Bien-Air Dental 1700588-001 Скачать руководство пользователя страница 1

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Rx Only

REF 2100289-0003/2021.11

Optima MCX

ENG

INSTRUCTIONS FOR USE

other languages available on www.bienair.com/ifu

Содержание 1700588-001

Страница 1: ...Rx Only REF 2100289 0003 2021 11 Optima MCX ENG INSTRUCTIONS FOR USE other languages available on www bienair com ifu ...

Страница 2: ...01 Light Blue REF 1600751 001 REF 1501938 001 Set Optima MCX REF 1700590 001 REF 1600966 001 Pastel Orange REF 1600751 001 REF 1501938 001 Set Optima MCX REF 1700591 001 REF 1600967 001 Limetree Green REF 1600751 001 REF 1501938 001 Set Optima MCX REF 1700592 001 REF 1600968 001 Pink REF 1600751 001 REF 1501938 001 Options REF 1600036 006 REF 1501988 001 REF 1502056 001 ...

Страница 3: ...data 8 4 5 Performances 9 4 6 Environmental protection and information for disposal 9 4 7 Electromagnetic compatibility technical description 10 4 7 1 Electromagnetic compatibility warnings 10 4 7 2 Electromagnetic compatibility emissions immunity 11 5 Installation 14 5 1 Install the Optima MCX system 14 6 Operation 16 6 1 MCX micromotor speed 16 6 2 MCX micromotor rotation direction 16 6 3 Standa...

Страница 4: ...r sale upon recommendation by an accredited practitioner Electrical safety Type B applied part CAUTION hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly followed WARNING hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed Separate collection of electric and e...

Страница 5: ...talogue number Electrical safety Type B applied part Medical Device Data Matrix code for product information including UDI Unique Device Identification Authorized EC Representative in the European Community Warning in accordance with federal law USA this device is only available for sale upon recommenda tion by an accredited practitioner Sterilizable in autoclave up to the specified temperature SN...

Страница 6: ...ntistry dental prophylaxis and orthodontics The system is designed to control a dental MCX micromotor which can drive a dental handpiece gear ratio 1 1 or 1 5 fitted with appropriate burs Any use other than that for which this product is intended is unauthorized and may be dangerous The medical device meets all the current legal requirements The intended EM environment per IEC 60601 1 2 ed 4 0 is ...

Страница 7: ...us 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 Observe relevant national regulations for detailed procedures 2 8 Notation A B C etc Text preceded by a letter indicates a procedure to be carried out step by step Indicates a procedure result 1 2 3 etc Text preceded by a number indicates tex...

Страница 8: ...d simultaneously to the administration of the anaesthetic substances to the patient CAUTION To prevent any risk of electric shock the Optima MCX unit must be connected only to a power supply network provided with a protective earth CAUTION The power plug is the device used for disconnection in case of problems it must be easily accessible at all times CAUTION Ensure that the micromotor hose is not...

Страница 9: ...wer supply cord 2 Power Supply and plug cord C 3 Optima MCX unit 4 Micromotor MCX hose output A 5 4 way connector input air and water inlet from your pneumatic unit B 6 Power input connector with lock C 7 Main power switch 8 Micromotor MCX connector A 9 Optima MCX status light green power on 10 MCX micromotor 11 Handpiece not provided in set 12 Dental unit with pedal B not provided in set Applied ...

Страница 10: ...bar Compatible with generic footpedals working within the pressure range of 3 5 bar and providing an output signal of 0 5V CAUTION If the input pneumatic pressure is below the minimum threshold indicated above the motor could not reach the setpoint speed Designation REF number CONSOLE OPTIMA MCX WHITE 1x 1600959 001 MOT MCX LED 1x 1600751 001 TRANSFORMER IOPTIMA 1x 1501938 001 CABLE MAINS 3 POLE E...

Страница 11: ...n force This unit 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 unit 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 Operating conditions Temperature limitation 10 C ...

Страница 12: ... the intensity of electromagnetic disturbances is high In any case ensure that no high frequency cables are routed above or near the device If in doubt please contact a qualified technician or Bien Air Dental SA Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the device including ca...

Страница 13: ...c establishments and those directly connected to the public low voltage power supply network that supplies buil dings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emis sions IEC 61000 3 3 Not applicable Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 8 kV contact 2...

Страница 14: ...e may occur in the vicinity of equipment marked with the following sym bol Radiated RF EM fields IEC 61000 4 3 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 3 V m 80 MHz 2 7 GHz 80 AM at 1 kHz Proximity fields from RF wireless communications equipment IEC 61000 4 3 Test freq MHz Max power W Immunity test level V m Distance 0 3 m 385 1 8 27 450 2 28 710 745 780 0 2 9 810 870 930 2 28 1720 1845 1970 2 28 2450...

Страница 15: ...1 At 80 MHz and 800 MHz the higher frequency range applies 2 These guidelines may not apply in all situations Electromag netic propagation is affected by absorption and reflection from structures objects and people ...

Страница 16: ...ontact with liquids FIG 2 B Connect the power cord 2 to the power supply 1 and plug to the mains Note 2 FIG 3 C Connect the power supply cable 1 to the input connector 2 and turn right to lock CAUTION Ensure that the power switch 3 is off O FIG 4 D Connect the MCX cable 2 to the MCX micromotor 1 by guiding the connector and plug with the index pin on the connector and tighten CW CAUTION Always ens...

Страница 17: ...from direct sunlight and dust Keep the ori ginal packaging for storage and shipment 2 The equipment is powered by your mains power supply 100 240 VAC FIG 5 FIG 6 1 2 2 1 FIG 5 E Connect the 4 way hose 1 to the 4 way connector of the Optima MCX unit 2 First guide the sleeve and carefully and firmly insert the hose sleeve by matching the connector and the coupling Tighten CW FIG 6 F Switch on the wa...

Страница 18: ...ounterClockWise CCW Unpressed or normal status Forward ClockWise CW CAUTION Always check the instrument rotation direction CW or CCW before using it 6 3 Standard Use A Connect a handpiece B Set the maximum speed C Select the rotation direction to Forward or Reverse D Press the dental unit pedal to start the MCX micromotor pedal mode is progressive CAUTION If the footpedal is pressed before switchi...

Страница 19: ...r cable may be defective Check motor cable Contact Bien Air Dental SA System electrical fault Contact Bien Air Dental SA The motor stops The motor is blocked for more than 2 seconds Release the footpedal and press again The motor control card limits the power supplied to the motor to prevent motor overheating Avoid extended use Overheating of motor control card electrical control of motor Wait unt...

Страница 20: ...n the surfaces of the Optima MCX unit by gently rubbing for about 15 seconds with a clean cloth soaked in a suitable product i e Bien Air Dental Spraynet or isopropyl alcohol Do not immerse in disinfectant solution Do not immerse in an ultrasonic bath 8 3 Important For maintenance of micromotors see IFU 8 4 Replace 4VL seal FIG 1 CAUTION Immediately replace any damaged or leaking O rings and seals...

Страница 21: ...ENG 19 NOTES 1 Bien Air Dental SA asks the user to check the relevant IFU for the dynamic devices inspection ...

Страница 22: ...wer supply 24 months for the Optima MCX unit 36 months for series MCX LED electric micromotors from the date of invoicing In case of justified claim Bien Air Dental SA or its authorized representative will fulfill 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 a...

Страница 23: ......

Страница 24: ...l 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 EC REP Bien Air France Sàrl 19 21 rue du 8 mai 1945 94110Arcueil France ...

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