Varios Combi Pro Ultrasonic and Powder Combination System Operation Manual April 2019

WARNING <Ultrasonic Mode and Powder Mode> t
Do not handle the power cord with wet hands. Wet hand contact with electricity may result in an electric shock. t
Keep away from explosive substances and flammable materials. t
If the product overheats or smells of burning, immediately turn off the power and disconnect the main power cord. Contact your Authorized NSK Dealer. t
TO PREVENT ELECTRIC SHOCK, use a main electrical outlet that is earthed. t
Do not operate close to patients with cardiac pacemakers as there is a danger that it may affect the pacemaker. t
The system functions normally in the environment where the temperature is at 0 - 40°C (32 - 104°F), humidity at 35 - 75% RH, and no moisture condensation in the Control Unit. Using in conditions outside these limits may cause malfunction. t
Be careful not to get water or liquid disinfectant in the Control Unit. This could cause short circuits and lead to fire and/or electric shock. t
Repeatedly turning the Main Power Switch ON and OFF may blow a fuse. t
If water droplets, chemicals, solvents or antiseptic solution come into contact with the Control Unit, Handpiece, Handpiece Cord, Handpiece Hose, etc., wipe them off immediately. Failure to do so may result in discoloration or deformation. t
Connect to a public water system that provides drinkable water at a water pressure between 0.1 and 0.3MPa. Using with an incorrect water pressure may result in insufficient water supply, inoperability, or malfunction. t
Use a water softener, etc. to lower the hardness of the water, because using water with a high degree of hardness may cause mineral or limescale deposits in the water circuit, which can lead to problems such as insufficient water levels, operation problems, or breakdown. When doing so, use a Water Tube with a Water Filter to prevent device breakdown due to the foreign material in tap water, and refer to “10-3 Changing the Water Filter” to replace the Water Filter as required. t
Do not sterilize using ultraviolet light. Doing so may result in discoloration of the Handpiece. t
Hold the plug when pulling out the Handpiece Cord or Handpiece Hose. Pulling the Cord or Hose may cause disconnection or damage. <Ultrasonic Mode> t
Always use the water supply. Insufficient water supply results in overheating, which may damage the surface of the patient’s tooth. t
Do not allow the patient or assistant to look directly into the LED of the Handpiece or Handpiece Cord. Doing so may damage eyesight. <Powder Mode> t
Do not use on the following patients. – Those with medical complications or allergies – Those who have pre existing conditions (Eg Cardiac, Pulmonary, Renal disturbance or High blood pressure) – Those with respiratory diseases. – Those with pathologically deep periodontal pockets (6mm or more) or mucosal lesions. Prolonged application of the spray to soft tissue or salivary glands may cause powder air to enter soft tissue or salivary glands, resulting in emphysema. – Those with severe digestive ulcers. – Those with renal dysfunction. – Those with lung or cardiac disturbance or ventilatory impairment. – Those with an artificial heart valve or artificial joint – Those with allergies. Depending on the patient’s constitution, allergy symptoms or stomatitis may be caused in very rare cases. If such symptoms are detected, stop using the product immediately and seek medical attention. t
During use, both the operator and the assistant should always wear protective glasses and protective face masks. Also, continuously vacuum and collect ejected powder during use. If any powder gets into the eyes, eyes wash out immediately with copious amount of water and consult an ophthalmologist. t
Set the supply air pressure to 0.55 - 0.75MPa and use clean, dry air. Using with the incorrect pressure may result in insufficient spray pressure (power), inoperability or malfunction. <Prophy Mode> t
Do not spray directly onto the cement in the root canal, decalcified enamel, filling, margin of a prosthesis or filling.

2

WARNING

t
When using Perio Mode, pay attention not to cause emphysema as air containing powder is sprayed into periodontal pockets. If emphysema is caused by treatment using Perio Mode, stop using this product immediately and seek medical attention. t
Do not use on the following patients. Using on periodontal pockets for these patients may result in bacillemia. – Patients with endocardial inflammation – Patients who have a contagious illness or disease – Patients with an immune deficiency disease (neutropenia, granulocytopenia, agranulocytosis, diabetes, hemophilia) – Patients undergoing irradiation treatment, chemotherapy, or antibiotic treatment t
Do not use on the following patients. (Excluding the using without the Nozzle Tip) – Those with damage or abnormality in the oral cavity. – Those with hyperemia, hemorrhage or inflammation in the oral cavity. – Those that tend to develop inflammation or sores in the oral mucous membrane. t
Use this product only for maintenance after basic periodontal treatment. Never use it for other purposes. t
Use Perio Mode only on periodontal pockets that meet the following conditions: – Periodontal pockets caused by gum disease – Periodontal pockets of less than 6mm that have undergone basic periodontal treatment t
Check the depth of periodontal pockets with a measurement probe or photography before use. t
Use the designated cleaning powder only. Use of other powders may result in malfunction, substandard performance or damage to the substantia ossea and dentine, or may cause emphysema. NSK cannot accept any liability for issues that occur as a result of the use of powder other than those designated. t
Nozzle Tip for Perio Mode included in the product package is a sterile item. When using these products, follow the instructions below. – Nozzle Tip is a single-use item. Do not reuse nor resterillize it as product breakage or infection could occur. – Check before use that the package is NOT open nor damaged. If the package is open or damaged, do not use that Nozzle Tip as it may be damaged or contaminated. – Observe the use-by date written on the Nozzle Tip package label. Do not use expired products as product breakage or infection could occur. CAUTION <Ultrasonic Mode and Powder Mode> t
Read this Operation Manual before use to fully understand the product functions and file for future reference. t
When operating the product always consider the safety of the patient. t
The end user shall be responsible for any judgment that relates to the application of this product to a patient. t
Users are responsible for the operational control, maintenance and continual inspection of this product. t
This device is for indoor use only. t
Keep the Control Unit on a level surface. t
Do not attempt to disassemble the product nor tamper with the mechanism except as recommended by NSK in this Operation Manual. t
Do not allow any impact on to the product. Do not drop the product. The Glass Rod and Handpiece may be damaged if the Ultrasonic Handpiece is dropped. t
Operators and all others in the area must wear eye protection and a mask while using this product. t
Should the product function abnormally, cease operation immediately and contact your Authorized NSK Dealer. t
Push the Handpiece securely and fully onto the Handpiece Cord or Handpiece Hose when connecting. t
Do not autoclave the Handpiece Cord or the Handpiece Hose. Use alcohol to disinfect the Cord or Hose after use. t
Do not use high acid water or sterilizing solutions to wipe, immerse or clean the product. t
This product is not delivered in a sterile condition, except for the Nozzle Tip (option) and must be autoclaved prior to use. Refer to “9-3 Sterilization” for details. t
Perform regular function and maintenance checks. t
If the product is not used for a long period check it is functioning correctly before using on a patient. t
To avoid clinical downtime it is recommended that a spare be kept on hand in case of a breakdown during surgery. t
Always replace the fuse with the same specified rating. t
This product is rated Medical Electrical equipment. EMC (Electromagnetic compatibility) is described in the documentation included. t
Installation and use of this product requires special precautions regarding EMC according to the EMC information. t
Portable and mobile RF communications equipment can affect Medical Electrical equipment. Do not use RF equipment near the product. t
The use of ACCESSORIES such as handpieces and cables, other than those specified by the manufacturer, with the exception of handpieces and 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. t
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.

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English

<Perio Mode>

CAUTION t
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. t
U.S. Federal law restricts this device to sale by or on the order of a licensed physician. t
For safety’s sake, install the Control Unit in a place where the AC Power Cord can be easily removed. (It is possible to disconnect the control unit from the power source by removing the AC Power Cord.) <Ultrasonic Mode> t
The temperature of the Tip surface may reach 65°C without using coolant water. To avoid this event, be sure to use coolant water. <Powder Mode> t
Be very careful to ensure cleaning powder does not enter the patient’s mucosal areas (eyes, nose, etc.) other than the oral cavity. Also, protect the face with a towel or protective glasses, etc., to prevent the cleaning powder from getting into the patient’s eyes. * If the patient wears contact lenses, have the patient wear safety glasses or remove his/her contact lenses before treatment. t
Make sure the compressed air supply is clean and dry. Water or oil content mixed in the air supply may cause solidification of the cleaning powder inside the product. t
Securely attach the Chamber Cap to prevent the chamber cap from being blown off, which may lead to an injury. t
Do not open the Chamber Cap during use. Doing so may result in powder being ejected from the chamber cap due to high pressure in the chamber. t
Before connecting the Handpiece Hose, Chamber and Handpiece, or the Chamber and Control Unit, be sure to blow off all water from the connections of the Hose and the Chamber with dry air. Failure to do so may result in moisture entering the air supply, causing solidification of the cleaning powder inside the product. t
Depending on the use environment, the temperature of the Powder Handpiece surface may reach 50°C. t
If too much cleaning powder is put into the Chamber, the proper amount of powder may not be sprayed at the start of use. t
Powder scatters easily because it is very fine. Fill the Chamber slowly and be sure to prevent the powder from scattering. t
Powder stored for a long time in opened packaging may become moist and clog. Always use new, dry powder. When using bottled powder (option), securely fasten the bottle lid after use. t
Apply Vaseline, etc., to the patient’s lips to prevent drying or chapping at the corners of the mouth. NOTICE t
No special training is required for this device. t
Repeated autoclaving may cause the ultrasonic handpiece to become discolored due to heat. However, this is due to properties of the product and is not a problem in terms of quality.

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English

3 Accessory List

Tip is mounted in the Tip Wrench

No. 1 2 3 4 5 6 7 8 9 10 11 12 13

Part Name Control Unit Irrigation Bottle Chamber (For Prophy use) AC Power Cord Foot Control Handpiece Cord Ultrasonic Handpiece Handpiece Hose (For Prophy use) Powder Handpiece (For Prophy use) Air Hose Water Filter Set Sterilization case Tip and Tip Wrench

Quantity 1 1 1 1 1 1 1 1 1 1 1 1 3

No. 14 15 16 17 18 19 20 21 22 23 24 25 26 27

* Not shown in the illustrations above

Part Name FLASH pearl Ring Wrench Spanner Wrench (5×8) Turbine Oil Spare O-Ring Cleaning Wire (L) Cleaning Wire (S) Cleaning File Cleaning Brush Unlocking tool Operation Manual (This manual)* Tip-Power Guide* Tip Card* Varios Combi Pro Quick Operation Guide*

Quantity 5 1 2 1 7 types 1 1 1 1 1 1 1 1 1

NOTICE t
FLASH pearl and Perio-Mate powder (option) used in Powder Mode are referred to as “Powder” in this Operation Manual unless otherwise specified. t
Optional Perio Kit need to be purchased separately in order to use Perio Mode. Refer to “20 Option Parts List” for details of Perio Kit.

5

4 Names of Components Irrigation Bottle Base Connector Handpiece Cord Connector Socket Ultrasonic Handpiece Handpiece Cord Plug Handpiece Cord Handpiece Cord Connector Irrigation Bottle Cap Irrigation Bottle Handpiece Holder

Chamber Base Connector Handpiece Holder Chamber Cap Handpiece Holder Chamber (For Prophy use) Nozzle (For Prophy use) Lock Button Powder Handpiece (For Prophy use)

Handpiece Hose Connector Socket

Handpiece Hose Plug (For Prophy use)

Handpiece Hose Connector Handpiece Hose (For Prophy use)

Air Filter Irrigation Pump

Fuse Box AC Power Cord Connector Socket Water Tube Connector Air Hose Connector Power Switch Foot Control Cord Connector Socket Foot Control Hanger Button B Button C

Button D Button A

Foot Control Cord Foot Control Cord Plug

6

4-1 Operation Panel (2) Power Level Key

(3) Irrigation Volume Key

(1) Ultrasonic Mode Select Key

(5) Auto-Cleaning Key (6) Irrigation Mode Select Key (5) Auto-Cleaning Key Starts Auto-Cleaning. Refer to “9-1-1 Auto-Cleaning” (Ultrasonic Handpiece) or “9-2-1 Auto-Cleaning” (Powder Handpiece) for details. Ultrasonic Mode: Sprays tap water for 15 seconds, then sprays water from the Irrigation Bottle for 30 seconds to clean the Ultrasonic Handpiece. Powder Mode: Sprays air and water at the same time for 10 seconds and then sprays only air for 35 seconds.

(1) Ultrasonic Mode Select Key Switches the Ultrasonic Mode between P (Perio), E (Endo), G (General). The strongest power level is G, followed by E and P. Power Level, Irrigation Level, and Irrigation Mode can be set for each mode. (2) Power Level Key Sets the power level using the

/

(3) Irrigation Volume Key Sets the irrigation volume using the

keys. /

keys.

(4) Operation Mode Select Key Switches between “Ultrasonic Mode” and “Powder Mode.”

(6) Irrigation Mode Select Key Switches the Irrigation Mode (Bottle or tap water) for Ultrasonic Mode. Tap water is always used for Powder Mode.

4-2 LCD Panel (1) Power Level Indicator

(2) Operation Mode Display

(8) Ultrasonic Mode Display

(3) Powder Mode Display

(4) Irrigation Volume Indicator

(7) Power Level Display

(5) Error Display (6) Irrigation Mode Display

(1) Power Level Indicator Displays the current power on the Bar Graph Indicator.

(5) Error Display Displayed when an error occurs. Refer to “13 Error Code” for details.

(2) Operation Mode Display Displays the current Operation Mode (Ultrasonic or Powder).

(6) Irrigation Mode Display Displays the Irrigation Mode (Bottle or tap water) for Ultrasonic Mode. Tap water is always used for Powder Mode.

(3) Powder Mode Display Displays the set chamber (Prophy or Perio) (only when Powder Mode is in use).

(7) Power Level Display Displays the current Power Level as a number.

(4) Irrigation Volume Indicator Displays the selected Irrigation Level on the Bar Graph Indicator.

(8) Ultrasonic Mode Display Displays the current Ultrasonic Mode (P/E/G).

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English

(4) Operation Mode Select Key

4-3 Foot Control When using Ultrasonic Mode

When using Powder Mode

B: Switches P/E/G

B: Rinse (Irrigation and air)

A: Power Down

C: Power up

D: Vibration and irrigation

D: Powder, irrigation, and air C: Power up

A: Power down

Ultrasonic Mode A: Power Down Reduces the power level. B: Switches P/E/G (Ultrasonic Mode) Toggles Ultrasonic Mode in the order of P (Perio) E (Endo) G (General) P (Perio)... every time the button is depressed. C: Power up Increases the power level. D: Vibration and irrigation Vibrates and irrigates while the button is depressed.

Powder Mode A: Power Down Reduces the power level. B: Rinse (Irrigation and air) Sprays water and air while the button is depressed. C: Power up Increases the power level. D: Powder, irrigation, and air Sprays powder, water, and air while the button is depressed.

5 Installation 5-1 Connecting the AC power cord 1) Turn the Power Switch to OFF before connecting the AC power cord. 2) Insert the AC Power Cord so that it correctly fits into the AC Power Cord Connector Socket at the back of the Control Unit (Fig. 1). 3) Plug the AC power cord into a wall outlet specified for medical use. t
Do not tug the AC power cord by holding and pulling its cord. CAUTION t
Make sure that the device has completely stopped before removing or inserting the AC power cord.

Fig. 1

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5-2 Connecting the Air Hose

English

1) Insert one end of the Air Hose deep into the Air Hose Connector (Fig. 2). 2) Pull the Air Hose gently and check that the Hose does not come out. 3) To remove the Air Hose, pull the Air Hose out while pushing the blue ring toward the Control Unit (Fig. 3). t
Use clean dry air. Powder may clog if the air contains moisture or oil. CAUTION

Push the blue ring

Air Hose

Fig. 3

Fig. 2

5-3 Connecting the Foot Control 1) Insert the Foot Control Hanger so that it fits correctly into the holes at the rear of the Foot Control (Fig. 4). 2) Insert the Foot Control Plug into the Foot Control Cord Connector Socket with the mark facing upwards (Fig. 5). mark

Foot Control Cord Plug

Fig. 4

Fig. 5

5-4 Connecting the Handpiece Cord (Ultrasonic Handpiece) Connect the Handpiece Cord Connector to the Handpiece Cord Connector Socket with the mark facing upwards (Fig. 6). Push it in all the way. t
Check that the Handpiece Cord Plug is clean and dry before connection. CAUTION

mark

Handpiece Cord

Fig. 6

9

5-5 Connecting the Handpiece Hose (Powder Handpiece) 1) Use air to dry the Handpiece Hose Connector Socket and Handpiece Hose Connector. 2) Insert the Handpiece Hose Connector so that it fits correctly into the hole on the Handpiece Hose Connector Socket and fasten the Connector nut (Fig. 7). Chamber

Handpiece Hose Connector nut

Fig. 7

5-6 Connecting and disconnecting the Handpiece t
Be sure to only use the supplied Handpiece. CAUTION Dots

5-6-1 Ultrasonic Handpiece (1) Connection Align the dots on the Ultrasonic Handpiece and the Handpiece Cord Plug. Push the Handpiece straight into the connector (Fig. 8). (2) Disconnection Hold the Ultrasonic Handpiece and the Handpiece Cord Plug and pull the Handpiece out.

Handpiece backend Ultrasonic Handpiece

Handpiece Cord Plug

Fig. 8

t
To avoid an electric shock, do not touch the electrical contacts of the handpiece backend and the handpiece cord. WARNING t
Do not twist the Handpiece or Handpiece Cord when removing the Handpiece. Doing so may damage the Connector electrical CAUTION contacts, resulting in malfunction. t
Before connecting the handpiece cord to the handpiece, face the handpiece connector side so light shines into it and check the end of the handpiece. If the light transmitted by the Optic Fiber End Face at the end is uniformly bright, it is functioning normally. If part or all is dark, the Optic Fiber End Face may be cracked or broken.

5-6-2 Powder Handpiece (1) Connection 1) Use air to dry the connection between the Handpiece and Handpiece Hose Plug. 2) Push the Powder Handpiece straight into the Handpiece Hose Plug (Fig. 9). (2) Disconnection Hold the Powder Handpiece and the Handpiece Hose Plug, and pull the Handpiece out.

Powder Handpiece

Handpiece Hose Plug

Fig. 9

10

1) Insert one end of the Water Tube (the end with the water filter) deep into the Water Tube Connector (Fig. 10). 2) Connect the other end of the Water Tube to the water outlet on the dental unit. 3) Pull the Water Tube gently and check that the Tube does not come out. 4) To remove the Water Tube from the Water Tube Connector, pull the Water Tube out while pushing the green ring toward the Control Unit (Fig. 11).

Push the green ring

Water Tube

Water Filter Case

Fig. 10

Fig. 11

t
Use a water softener, etc. to lower the hardness of the water, because using water with a high degree of hardness may cause WARNING mineral or limescale deposits in the water circuit, which can lead to problems such as insufficient water levels, operation problems, or breakdown. When doing so, use a Water Tube with a Water Filter to prevent device breakdown due to the foreign material in tap water, and refer to “10-3 Changing the Water Filter” to replace the Water Filter as required. t
If the water outlet on the dental unit has not been used for a long time, water may contain rust, etc. when it is run for the first CAUTION time. Make sure that the water is clear before connecting the Water Tube. t
Insert the Water Tube firmly into the Water Tube Connector when connecting it to the Control Unit. Water may leak if the Tube is not inserted correctly.

6 Check before treatment Before use, operate the product without a patient present to confirm there is no abnormal vibration, noise, heat, etc. Also check the following points. – Ultrasonic Handpiece: LED lights and water flows. – Powder Handpiece: Powder, air and water are supplied correctly. If you notice anything unusual when checking or operating this product, stop using it immediately and contact your authorized NSK dealer. When you perform Auto-Cleaning, the water inside the Handpiece Cord/Hose is ejected, which may make stop water from flowing when using the Control Unit the next time. If that happens, set the Irrigation Volume to 10, and operate the Handpiece for about 30 seconds after water starts to come out. Refer to “14 Troubleshooting” if water does not start to come out after more than 20 seconds, even if you set the Irrigation Volume to 10.

11

English

5-7 Connecting the Water Tube

7 Using the Ultrasonic Mode 7-1 Water System Setup Using the Bottle 1) Remove the Dust Cover from the Irrigation Bottle Base Connector (Fig. 12). 2) Remove the Irrigation Bottle Cap and fill the Bottle water or disinfectant solution to the desired level. 3) Close the Irrigation Bottle Cap securely and insert the Bottle Joint straight into the Irrigation Bottle Base Connector (Fig. 13). Pull the Irrigation Bottle straight up to remove it. Dust Cover

Irrigation Bottle Base Connector

Joint

Fig. 12

Fig. 13

t
Only use the dedicated Varios Combi Pro series bottle. CAUTION t
Insert the Irrigation Bottle straight. Failure to do so may damage the O-ring. t
Clean the Irrigation Bottle and the Irrigation Bottle Cap with clean water after use and before storage. t
Attach the Dust Cover to the Irrigation Bottle Base Connector when the Irrigation Bottle is not mounted. t
Ensure the liquid temperature is below 35˚C. t
Do not put strong acids (such as highly acidic water, superacid water, or electrolysis water) or hypochlorous acid water in the Irrigation Bottle as they may cause water clogging or metal corrosion. Using Tap Water 1) Make sure that the Water Tube is firmly connected to the Water Tube Connector of the Control Unit. Refer to “5-7 Connecting the Water Tube” for details. 2) Open the water valve of the dental unit and set the water pressure between 0.1 - 0.3MPa (1.0 - 3.0kgf/cm2). If the water pressure exceeds 0.3MPa, use a Water Pressure Reducing Valve (option) to adjust the water pressure to within the specified range. Refer to “20 Option Parts List” for details about the water pressure reducing valve.

7-2 Mounting the Tip 1) Check that the screw parts of the Handpiece and Tip are clean (Fig. 14). 2) Push the Tip into the distal end of the Handpiece and screw the Tip until it is lightly tightened (Fig. 15).

Screw Part

Fig. 14

12

Fig. 15

English

3) Match the square shape of the Tip with the hole of the Tip Wrench, then insert the Tip into the hole. Rotate the Wrench until it makes a click sound and cannot rotate any further. During this procedure, hold the Handpiece so that the Handpiece Cord does not become twisted. When removing the Tip, rotate the Wrench in the direction of the “Loosen” arrow (Fig. 16).

Tighten

Loosen

Fig. 16 t
Do not allow contact with gingival, mucosa and/or skin. Doing so may result in injury or burns. WARNING t
USE ONLY NSK genuine tips when using this product. Problems including Handpiece damage, failure and accidents resulting from the use of non-NSK tips are not covered in the warranty. The following types of issues may occur when using Non-NSK Tips: – Inappropriate vibration caused by incompatible screws. – Accidental ingestion of broken tips by the patient. – Damage or premature wear of the Handpiece screw t
Be careful not to twist the Handpiece Cord when tightening the Tip. CAUTION t
Be careful when attaching or removing a Tip that is longer than the Tip Wrench, as there is a risk of injury from the point of the Tip. t
Do not use a Tip which has been damaged, bent or corroded as it may break during use. t
To avoid damaging the Tip thread or disengagement of the Tip, always make sure that the Tip is inserted at the correct angle and firmly tightened. t
If debris is found on the Tip thread, clean the Tip immediately. Failure to do so may result in noise or insufficient vibration. t
Do not attempt to sharpen or bend the Tip as doing so may result in the Tip breaking during use, noise or insufficient vibration. t
The Tip is a wear item. Worn Tips have an increased risk of noise, breakage or insufficient vibration. Replace the Tip if noise or insufficient vibration occurs. t
Use the supplied Tip Wrench to mount the Tip. Rotate the Wrench until it makes a click sound and cannot rotate any further. If the Tip is not tightened sufficiently, insufficient vibration or noise may occur. t
When mounting a Tip, always wear sterile surgical gloves and use a sterilized Tip, Handpiece and Tip Wrench. t
Ensure that the power setting does not exceed the recommended Power Level. Failure to do so may result in noise, tip breakage or injury to the patient. t
Do not use Tips that are not designed for removing metal or prosthetic crowns for this purpose. Doing so may result in the tip breaking and falling into the patient’s mouth. t
Remove the Tip before attaching or removing the Handpiece or the Handpiece Cord to avoid to avoid injury with the Tip. t
If insufficient vibration is observed during operation, remove the Handpiece from the patient’s mouth, and depress the Foot Control again. If this does not improve the condition, the Tip may have loosened during use. Check that the Tip is securely mounted. t
If the Tip becomes loose, makes noise, or does not vibrate sufficiently even though it has been tightened until it makes a click sound, the Tip Wrench may be worn out. The Tip Wrench is a wear item and should be replaced once a year.

13

Using the Tip Card t
Tips are wear items. Use the supplied Tip Card to check the Tip condition and replace the Tip if necessary. CAUTION Place the neck of the Tip in the cut out of the Tip Card. Measure the length of the Tip and check the replacement timing (Fig. 17). To guarantee safe and effective use, it is recommended that Tips be replaced with the Tip meets the yellow line (1mm of wear). Tip Card Green: No wear - Tip is OK Tip replacement is not necessary.

Yellow: Wear of 1mm - Tip is showing some wear Tip replacement is recommended.

Red: Wear of 2mm - Tip is badly worn Tip must be replaced.

Fig. 17 t
Tips are consumables. The efficiency of dental scaling decreases CAUTION approximately 25% when the top of the Tip wears 1mm and approximately 50% when it wears 2mm. In addition, the vibration condition changes owing to the wear, which may damage a patient’s tooth surface. Periodically check the Tip wear condition using the Tip Card, and replace the Tip with a new one in good time. 25% decrease

50% decrease

Fig. 18

7-3 Power Level Setting 1) Touch the Ultrasonic Mode Select Key to select the Mode. The selected Mode is displayed on the LCD Panel as P/E/G (Fig. 19). 2) Touch the Power Level Key ( / ) to set the Power Level. The Power Level Display and the Power Level Indicator increase or decrease in accordance with the selected level (Fig. 20).

Ultrasonic Mode Select Key

t
Ensure the power setting does not CAUTION exceed the recommended Power Level. (Refer to the supplied “Tip-Power Guide” or “Tip Guide” for the maximum power of each Tip.)

Operation Mode Display

Fig. 19 Power Level Key Power Level Indicator

NOTICE t
Touch and hold the Power Level Key to increase or decrease the Power Level continuously. An alarm is heard when the maximum or minimum level is reached. t
To irrigate without vibrating the Tip, set the Power Level to “0 (zero)” and the Irrigation Volume to 1 bar or more. Power Level Display

Fig. 20

14

7-4 Irrigation setting Bottle

Tap water

English

Touch the Irrigation Mode Select Key to select the Irrigation Mode (Bottle or tap water). The selected Mode is displayed on the LCD Panel as an icon (Fig. 21).

Fig. 21

7-5 Operation 1) Depress the desired button on the Foot Control. A “beep” sound is heard, the Tip starts vibrating and the LED on the Handpiece lights up. 2) Adjust the Irrigation Volume by touching the Irrigation Volume Keys ( / ) while checking the irrigation from the Tip. t
As a safety feature, this product does not operate when the power switch is turned on while the Foot Control is depressed. In CAUTION this case, an alarm sound is heard and the Ultrasonic Mode Display (P/E/G) and “ULTRASONIC” blinks alternately. Release the Foot Control and depress it again. t
Always use irrigation. If there is insufficient irrigation the Handpiece will overheat and may injure the surface of the patient’s tooth. t
Check that clean water is spraying adequately before use. t
Water may not spray smoothly if the Irrigation Volume is set to a low level. In this case, temporarily increase the Irrigation Volume temporarily and depress the Foot Control. Check that water is spraying smoothly from the Tip and adjust the Irrigation Volume again. t
Do not forcibly rotate the Handpiece Holder as doing so may damage the Holder. NOTICE t
The LED of the Handpiece stays lit for about 5 seconds after the Foot Control is released (Afterglow function). t
Ultrasonic Mode (P/E/G), Power Level, Irrigation Mode settings and Irrigation Volume are stored after the power is turned off and the same settings are applied when the power is turned on next time (Last Memory function). t
If the Irrigation Volume is too low with the Irrigation Volume set to 10 or the Irrigation Volume is too high with the Irrigation Volume set to 1 while the Irrigation Mode is set to tap water, adjust the basic Irrigation Level. Refer to “11-3 Basic Water Level Setting” for details. t
A buzzing sound may be emitted, but this does not indicate a malfunction. During the Handpiece operation : You can: Adjust the Power Level and Irrigation Volume You cannot: Change the Ultrasonic Mode or Irrigation Mode settings and perform Auto-Cleaning

7-6 After treatment Perform maintenance after use on each patient. Refer to “9 Maintenance” for details. t
This product may malfunction if correct maintenance is not performed. CAUTION

7-7 Protection Circuit This product may overheat internally if the control unit is used at power 8 or higher in G mode for an extended amount of time. In this case, the Protection Circuit reduces the Power automatically (Power 7). Bar Graph Indicator flashes from 8 to 10 (Fig. 22). The indicator stops flashing when the protection circuit is released. However, in this case the Power Level does not increase automatically. Increase the Power Level manually if required. Fig. 22 NOTICE t
The Power Level cannot be increased to 8 or higher when the protection circuit has operated (while the bar graph indicator is flashing). t
The Bar Graph Indicator stops flashing when the Power Level is reduced below 7. It starts flashing again if the Power Level is increased to 7 while the Protection Circuit function is active.

15

8 Using the Powder Mode The optional Perio Kit must be purchased in order to use the Perio Mode. Refer to “20 Option Parts List” for details about the Perio Kit.

8-1 Water System Setup 1) Make sure that the Water Tube is firmly connected to the Water Tube Connector of the Control Unit. Refer to “5-7 Connecting the Water Tube” for details. 2) Open the water valve of the dental unit and set the water pressure between 0.1 - 0.3MPa (1.0 - 3.0kgf/cm²). If the water pressure exceeds 0.3MPa, use a Water Pressure Reducing Valve (option) to adjust the water pressure to within the specified range. Refer to “20 Option Parts List” for details about the water pressure reducing valve. t
Only use drinkable water for irrigation. CAUTION

8-2 Powder Preparation

“MAX” line

1) Select the Chamber and powder to be used with this Mode. Fill the Chamber with powder up to the “MAX” line (approximately 80g of FLASH pearl or approximately 50g of Perio-Mate powder) (Fig. 23). Mode Prophy Mode Perio Mode

Chamber For Prophy use For Perio use

Powder FLASH pearl Perio-Mate powder

2) Close the Chamber Cap securely until it fits the Chamber completely and insert the Chamber straight to the Control Unit (Fig. 24). The type of inserted Chamber is displayed on the LCD Panel as one of the following icons (Fig. 25). Fig. 23

Perio Mode

Prophy Mode

Fig. 25 Fig. 24 t
Use the designated powder only. Using other powders may lead to product failure, damage to the tooth or may cause WARNING emphysema. In addition, it may also cause performance reduction of the product. We cannot accept any liability for failures caused by using other powders. t
Securely attach the Chamber Cap to prevent the chamber cap CAUTION from being blown off, which may lead to an injury (Fig.26). t
Before inserting the Chamber into Control Unit, make sure the O-Rings of the Chamber Base Connector are not damaged or torn (Fig.24). Damaged or torn O-Rings could lead to poor Fig. 26 operation or malfunction. t
Insert the Chamber into the Control Unit straight. Inserting at an angle could damage the O-Rings, leading to malfunction. t
If too much cleaning powder is put into the Chamber, the correct amount of powder may not be sprayed immediately after starting use. t
Do not use powder that has been stored in an open package or leftover powder. Using such powder may cause clogging of the Nozzle. Do not mix leftover powder with new powder. t
Before inserting the Chamber, check the Chamber Base Connector for water, etc., and wipe it clean if it is wet. Failing to do so may cause powder clogging. t
Do not use discolored powder. t
Always securely close the powder container lid. Failure to do so will attract moisture which may cause clogging. t
If powder adheres to the Chamber and/or the Chamber Cap, clean it immediately or the Cap will become difficult to close. t
Do not invert the Chamber while it contains powder inside. Inverting the Chamber could lead to powder clogging. 16

8-3 Attaching/removing the Nozzle Tip 8-3-1 Attaching the Nozzle Tip Attach the Nozzle Tip (option) securely and firmly to the Nozzle of the Powder Handpiece (for Perio use) (Fig. 27). Nozzle Tip

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Do not use a deformed or damaged Nozzle Tip. It may detach during WARNING use.

Fig. 27 t
Be sure to attach the Nozzle Tip securely and firmly as illustrated CAUTION (Fig. 28). If the Tip is attached incorrectly, it will fall off and may be accidentally ingested by the patient. t
When attaching a Nozzle Tip to the Powder Handpiece, always wear sterile surgical gloves and make sure that the Powder Handpiece is sterilized.

Fig. 28 8-3-2 Removing the Nozzle Tip Use the Perio-Mate Nozzle Tip Remover (option) to remove the Nozzle Tip (Fig. 29) and dispose of the Nozzle Tip when removed. Perio-Mate Nozzle Tip Remover

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The Nozzle Tip can only be used once. Do not reuse or sterilize the WARNING Nozzle Tip as it may be damaged or contaminated. If the Nozzle Tip is reused, it may not operate correctly due to deformation during removal, or it may detach during use resulting in accidental ingestion by the patient. The same applies to a Tip that has been accidentally removed. Fig. 29

8-4 Power Level Setting

Power Level Key

Touch the Power Level Keys ( / ) to set the Power Level. The Power Level Display and the Power Level Indicator increase or decrease in accordance with the selected Power Level (Fig. 30).

Power Level Indicator

NOTICE t
If you specify this setting without attaching the Chamber, the Power Level when using the Prophy mode is set. Power Level Display

Fig. 30

8-5 Irrigation setting 1) Touch the Irrigation Volume Keys ( / ) to adjust the Irrigation Volume. 2) Depress the Foot Control to spray powder into a spittoon, etc., to confirm that powder, air and water are appropriately sprayed. 3) Adjust the Irrigation Volume while checking the irrigation from the Nozzle. NOTICE t
If the Irrigation Volume is too low with the Irrigation Volume set to 10 or the Irrigation Volume is too high with the Irrigation Volume set to 1, adjust the basic Irrigation Level. Refer to “11-3 Basic Water Level Setting” for details. t
If you perform adjustment without attaching the Chamber, the Irrigation Volume when using the Prophy mode is set. 17

English

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As a safety feature, this product does not operate if the Foot Control is depressed when the Chamber is mounted incorrectly. An CAUTION alarm sounds heard and the tooth icon and “POWDER” flash alternately. Mount the Chamber correctly. t
The Perio-Mate Powder (option) scatters easily because it is made of very fine particles. Fill the Chamber slowly to prevent the powder from scattering, and be careful not to swallow the powder or allow it to get into eyes. t
FLASH pearl is almost insoluble in water. To avoid clogging of the pipes by using FLASH pearl, periodical cleaning and maintenance of the vacuum hose, saliva ejector and separator are necessary.

8-6 Operation Powder, water, and air are supplied when the Foot Control button D is depressed. Water and air are supplied when the Foot Control button B is depressed. Observe the operating instructions explained in “8-6-1 Using Prophy Mode” and “8-6-2 Using Perio Mode.” t
Never spray powder toward a human body including the operator and the assistant other than to the tooth surface. WARNING t
Stop use immediately if the hose swells or air or powder leaks from connections between the Chamber and Hose during use. t
Spray water while using this product. t
Be sure to use a vacuum tube (and a saliva discharge tube together if necessary) to prevent the patient from ingesting a large amount of powder. Avoid continuous use over long periods and allow the patient to rinse out the mouth whenever necessary. t
As a safety feature, this product will not switch on when the Power Switch is turned to ON while the Foot Control is depressed. CAUTION An alarm sound is heard and the tooth icon and “POWDER” flash alternately. Release the Foot Control then depress it again. t
Before treatment, adjust the Power Level and the Irrigation Level before using on the patient. t
Reduce the Power Level when treating around marginal gingiva. t
Do not spray vertically onto the tooth surface. t
Maintain the distance between the tip of the Nozzle of the Handpiece to the tooth surface as explained in “8-6-1 Using Prophy Mode” and “8-6-2 Using Perio Mode.” t
Do not rotate the Handpiece Holder forcibly as it may damage the Holder. NOTICE t
A buzzing sound may be emitted, but this does not indicate a malfunction.

8-6-1 Using Prophy Mode Keep the Nozzle at a distance of 3 - 5mm from the tooth surface and at an angle of 10 - 60 degrees (Fig. 31).

3 - 5mm

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Never point toward soft tissue, gum, or the subgingival area. WARNING 10 - 60 degrees

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Spray from the root to the incisal edge of the tooth.

Fig. 31

CAUTION

8-6-2 Using Perio Mode Using with the Nozzle Tip Insert the Nozzle Tip deeper than 3mm into the periodontal pocket (Fig. 32). Powder may not be sprayed efficiently into the periodontal pocket if the depth is less than 3mm. Using without the Nozzle Tip Remove the Nozzle Tip from the Nozzle of the Handpiece to remove plaque at the supragingival area and gingival margin, or to remove biofilm and light stains. Keep the Nozzle at a distance of 5 - 10mm from the tooth surface and at an angle of 30 - 60 degrees (Fig. 33). Never point the Nozzle directly toward the oral mucous membrane or in periodontal pockets.

Fig. 32

30 - 60 degrees 5 - 10mm

Fig. 33

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The alarm sound is heard every 5 seconds when using Perio Mode. CAUTION t
In Perio Mode, the Power Level is automatically reduced to a weaker level compared to the same setting for Prophy Mode. 8-6-3 During Handpiece operation You can: Adjust the Power Level and Water Volume You cannot: Change Irrigation Mode settings and perform Auto-Cleaning 8-6-4 Releasing residual pressure The Chamber Cap cannot be opened after operation due to buildup of air pressure inside the Chamber increasing during operation. Release the pressure remaining in the Chamber before putting powder in the Chamber or removing the Chamber from the Control Unit. t
The remaining powder and water comes out of the Handpiece while releasing the residual pressure. Prepare a container such as CAUTION a cup to catch the powder and water. 1) Take the Powder Handpiece out of the Handpiece Holder. 2) Place the Handpiece into the container to catch powder and water. 3) Touch and hold the Auto-Cleaning Key for about 1 second. Beeps are heard and the residual pressure starts to be released. 4) The operation stops when all the residual pressure is released from the Chamber.

8-7 After treatment Perform maintenance after use on each patient. Refer to “9 Maintenance” for details. If the Nozzle Tip (option) is attached to the Nozzle, remove and dispose of it before maintenance. t
Failure to perform maintenance may result in malfunction. CAUTION NOTICE t
The Power Level and Irrigation Mode settings are stored after the power is turned off (Last Memory function).

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t
When using without the Nozzle Tip, never point toward the oral mucous membrane. WARNING t
Do not use this product in an area immediately after scaling the tooth surface in a periodontal pocket. Doing so may cause bacteremia. t
Do not insert the Nozzle Tip more than once into the same periodontal pocket during the same treatment. t
Powder may be sprayed for a maximum of 5 seconds in the same periodontal pocket (maximum 20 seconds for one tooth). Never spray powder for longer than the specified time. t
Do not force the Nozzle Tip into a periodontal pocket. t
Do not spray powder while the Nozzle Tip end is located at the bottom of a periodontal pocket. Doing so may cause emphysema. t
Do not use the Nozzle Tip in any places other than periodontal pockets. t
Setting the Power Level too high may cause emphysema. Adjust the Power Level to an adequate level while checking the patient’s condition.

9 Maintenance Perform the following maintenance after use on each patient. t
Failure to perform maintenance may result in malfunction. CAUTION

9-1 Ultrasonic Handpiece 9-1-1 Auto Cleaning t
Water comes out of the Handpiece during Auto-Cleaning. Perform cleaning after placing the Handpiece into a cup. CAUTION 1) Take the Ultrasonic Handpiece out of the Handpiece Holder and remove the Tip from the Handpiece. 2) Remove the Irrigation Bottle and wash inside with running water. When tap water is selected for the Irrigation Mode, open the water valve of the irrigation source. 3) Fill more than half of the Irrigation Bottle with distilled water or purified water. (Do not use saline). 4) Close the Cap securely. 5) Insert the Bottle straight into the Irrigation Bottle Base Connector. Water may leak if the Bottle is not inserted firmly. 6) Place the tip of the Handpiece into the container to catch water. 7) Touch and hold the Auto-Cleaning Key for about 3 seconds to start Auto-Cleaning. Auto-Cleaning Bar Graph Indicator takes about 45 seconds. “AC” is displayed on the LCD Panel during Auto-Cleaning and the approximate remaining time is displayed in the Bar Graph Indicator (Fig. 34). 8) When Auto-Cleaning is finished, the Control Unit returns to the settings prior to cleaning. 9) Remove the Irrigation Bottle. Wash the Irrigation Bottle and Cap with running water and allow “AC” display them to dry. Fig. 34

To stop Auto-Cleaning, touch the Auto-Cleaning Key again.

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After each use, perform Auto-Cleaning (cleaning of Irrigation Tube). If the system is not cleaned, the inside of the Irrigation Tube CAUTION may become clogged or some metal parts may rust. t
Use distilled water or purified water to fill the Irrigation Bottle. Using impure water may cause clogging of the Irrigation Tube. t
Make sure the Handpiece and Handpiece Cord are firmly attached. NOTICE t
During Auto-Cleaning, the Handpiece LED does not light. 9-1-2 Cleaning the Handpiece 1) Remove any debris from the product. Do NOT use a wire brush. 2) Wipe clean with a cloth soaked in ethanol, or ethanol with isopropyl alcohol. This icon denotes that the product can be washed using a Thermo Disinfector. Operation only confirmed with the GETINGE WD46-4 model. Refer to the Thermo-Disinfector manual. t
Be careful not to hit the tip of the Handpiece against anything while washing it as it may damage the Glass Rod. CAUTION t
After cleaning with the Thermo Disinfector, dry the Handpiece thoroughly and remove water from the inside. t
Never use solvents such as benzine and thinner for cleaning. t
When cleaning, use ethanol, or ethanol with isopropyl alcohol to wipe the surface of the handpiece. Use of chemicals other than those may cause the handpiece to discolor, crack, etc.

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