MC2 and Isolite Micromotors Instructions Sept 2019

Isolite 100 Isolite 300 MC2 LED

Isolite 300 2a 5a 2c

2b

5b fig. 2

fig. 5

Isolite 100 Isolite 300 MC2 LED

Isolite 100 Isolite 300 MC2 LED 3a

3b

fig. 1

MC2 GTAV

fig. 3

fig. 6

MC2 IR MC2 GTAV

MC2 IR

fig. 4

fig. 7

3x REF 1300145-010

fig. 8 REF 007.22.05-001

REF 1302447-001 MC2 Isolite 100 REF 1500246-001 MC2 Isolite 300

fig. 11 REF 1500241-010

REF 1301646-010

2.5 bar

MC2 IR MC2 GTAV fig. 9

fig. 12 REF 1500241-010

fig. 10

2x REF 1300992-010

fig. 13

This product may be covered by one or more of the following patents: EP Europe: 745358 / 688539 / 948294 / 1145688 / 1563800 / 1563801 / 1675523 / 1753360 DE Germany: 29616023.7 DK Denmark: 9600315 FR France: 2722972 CH Switzerland: 693922 CN China: 100528099 / 100522100 / 100522099 / 100553584 JP Japan: 3892485 / 4298933 / 7000419 US United-States: 5453008 / 6033220 / 6319003 / 7214060 / 7448870 RU Russia: 2361540 / 2361541 / 2372046 REF 1600681-001 MOT MC2 LED /REF 1600073-001 MOT MC2 IR /REF 1600075-001 MOT MC2 GT AV /REF 1600078-001 MOT ISOLITE LK / REF 1600079-001 MOT ISOLITE LI

Warranty · Garantie Garantie · Garantía Garanzia · Гарантия

18

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English

Intended use

Medical devices by Bien-Air Dental SA. Type MC2 IR, MC2 GTAV, Isolite 100 and 300 electric dental micromotor with brushes. Non-sterilizable, protected to the oil of the hand-pieces. Removable, sterilizable sleeve. Interchangeable brushes. MC2 LED description: micromotor with internal spray and light with LED and switch integral with the motor. MC2 IR description: without light, internal spray. MC2 GTAV description: micromotor with higher torque, selfventilating. Isolite 100 description: micromotor with Isolux lighting system with electric contacts to supply the bulb situated in the contraangle. Isolite 300 description: micromotor with internal spray and light with bulb and switch integral with the motor.

Product intended for professional use only. Use in dentistry for prophylaxis, general dentistry and endodontic work, and in the field of body care and health treatment. The device is not designed for use in an explosive atmosphere (anaesthetic gas). Any use other than that for which this device is intended is prohibited and may prove dangerous. The intended EM environment (per IEC 60601-1-2 ed. 4.0) is Professional healthcare facility environment. Technical data and assembly Classification Class IIa in accordance with European Directive 93/42/EEC concerning medical devices. This medical device is in compliance with the legislation in force. Coupling The most commonly used coupling in the world as per ISO Standard 3964.

Dimensions MC2 GTAV: 24x92.6 mm / Isolite: 23.3x86 mm / MC2 IR: 23.5x81 mm MC2 LED: 23.3 x 86 mm. Weight MC2 GTAV: 111 g / Isolite: 97 g / MC2 IR: 75 g. Speed Maximal 40.000 rpm. Recommanded rotation speed 60 rpm (minimum is variable, depending on the electronic power supply used) up to 40,000 rpm ± 10%; rotation in both directions. Nominal voltage In accordance with ISO 11498: 0 – 24 Vdc. Continuous operation MC2 GTAV: 1.5 A; approx. 0.8 Ncm Isolite: 1 A; approx. 0.6 Ncm MC2 IR: 1 A; approx. 0.6 Ncm MC2 LED: 1 A; approx. 0.6 Ncm. Intermittent operation According to CEI 34-1, Type S3. 3 A for 60 seconds; 5 A for 10 seconds; air cooling in 3 min. or without air in 20 min. Mechanical power MC2 GTAV: 74.2 W / Isolite: 54 W MC2 IR: 56 W / MC2 LED 54 W

Torque MC2 GTAV: 2.3 Ncm / Isolite: 2.1 Ncm MC2 IR: 2.1 Ncm / MC2 LED 2.1 Ncm Idle current 0.3 A - 24 Vdc Current at max. power MC2 GTAV: 5 A / Isolite: 4 A MC2 IR: 4 A / MC2 LED : 4A Internal resistance MC2 GTAV: 2.15 Ω / Isolite: 2.61 Ω / MC2 IR: 2.73 Ω / MC LED: 2.61 Ω Noise In accordance with ISO 7785-1, less than 62 dBA at 45 cm (17.72 in). Bulb Isolite 300: 3.5 V; 0.74 A. LED variable from 2.5 to 4.0 Vdc, 0.1 to 0.5 A, 15-38 klux. Comments The performance of the micromotor varies, depending on the type of electronic power supply used. We recommend that you use Bien-Air Dental electronic control units for optimum micromotor performance. Electromagnetic compatibility Corresponds to the electromagnetic compatibility in accordance with IEC 60601-1-2. Declaration by the manufacturer regarding electroma2

gnetic compatibility: refer to the insert until stop position. tables on pages 41-42-43-44. Fully tighten tube retainer. Replace sleeve fig. 2-4. Electrical safety According to IEC 60601-1 standard Cooling (General safety for Medical Electrical Via compressed air from the unit. Equipement), the device shall be Place the flow-meter on the coupling classified as a class II type B device. and regulate the flow at 8 normInformation liter/min. for the Isolite and MC2 The technical specifications, illustra- LED micromotor, and at 3 normtions and dimensions contained in liter/ min. for the MC2 micromotor these instructions are given only as a fig. 1, except for the MC2 GTAV miguide. They may not be the subject cromotor, which is self-ventilating. of any claim. The manufacturer reserves the right to make technical Important improvements to its equipment, Liquid or spray must not be allowed without amending these instruc- to penetrate inside the micromotor, tions. For all additional information, due to risk of irreversible damage. please contact Bien-Air Dental SA at Never connect an instrument with a the address indicated on the back micromotor that is running. cover. Changing the bulb Assembly Isolite 300 fig. 5. Box of 5 bulbs. Wear rubber gloves when carrying Connecting the hoses out this changing operation. Connection recommended using hoses see table page 17. Changing the LED Check the rear of the motor and the MC2 LED: The LED must only be joint on the hose are clean. Line up changed by a Bien-Air Dentalthe connection components on the approved repair centre. motor with those of the plug and

Changing the brushes Note: fine work; keep the brushes dry, never in contact with the lubricant, otherwise there is a risk of irreversible damage. Before removing the two carbon brushes, wipe the back of the micromotor with a dry cloth. Remove the sleeve Micromotor MC2 IR fig. 7 Micromotor MC2 GTAV fig. 8 Micromotors Isolite 300 and 100 fig. 6 To change the two carbon brushes, remove the used carbon brushes. Blow dry, clean air across the apertures at the rear of the body of the micromotor fig. 9. To reassemble, put the brushes in place and secure them fig. 10 with the spring. Replace the sleeve Take care not to damage the O ring when replacing the sleeve. Micromotor MC2 IR fig. 7 Micromotor MC2 GTAV fig. 8 Micromotors Isolite 300 and 100 fig. 6 Seals replacement To change the O rings REF 1300145010 fig. 11. Only valid for motors

with internal spray. Changing of the O ring REF 1301646-010 fig. 12, not valid for the Isolite 100 and 300 micromotors. Changing of the O ring REF 1300992-010 fig 8 + 13, not valid for the GTAV micromotors. Disposal This device must to 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). Maintenance

 Important Never lubricate the electric brush motor. Only use maintenance products and components from Bien-Air Dental. The use of other products and components can void the guarantee. 3

ENG

Precautions for maintenance: tone aldehydes or bleaches. Conditioning process The universal precautions, in partic- • Only use original Bien-Air Dental Wrap the removable sleeve in approular wearing of personal protective maintenance products and parts ved packaging for steam sterilisaequipment (gloves, goggles, etc.), or those recommended by Bien- tion. should be complied with by medical Air Dental. Using other products personnel using or performing or parts may cause operational Important maintenance on medical devices failure and/or void the guarantee. The quality of the sterilisation that are contaminated or potentially depend very much on the clean0 Manual cleaning/ contaminated. liness of the device. Only perfectly disinfection only Pointed and sharp instruments clean devices may be sterilised. should be handled with great Do not use a sterilisation proce Attention : caution. dure other than the one Electric motors with brushes are not described below. Check that the steriliser and the suitable for automatic cleaning/ Procedure: Fractionated pre-vacuwater that is used are clean. After disinfection (in a washer/disinfector um steam sterilisation, Class B cycle each sterilisation cycle, remove the machine). acc. to EN13060. The procedure has device from the sterilising apparatus been validated according to ISO immediately, in order to reduce the Clean and disinfect using a clean 17664. All Bien-Air Dental straight risk of corrosion. cloth soaked in a suitable product. handpieces are sterilisable in an • Never immerse in disinfectant autoclave up to 135°C (273.2°F). Suitable detergent solutions. Duration: 3 or 18 min., depending to For manual cleaning-disinfec- • Do not soak in physiological the national requirements in force. tion: liquid (NaCl). Overhaul • Detergent or detergent-disinfec- • Do not immerse in an ultrasonic Never disassemble the device. For tant (pH 6- 9.5) recommended for bath. any modification and repair, we reccleaning-disinfection of dental or ommend that you contact your regusurgical instruments. Quaternary 1 Sleeve sterilisation lar supplier or Bien-Air Dental diammonium- and/or enzymerectly. Bien-Air Dental asks the user  Only for motors with remov- to have its dynamic instruments based surfactants. • Do not use detergents that are cor- able sleeve fig. 6. checked or inspected at least once a rosive or contain chlorine, aceyear.

Transport and storage conditions Temperature between -40°C (-40°F) and 70°C (158°F), relative humidity between 10% and 100%, atmospheric pressure 50 kPa to 106 kPa (7.3 to 15.3 psi). Other precautions for use The device must be used by a qualified professional in compliance with the current legal provisions concerning workplace safety, health and accident prevention measures, and these working instructions. In accordance with these requirements, the operators: • must only use operating devices that are in perfect working order; in the event of irregular functioning, excessive vibration, abnormal heating or other signs indicating malfunction of the device, the work must be stopped immediately; in this case, contact a repair centre 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 4

themselves, their patients and Guarantee third parties from any danger, and must avoid contamination Terms of guarantee through the use of the product. Bien-Air Dental grants the operator a guarantee covering all functional Rest the device on a suitable support defects, material or production to avoid risks of infection for your- faults. The device is covered by this self, the patient or third parties. guarantee for 18 months from the date of invoicing. Bien-Air Dental It is essential to use dry, purified offers a 24-month guarantee for the compressed air in order to ensure the glass-bar light conductors. long working life of the device. Maintain the quality of the air and In the event of justified claim, Bienthe water by regular maintenance Air Dental or its authorised represenof the compressor and the filtration tative will fulfil the company’s oblisystems. The use of unfiltered hard gations under this guarantee by water will lead to early blockage of repairing or replacing the product the tubes, connectors and spray free of charge. Any other claims, of cones. 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 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.

The guarantee does not cover flexible “fibre optic” type conductors, or any parts made of synthetic materials.

Designation micromotor MC2 IR MC2 GTAV REF micromotor 1600073-001 1600075-001 Designation hose REF hose Grey hose ECO with fixed connector (L=2m) 1600120-001 x (x) Black hose ECO with fixed connector (L=2m) 1600297-001 x (x) Grey hose, revolving connector (L=2m) 1600298-001 Black hose, revolving connector (L=2m) 1600299-001 White hose ECO, with fixed connector (L=2m) 1600314-001 x (x) Black coiled hose with fixed connector (L=2m)1600315-001 x (x) White hose, revolving connector (L=2m) 1600316-001 (X) Do not connect supply of water and air spray (risk to damage the micromotor)

MC2 Isolite 300 MC2 Isolite 100 1600078-001 1600079-001 x x x x x x x

x x x x x x x

MC2 LED 1600681-001 x x x x x x x 5

ENG

REF

Legend

1600681-001 1600073-001 1600075-001

MC2 LED micromotor, with internal spray and light LED MC2 IR micromotor, with internal spray, without light Micromotor MC2 GTAV self-cooling, without internal spray, without light 1600078-001 Isolite 300 micromotor, with internal spray and light 1600079-001 Isolite 100 micromotor, with internal spray, without light 1302447-001 Sleeve for MC2 Isolite 100 1500246-001 Sleeve for MC2 Isolite 300 3300168-001/007.22.05-001 Extraction tongue for the brush springs 1500241-010 Pack of 10 brushes for MC2 and Isolite micromotors 1500007-005 Pack of 5 bulbs, for micromotors 1300145-010 O-Ring 1301646-010 O-ring for GTAV 1300992-010 O-ring for Isolite 1600307-001 Flow-meter for MC2 micromotors a Set supplied See cover page.

Optional components See cover page. b

List of Bien-Air Dental SA registered trade mark products ®: Aquilon® Bora® Boralina® ChiroPro®

Eolia® Gyro® Gyrolina® Isolite®

Lubrifluid® Lubrimed® MX® PowerCare®

Prestilina® Spraynet®

In these instructions, “Device” corresponds to the product described in the heading “Identification”. For example, turbine, contra-angle, handpiece, micromotor, tube, electronics, connectors, station etc. Symbols Manufacturer.

 Attention.

CE Marking with number of the notified body. Recyclable electrical and electronic material.

Wear rubber gloves. Sterilisable at the specified temperature. Light.

Move in the direction indicated. Move fully to the stop, in the direction indicated.

6



39 JPN

EMC Precautions Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the user's manual. 1. Use of MC2  Attention : The MC2 should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, the MC2 should be observed to verify normal operation in the configuration in which it will be used. 2. Use of Accessoires  Attention : The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air as replacements parts for internal components, may result in increased emissions or decreased immunity of the MC2. 3. Radio Transmitting Equipment  Attention : The MC2 motors comply with the EMC requirements according to IEC 60601-1-2. Radio transmitting equipment, cellular phones, etc. shall not be used in the close proximity of the device since this could influence the performance of the device. Particular precaution must be considered during use of strong emission sources such as High Frequency surgical equipment and similar so that e.g. the HF cables are not routed on or near the device. If in doubt, please contact a qualified technician or Bien-Air Dental. 4. Portable RF communication  Attention : 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 cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Guidance and manufacturer’s declaration – electromagnetic emissions The MC2 motors are intended for use in the electromagnetic environment specified below. The customer or the user of the MC2 motor should assure that it is used in such an environment. Emissions test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3

Compliance Group 1 Class B Not applicable

Electromagnetic environment - guidance The MC2 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. The MC2 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Not applicable

42

Guidance and manufacturer’s declaration – electromagnetic immunity The MC2 motors are intended for use in the electromagnetic environment specified below. The customer or the user of the MC2 motor should assure that it is used in such an environment. Immunity test IEC 60601 test level Electromagnetic environment - guidance Compliance level ±8 kV contact ±8 kV contact Electrostatic discharge (ESD) ±2 kV air Floors should be wood, concrete or ceramic tile. If floors are ±2 kV air IEC 61000-4-2 ±4 kV air covered with synthetic material, the relative humidity should ±4 kV air ±8 kV air be at least 30%. ±8 kV air ±15 kV air ±15 kV air Electrical fast transient/burst ±2 kV for power supply lines IEC 61000-4-4 ±1 kV for other lines ±0.5 kV line to line Surge ±1 kV line to line IEC 61000-4-5 ±0.5 kV line to earth ±1 kV line to earth ±2 kV line to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

0% UT for 0.5 cycle, at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°. 0% UT for 1 cycle and 70% UT for 25/30 cycles at 0° 0% UT for 250 cycles at 0°

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Not applicable

Magnetic field due to mains Magnetic fields generated by the mains frequency should be frequency (50/60 Hz) 30 A/m at levels characteristic of a typical location in a typical com30 A/m IEC 61000-4-8 mercial location 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 ± 10%. 43

Guidance and manufacturer’s declaration – electromagnetic immunity The MC2 motors are intended for use in the electromagnetic environment specified below. The customer or the user of the MC2 motors should assure that it is used in such an environment. Immunity test Conducted disturbances induced by RF fields IEC 61000-4-6

Radiated RF EM fields IEC 61000-4-3

Proximity fields from RF wireless communications equipment IEC 61000-4-3

NOTE 1 NOTE 2 a

IEC 60601 test level 3 Vrms 0.15 MHz - 80 MHz 6 Vrms in ISM bands 0.15 MHz - 80 MHz 80% AM at 1 kHz 3 V/m 80 MHz - 2.7 GHz 80% AM at 1 kHz Test freq. [MHz]

Compliance level 3 Vrms 0.15 MHz - 80 MHz 6 Vrms in ISM bands 0.15 MHz - 80 MHz 80% AM at 1 kHz 3 V/m 80 MHz - 2.7 GHz 80% AM at 1 kHz Immunity test level [V/m] Max. power [W]

385 450 710, 745, 780 810, 870, 930 1720, 1845, 1970 2450 5240, 5500, 5785

1.8 2 0.2 2 2 2 0.2

27 28 9 28 28 28 9

Electromagnetic environment - guidance 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. Interference may occur in the vicinity of equipment marked with the following symbol:

Distance: 0.3m

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 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 MC2 is used exceeds the applicable RF compliance level above, the motor MC2 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the MC2 motor. 44