ISOLITE LK and LED Micromotor Instructions for Use Sept 2022

Packaging content (REF)

MOT ISOLITE LED

MOT ISOLITE LK

REF 1600681-001

REF 1600078-001

Optional accessories

BACK COVER WITH RING LK

COVER MC2 LK LED

REF 211.60.18-001

REF 1501368-001

BULB MOT

O-RING 8.1x0.73

Compatible with

Compatible with

REF 1500007-005

REF 1300967-010

MOT ISOLITE LK

MOT ISOLITE LED

MAINT SPRAYNET® (BOX OF 6 CANS)

FLOWMETER

HOSE ISOLITE/MC2 COILED BLACK

HOSE ISOLITE/MC2 GREY

REF 1600036-006

REF 1600307-001

REF 1600315-001

REF 1600120-001

HOSE ISOLITE WATER ADJ GREY

HOSE ISOLITE SWIVEL GREY

HOSE ISOLITE/MC2 SWIVEL GREY

REF 1600134-001

REF 1600132-001

REF 1600298-001

REF 2100194-0006/2022.09

MOT MC2 ISOLITE - LK & LED • © Bien-Air Dental SA

Table of contents 1 Symbols 1.1 Description of symbols used

4 4

2 Identification & Intended Use 5 2.1 Identification 2.2 Intended use 2.3 Intended patientpopulation 2.4 Intended user 2.5 Use environment 2.6 Intended medicalconditions 2.7 Patient contra-indications and side effects 2.8 In case of accident

3 User and Patient Safety: Warnings and Precautions for use 3.1 Installation

Electromagnetic Com4 patibility (EMC)

5 5 5 5 5 5 5 5

5.6 Operating conditions

17

6 Maintenance and servicing 18 6.1 Maintenance - General information

18

6.1.1 Suitable maintenance products

18

6.2 Cleaning 6.3 Sterilization of the external sleeve

19

6.3.1 Procedure

19 19

6.4 Packing and storage 6.5 Servicing

21 21

7 Transport & disposal

22

7.1 Transport 7.2 Disposal

22 22

6

8 General information

23

8

8.1 Terms of guarantee 8.2 References

23 24

9

4.1 EMC Caution 9 4.2 Electromagnetic compatibility – emissions & immunity 10

5 Description 5.1 Overview 5.2 Assembly and preparation 5.3 Technical data 5.4 Classification 5.5 Performances

13 13 14 17 17 17

3

ENG INSTRUCTIONS FOR USE 1 Symbols 1.1 Description of symbols used Symbol

Description

Description

Manufacturer.

Catalogue number.

CE Marking with number of the notified body.

Serialnumber.

WARNING: hazard that could result in serious injury or damage to the device if the safety instructions are not correctly followed.

MedicalDevice.

CAUTION: hazard that could result in light or moderate injury or damage to the device if the safety instructions are not correctly followed.

Authorized EC Representative in the European Community.

Wear protective gloves.

Lamp; lighting, illumination.

Electricalsecurity. Applied part type B.

Sterilizable in a steam sterilizer (autoclave) at the specified temperature.

Warning: in accordance with federal law (USA), this device is only available for sale upon recommendation by an accredited practitioner.

Consult instructions for use or consult electronic instructions for use.

Data Matrix code for product information including UDI (Unique Device Identification).

Temperature limit.

Humidity limitation.

Atmospheric pressure limitation.

Keep away from rain.

Generalsymbolfor recovery/recyclable.

Recyclable electricaland electronic material.

4

Symbol

2.1 Identification Medical devices manufactured by BienAir Dental SA.

Type: Electric dental micromotor with internal spray and brushes. Nonsterilizable, protected from the oil of the handpieces. Removable, sterilizable sleeve.

MOT ISOLITE LK Version with light bulb

2.4 Intended user Product intended for professional use only. Used by dentists and dental professionals.

2.5 Use environment Professional healthcare vironment.

facility en-

2.6 Intended medical conditions General dentistry which includes restorative dentistry, dental prophylaxis, orthodontics and addresses the maintenance or reestablishment of dental health.

Version with LED light

2.7 Patient contra -indications and side effects

Note : MC2 nomination includes MOT ISOLITE LK & MOT ISOLITE LED

No specific patient contra- indication, side effects nor warning exist for the device when it is used as intended.

Description:

2.8 In case of accident

Bien-Air Dental micromotors are designed to transform electricity into mechanic rotation to drive dental straight handpieces and contra-angles.

If an accident occurs, the device must not be used until repairs have been completed by a qualified, authorized and trained technician in a repair center.

MOT ISOLITE LED

2.2 Intended use Product intended for use in general dentistry which includes restorative dentistry, dental prophylaxis and orthodontics treatments.

2.3 Intended patient population

ENG

2 Identification & Intended Use

If any serious 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.

WARNING The intended patient population for the Any use other than that for which this device includes any person visiting a device is intended is unauthorised and dental practitioners’ office to receive may be dangerous. treatment in line with the intended medical condition. There is no restriction concerning subject age, race, or culture. The intended user is responsible to select the adequate device for the patient according to the specific clinical application. 5

FIG. 1 Number of Mean of Protection required : [A] 1MOPP [B] 1MOPP [C] 2MOPP [I] 2MOPP Insulation diagram corresponding to the recommended installation of the motor in the dental unit.

3 User and Patient Safety: Warnings and Precautions for use This medical device must be used by professionals in compliance with the legal provisions in force regarding occupational safety, health and accident prevention measures, and these instructions for use. In accordance with these provisions, the user is responsible for ensuring he or she only uses devices which are in perfect working order.

6

WARNING Electrical safety can only be claimed when the device is used according to the insulating diagram above. FIG. 1. l Always refer to the dental unit instruction for use to confirm compatibility with the device and electrical safety compliance. l When used according to the insulating diagram FIG. 1, the device is compliant to the following clauses of IEC 60601-1: l Leakage currents (clause 8.7) l Electrical insulation (dielectric strength) clause 8.8.3

To prevent any risk of explosion, the warning below must be observed: WARNING According to IEC 60601- 1:2005 +A1 2012 / AnnexG, electrified devices (motors, control units, couplers and attachments), can be safely used in a medical environment in which potentially explosive or flammable mixtures of anaesthetic substances are delivered to the patient only if: l The distance between the motor and the anaesthetic breathing circuit exceeds 25 cm. l The motor is not used simultaneously to the administration of the anaesthetic substances to the patient.

ENG

Electrical safety:

For preserving partial compliance with To prevent any risk of infection, the IEC 60601-1, regular maintenance as warnings below must be observed: well as a servicing every 12 months is recommended. Partial compliance with WARNING IEC 60601-1 is not guaranteed for a serl The device is supplied not sterile. vice period longer than 5 years. To avoid any infection, respect the cleaning, sterilization and mainAny motor not compliant with IEC tenance procedure detailed in 60601-1 must be installed according to section 5. Only the removable IEC 60601-1 by posing adequate means sleeve can be sterilized. of patient protection. l Medical personnel using or perElectromagnetic compatibility: forming maintenance on medical devices that are contaminated or WARNING potentially contaminated must comply with universal preElectromagnetic compatibility of mocautions, in particular the wearing tors and compatible hoses has been of personal protective equipment verified for a test setup representing (gloves, goggles, etc.). Pointed and typical final application according to the sharp instruments should be insulating diagram FIG. 1 . Elechandled with great care. tromagnetic compatibility must be l Rest the device on a cleanable supvalidated for the final application after port. installation of the motor in the dental unit. Magnetic disturbance can occur from other electromedical devices; refer to the EMC specifications below.

7

To prevent any risk of motor overheating, the cautions below must be observed: CAUTION The motor needs to be connected to the dental unit air cooling system to avoid overheating and/or auto- limitation of the speed via the electronic board safety control. l Always ensure that the micromotor hose is not bent and that both the hose and the motor are in good condition. l

To prevent any risk of injury and/or material damage the cautions below must be observed: CAUTION In the event of excessive vibrations, abnormal heating, unusual noise or other signs suggesting that the device is malfunctioning, work must be suspended immediately. In this case, contact a repair centre approved by Bien-Air Dental SA. l Never connect an instrument on a running micromotor. l Do not spray any lubricant or cleaning solution into the motor. l Never rinse the device to cool them. l It is essential to use dry, purified compressed air in the dental unit in order to ensure the long working life of the device. Maintain the quality of the air and the water by regular maintenance of the compressor and the filtration systems. The use of unfiltered hard water will lead to early blockage of the tubes and connectors. l

8

3.1 Installation WARNING Recommended installation corresponds to the insulation diagram FIG. 1.

4 Electromagnetic Compatibility (EMC) 4.1 EMC Caution CAUTION Since compliance with the international standard IEC 60601-1-2 does not guarantee immunity against 5G worldwide (due to the different frequency bands used locally), avoid the presence of devices equipped with 5G broadband cellular networks in the clinical environment or ensure that the network functionality of these devices is disabled during the clinical procedure. l Radio transmitting equipment, cellular phones, etc., should not be used in the immediate vicinity of the device, since this could affect its operation. Special precautions should be taken when using strong emission sources such as high-frequency surgical equipment and other similar devices, to ensure that HF cables are not routed above or near the device. If in doubt, please contact a qualified technician or Bien-Air. l 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. l Since this device is intended to be used adjacent to or stacked with other equipment, the responsibility of verifying normal operation in the configuration in which it will be used falls onto the dental unit manufacturer. l The use of accessories, transducers and cables other than those specified, with the exception of transducers and cables sold by Bien-Air as spare parts for internal components, may result in increased emissions or decreased immunity.

ENG

l

9

4.2 Electromagnetic compatibility – emissions & immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment.

Guidance and manufacturer’s declaration – Electromagnetic emissions: Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR11

Group 1

The device uses RF energy for its internal operation only. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR11

Class B

Harmonic emissions IEC 61000-3-2

N/A

The device is suitable for use in any building, including residential buildings and those directly connected to the public low-voltage power supply network that supplies buildings used for residential purposes.

Emissions due to voltage N/A fluctuations (flicker) IEC 61000-3-3

10

Guidance and manufacturer’s declaration – Electromagnetic immunity:

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient burst IEC 61000-4-4

IEC 60601 test level

Compliance level

±8 kV contact

±8 kV contact

±2 kV air

±2 kV air

±4 kV air

±4 kV air

±8 kV air

±8 kV air

±15 kV air

±15 kV air

±2 kV for power sup- N/A ply lines

Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

ENG

Immunity test

N/A

±1 kV for other lnes Surge IEC 61000-4-5

±0.5 kV line to line

N/A

N/A

0 % U T for 0.5 cycle, N/A at 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

N/A

±1 kV line to line ±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 1 cycle 70 % U T for 25/30 cycles at 0° 0 % UT for 250/300 cycles at 0°

Magnetic field due 30 A/m to mains frequency (50/60 Hz) IEC 61000-4-8

30 A/m

Magnetic fields generated by the mains frequency should be at levels characteristic of a typical location in a typical commercial or hospital environment.

11

IEC 60601 test level

Immunity test

Compliance level

Conducted dis- 3 VRMS 3 VRMS 0,15 MHz – 80 MHz turbances induced 0,15 MHz – 80 MHz by RF fields 6 VRMS in ISM 6 VRMS in ISM bands IEC 61000-4-6 bands 0,15 MHz – 80 0,15 MHz – 80 MHz MHz 80% AM at 1 kHz 80 % AM at 1 kHz Radiated RF fields IEC 61000-4-3

EM 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] 385

Electromagnetic environment - guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey 1 should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

3 V/m 80 MHz - 2,7 GHz 80 % AM at 1 kHz Max. power [W]

Distance: 0.3 m Immunity test level [V/m]

450 1.8

27

2

28

0.2

9

2

28

2

28

2

28

0.2

9

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

Note : UT is the AC mains voltage prior to application of the test level. Essential performance per IEC 60601-1: The essential performance is to maintain the visual luminous intensity of the LED and the motor speed. The maximum speed deviation is ±10%. Note1:At 80 MHz and 800 MHz, the higher frequency range applies. Note2:These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

(1) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and mobile field radios, amateur radios, AM and FM radio broadcasts and TV broadcasts 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 device is used exceeds the RF compliance level mentioned above, the device 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 device.

12

ENG

5 Description

FIG. 2

5.1 Overview FIG. 2 (1) Motor nose (2) Motor body (3) Hose/motor connection

Note : The technical specifications, illustrations and dimensions contained in these instructions are given merely as an indication. They may not give rise to any claim. The original language of those instructions for use is English. For any further information, please contact Bien-Air Dental SA at the address given on the back cover. 13

FIG. 3

FIG. 4

FIG. 5

5.2 Assembly and preparation 1. Check that the rear of the motor and the hose connector are clean and dry. 2. Position the motor and its proprietary hose (without the ring provided with hoses REF. 1600120-001 & REF. 1600315-001) as shown in (FIG. 3). Rotate it to find the exact position and push it into the motor. 3. Holding the motor fully screw the hose sleeve to the rear motor connection (FIG. 4). 4. Place the flowmeter on the nose attachment then activate the cooling air and measure the airflow. The value is measured in the middle of the flowmeter’s ball according to standard JIS B7551 (FIG. 5). 5. If the cooling airflow is not in the range of 8 normliter/min (+/-10%), tune the air pressure to meet this requirement.

14

ENG FIG. 6

FIG. 7

Removing and replacing the sleeve: 1. Remove the motor from its hose. 2. In order to remove the sterilizable sleeve from the motor, push it forward as shown in FIG. 6a. 3. Replace the sterilizable sleeve by pushing it (FIG. 6b). Great care should be taken during this operation as to not damage the nose O-ring when replacing the sleeve.

Changing the bulb: FIG. 7

ISOLITE LK Wear rubber gloves when carrying out this changing operation. 1. Remove the sterilizable sleeve. 2. Remove the bulb using the small hole on the side by pushing it forward (avoid touching the glass part of the bulb) (FIG. 7).

ISOLITE LED The LED must only be changed by a Bien-Air Dental approved repair centre.

15

FIG. 8

Changing the seals manually (no tool required) FIG. 8 l l l

16

Do not lubricate the O-ring Use proprietary O-ring only Check that the O-rings are neither broken nor scratched after mounting them

Technical data

MC2

Recommended air flow (measured at the motor nose)

8 Nl/min (+/-10%)

Air pressure range

2.5 - 5 bar

Coupling

Nose in accordance with ISO 3964

Operating times

No limitations for the user. Operating times are electronically imposed by Bien- Air control boards, as a function of the applied torque.

Rotation speed range

60 - 40'000 rpm

Direction of rotation

Clockwise and anticlockwise

Luminous intensity

LED or bulb, 10 klux

ENG

5.3 Technical data

5.4 Classification Class IIa in accordance with European Medical Regulation (EU) 2017/745. Class II type B device in accordance with IEC 60601-1 standard.

5.5 Performances Performances

MC2

Give speed and torque as preset

No maximum speed is defined by the user by imposing the voltage. Torque can be monitored via the current supply.

Speed value accuracy

+- 10%

5.6 Operating conditions Operating conditions

Temperature range:

+10°C - +35°C (+50°F - +95°F)

Relative humidity range:

30% - 80%

Air pressure range:

700 hPa - 1060 hPa

17

FIG. 9

6 Maintenance and servicing 6.1 Maintenance - General information Clean the device and sterilize the removable sleeve prior to first use. Within a maximum of 30 minutes after each treatment, clean the motor. Observing this procedure eliminates any blood or saliva residues. WARNING Follow your national directives, standards and guidelines for cleaning and sterilization recommendations. l Electric motor with brushes are not suitable for automatic cleaning/disinfection in a washer-disinfector machine. l

CAUTION Do not spray any lubricant or cleaning solution into the motor. FIG. 9. 6.1.1 Suitable maintenance products Only use original Bien-Air Dental SA maintenance products and parts or those recommended by Bien-Air Dental SA. Using other products or parts may cause faults during operation and/or void the warranty. l Spraynet® l Alkaline detergent or detergent disinfectant (pH 8-11) recommended for cleaning-disinfection of dental or surgical instruments. Disinfectant products composed either of didecyldimethylammonium chloride, quaternary ammonium carbonate or neutral enzymatic product. (e.g. neodisher® Mediclean) are also allowable.

18

l

Only use dynamic air removal cycles: pre-vacuum or steam flush pressure pulse (SFPP) cycles. If the sterilization is required by national directives, use only dynamic sterilizers: do not use a steam sterilizer with a gravity displacement system. As with all instruments, following each sterilization cycle, including drying, remove the device to avoid an excessive exposure to heat which can result in corrosion.

CAUTION l Do not submerge in physiological liquid (NaCI) nor use saline solution to keep the device moist until it can be cleaned. l Do not submerge in a cleaning bath. l Do not clean in a washer- disinfectant unit, nor ultrasonic cleaner. l Do not spray any cleaning solution into the motor. 6.3.1 Procedure l Always ensure that the motor contacts are kept clean. 1. Disassemble the external sleeve from the motor. The external surface of the motor must be cleaned to remove impurities as fol- 2. Pack the sleeve in a packaging approved for steam sterilization. lows: 3. Sterilize using steam, following dyl Clean the external surface of the namic air removal cycle (ANSI/AAMI motor using low- linting textile ST79, Section 2.19), i.e. air removal moistened with recommended via forced evacuation (ISO 17665-1, cleaning products. ISO/TS 17665-2) at 135°C (275°F), l Do not allow water to seep in the for 3 minutes or at 132°C (269.6°F) motor either by the nose or by the for 4 minutes. In jurisdictions where hose connector. sterilization for prions is required, l Dry the external surface of the sterilize at 135°C (275°F) for 18 motor with low linting textile minutes. moistened with Spraynet®. l

ENG

6.2 Cleaning

6.3 Sterilization of the external sleeve CAUTION Only applicable for motors with removable sleeve. l The quality of the sterilization is highly dependent on how clean the device is. Only perfectly clean devices may be sterilized. l To improve the effectiveness of the sterilization, make sure the motor is completely dry. l Do not use a sterilization procedure other than the one described below. l

19

The recommended parameters for the sterilization cycle are: l

l

l

l

l

l

20

The maximum temperature in the autoclave chamber does not exceed 137°C (278.6°F), i.e. the nominal temperature of the autoclave is set at 134°C (273.2°F), 135°C (275°F) or 135.5°C (275°F) taking into account the uncertainty of the sterilizer with regard to temperature. The maximum duration of the interval at the maximum temperature of 137°C (278.6 °F) is in accordance with national requirements for moist heat sterilization and does not exceed 30 minutes. The absolute pressure in the chamber of the sterilizer is comprised in the interval 0.07 bar to 3.17 bar (1 psia to 46 psia). The rate of change of temperature does not exceed 15°C/min (59°F/min) for increasing temperature and 35°C/min (- 31°F/min) for decreasing temperature. The rate of change of pressure does not exceed 0.45 bar/min (6.6 psia/min) for increasing pressure and -1.7 bar/min (-25 psia/min) for decreasing pressure. No chemical or physical reagents are added to the water steam.