in the electromagnetic environment specified below. The customer or the user of the CHIROPRO L PREMIUM must ensure that it is actually used in such an environment.
Page 19
IEC 60601 test IEC 60601 test Electr Electromagnetic en omagnetic envir vironment onment Immunity test Immunity test Compliance lev Compliance level el level el - guidance - guidance Radiated RF EM fields 3V/m 10V/m Distance: 0.3 m IEC 61000-4-3 80MHz - 2,7GHz 80MHz - 3GHz Minimum separation distance 80% AM at 1 kHz...
Page 20
CHIROPRO L PREMIUM is used exceeds the RF compliance level mentioned above, the CHIROPRO L PREMIUM should be observed to verify that it is operating normally. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the...
OPRO L PREMIUM sy O L PREMIUM system stem A A . . CHIROPRO L PREMIUM may be positioned on a table, on a trolly or another surface, but in no case on the floor. As the power plug (14) is the disconnection device.
Page 22
G G . . Align and attach the bracket to the housing provided on the console’s rear (11) and suspend the irrigation solution flask or bottle FIG. FIG. 4 . 4 H. H. Check the packaging integrity, as well as the expiration date of the irrigation line.
Page 23
Fitting on the spray tube J. J. Connect the flexible hose of the irrigation line to the spray tube of the handpiece or contra- angle FIG. FIG. 7 . 7 Installation on the peristaltic pump K. K. Install the plastic cassette in the peristaltic pump.
Page 24
N. N. An additional earth connector (13) is provided on the back of the device FIG. FIG. 10 . 10...
6 Interface overview Operation mode Note : Note : The Operation mode is the default startup mode. Any foot control action will be ignored when the motor is running. Starting display...
7 List of error & Troubleshooting Message Message Cause of err Cause of error or A A ction ction The pedal is pressed when starting the device. Release the pedal and Safety Release The motor is blocked for more than 2 sec. press again.
Page 27
Message Message Cause of err Cause of error or A A ction ction Device oper Device operating err ating error or The f The fol ollo lowing err wing error ors ma s may occur during oper y occur during operation of the device ation of the device 1.
8 Default Values Implantology: Default values : "Operative parameters default values for implantology., p. 35" The table shows the default operating values for 8 different implantology sequences. Surgery: Default values : "Operative parameters default values for surgery., p. 35" The table shows the default operating values for 4 different surgical sequences.
9 Maintenance and Servicing 9.1 Servicing Servicing CAUTION Never disassemble the device. For all servicing or repair operations, you are advised to contact your regular supplier or Bien-Air Dental SA directly. Service period The device was tested by simulating 10,000 clinical procedures (corresponding to a service period of 6 to 10 years).
9.3 R R eplac eplacement of fuses ement of fuses A A . . Switch off the CHIROPRO L PREMIUM unit "O". B. B. Disconnect the main cable. CAUTION The power cable must be disconnected at least 10 seconds before opening the fusebox.
9.4 P P ack ackaging and Stor aging and Storage Stor Storage conditions age conditions [0°C; +40°C] Temperature range: [+32°F; +104°F] Relative humidity range: [10%; 80%] [650 hPa; 1060 hPa] Atmospheric pressure limitation: [490 mmHg; 795 mmHg] Keep away from rain...
10 Transport & disposal 10.1 10.1 T T r r ansport ansport T T r r ansport ansport [-20°C; +50°C] Temperature range: [-4°F; +122°F] Relative humidity range: [5%; 80%] [650 hPa; 1060 hPa] Atmospheric pressure limitation: [490 mmHg; 795 mmHg] Keep away from rain 10.2 10.2 Disposal...
Y The device is covered by this guarantee from the date of invoicing for: • 12 months for the motor cable; • 24 months for the CHIROPRO L PREMIUM unit and CA 20:1 L Micro-Series; • 36 months for the MX-i LED micromotor.
11.2 11.2 R R ef efer erenc ences es Device REF Device REF LEGEND LEGEND 1600855-001 Console CHIROPRO L PREMIUM A A ccessories REF ccessories REF LEGEND LEGEND 1600755-001 Electric micromotor MX-i LED. 1600881-001 MX-i LED cable 3 meters length.
12 DEFAULT VALUES Operative parameters default values for implantology. CAUTION All the pre-programmed settings are indicative and MUST be validated by the user before starting the treatment/ operation. Always follow the implant manufacturer recommendations. Operative parameters default values for surgery. The table shows the default operating values for 4 types of surgical operations proposed by the system:...
Need help?
Do you have a question about the CHIROPRO L PREMIUM and is the answer not in the manual?
Questions and answers