Instructions for UsePlatinum Line 450KL / 550K / 550KL / 450NL / 550N / 550NL

Dureka Dental Ltd

Unit 15,The Brewery Business Park, Dundalk, Co Louth, Ireland A91AV84

PN: D0001 Rev 12 2018

Manufacturer: Dureka Dental Ltd Unit 15,The Brewery Business Park, Dundalk, Co Louth, Ireland A91AV84

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TABLE OF CONTENTS

1. Important Information.................................................... 4

2. Operation ...................................................................... 8

3. Specification ................................................................. 11

4. Reprocessing methods according to ISO 17664........... 12

5. Maintenance / Care & Accessories ............................... 17

6. Limited Warranty ........................................................... 19

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IMPORTANT INFORMATIONExplanation of symbols.

Caution e.g. Situations where failure to follow the instructions may lead to injury to patient or operator or damage to hand piece. Important information for operator and engineer.

Consult instructions for use

Sterilizable up to 135°C (275°F)

Suitable for washer disinfector

Item No e.g. 550KL or 550NL

Serial Number

CE Marking with number of the notified body

Do not use if packaging is damaged

Protect from moisture

Manufacturer

The manufacturer assumes no responsibility for damage arising through:

• External influences, e.g., faulty installation

• Use of incorrect information

• Improper use

• Improperly performed repairs.

REF

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IMPORTANT INFORMATION

For Professional Use Only:

• Warning: This product is intended for use by dental professionals only. Before operating handpiece, carefully read and follow these instructions.

• Save instructions for future use.

• Observe all Warnings and Cautions.

To reduce the risk of serious injury:

• Prior to each use, instruments must be inspected for proper operation.

• Clean and sterilize handpieces as soon as practical before first use and after each patient.

• Always insert bur the full length of the chuck. If you attempt to extend it from the chuck, the bur may dislodge during use and possibly injure you or your patient.

• Before use, ensure that bur is completely seated and locked in the instrument.

• An annual check up and service of this product is recommended by Dureka Dental Ltd or an approved representative of Dureka.

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IMPORTANT INFORMATION

Repair and maintenance work, apart from the activities described in this manual, may be performed only by Dureka Dental Ltd or a third-party repair partner approved by Dureka Dental Ltd.

• In the event of modifications by third parties, the warranty becomes null and void. Any claim shall be excluded if defects or the consequences thereof are due to manipulation or modifications to the product by the customer or by a third party.

Hazards for the care provider and the patient.

In the case of damage, irregular running noise, excessive vibration, untypical warming or when the bur cannot be held in the handpiece spindle.

• Do not continue to use and contact Dureka Dental Ltd or an approved representative.

Premature wear and malfunctioning from improper storage during long periods of non-use will cause reduced product life.

• The handpiece should be cleaned, dried, oiled and stored in a dry location, before long periods of non- use.

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IMPORTANT INFORMATION

Intended Use - Purpose

• This medical device is Intended for professional use only in dentistry for general dentistry work. Any use other than that for which this device is intended is prohibited and may prove dangerous.

According to these provisions, this device may only be used for the described application by a knowledgeable user. The following must be observed:

• The applicable health and safety regulations.

• The applicable accident prevention regulations.

• These operating instructions.

According to these regulations, it is the responsibility of the user to:

• Only use equipment that is operating correctly.

• Use the equipment for the proper purpose.

• Protect him or herself, the patient and third parties from danger.

• Avoid contamination from the product.

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OPERATION

Check the air pressure:

• It is recommended that this handpiece be operated with an air pressure of 2.8 bar (40 psi). For maximum turbine life do not operate the handpiece outside the recommended air pressure of 35-42 psi.

Damage from contaminated and moist air.

• Contaminated and moist air can cause malfunctions and leads to premature handpiece failure.

• Ensure that the supply of compressed air is dry, clean and uncontaminated according to ISO 7494-2.

Overheating of the tooth due to lack of cooling water / spray cooling

• Lack of cooling water can cause thermal damage to the dental pulp.

• Adjust the water amount for the spray cooling to a minimum of 50 ml/mi

• Adjust the Water Pressure to 0.8 - 2.5 Bar.

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OPERATION

Connection to Unit

• Slide the handpiece onto the handpiece coupling in an axial direction until it clicks audibly into place

• Check for secure seating on the coupling by pulling on the handpiece and ensuring that it is securely locked in place

Disconnecting the handpiece from the coupling

• Hold the coupling and pull the handpiece off in an axial direction

• Do not connect or disconnect the handpiece while the footswitch is pressed.

BURS:

Only use burs that have shafts compliant with ISO1797-1 type 3, made from steel or tungsten carbide and that meet the following criteria:

• Shaft diameter from 1.59 – 1.60 mm

• Overall length up to max. 25 mm

• Shaft clamping length of at least 11 mm

• Cutting edge diameter up to max. 2 mm

• Short shank burs are recommended for the Dureka Platinum 450KL / NL models.

DISCONNECTING

CONNECTING

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OPERATION

Ensure that the handpiece is used for its intended purpose only and in compliance with the instructions. Burs that do not meet the above criteria must not be used. Never use a blunt bur or a bur with a worn shaft as this can cause injury.

Inserting the bur:

Press the push-button firmly with thumb. At the same time, insert the bur as far as it will go. Check the function of the chuck by pulling on the bur. Use gloves or another type of finger protection to test.

Removing the bur:

After the bur stops rotating, press the push-button firmly and remove the bur. Do not press the push-button while the bur is in motion. Actuation during operation may result in damage to the chuck system and cause injury. It is essential to avoid contact between a patient’s skin or tissue and the back-cap of the handpiece. In the event of handpiece damage, heating-up of the back cap can happen and associated burns are possible.

Remove bur from the handpiece when finished with treatment. Placing the instrument in its holder with a bur remaining in the chuck may result in injury and infection. Secure the handpiece to prevent it from dropping since this may damage the handpiece.

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SPECIFICATIONS

Technical Specifications

Model Platinum Line 450KL

Platinum Line 550K

Platinum Line 550KL

Platinum Line 450NL

Platinum Line 550N

Platinum Line 550NL

Drive air pressure (bar)

2.8 (40psi) 2.8 (40psi) 2.8 (40psi) 2.8 (40psi) 2.8 (40psi) 2.8 (40psi)

Pressure of spray water (bar)

0.8 - 2.5 0.8 - 2.5 0.8 - 2.5 0.8 - 2.5 0.8 - 2.5 0.8 - 2.5

Pressure of spray air (bar)

1.0 - 4.0 1.0 - 4.0 1.0 - 4.0 1.0 - 4.0 1.0 - 4.0 1.0 - 4.0

Air consumption NL/min

39-55 NI/min 39-55 NI/min 39-55 NI/min 39-55 NI/min 39-55 NI/min 39-55 NI/min

Water consumption ML/min

>50 >50 >50 >50 >50 >50

Rotation speed RPM 380K - 460K 330K - 410K 330K - 410K 380K - 460K 330K - 410K 330K - 410K

Light guide YES NO YES YES NO YES

Connection type Kavo Kavo Kavo NSK NSK NSK

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REPROCESSING METHODS ACCORDING TO ISO 17664Method: According to ISO 17664

Note: Follow your local directives, standards and guidelines for cleaning, disinfection and sterilization. Dureka Dental handpieces can be processed manually or automatically.

INSTRUCTIONS

Processing at the site of use:

• Run handpiece for a minimum of 10 seconds after each patient to expel material that may have entered the handpiece.

• Immediately remove all residual debris of cement, blood or composite.

• Process the medical device within one hour after treatment.

• Remove the bur or grinder from the medical device.

• The medical device must be dry when transporting for processing.

• Do not place the medical device into any kind of solution or into ultrasonic unit.

Warnings and limitations on reprocessing:

• Always ensure to wear suitable personal protective equipment as risk of infection due to instrument being non sterile.

• Do not clean the device using an Ultrasonic unit as this will cause the device to malfunction. These handpieces are approved for use with Thermodisinfector units only.

• Do not wash, soak or wipe the device with an oxidation potential solution such as a cold sterilisation solution.

Preparation for cleaning:

Pre-Cleaning.

If the device is heavily soiled, clean with a disinfectant cloth such as Minuten Wipes and brush with a plastic brush and rinse with tap water for a minimum of 10 seconds.

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Manual: External Cleaning

Manual External Cleaning:

• Brush with a plastic brush and rinse with tap water for a minimum of 10 seconds.

• Clean optical surfaces with a cotton swab or soft cloth.

• Dry device with a paper towel.

Manual Internal Cleaning

Dureka Dental recommends WL-Clean and WL-dry from Alpro Medical GMBH Products for internal cleaning of our handpieces.

Cover the Device with a paper towel to contain any overspray.

Attach the device to the corresponding adaptor on the WL-clean spray container.

Press the spray button 3 times for 2 seconds duration per spray.

Remove the device from the WL-clean container and wait for 1 minute until cleaning has been completed.

On completion of the 1 minute dwell time , remove any residual WL-clean by covering the device with a paper towel and attaching the device to the adaptor on the WL-dry spray container.

Press the spray button on the WL-dry container for 3-5 seconds continuously to remove the WL-clean residue and to dry the device.

For further information on Alpro Medical GMBH WL-clean and WL-dry please refer to instructions for use accompanying these products.

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Manual: External Disinfection

Manual External Disinfection:

• Dureka Dental recommends Clean Wipes/Minuten wipes and WL-cid disinfectant spray from Alpro Medical GMBH Products for disinfection of our handpieces.

• Thoroughly wipe down the device with disinfectant wipes or a cloth sprayed with WL-cid and allow the disinfectant to dry on to the device as per the manufacturer’s instructions. ( Ref Alpro Medical GMBH Product instructions for use).

• Cover the Device with a paper towel to contain any overspray.

• Attach the device to the corresponding adaptor on the WL-cid spray container.

• Press the spray button for 3 seconds duration.

• Remove the device from the WL-cid container and wait for 2 minute until disinfection has been completed.

• On completion of the 2 minute dwell time , remove any residual WL-cid by covering the device with a paper towel and attaching the device to the adaptor on the WL-dry spray container.

• Press the spray button on the WL-dry container for 3-5 seconds continuously to remove the WL-cid residue and to dry the device.

• Immediately following the internal cleaning and disinfection process and prior to sterilisation, ensure that the device is lubricated with a dental handpiece service oil such as Silver Easyspray. See section on Maintenance and Care for additional instructions.

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Automated cleaning and disinfection of the interior and exterior:

Dureka Dental Ltd recommend Thermodisinfectors that fulfill the EN ISO 15883-1 requirements and are approved by the manufacturer for highspeed (turbines), contra angles and straight dental handpieces. The cleaning should be carried out at a minimum of 55 °C and for at least 6 minutes, the disinfection at a minimum of 90 °C and for at least 5 minutes (for an A0-value > 3,000). For the cleaning a mild alkaline cleaning agent with a pH of 9 to 11 is recommended, e.g. Dr. Weigert Neodisher® MediClean Forte.

• Refer to the instructions for use of the Thermodisinfector for program settings as well as cleansers and disinfectants to be used (complying with max. pH value of 11) .

• For internal cleaning of dental handpieces the correct insert / adapter must be used.

• In order to prevent any negative effects to dental handpieces, make sure that the interior and exterior are dry after completion of the cycle. Immediately afterwards handpieces must be lubricated with a quality dental handpiece service oil e.g. Silver Easyspray. See section on maintenance and care.

Validation of the cleaning and disinfection processes:

The validation of the cleaning and of the disinfection processes was carried out with the WD BHT INNOVA® M3 instrument using the programme Nr.14 Reinigung for Cleaning and Program Nr.03 Thermodesinfektion for Disinfection with the cleaner Dr. Weigert Neodisher® MediClean Forte.

Program information Cleaning; Programme Nr.14 Reinigung

• Step 1 cleaning 0.5% cleaner 30°C for 1 min

• Step 2 cleaning 0.5% cleaner 55°C for 6 min

• Step 3 rinsing with A. demin. for 1 min

• Step 4 rinsing with A. demin. for 1 min

Cleaner: 0.5 % Dr. Weigert Neodisher® MediClean Forte.

Program information Disinfection; Program Nr.03 Thermodesinfektion

• Step 1 cleaning 0.5% cleaner 30°C for 1 min

• Step 2 cleaning 0.5% cleaner 55°C for 6 min

• Step 3 rinsing with A. demin. for 1 min

• Step 4 rinsing with A. demin. for 1 min

• Step 5 Thermodisinfection with A. demin. at 90°C for 5 min

Cleaner: 0.5 % Dr. Weigert Neodisher® MediClean Forte.

Application: Reprocessing was carried out in instrument sieves for the Dureka handpieces. Handpieces were connected to a Luer-Lock adapter of the machine via a silicone tube.

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Sterilization: Sterilization with a steam sterilizer (autoclave) according to EN 13060 / ISO 17665-1

Caution:

• Lubricate the medical device with quality handpiece service oil prior to sterilization See Maintenance and Care.

• Contact corrosion caused by moisture, result damage to medical device. Immediately after sterilization remove the medical device from the autoclave.

• Never use the medical device before it has cooled down, always allow it cool down naturally do not place under water to cool.

Dureka Dental Ltd medical devices have a temperature resistance of up to Max 138°C (275°F)

• Wrap medical device individually in a sterilization bag. The sterilization bag must be large enough for the device so as the bag is not stretched. The quality and use of the sterilization packaging must satisfy applicable standards and be suitable for the sterilization procedure.

• Apply the following sterilization process:

• Autoclave with a triple pre-vacuum: at least 5 minutes at 134°C -1°C / +4°C

• Use autoclave in accordance to the manufacturers Instruction for Use.Storage: • Reprocessed items should be stored protected from dust with minimum

exposure to germs in a dry, dark and cool space.

• Comply with the expiry date of the sterilized items.

Check that the sterilizer and the water it uses are clean. After each sterilization cycle, remove the device from the sterilizing apparatus immediately, in order to reduce the risk of corrosion.

Never use handpiece before it has cooled down, always allow it cool naturally and do not place under water to cool it.

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MAINTENANCE AND CAREImmediately after internal cleaning and disinfection, manual or automated and before sterilization dental handpieces must be lubricated with a quality dental handpiece service oil e.g. Silver Easyspray, failure to do this will result in premature failure of handpiece.

Accessories:LU0001 Lubrication adapter for spindelLU0002 Lubrication adapter for Kavo fitting LU0003 Lubrication adapter for NSK FittingD0025 Interdental Brush

Lubrication:

Cover the handpiece with paper towel (to contain overspray), using the correct lubrication adapter on the oil can firmly insert the nozzle into the rear of the handpiece and activate the spray for 2-3 seconds until the oil exhausts from the handpiece head (see fig 1) or use an automated handpiece care system.

Expel debris and excess lubricant

Connect handpiece to the coupling or to cleaning station and run for 10 to 15 seconds to expel debris and excess lubricant.

Lubricate handpiece after each use prior to sterlization.

Dureka Dental Ltd will assume responsibility for proper functioning of these products only if the maintenance guidelines in these instructions are followed and servicing is carried out by an approved representative.

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Lubrication and cleaning of the chuck (bur holding mechanism)

The chuck/bur holding mechanism should be lubricated at least once a day and cleaned once a week.

To lubricate the chuck using a spindle or pointed adaptor on your can of lubricant, insert the adaptor point into the chuck and activate the spray for 1-2 seconds. (See fig 2).

To clean the chuck, after lubricating it push in the head cap to fully open the chuck. With the chuck held fully open insert the interdental brush in and out repeatedly. This will remove any debris from the chuck. (See Fig 3)

For more handpiece care and maintenance advice please contact Dureka Dental Ltd or an approved representative.

Handpiece care

Only use quality maintenance products and/or components approved by Dureka Dental Ltd. The use of other products and components can void the warranty. The handpiece is supplied in non-sterile form. Before first use and for correct maintenance and care of your handpiece please follow these instructions.

Servicing

Improper servicing and maintenance may result in premature wear and failure of the handpiece.

Dureka Dental Ltd will assume responsibility for proper functioning of these products only if the maintenance guidelines in these instructions are followed and servicing is carried out by an approved representative.

Fig.2

Fig.3

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LIMITED WARRANTYDureka Dental Ltd grants a warranty for this handpiece, covering all functional defects, material or production faults. The device is covered by this warranty for 1 year from the date of invoicing from distributor. In the event of justified claims, the 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 and interest, are excluded. Dureka Dental Ltd shall not be held responsible for damage or injury and the consequences thereof, resulting from:

• Excessive wear and tear

• Improper handling

• 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 authorized by Dureka Dental Ltd. 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 technical specifications, illustrations and dimension contained in these instructions are given only as a guide. They may not be the subject of any claim. The manufacturer reserves the right to make technical improvement to its equipment without amending these instructions.