OPERATION MANUAL

Please read this Operation Manual carefully

before use, and le for future reference.
OM-E0559E
Ultrasonic Bone Surgery System
1
English
Thank you for purchasing VarioSurg. This product is for use by dentists and oral surgeons.
Implant site preparation, Bone harvesting, Sinus surgery, Osteoplasty, Osteotomy, General oral surgery,
Tooth extraction, Syndesmotomy, Tooth avulsion, Periodontal surgery, Cyst surgery.
Read this Operation Manual carefully before use for operation instructions and care and
maintenance guidelines. Keep this Operation Manual for future reference.
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 classied 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
Classication of Devices
Classication by type of protection against electric shock:
Class I devices.
Classication by degree of protection against electric shock:
Applied part type BF.
Classication by sterilization or disinfection method allowed by the manufacturer:
Refer to Sterilization.
Classication by degree of protection against harmful intrusion of liquid based on IEC60529:
Foot Control IPX8 (protected against immersion)
Classication by safety level of use in air, ammable anesthetic gas or dinitrogen monoxide (laughing gas), ammable
anesthetic gas:
Not suitable for use in the presence of a ammable anesthetic mixture with air or oxygen or nitrous dioxide (Without
Foot Control)
Classication by mode of operation:
Continuously operating device.
1. Safety precautions prior to use
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 ammable 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 re
and/or electric shock. Should any water or liquid disinfectant get on the Control Unit, wipe it off immediately.
Be careful not to give strong shock (dropping, in particular) to a Handpiece. This might break the optics (Optic
Handpiece only) or give you an electric shock.
Never touch the connecting part (electric pins) for the Handpiece and Handpiece Cord.
Never attempt to take apart or recongure the Control Unit/Handpiece in any method not described in the manual.
Keep away from patients with cardiac pacemakers (There is danger that it may affect the pacemaker).
WARNING
Classication Degree of Danger or Danger and Seriousness
WARNI NG Explains an instruction where personal injury or physical damage may occur.
C A U T I O N Explains an instruction where minor to medium injury or physical damage may occur.
N O T I C E Explains an instruction that should be observed for safety reasons.
2
WARNING
Do not ick 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 patients age (except infants), gender, weight or nationality.
This product does not consider operators 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 tted
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 nd 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. Insufcient 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.
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 patients 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
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.
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 specied, 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 conguration in which it will be used.
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.
4
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 Specication...T2AL 250V
230V Specication...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. Specications
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
2 Foot Control 1
3 AC Power Cord 1
4 Handpiece with Cord (unshielded 2m) (Optic / Non-Optic) 1*
5 Irrigation Tube 5
6 Saline Solution Hanger Post 1
7 Handpiece Stand 1
8 Tube Holder 7
9 Tip Wrench 1
10 Tips 6 (Basic kit)
11 Tips Holder 1
12 Sterilization Cassette 1
* One of these Handpiece with Cord should be packed.
10
7
12
8
1
4
5
6
9
11
3 2
6
4. Control Unit with an Irrigation Pump
Pump Cover
Operation Panel
Handpiece Cord Jack Front Panel
LCD display
AC Power Cord
Connection
Foot Control Cord Jack Main Power Switch
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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 Mode MEMORIZE 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 ow level selected on a scale of 5.
Vibration Mode
Indicates the vibration mode selected.
LCD display
8
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 cant 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 ow level. There are 5 ow 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
ow 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
6
ENDO 5-50%, in 5% increments
60% and up, in 10%
increments
9~38ml/min*
2
7
8
PERIO
9
*1 Burst function: Vibration levels can be changed at certain intervals. Levels can be selected depending on patients 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 safetys 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 t 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
A
B
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 t it into B in Fig. 8.
Pump Knob
12
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.11 Optic 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 rst and, next, onto the Irrigation Tube.
CAUTION
Handpiece Cord Handpiece 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
14
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
Tighten Tighten
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 ow
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 range Mode
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 ow 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
16
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 ow 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 patients mouth, test to make
sure it works properly, specically 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 patients mouth to make sure
saline comes out of the end of the Tip.
Taking the patients condition into consideration, start with a lower power level within the power range.
Always irrigate with saline when using. Insufcient 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 ow 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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CAUTION
Only handpiece with cord can be washed via Thermo Disinfector.
8-2 Sterilization
Autoclave sterilization is recommended.
Autoclave sterilization is required for the rst 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, Tube Holder, and
Sterilization Cassette.
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.
4) Set the Handpiece with Handpiece Cord in the Sterilization Cassette.

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.
4) Set the Handpiece with Handpiece Cord in the Sterilization
Cassette.
8-2-2 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 before setting it in the Sterilization Cassette. The case accommodates up to 2
Tips Holders.
3) Set the Tip Wrench in the Sterilization Cassette.
CAUTION
Use rubbing alcohol only.
Tube holder
Tips Holder
Tip wrench
Handpiece Handpiece Cord
Another Tips Holder
can be set here.
An optional wrench
for E Tips (V10-S)
can be set here.
* A Sterilization Cassette with a Handpiece and other items set in it.
* Conrmed Thermo Disinfector is Type: G7882 (Miele & Cie)
Nose Cover
Tighten
Loosen
Nose Area
Fig.26
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CAUTION
8-2-3 Autoclave
Autoclave up to max. 135C.
Autoclave for 20 min. at 121C, or 15 min. at 132C.
Keep the sterilization cassette to keep it clean until you use it.
* Sterilization at 121 C for more than 15 minutes is recommended by EN13060 or EN ISO17665-1.
8-2-4 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
10. 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. *
CAUTION
Do not autoclave the Control Unit and the Foot Control.
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.
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
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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Case Possible Cause Remedy
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 sufciently. 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. *
The Tip breaks easily. Power Level is not right for the Tip mounted.
Change to the correct mode and power level
as indicated on the Tip case.
The Tip comes off. The Tip is not tightened sufciently Tighten the Tip until the Tip Wrench clicks.
Handpiece makes a loud noise.
Power Level is not right for the Tip mounted.
Change to the mode and power level
indicated on the Tip case.
Tip is not tightened sufciently. Tighten the Tip until the Tip Wrench clicks.
Failure inside the Handpiece or the Control
Unit.
Contact dealer. *
Handpiece gets hot.
Power Level is not right for the Tip mounted.
Change to the mode and power level
indicated on the Tip case.
Tip is not tightened sufciently. Tighten the Tip until the Tip Wrench clicks.
Failure inside the Handpiece or the Control
Unit.
Contact dealer.*
Foreign substance is clogging Handpiece
and blocking saline.
Place air syringe against Water Pipe and
blow air through it.
If this does not clear it, contact dealer.
Saline is not supplied.
Make sure bottle still has saline in it and
Irrigation Tube has no cracks.
Saline does not come out as
spray.
It depends on the combination of ow level,
power level, and Tip shape.
With some ow levels and Tip shapes, it is
more difcult to form a spray. This is not a
malfunction.
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Case Possible Cause Remedy
Water does not come out, or ow
level is low.
Foot Control is not connected. Make sure it is connected.
Irrigation Tube is not connected to bottle or
Handpiece.
Make sure they are connected.
Irrigation Tube is not properly mounted to
the pump.
Make sure it is mounted properly (Refer to
6-5-1 Mounting to the Irrigation Pump).
The Pump Cover is open. Close the cover.
The Irrigation Tube is broken (leaking).
Replace the Irrigation Tube (Refer to 6-5
Mounting the Irrigation Tube).
Water leak.
Leak from the connection between bottle
and Irrigation Tube.
Insert Irrigation Tube Needle all the way into
the bottle (Refer to 6-5-3 Mounting to the
Bottle).
Leak from the connection between
Handpiece and Irrigation Tube.
Insert end of Irrigation Tube all the way into
the Handpiece water pipe (Refer to 6-5-2
Mounting to the Handpiece).
Leak from Irrigation Tube.
Replace the Irrigation Tube (Refer to 6-5
Mounting the Irrigation Tube).
Irrigation doesnt stop.
Mode is set to Auto Cleaning. To stop irrigation, press the Flow Key.
ON-OFF Switch for Water Flow on Foot
Control is being operated.
Remove foot from the Foot Control.
Faulty circuit. Contact dealer.*
Handpiece LED does not
illuminate. (optic Handpiece)
LED is burned out. Contact dealer.*
Failure inside the Control Unit or inside the
Handpiece Cord.
Contact dealer.*
Failure or disconnection of the circuit. Contact dealer.*
LCD display does not properly
display.
Part of display is missing.
Overheating.
Heat can cause LCD display malfunction.
Turn the Main Power OFF to cool down.
Error Code is displayed. Refer to the Error Code table.
Failure of the LCD display or driving circuit.
Turn the Main Power OFF and then back
ON. If part of initial display is still missing,
contact dealer.
Settings are not memorized.
Wrong settings are memorized.
Figures have been temporarily changed.
Increase or decrease the Program No. by
one, and then return.
Foot control is being operated.
Settings cannot be saved while Handpiece
is operating.
An Error Code is displayed. Refer to the Error Code table.
* Repairs cannot be made by the customer.
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Error Codes
The LCD display shows an Error Code when vibration stops due to malfunction, overload, disconnection, human error, etc.
These codes should be used to understand the condition of the control unit and the cause of abnormality.
11. Optional Accessories
Error code Cause of error Check / Remedy
E-0 Faulty circuit. Contact dealer.*
E-2
The end of the Tip is under too much
pressure, or stuck .
Step on the Vibration ON-OFF Switch on the Foot
Control and slowly pull the Tip out as it vibrates.
Be careful not to apply too much pressure to the end
of the Tip.
Tip is not tightened sufciently. Tighten the Tip until the Tip Wrench clicks.
No Tip is mounted. Mount the Tip.
Cord disconnection, or a disconnection inside
Handpiece.
Use a backup Handpiece, or contact dealer.
E-4
Control Unit overheats due to long use under
large load.
Turn the Main Power OFF to cool down before using
again. If this happens often under normal use,
contact dealer.
E-F Foot Control disconnection. Replace the Foot Control or contact dealer.
E-P
Irrigation Tube is caught in pump roller.
Faulty pump.
Check the Irrigation Tube.
If Irrigation Tube is in normal condition and Error
Code is still displayed, contact dealer.
* Repairs cannot be made by the customer.
Product Name Items pictures Order Code
Handpiece with cord
(Optic)
E1084
Handpiece with cord
(Non-Optic)
E377
Set of 5 Irrigation Tubings Y900113
Set of 7 Tubing holders Y900767
Sterilization Cassette 20001326
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12. Disposing Product
Consult with dealer from whom you purchased it about waste disposal.
Product Name Items pictures Order Code
Tips Holder 20001327
Tip Wrench 10000977
E Tip Replacement Wrench
For V10-S
Z217399
13. Warranty
The manufacturer will warrant the quality of the product for one year after you purchased it, provided that you use it in
accordance with the method and procedures described in this operation manual.
Note, however, that if you did not observe what is written in this operation manual or for any single use goods, the
warranty will not apply.
Symbols
TUV Rhineland of North America is a Nationally Recognized Testing Laboratory (NRTL) in the United States and is accredited
by the Standards Council of Canada to certify electro-medical products with Canadian National Standards.
The product is designed not to become the ignition source in air and ammable anesthetic gas.
*Only Foot Control is AP equipment.
The EU directive 93/42/EEC was applied in the
design and production of this medical device.
Protected against the effects of continuous
immersion in dust and water.
Dispose of this device and its accessories via methods approved for electronic device and in compliance with the Directive
2002/96/CE.
Type BF applied part. Follow Operation Manual for use. Manufacturer
Authorised representative in the European community.
Autoclavable up to Max.135C.
*for detail see Sterilization.
This product can be cleaned and disinfected with a Thermo-Disinfector.
Marking on the outside of Equipment or Equipment parts that include RF transmitters or that apply RF electromagnetic energy
for diagnosis or treatment.
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Guidance and manufacturer's declaration - electromagnetic emissions
The VarioSurg is intended for use in the electromagnetic environment specied below. The customer or the user of the VarioSurg should assure that is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR11/EN55011
Group 1 The VarioSurg uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR11/EN55011
class B The VarioSurg is suitable for use in all establishments other than domestic, and may be used in domestic establishments
and those directly connected to public low-voltage power supply network that supplies buildings used for domestic
purposes, provided the following warning is heeded:
Warning: VarioSurg is intended for use by healthcare professionals only. VarioSurg may cause radio interference or may
disrupt the operation of nearby equipment.
It may be necessary to take mitigation measures such as re-orienting or relocating the VarioSurg or shielding the location.
Harmonic emissions EN/IEC61000-3-2 class A
Voltage uctuations/ icker emissions
EN/IEC61000-3-3
Complies
Guidance and manufacturer's declaration - electromagnetic immunity
The VarioSurg is intended for use in the electromagnetic environment specied below. The customer or the user of the VarioSurg should assure that it is used in such an environment.
Immunity test EN/IEC60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
EN/IEC61000-4-2
6kV contact
8kV air
6kV contact
8kV air
Floors should be wood, concrete or ceramic tile. If oors are
covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast transient/burst
EN/IEC61000-4-4
2kV for power supply lines
1kV for input/output
2kV for power supply lines
1kV for input/output
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
EN/IEC61000-4-5
1kV line to line
2kV lines to earth
1kV line to line
2kV lines to earth
Mains power quality should be that of a typical commercial or
hospital environment.
Voltage dips, short interruptions and
voltage variations on power supply input
lines
EN/IEC61000-4-11
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
<5% Ut (>95% dip in Ut)
for 0.5 cycle
40% Ut (60% dip in Ut)
for 5 cycles
70% Ut (30% dip in Ut)
for 25 cycles
<5% Ut (>95% dip in Ut)
for 5 sec
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the VarioSurg requires
continued operation during power mains interruptions, it
is recommended that the VarioSurg be powered from an
uninterruptible power supply or a battery.
Power frequency (50/60Hz)
magnetic eld
EN/IEC61000-4-8
3 A/m 3 A/m Power frequency magnetic elds should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
NOTE: Ut is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration - electromagnetic immunity
The VarioSurg is intended for use in the electromagnetic environment specied below. The customer or the user of the VarioSurg should assure that it is used in such an environment.
Immunity test EN/IEC60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF EN/IEC61000-4-6
Radiated RF EN/IEC61000-4-3
3Vrms150 kHz to 80MHz
3V/m80MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should be used
no closer to any part of the VarioSurg, including cables, than the
recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = 1.2 P
d = 1.2 P 80MHz to 800MHz
d = 2.3 P 800MHz to 2.5GHz
Where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended
separation distance in meters (m).
Field strengths from xed RF transmitters as determined by an
electromagnetic site survey, should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.
a Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobiles radios, amateur radio, AM and FM radio broadcast and
TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the VarioSurg is used exceeds the applicable RF compliance level above, the VarioSurg should be observed to
verity normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the VarioSurg.
b Over the frequency range 150kHz to 80MHz, eld strengths should be less than 3 V/m.
24
Recommended separation distances between portable and mobile RF communications equipment and the VarioSurg
The VarioSurg is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the VarioSurg can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VarioSurg as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
Separation distance according to frequency of transmitter
m
150kHz to 80MHz
d = 1.2 P
80MHz to 800MHz
d = 1.2 P
800MHz to 2.5GHz
d = 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects and people.
Cables and accessories Maximum length Complies with
Handpiece cord
Foot Controller
2m
2m
RF emissions, CISPR11, EN55011
Harmonic emissions,
Voltage uctuations/ icker emission,
Electrostatic discharge(ESD),
Electric fast transient / burst
Surge
Voltage dips, short interruptions and voltage variations on power supply input lines
Power frequency(50/60Hz) magnetic eld
Conducted RF
Radiated RF
Class B/ Group 1
EN/IEC61000-3-2
EN/IEC61000-3-3
EN/IEC61000-4-2
EN/IEC61000-4-4
EN/IEC61000-4-5
EN/IEC61000-4-11
EN/IEC61000-4-8
EN/IEC61000-4-6
EN/IEC61000-4-3