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This document is an excerpted version of the operation manual (OM-T0517E008) which contains only a single language.
・User: Qualified professionals (dentist) ・Intended purpose: The dental handpiece is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), and finishing of teeth and dental restorations (preparation and adjustment). Only for Ti-Max X450 series : The Ti-Max X450 series is pnenumatic dental drilling system handpiece with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. ・Patient population : Any patient (ages 2 and over). The user's discretion is required prior to use.
Depressing the Push Button while the handpiece is in rotation may lead to overheating, causing burn injuries or product failure. Avoid the push button to contact with any oral tissue.
・When operating the product always consider the safety of the patient. ・Users are responsible for the operational control, maintenance and continual inspection of this product. ・Do not disassemble or alter the handpiece and cartridge, etc. except as recommended by NSK in this Operation Manual. ・Do not drop the handpiece from a height of more than 1 m. ・Should the handpiece function abnormally during use, stop using the handpiece immediately and contact your Authorized NSK Dealer. ・The product is delivered in a non-sterile condition. Be sure to sterilize the product and the bur prior to use. ・Follow the specifications described in this operation manual as to the bur to be used, etc. to prevent accidental release or breakage of the bur during rotation. ・Perform regular function and maintenance checks. ・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.（Z890BL / Z800BL / Z890WL / Z800WL / Z990BL / Z900BL / Z990WL / Z900WL / Z micro WL / X450BLED / X450WLED / M800BL / M500BLED / M800WL / M500WLED / M900BL / M600BLED / M900WL / M600WLED / S-Max pico BLED / S-Max pico WLED） ・This handpiece is a LED product classified in the "Exempt Group" (no photobiological hazard) in accordance with IEC62471/EN62471. ・Use a power source which meets the following requirements. 1. The electricity supply of the power source is below 15W both under normal and single-failure conditions. 2. The power source uses a SELV circuit for electricity supply. 3. The output voltage of the power source is within the range recommended by the manufacturer of this product. ・Contact your Authorized NSK Dealer if repairs are necessary. 1 / 12
・An accidental symptom, such as subcutaneous emphysema may be developed in the use of this product for extraction of wisdom teeth. Do not direct air exhausted from the handpiece to the bleeding area (wound) or into periodontal pockets. ・Report all serious events related to the product immediately to the manufacturer and the responsible national authority. ・Do not apply excess pressure to the bur as it may break or bend and become difficult to remove. ・Always follow the instructions provided by the bur manufacturer regarding the bur usage and rotation speed, etc.
・This product is equipped with the Quick Stop Function, which means that when the air supply is stopped, the rotation stops in a shorter time than conventional handpieces. Also, when you turn the attached bur by hand, there will be resistance, but this is not a malfunction. ・This product has a structure that a small amount of air escapes from the joint with the coupling. If liquid such as lubricating oil remains inside the handpiece, the liquid may leak from the joint, but this is not a malfunction. (Z890L /Z990L / Z890KL / Z990KL / Z890SL / Z990SL) ・Substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council, or substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5 of Regulation (EU) No 528/2012 of the European Parliament and the Council, in accordance with the criteria that are relevant to human health amongst the criteria established therein: lead (Pb), cobalt (Co). - This product can be safely used in the treatment of children, pregnant or breastfeeding women, or other patient groups considered particularly vulnerable to such substances.
Follow the specifications described in this operation manual as to supply pressure, the bur to be used, etc. Do not use air contaminated by dust, moisture or oil.
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Sudden release of the handpiece may cause injury.
If blood or debris is stuck, wipe in and around the bur insertion hole with a cloth moistened with disinfectant solution until all residues are thoroughly removed. Residual blood or debris may enter the handpiece while changing burs, which could lead to higher risk of cross-contamination.
・To ensure cleaning and sterilization efficacy, use only the following procedures for reprocessing. ・Follow local rules, regulations, and guidelines regarding the reprocessing of devices. ・Immediately after a treatment (within 1 hour), perform maintenance and then store the handpiece. Failure to 3 / 12
properly maintain the handpiece may cause infection, product failure, overheating leading to burn injuries. ・If blood infiltrates inside a handpiece, an automatic handpiece cleaning and lubrication system may not totally clean the internal handpiece components and may lead to blood coagulation inside the handpiece. Coagulated blood may cause handpiece failure and overheating, causing burn injuries. To avoid the risk, NSK recommends to immediately lubricate those handpieces with PANA SPRAY Plus.
・Do not use the following fluids to wipe, immerse or clean the product; strong/super acid water, strong acid/alkaline chemicals, chlorine containing solutions, solvents such as benzine or thinner. ・After washing with washer-disinfector, prior to lubrication, dry the product until all internal moisture is completely removed. Remaining moisture inside the product could reduce the effect of lubrication and could cause corrosion inside of the product. ・Remove the handpiece from the washer-disinfector immediately after the cleaning, disinfecting, and drying cycle
is
complete (within 1 hour), otherwise it may cause corrosion. ・Do not use sprays other than NSK PANA SPRAY Plus. Using other sprays may cause handpiece overheating. ・Clean and lubricate the handpiece prior to sterilization. If blood remains on the internal surface, it may become clotted and cause product failure. ・Immediately after sterilization is complete (within 1 hour), remove the handpiece from the sterilizer. Failure to do so may cause corrosion. ・Do not perform steam sterilization on the product with other instruments even when it is in a pouch. This is to prevent possible discoloration and damage to the product from chemical residue on other instruments. ・Sterilization is not guaranteed after the sterilization retention period specified by the manufacturer and seller of the sterilization pouch has elapsed. If the sterilization retention period has elapsed, perform sterilization again with a new sterilization pouch. ・Do not use sterilization pouches containing water-soluble adhesive components such as PVA (polyvinyl alcohol). Adhesive components washed out during sterilization may enter the product, causing problems such as poor rotation, sticking and failure to operate correctly. ・Do not heat or cool the product too quickly. Rapid change in temperature could cause damage to the product. ・The product lifetime and product’ s ability to operate correctly are mainly determined by mechanical stresses during use and the chemical influences due to processing. If you detect any abnormality such as center run-out of bur, heat generation, vibration or noise, or if the exterior markings (serial number or model number) have become unreadable before or during use, stop using the product immediately and request your nearest NSK dealer, or one of the NSK branches for a periodic inspection. ・When the product has been reprocessed 250 times or has been in use for one year, it is recommended that a periodic inspection be performed by an authorized NSK service. ・Store the product in a well ventilated place out of direct sunlight and within the range of temperature, humidity and pressure specified in specifications.
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If another cartridge is used NSK cannot guarantee performance and the handpiece warranty would become invalid.
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・Replace the O-rings if water is present in the exhaust air line. This is an indication of possible water leakage within the coupling. ALWAYS change the complete set of O-rings. ・Do not force the new replacement O-ring with excessive pressure. ・When inserting new O-rings, make sure they are inserted in the correct grooves.
Make certain that the taper ring is firmly tightened. If the taper ring is loose water and air leakage could occur.
Checking the Handpiece Before
Periodical Maintenance Checks
Each Use
(Every 3 months)
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When your medical device has reached the end of its service life, it must be disposed of via a specialist collection, removal, recycling or destruction channel. Prior to do so, in order to avoid the health risks to operators handling the disposal of medical equipment, as well as the risks of environmental contamination caused thereof, you need to confirm the equipment is sterile. Therefore contact your nearest NSK dealer, or one of the NSK branches to find out how to proceed.
Refer to the link below:
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.
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*Non-CE Model. Not for sale in the EU. ・For lighting power, follow the IEC 60601-1, IEC 80601-2-60 and ISO 74941(where applicable)
WARNING: 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.
NOTICE: General product specification information highlighted to avoid product malfunction and performance reduction.
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Move in the direction indicated.
Move fully to the stop, in the direction indicated.
Prohibited / Process NOT permitted / Wrong
Do the step / Process permitted / Correct
If...(Hypothetical situation)
State of being fixed.
Call for maintenance
Blowing off with compressed air
Wear protective gloves
Wear a face mask
Wear eye protection
Temperature
Ultrasonic bath The instrument can be used with a washer-disinfector for thermal disinfection. This product can be sterilized in a steam sterilizer at 135°C.
Drying time
Lamp / lighting / illumination
Drinkable tap water
Visual check
Do not use any object with a sharp edge.
Hand operated
Caution, hot surface
Consult operation instructions
Specifications
Conforms to European "Medical Device Regulation"
The EU directive 93/42/EEC was applied in the design and production of this medical device.
Manufacturer
Importer for Europe
Authorized representative in the European Community Authorised representative for Switzerland
Medical Device
MODEL:
Catalog number (Order code)
Serial No.
Date of manufacture
Unique Device Identifier
GS1 DataMatrix for Unique Device Identifier.
Contains hazardous substances
Recommend 11 / 12
Drive air pressure
Water Pressure
Chip air pressure
Exhaust air pressure
Transportation and Storage Environment
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Keep away from sunlight
fragile / handle with care
Keep dry
NSK original surface treatment
2024-05-13 CACE0610 20S
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