NSK VarioSurg User manual

OM-E0794E 002
Ultrasonic Bone Surgery System
OPERATION MANUAL
2020.04.00 00 N

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English
Thank you for purchasing VarioSurg.
Read this Operation Manual carefully before use for operation instructions and care and
maintenance guidelines. Keep this Operation Manual for future reference.
Classification of Devices
• Classification by type of protection against electric shock:
— Class I devices.
• Classification by degree of protection against electric shock:
— Applied part type BF.
• Classification by sterilization or disinfection method allowed by the manufacturer:
— Refer to Sterilization.
• Classification by degree of protection against harmful intrusion of liquid based on IEC60529:
— Foot Control ··· IPX8 (protected against immersion)
• Classification by safety level of use in air, flammable anesthetic gas or dinitrogen monoxide (laughing gas), flammable
anesthetic gas:
— Not suitable for use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous dioxide (Without
Foot Control)
• Classification by mode of operation:
— Continuously operating device.
Indications for Use
The VarioSurg device is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of
root canals.
We recommend that prior to using the device; you read carefully the safety precautions in order to operate it correctly.
Indications of Dangerous Items is designed so that you can use the product safely, thus obviating any safety hazard or
damage to you or others. They are classified according to their magnitude and emergency degree of safety hazard or
damages. As each and every item concerns safety, observe them.
Safety Precautions and Indications of Dangerous Items
1. Safety precautions prior to use
WARNING
Classification Degree of Danger or Danger and Seriousness
WARNING Explains an instruction where personal injury or physical damage may occur.
CAUTION Explains an instruction where minor to medium injury or physical damage may occur.
NOTICE Explains an instruction that should be observed for safety reasons.
• Do not plug or unplug the AC Power Cord with wet hands. This could cause electric shock.
• Do not use in a room where an explosion might occur. Do not use in the vicinity of flammable materials. Do not use
in the vicinity of a patient who has been administered anesthesia (laughing gas).
• Be careful not to get water or liquid disinfectant on the Control Unit. This could cause short circuits and lead to a fire
and/or electric shock. Should any water or liquid disinfectant get on the Control Unit, wipe it off immediately.
• Do not drop, hit, or give excessive shock on the Control Unit/Handpiece. This could lead to electric shock or product
failure. In case of giving shock to an optic handpiece, illumination parts that are equipped with the handpiece could
be damaged and drop out of the handpiece.
• Never touch the connecting part (electric pins) for the Handpiece and Handpiece Cord.
• Never attempt to take apart or reconfigure the Control Unit/Handpiece in any method not described in the manual.

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WARNING
•Keep away from patients with cardiac pacemakers (There is danger that it may affect the pacemaker).
•Do not flick the Main Power Switch ON and OFF repeatedly. There is danger that it will blow a fuse.
•Turn off the Control Unit if there are any abnormal vibrations, heat generation, abnormal noise, etc., before or during
use.
•Do not place anything within 10 centimeters around the Control Unit.
CAUTION
•This product should be used only by physicians, dental hygienists, dental technicians and others with professional
training. It should be used only in dental clinics, hospitals or other medical institutions. Assistants should use it
under the supervision of a specializing physician.
•It is recommended that a spare system be kept on hand in case of a breakdown during surgery.
•When operating the product always consider the safety of the 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.
•Do not use this product if the patient has the any of the following conditions:
• Patient complications • Patient allergic reactions
• Patient has preexisting condition e.g. (heart, lung, renal, high-blood pressure)
• Patient is Pregnant, patient of child-bearing potential or lactating patient
• Patient is an infant (Age) • Patient has a heart pace maker fitted
•The end user shall be responsible for any judgment that applies this product to a patient.
• Keep the Control Unit on a level surface and make sure it is not subject to strong impact (such as being dropped, etc.) .
•Before using the product, make sure to operate it outside the oral cavity for checking. Then, if you find any
abnormality, immediately stop using it and contact the dealer.
•Disconnect from AC Power Cord and remove the Handpiece Cord after turning off the Control Unit. Pull the plug
out holding the plug itself. Pulling by the Cord will result in damage to the Cord.
•Use only the fuses indicated.
•Do not insert or remove the AC Power Cord or Handpiece Cord with foot on the foot control.
•When the pump gets wet, wipe well and dry it. If the pump remains wet, it may not work normally as the roller
inside the pump may slip.
• If the Irrigation Tube is bent or folded while the Irrigation Pump is in operation, the tube may be damaged or disconnected .
•If the irrigation seems abnormal, it may be because of wear of the Irrigation Tube or that saline, etc. is leaking from
the tube. Replace the Irrigation Tube.
•The Irrigation Tube cannot be reused. After using, dispose of it as medical waste.
•Do not remove both the Handpiece and cord.
•Do not turn ON the Main Power with the Handpiece disconnected or while foot is on the Foot Control.
•Remove the Tip when inserting or removing the Handpiece Cord or Irrigation Tube. It could cause injuries.
•When in use, always pump cool saline, etc. Insufficient liquid will destroy bone tissue or damage tooth surface.
• In use, never allow the vibrating Tip to touch any prosthesis such as ceramics. Touching might cause break or chipping .
• In use, never allow the vibrating Tip to touch a metal crown, porcelain crown, etc., which may cause loosening or breakage, etc.
•During its operation, the whole tip vibrates. Do not bring any part of the tip into contact with soft tissue, gums or
skin. Regardless of use of coolant water, the tip in vibration could cause burn injury.
•Use the Tip within the power range indicated on the tip case. If you use it out of the power range, the Tip might
break or damage an operative site.
•Do not use the Tip that is damaged, bent or rusted. The Tip could break while in use.
•Do not sharpen the Tip or bend it to change the angle. The Tip could break during use or fail to vibrate.
•Even if used within the recommended power range, a Tip could become chipped or break due to an overload. Be
sure to use suction to make sure no pieces of a broken Tip are left in the patient’s mouth.
•Make sure that the saline, etc. that emits from the Tip does not come into contact with the control unit. It could
cause color to fade or rusting.

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CAUTION
•The diamond coated tips are "Single use". Do not reuse.
•Only Use Tips that NSK has approved for VarioSurg use. Damage, failure or an accident may occur; the following
are possible failure modes (NSK Warranty Exclusions).
• Vibration failure caused by using non conforming screws (Incorrect Tip).
• Patients’ accidental ingestion of Broken or damaged Tip.
• Damage to thread of Handpiece output shaft.
• Handpiece, Handpiece Cord, Tips, Tip Wrench, and Tips Holder are all non-sterile items. Be sure to sterilize them
before use. Refer to "8-2 Sterilization".
• Never sterilize the Handpiece etc., using ultraviolet sterilization. It may cause discoloring.
•After autoclave sterilization, wipe away any remaining water drops. They may cause discoloring.
• Do not press the Tip against anything unless it is part of treatment. Ultrasonic vibrations may damage tooth surface .
• The Tip wears down after every use. After wearing down, vibrations become weak and coating may come off. If these
problems occur, be sure to replace the Tip with a new one. It is recommended that the Tip be changed after 5 uses.
•When replacing the Tip, use the Tip Wrench to ensure that the new Tip is securely mounted to the Handpiece. If
mounting is loose, vibrations may be weak and output inadequate.
•If a new Tip is mounted with stray objects on the screw, vibrations may be weak and output inadequate. If there is
anything on the Tip, clean it off before mounting to Handpiece.
•If it feels as though the Tip is not vibrating during use, remove the Handpiece from the mouth of the patient, and
step on the foot control again. If the situation is no better, the Tip may have become loose during use, so check to
make sure it is securely mounted.
• Do not shine the LED into the eyes of the patient or the operator. It may damage eyesight.
• This product is Medical Electrical equipment. EMC (Electromagnetic compatibility) is described in the
accompanying documentation.
•This product needs special precautions regarding EMC and needs to be installed and put into service according to
the EMC information.
•Portable and mobile RF communications equipment can affect Medical Electrical equipment. Do not use RF
equipment outskirts for the product.
• The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers
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.
•This system should not be used adjacent to or stacked with other
equipment and that 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.
• Grounding reliability can only be achieved when the equipment is
connected to an equipment receptacle marked "Hospital Only" or "Hospital Grade".
• U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
NOTICE
• During vibration, the Handpiece and the Handpiece Cord may affect computer and LAN cable. Noise could be heard
during operation near a radio receiver.
• Turn the Main Power Switch OFF when not in use. If left unused for a long period of time, remove the plug from the
power outlet.
• Clean and sterilize immediately after use and before storing. Lack of cleaning or sterilization could result in
breakdowns.
• When you have not used the product for long time and use it again, check the operation before use.
• Users are responsible for operational control, maintenance and inspection.
• No special training is required for this device.
• Applied parts for patient and/or operator are/is Tip and Handpiece.
Power plug below is used in North America area.
Plug Type NEMA 5-15P (Hospital Grade Type)

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Type NE214
Rated power supply AC100V 50/60Hz, AC120V 50/60Hz, AC230V 50/60Hz
Resonance frequency 28~32kHz
Maximum output 17W
Power supply input 50VA
Lighting White LED (Optic Handpiece (VS-LED-HPSC) only)
Activate Voltage 3.5V
Consumption current 0.1A (Typ. 3.5V)
Dimensions W268 x D230 x H103(mm)
Weight 3.1kg
Fuse 100/120V Specification...T2AL 250V
230V Specification...T1AL 250V
Use environment
Temperature 0 - 40 ˚C*
Humidity 30 - 75 %**
Atmospheric pressure 70 - 106 kPa
Transportation and Storage
environment
Temperature -10 - 60 ˚C
Humidity 10 - 85 %**
Atmospheric pressure 50 - 106 kPa
* No liquid freezing allowed
** No condensing allowed
2. Specifications
Principle of Operation
A sinusoidal electrical signal, at ultrasonic frequency, is delivered by the generator. This signal is applied to the
piezoelectric ceramic located inside the transducer. Piezoelectric ceramic converts this signal into mechanical
vibrations. These vibrations are at the same ultrasonic frequency as the electrical signal. The mechanical vibrations
are propagated towards the distal end of the transducer. The insert, which is attached at the distal end of the
transducer, vibrates at ultrasonic frequency and makes it possible to achieve the aimed purpose.

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3. Package Contents
No. Part Name Quantity
1 Control Unit with Irrigation Pump 1
2Foot Control 1
3 AC Power Cord 1
4 Handpiece with Cord (unshielded 2m) (Optic / Non-Optic) 1*
5Irrigation Tube 5
6 Saline Solution Hanger Post 1
7 Handpiece Stand 1
8Tube Holder 7
9 Tip Wrench 1
10 Tips 6 (Basic kit)
11 Tips Holder 1
* One of these Handpiece with Cord should be packed.
10
7
8
1
4
5
6
9
11
32

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4. Control Unit with an Irrigation Pump
Pump Cover
Operation Panel
Handpiece Cord JackFront Panel
LCD display
AC Power Cord
Connection Jack
Foot Control Cord JackMain Power Switch

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English
Front Panel and Operation Panel
Flow Key
Program Key
Power Key
Ultrasonic Output Display
Bar Graph
Program No. Flow Level
Vibration Level
Select Mode Key Vibration ModeMEMORIZE Key
Program No.
Indicates the Program No. selected.
Ultrasonic Output Display
Indicates via animation that ultrasonic waves are being transmitted.
Bar Graph
Indicates the power level selected on a scale of 10.
Vibration Level
Indicates the power level selected.
Flow Level
Indicates the flow level selected on a scale of 5.
Vibration Mode
Indicates the vibration mode selected.
LCD display

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NOTICE
CAUTION
Select Mode Key
For switching to SURG, ENDO, and PERIO modes. Switching modes will automatically change the program number and
power range.
Program Key
For selecting a program number. Press the “+” key to increase the number by one, or the “-“ key to decrease by one.
The program numbers that can be selected are different depending on the mode selected. Program numbers can’t be
changed while the Handpiece is in operation.
Power Key
For adjusting power level. Press the “+” key to increase the number by one, or the “-“ key to decrease by one. The power
range is different depending on the mode selected. This key can be used while the Handpiece is in operation.
Flow Key
For adjusting the flow level. There are 5 flow levels to choose from (see the table above).
Auto Cleaning mode
Pressing the Flow Key for 3 seconds will activate the Auto Cleaning mode in which the pump rotates at maximum
flow rate for 30 seconds to clean the inside of handpiece. Refer to 8-1 Auto Cleaning for more details.
MEMORIZE Key
For saving settings. Press the key for about 1 second, and the current settings will be saved under the program number
selected and a beep will let you know memorizing is complete.
How the keys work
Be careful not to place heavy things on the LCD display of the Operation Panel and avoid any strong impact (e.g.
dropping something onto it). This may lead to damage or malfunction.
A program number is given to each of the different modes as shown in the table below. Only the preprogrammed
modes can be selected.
Program No Vibration mode Power range Flow level (5 levels)
1
SURG
With Burst function *1 10Hz
10-100%, in 10%
increments 15~90ml/min*2
2 With Burst function *1 30Hz
3 With Burst function *1 60Hz
4 No Burst function *1
5 No Burst function *1
6ENDO 5-50%, in 5% increments
60% and up, in 10%
increments
9~38ml/min*2
7
8PERIO
9
*1 Burst function: Vibration levels can be changed at certain intervals. Levels can be selected depending on patient’s bone
hardness (density).
*2 Amount of water may vary slightly depending on the condition of the Irrigation Tube.

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CAUTION
ON-OFF Switch for Water Flow
While you are pressing on that switch, irrigation is delivered at the setting of 5.
LED of handpiece will LIGHT ON without vibrating the Tip (Optic Handpiece).
PROGRAM (+) Switch
Every time you step on the switch, the program number increases by 1.
PROGRAM (–) Switch
Every time you step on the switch, the program number decreases by 1.
Vibration ON-OFF Switch
While you are pressing on the switch, vibration are generated at the setting level displayed on the panel.
5. Foot Control
Turning the Main Power Switch ON while stepping on the Vibration ON-OFF Switch will not, for safety’s sake,
activate the Handpiece, but there will be a warning sound.
Foot Control plug
PROGRAM (+) Switch
ON-OFF Switch
for Water Flow
PROGRAM (–) Switch
Vibration ON-OFF Switch
Foot Control cord

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6. Installation
6-1 Connecting the Handpiece Cord
Align the mark on the Handpiece Cord with mark on the
Control Unit; push the Base of Handpiece Cord Plug into the jack
until the locking joint ‘clicks’ into place (Fig. 1).
To disconnect the plug; pull back the Lock Joint, pull further to
disconnect the cord.
Lock Joint
Fig.1
6-2 Connecting the Foot Control
Matching the shapes of the Foot Control Plug and the Foot
Control Cord Jack of the control unit, insert the plug into the jack
and then tighten the Lock Ring (Fig. 2).
Lock Ring
Fig.2
6-3 Connecting the AC Power Cord
Before connecting the AC Power Cord, make sure the Main
Power Switch is OFF (on the side).
Matching the shapes of the AC Power Cord and the AC Power
Cord Connection Jack on the back of the control unit, insert the
cord tightly into the AC Power Cord Connection Jack (Fig. 3).
Then plug the AC Power Cord into the outlet.
Fig.3
Fig.4 Fig.5
6-4 Mounting the Saline Solution Hanger Post
Insert the Saline Solution Hanger Post into the holder, making sure to fit the guiding pin of the hanger into the slit of
the holder (Fig. 4 and 5). The bottle should be hung facing the side of the Control Unit.
AC Power Cord Connection Jack
Main Power Switch

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Fig.6
Fig.7 Fig.8
Pump Knob
AB
4) Make sure that the tube is inserted well behind the roller as shown in Fig. 9. If not, the tube may be damaged
or cut when the Pump Cover is closed.
5) Close the Pump Cover.
Fig.9
Roller
Fig.10
6-5 Mounting the Irrigation Tube
Mount the Irrigation Tube as shown in Fig. 6.
6-5-1 Mounting to the Irrigation Pump
1) Turn the Pump Knob on the side of the Control Unit 180 degrees to the right to open the Pump Cover.
2) Insert the Irrigation Tube (on the bottle side) into the Irrigation Pump, hitching it onto A in Fig. 7.
3) Insert the Irrigation Tube along the guide and fit it into B in Fig. 8.
Pump Knob

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CAUTION
• Use only 500ml saline solution bottles. Never hang more than 800 grams to the hanger post.
• At any time, insure that there is enough saline solution inside the bottle.
6-5-3 Mounting to the Bottle
1) Close the Tube Clamp located between the Irrigation Tube Needle and the irrigation pump, as illustrated in
Fig.12.
2) Hook the bottle to the hanger post and insert the Irrigation Tube Needle into the Bottle Cap.
Bottle Cap
Irrigation Tube Needle
Fig.13
Tube clamp
Fig.12
Tube Cap
Fig.14
Non-Optic handpiece
CAUTION
Improper connection of the Irrigation Tube can lead to water leakage. Make sure that the Irrigation Tube and Water
pipe are connected tightly.
Water pipe
Fig.11Optic handpiece
3) Open the Tube Cap to supply air into the bottle.
6-5-2 Mounting to the Handpiece
Insert the end of the Irrigation Tube all the way into the Water pipe of the Handpiece (Fig. 11).
Water pipe

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6-6 Attaching the Tube Holder
Use the Tube Holder to bundle together the Handpiece Cord and
the Irrigation Tube. It is easier to fasten them onto the Handpiece
Cord first and, next, onto the Irrigation Tube.
CAUTION
Handpiece CordHandpiece Cord
Irrigation Tube
Irrigation Tube
Tube Holder
Tube Holder
Fig.15
CAUTION
6-7 Handpiece stand
Place the Handpiece horizontally on the Handpiece stand
(Fig. 17).
Fig.17
• Bundle the Handpiece Cord and the Irrigation Tube at a total of
7 locations as shown in Fig. 16.
• The tube may burst or come off the bottle if the Irrigation Pump
is activated with the tube bent, the Tube Clamp closed, or the
bottle empty.
Fig.16
• Make sure that the Tip does not contact the Handpiece stand (Fig. 18).
• Make sure that the Handpiece is placed on the Handpiece stand
horizontally, and not at an angle.
• To clean the Handpiece stand, wipe with a cloth dampened with alcohol.
Fig.18
No contact!
Horizontal Not horizontal

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7. Operation
7-1 Mounting and Removing the Tip
1) First, lightly screw in the Tip with your hands (Fig. 19).
2) Matching the square shapes of the Tip and the hole of the Tip Wrench, insert the Tip into the hole (Fig. 20).
3) Rotate the wrench in the tightening direction, as shown in Fig. 21 and 22, until it makes a clicking sound as it
spins without tightening any further.
To remove the Tip, rotate the wrench in the loosening direction shown in Fig. 21 and 22.
CAUTION
Fig.19 Fig.20
Fig.21
TightenTighten
Loosen
Loosen
Fig.22
Loosen Tighten
• Be careful when mounting or removing a Tip that is longer than the Tip Wrench, as the end of the Tip that sticks
out of the wrench might cause injury.
• Rotating the wrench at an angle may damage the thread or the Tip so that it cannot be tightened enough to
produce vibrations.
• Always mount a sterilized Tip.
• Do not use damaged, bent, or rusty Tips as they might break during use.
• Tips wear down and decrease in cutting power. Change the Tip when its cutting power has decreased.
• Tip Wrench is consumable. For reliable operation replace annually.

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CAUTION
Set to the Power indicated on the Tip Case. Use Tips within the appropriate Power Range (Fig. 23). The abbreviations
for the selection modes mean the following : S: SURG mode, E: ENDO mode, P: PERIO mode
7-2 Checking and Setting Up
(1) Checking the Irrigation Tube
Make sure the Irrigation Tube is mounted properly to the bottle, Irrigation Pump, and Handpiece.
(2) Main Power
Turn on the Main Power Switch.
(3) Checking water flow
Open the Tube Clamp that is located between the Irrigation Tube Needle and the Irrigation Pump, press the ON-OFF
Switch for Water Flow on the Foot Control, and make sure that saline comes out of the Tip. With a new tube, it usually
takes several seconds before saline comes out.
(4) Setting the output
Power rangeMode
Fig.23
1) Switch modes using the Select Mode key.
2) Select a program number using the Program Key.
3) Adjust power level using the Power Key.
4) Adjust flow level using the Flow Key.
* See Fig. 24 for a comparison of outputs of different modes.
CAUTION
Always use a Tip within the mode and power range indicated on the label on the Tip Case. Using a Tip outside its
power range may lead to Tip breakage or damage to tooth surface, gums, or soft tissue.
Power OFF Power ON
SURG
ENDO
PERIO
Output
0 20 40 60 80 100 %
Fig.24

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CAUTION
NOTICE
When the Main Power Switch is turned ON, the settings selected at the time the Main Power was last turned OFF
(mode, program No., power level, and flow level) will be retrieved (from the memory function).
7-3 Operation
Operating the Foot Control activates the Tip. Before actually using the Tip inside a patient’s mouth, test to make
sure it works properly, specifically in terms of the points listed below. If there is any abnormalities, immediately stop
using and contact the dealer.
• Make sure the Tip supplies saline properly.
• Make sure the Tip vibrates properly.
• Make sure there is no Tip looseness, abnormal vibrations, noise, or overheating.
• Make sure the Optic Handpiece lamp turns on.
8. Maintenance
8-1 Auto Cleaning
After using saline, clean the inside of the Handpiece with distilled water or equivalent.
Remove the Irrigation Tube Needle from the bottle and put it in a container (such as a cup, etc.) of distilled or pure
water. Then press the Flow Key for about 3 seconds to start Auto Cleaning.
During Auto Cleaning, a Water Mark ( ) blinks above the Flow Level and the Vibration Level display indicates “CLN.”
Meanwhile, the Bar Graph indicates remaining time for Auto Cleaning, turning off one bar about every 3 seconds.
Auto Cleaning takes about 30 seconds. When it is complete, the LCD display returns to its normal indication.
CAUTION
Bar Graph
“CLN” indication
Water Mark
Fig.25
• After a new saline bottle is installed, always test the Tip before putting it inside patient’s mouth to make sure
saline comes out of the end of the Tip.
• Taking the patient’s condition into consideration, start with a lower power level within the power range.
• Always irrigate with saline when using. Insufficient irrigation might cause the Handpiece to overheat or damage
the treatment area and tooth surface.
• Do not apply more pressure than necessary to the end of the Tip.
• If the Irrigation Pump does not work due to some type of malfunction, the Vibration Level displays shows an error
code, “E-P” (refer to the Error Code table).
• During Auto Cleaning, the Irrigation Pump feeds
at full flow rate and the Tip of the Handpiece
discharges water that was used for cleaning. Have
a glass or other container ready to receive the
water.
• Always conduct Auto Cleaning after using saline,
otherwise the Handpiece will clog or break.

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8-2 Sterilization
Autoclave sterilization is recommended.
Autoclave sterilization is required for the first time use and after each patient as noted below.
The following items can be autoclaved.
Handpiece with Handpiece Cord (Optic/Non-Optic), Tip, Tip Wrench, Tips Holder, Handpiece stand and Tube Holder.
Note the following when sterilizing a diamond coated tip:
-Follow your local directives, standards, and guidelines.
-Sterilize a tip in a U.S. FDA-cleared sterilization pouch, compliant to ISO 11607-1.
-NSK recommends sterilization according to ANSI/AAMI ST79 and EN 13060 (class B).
- Follow the manufacturer's instructions for use that came with your sterilizer.
- For more information about sterilization standards, refer to the medical device regulations specific to your location.
*
U.S.: The recommended sterilization procedures require the use of FDA-cleared sterilizers, sterilization trays,
sterilization wraps, biological indicators, chemical indicators, and other sterilization accessories labeled for the
sterilization cycle recommended.
8-2-1 Handpiece
Optic Handpiece
1) Disconnect the Handpiece cord from the Control Unit.
2) Remove the Irrigation Tube from the Handpiece and dispose of it.
3) Brush (do not use a metal brush) dirt off the surface, and then wipe with alcohol soaked cloth.
Non-Optic Handpiece
1) Turn the Nose Cover counter-clockwise to remove.
2) Brush any contaminants from inside the Nose Area with a soft
brush. (Do not use metal brush) Wipe with alcohol soaked cloth
(Fig. 26).
3) Replace the Nose Cover onto the Handpiece turn clockwise.
CAUTION
Only handpiece with cord can be washed via Thermo Disinfector.
* Confirmed Thermo Disinfector is “Type: G7882” (Miele & Cie)
The Handpiece can not be removed from the
Handpiece Cord. Removing or twisting the Handpiece
could cause damage to the internal parts and failure
may occur.
CAUTION
Handpiece CordHandpiece
Nose Cover
Tighten
Loosen Nose Area
Fig.26

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8-2-3 Tip, Tip Wrench, and Tips Holder
1) Brush (do not use a metal brush) dirt off the surfaces of the Tip, Tip Wrench, and Tips Holder, and then wipe with
alcohol soaked cloth.
2) Mount the Tip to the Tips Holder.
CAUTION
Use rubbing alcohol only.
8-2-2 Cleaning of Optic Fiber (Optic Handpiece)
Wipe the debris off the end of the Optic Fibers at the Handpiece
with alcohol soaked cotton swab (Fig. 27).
CAUTION
Fig.27
Do not use any sharp pointed tools to clean the Optic Fiber End
Face. In case the light degradation, contact dealer.
Cotton swab
Fiber end-face
CAUTION
8-2-4 Autoclave
Autoclave up to max. 135˚C.
When sterilizing a Tip alone in an autoclaving pouch
1) Insert diamond coated tip into a U.S. FDA-cleared sterilization pouch, compliant to ISO 11607-1. Seal the pouch .
Steam Sterilization Cycle
Type Gravity Displacement Pre-Vacuum (Dynamic Air Removal)
Minimum Temperature 132°C 135°C 132°C 134°C* 135°C
Full Cycle Time 15 minutes 10 minutes 4 minutes 3 minutes 3 minutes
Minimum Drying Time 15 minutes 30 minutes 20 minutes 30 minutes 16 minutes
* Not for use in the U.S.
2) Keep the tips in the autoclave pouch until ready to use.
3) Store in a dry and dust-free location up to the period specified by the sterilization pouch manufacturer. If sterility
cannot be confirmed, sterilize again prior to use.
When sterilizing other components
1) Insert the products into a U.S. FDA-cleared sterilization pouch, compliant to ISO 11607-1. Seal the pouch.
* Sterilization at 121 ºC for more than 15 minutes is recommended by EN13060 or EN ISO17665-1.
<When sterilizing components except for a Tip>
Steam Sterilization Cycle
Type Gravity Displacement Pre-vacuum
Minimum Temperature 121˚C 132˚C 135˚C 135˚C
Full Cycle Time 20 minutes 15 minutes 10 minutes 10 minutes
Minimum Dry Time 10 minutes 10 minutes 10 minutes 15 minutes
2) Keep the products in the autoclave pouch until ready to use.
3) Store in a dry and dust-free location up to the period specified by the sterilization pouch manufacturer. If sterility
cannot be confirmed, sterilize again prior to use.
Do not mount a maintenance Tip (V10-S or V-P10) to the Tips Holder as the holder lid cannot be fully closed. Use a
autoclaving pouch for autoclave sterilizing of maintenance Tips.

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9. Troubleshooting
When you suspect a failure, refer to the following before requesting a repair. If your problem does not fall into any of the
following, or troubleshooting as suggested does not improve the problem, contact dealer as it is likely that the product is
faulty.
Case Possible Cause Remedy
Control Unit cannot be turned ON
(LCD display does not turn on).
AC Power Cord is not connected to Control
Unit. Make sure it is connected.
AC Power Cord is not plugged into wall
outlet. Make sure it is plugged in.
Fuse has blown. Contact dealer. *
Control Unit turns ON but displays
Ultrasonic Output Display and
beeps. Foot Control is being operated.
To prevent accidents, the Handpiece will
not work if the Main Power is turned ON
while the Foot Control is being operated. Try
stepping on the Foot Control again.
The Tip does not vibrate (no
indication of Ultrasonic Output
Display).
Foot Control is not connected. Make sure it is connected.
Handpiece with Handpiece Cord are not
connected, or Handpiece Cord is not
connected to Control Unit.
Make sure they are connected.
The Tip does not vibrate
(indication of Ultrasonic Output
Display).
Faulty circuit. Contact dealer. *
Weak vibrations.
Worn or broken the Tip. Replace with a new Tip.
Wrong mode. Change to the correct mode.
The Tip not tightened sufficiently. Tighten the Tip until the Tip Wrench clicks.
Improper power setting. Change to the correct mode and power
range as indicated on the Tip case.
Foot Control not connected properly. Connect Foot Control properly.
Failure inside the Handpiece. Contact dealer. *
Failure inside the Foot Control. Contact dealer. *
• Do not autoclave the Control Unit and the Foot Control.
•Do not exceed 138°C during sterilization.
• Never sterilize the Handpiece, etc., with ultraviolet radiation, which might cause discoloration.
• If you autoclave the Handpiece together with any instrument to which antiseptic solution adheres, discoloration
might occur.
• If any saline solution or stain adheres to the Control Unit, well wipe it off with a cloth impregnated with clean water
and squeezed out. Then, wipe the Control Unit well with a dry cloth.
• Do not clean the Control Unit with any solvent such as thinner, benzene, etc.
• We do not recommend you to sterilize on plasma sterilization or EOG sterilization.
CAUTION