M40 XS and M40N XS Micromotor Operation Manual Aug 2021

ENGLISH

1. User and Intended Use User : Qualified Professionals Intended Use : Dental Treatment (Do not use for surgical treatment.)

2. Precautions for handling and operation • Please read these precautions carefully and use only as intended or instructed. • Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device. Safety instructions are classified as follows in accordance with the seriousness of the risk. Class

Degree of Risk

WA R N I N G

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

CAUTION

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

N OT I C E

General product specification information highlighted to avoid product malfunction and performance reduction. 1

WARNING • Keep away from explosive substances and flammable materials. • Do not operate close to patients with cardiac pacemakers as there is a danger that it may affect the pacemaker.

CAUTION

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• Read this Operation Manual before use to fully understand the product functions and file for future reference. • When operating the product always consider the safety of the patient. • This motor cannot operate without a control unit. • The end user shall be responsible for any judgment that relates to the application of this product to a patient. • This product does not consider patient’s age (except infants), gender, weight or nationality. • This product does not consider operator’s age (mature person), height, weight, gender, or nationality. • Users are responsible for the operational control, maintenance and continual inspection of this product. • Do not attempt to disassemble the product nor tamper with the mechanism except as recommend by NSK in this Operation Manual. • Do not allow any impact on to the product. Do not drop the product.

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• Operators and all others in the area must wear eye protection and a mask when operating this motor. • Should the product function abnormally, cease operation immediately and contact your Authorized NSK Dealer. • Do not exceed the motor speed recommended by the handpiece and bur manufacturer. • Never lubricate the motor. Oil could cause overheating and damage to the motor. • Do not use high acid water or sterilizing solutions to wipe, immerse or clean the product. • The motor and motor cord cannot be cleaned and disinfected with a Thermo Disinfector. • Do not sterilize the motor and motor cord. • Perform regular function and maintenance checks. • If the product is not used for a long period check it is functioning correctly before using on a patient. • Air Requirements: The air should be dry, free from contamination and oil. Use a compressor with a dry air system. Install an air filter if necessary. Blow out the lines before installation. • Do not use this motor under stress for long time as this will cause overheating. • Do not pull the Motor excessively as this may loosen or disconnect the motor cord and cause malfunction. • Surface temperature shall be more than 60°C without using a coolant air. To avoid this occurrence, be sure to use sufficient coolant air. • When using the micromotor for more than 2 minutes continuously it will become hot. (The maximum surface temperature might reach 45°C) In such cases, stop using the micromotor until the motor has cooled down sufficiently. • To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during surgery. • Avoid continual eye contact with the LED light. (M40 XS)

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• This product is rated Medical Electrical equipment. EMC (Electromagnetic compatibility) is described in the documentation included. • Installation and use of this product requires special precautions regarding EMC according to the EMC information. • Portable and mobile RF communications equipment can affect Medical Electrical equipment. Do not use RF equipment near the product. • The use of ACCESSORIES such as cables, other than those specified by the manufacturer, with the exception of cables sold by the manufacturer of this product as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of this product. • This product should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, this product should be observed to verify normal operation in the configuration in which it will be used. • The system may present a possibility of malfunction when used in the presence of an electromagnetic interference wave. Do not install the system in the vicinity of any device which emits magnetic waves. Turn off the Main Power Switch of the system as an ultrasonic oscillation device or an electrode knife is located close to the vicinity of use. • U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

NOTICE The micromotor and motor cord during operation could interfere the computers, LAN cables in vicinity of use or could cause noise in radio receivers nearby. 4

3-1 Connection 1) Align the coupling to the correct holes and pins then insert the motor firmly into the motor cord. 2) Tighten the Motor Cord Nut securely. 3-2 Disconnection Loosen the Motor Cord Nut. Gently separate the motor from the cord.

Motor

Motor Cord Nut

Motor Cord Adaptor

Motor Cord

*Picture shows M40 XS.

Fig. 1

CAUTION Make sure that the motor cord nut is firmly tightened. Loose connection may cause a water leakage or motor may not function properly.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

3. Connection & Disconnection of the Motor and the Motor Cord

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4. Connection & Disconnection of the Handpiece and Motor 4-1 Connection 1) Connect the handpiece direct to the motor. (Fig. 2) When connecting an optic handpiece, twist the handpiece until it clicks into position. *NOTE: Optic handpieces will attach only to Optic Micromotors. 2) Make sure the handpiece is correctly connected to the motor. 4-2 Disconnection Hold the motor and the handpiece separately and disconnect with care.

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Motor Insert

Handpiece (Option)

Fig. 2

5. Check before treatment Connect the handpiece to the motor and check for motor vibration, noise and overheating. If any abnormalities are found do not use the motor and contact your Authorized NSK Dealer.

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CAUTION • Disconnect the handpiece only after the motor has completely stopped rotating. • Connect ONLY to E type Handpiece (ISO 3964). • After lubrication, stand the handpiece to drain excess oil and wipe off the oil inside the handpiece. Then connect it to the motor. • After lubrication, do not immediately attach the handpiece to the micromotor. This will avoid micromotor internal damage due to possible infiltration of excess oil.

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6. Maintenance After each patient maintain the product as follows. 1) Remove dirt and debris from the product. Do not use a wire brush. 2) Wipe clean with alcohol-immersed cotton swab or cloth.

CAUTION • To clean the product never use any solvent such as benzine or thinner. • Do not use high acid water or sterilizing solutions to wipe, immerse or clean the product. • Never lubricate the motor. Oil could cause overheating and damage to the motor. • Do not sterilize the motor and motor cord. • Keep the product in suitable atmospheric pressure, temperature, humidity, ventilation, and sunlight. The air should be free from dust, salt and sulphur.

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O-ring (Blue)

Replace the O-rings if water or air leakage is present from the motor insert. ALWAYS change the complete set of O-rings. 1) Gently remove each O-ring by hand. 2) Insert the complete set of new O-rings in the correct grooves. *Refer to Spare Parts List to identify the correct parts.

Motor Insert

O-ring (Black)

Fig. 3

CAUTION • When inserting new O-rings, make sure they are inserted in the correct grooves. • The blue O-Ring is thinner than the 3 black O-Rings. When inserting new O-rings, make sure they are inserted in the correct grooves as shown in the Fig. 3. • Worn O-Rings may cause: -Air/Water leakage -Air/Water blockages -Abnormal Vibration -Difficulty connecting/disconnecting the handpiece • Use ONLY genuine NSK O-Rings. Use of nonconforming O-Rings might lead to water leakage or the handpiece might become difficult to connect/disconnect.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

7. Replacing the O-rings

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8. Periodical Maintenance Checks Perform periodical maintenance checks every three months, referring to the check sheet below. If any abnormalities are found, contact your Authorized NSK Dealer. Points to check Rotation Coolant Water

Details Rotate the motor and check for abnormalities such as abnormal rotation, vibration, noise, and overheating. Connect the motor to the handpiece then operate the motor, and check that the coolant water is flowing properly.

9. Troubleshooting When a problem is detected, check the following again before requesting a repair. If none of these is applicable or if the trouble is not remedied even after an action has been taken, a failure of this product is suspected. Contact your Authorized NSK Dealer. Trouble Motor does not run. 10

LED does not light.

Cause Carbon brush is worn out. Motor Cord is not connected correctly. Reached the end of life expectancy.

Remedy Contact your dealer. Check the connection. Contact your dealer.

Water leakage

Cause Motor Cord is not connected correctly. Water is leaking from the motor insert.

Remedy Check the connection. Replace with new O-ring.

10. Classification of equipment • Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide : -EQUIPMENT not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. • Mode of operation : -Intermittent operation (ON : 2min, OFF : 5min (3A, with air cooling) ) (IEC 60034-1: Type S3)

11. Symbol Conforms to CE European Directive of “Medical device directive 93/42/EEC.” Manufacturer. Authorized representative in the European community. Caution: U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

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Trouble

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12. Warranty NSK products are warranted against manufacturing errors and defects in materials. NSK reserves the right to analyze and determine the cause of any problem. Warranty is voided should the product be not used correctly or for the intended purpose or has been tampered with by unqualified personnel or has had non NSK parts installed. Replacement parts are available for seven years beyond discontinuation of the model.

13. Spare Parts List Model O-ring* O-ring* *Attached item

Order Code 0313084070 0312074080

Remarks Blue Black

14. Disposing product In order to avoid the health risks of operators handling the disposal of medical equipment, as well as the risks of environmental contamination caused thereof, a surgeon or a dentist is required to confirm the equipment is sterile. Ask specialist firms who are licensed to dispose of specially controlled 12 industrial wastes, to dispose the product for you.

Model Handpiece Connection Type Rotation Speed Dimensions Rated Input Coolant Water Supply Chip Air Supply Coolant Air Supply Optic Voltage Active Voltage Consumption Current Use Environment Transportation and Store Environment

M40 XS

M40N XS E Type ISO 3964 60 - 40,000min-1 ø22 x L91mm DC 0 - 24V 65mL/min and more (0.2 - 0.25MPa) 1.5L/min and more (0.2 - 0.25MPa) 6.5NL/min and more (0.2 - 0.25MPa)

White LED DC 3.3±0.5V 2.5 - 4.0V 0.2A Typical (3.3V) Temperature: 10 - 40°C, Humidity: 30 - 75%*1 Temperature: -10 - 50°C, Humidity: 10 - 85%*1, Atmospheric Pressure: 500 - 1,060hPa

*1 No liquid freezing allowed. / * Using in conditions outside the limits above may cause malfunction.

ENGLISH GERMAN FRENCH SPANISH ITALIAN

15. Specifications

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OM-E0634E 002

2021-08-XX CACB09XX XXN