NSK Varios 370, Varios 370 Lux Operation Manual

Multi Function Ultrasonic Scaler
OPERATION MANUAL
Please read this Operation Manual carefully before use, and file for future reference.
Varios 370
OM-E0620E 001
Original Operation Manual
Classifications of equipment
• Type of protection against electric shock:
– Class II equipment
• Degree of protection against electric shock: – Type BF applied part:
• Method of sterilization or disinfection recommended by the manufacture:
– See 12. Sterilization
• Degree of protection against ingress of water as detailed in the current edition of IEC 60529: – Foot Control: IPX1 (Protected against vertically falling water drops)
• Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: – EQUIPMENT not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous
oxide.
• Mode of operation:
– Continuous operation
Intended to Use
This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in
dental applications such as scaling, root canal treatment, periodontal and cavity preparation.
Rx Only Caution: U.S. Federal law restricts this device to sale by or on the order of a dentist.
ENGLISH
Cautions for handling and operation
Read these cautions carefully and use only as intended or instructed. Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device. Safety instructions are classified as follows in accordance with the seriousness of the risk.
English
A hazard that could result in bodily injury or damage to the device if the safety instructions
WARNING
CAUTION
NOTICE
are not followed.
A hazard that could result in light or moderate bodily injury or damage to the device if the
safety instructions are not followed.
General information needed to operate the device safely.
WARNING
· TO PREVENT ELECTRIC SHOCK Do not unplug the AC Adaptor with wet hands.
· TO PREVENT ELECTRIC SHOCK Make sure not to get water on the Control Unit.
· TO PREVENT ELECTRIC SHOCK Do not touch the handpiece backend electrical connections.
· TO PREVENT ELECTRIC SHOCK Use an electrical outlet that is grounded.
· If you feel any abnormality such as vibration, heat generation, abnormal noise, etc., prior or during the use of the unit, stop
using it immediately.
· This product is Medical Electrical equipment Electromagetic compatable (EMC). As described in the accompanying
documentation.
· Portable and mobile RF communications equipment can affect Electrical Medical equipment. Do not use RF equipment in close proximity to the product.
· When installing the product, provide space of approximately 10cm around the Control Unit for easy access to the inlet and the AC Adaptor.
1
· Be sure to always use with sufficient coolant water. Insufficient coolant water could cause a burn of the affected area or
the overheating of the instrument.
· Be aware of the tip end position. Constantly move the tip so that it does not stagnate at one point. If the tip is stagnated at
a single point, there will not be enough cooling, and this could result in overheating of the tooth or root canal, or excessive
cutting of the tooth or root canal.
· USE ONLY NSK genuine Tips when using NSK Varios Ultrasonic Scaler (Varios 370 or Varios 370 Lux) problems such as
damage, failure and accident of Handpieces resulting from use of Non-NSK Tips are not included in the warranty. The following are the possible failure that could happen when using the Non-NSK Tips;
· Vibration failure caused by using non conforming screws.
· Patients accidental ingestion of broken Tips.
· Damage of thread ridge of handpiece.
· You must use the Tip within the power range described on the Tip Power Guide. If you use it out of the power range, the
Tip might break or damage an operative site.
· When operating the product always consider the safety of the patient.
· Use by medical professional, such as doctor or dental hygienist, is intended.
· Check the vibration outside the patient’s oral cavity before use. If any abnormalities are found, stop using immediately and
contact dealer.
· 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.
· To prevent possible tooth plane damage and handpiece overheating, always use with sufficient water.
· Do not sterilize by ultraviolet light. Handpiece could discolor.
· Sterilize the Tip (except for all diamond coated tip), Handpiece, Tip Holder, Tip Cover S and Tip Wrench by autoclaving. Wipe
the Control Unit, Tip Holder, Tip, AC Adaptor, Foot Control, Tip Card, Tip Power Guide, and Handpiece Cord including the
cover with alcohol soaked cotton.
· If chemical, solvent or antiseptic solution is deposited on this product, immediately wipe it away. Discoloration or
deformation may occur if left.
· Do not disassemble or alter the handpiece/Control Unit.
· Keep away from patients with cardiac pacemakers.
· Keep away from explosive substances and flammable materials. Do not use for patients anesthetized under laughter gas.
(Nitrous oxide)
· Staring directly into LED may result in eye damage. Do not turn it to the eyes of the patient or operator.
· This product needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information.
· Electromagnetic Compatibility: 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 product 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.
· If any water drops remain on the handpiece or handpiece cord after autoclaving, wipe them off. Staining may result if left.
· Users are responsible for operation control and maintenance.
· Do not use water tubes of other companies. Doing so may cause a malfunction.
· There is the judgment that applies this product to a patient in the user side.
· Do not apply excessive power to the Tip. It may damage the teeth because of the ultrasonic vibration.
2
CAUTION
· During operation, high frequency oscillations in the handpiece and handpiece cord may affect computer and LAN Noise
may be heard during operation near a radio receiver.
· Be sure to turn off the Power/Volume Knob after use. Remove the AC Adaptor when not using it for long periods of time.
·
The surface of the Control Unit may feel warm after prolonged use. Turn the Power/Volume Knob to OFF and cool the device.
· Users are responsible for operational control, maintenance and inspection.
· Clean/sterilize the product immediately after using it. Then store it. Leaving it non-sterile might lead to failure.
· When you have not used the product for long time and use it again, check the operation before use.
· When abnormalities are found with a Control Unit and /or an AC adaptor, pull the AC adaptor from AC Outlet immediately.
· Do not turn the Power/Volume Knob to ON or OFF needlessly.
· No special training is required for this device.
· Applied parts for patient and/or operator are/is Tip and Handpiece.
· When using a file as a tip for root canal treatment (for enlarging, cleaning, etc.), use it after confirming its characteristics
and areas where it can be applied.
· Operators and all others in the area must wear eye protection and a mask when operating this product.
· Before use, be sure to always check that the power level is set to the proper settings.
· During vibration, do not grasp the tip nor make contact with the tip for an extended time.
· Do not use tips that are damaged, bent, corroded, or show other imperfections. The tip could break or fail to vibrate.
· Do not apply more pressure than required to the tip end. This could cause the tip to break or warp. Do not twist or strain
the tip, and do not use it as a replacement for surgical tools. This could cause the tip to deform or break.
· If the tip cracks or breaks during use, immediately stop operation, and replace with a new tip. Operation with a damaged
tip could injure the gums, periodontal tissue, or other locations.
· The diamond coating on the tip surface may peel off depending on the tooth condition or root canal condition. If the
diamond coating peels off, the cutting efficiency becomes less, resulting in reduced cutting performance. If you sense this
type of condition, replace with a new tip.
· All sterilizable components of this device are delivered in a non-sterile condition and must be autoclaved prior to use. Refer
to "4.Sterilization before first time use".
· The diamond coated tips are "Single use". Do not reuse.
· U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
* Operation Principle
A sinusoidal electrical signal, at ultrasonic frequency ( f > 20kHz ), is delivered by a 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 “TIP” insert, which is attached at the distal end of the transducer, vibrates at ultrasonic frequencies and makes it possible to achieve the aimed purpose.
English
3
1. Component Names
DC Plug
2
No. Parts Name Quantity
Control Unit
1
(
with Handpiece Cord Unshielded 2M
Handpiece (Varios2 or Varios2 Lux)
2
Control Unit Holder
3
1
AC Adaptor (Unshielded cord 5M
4
Handpiece Holder
5
Foot Control (Unshielded 4M
6
Water Tube Set
7
Tip (G4,G6, G8
8
)
)
)
1
)
1 1 1 1 1 1 1
No. Parts Name Quantity
Rubber Pad
9
Tip Wrench
10
Spanner Wrench (5x8
11
O Ring
12
Tip Cover S (Option
13
Tip Holder (Option
14
15
Set Screw
1
Adaptor will change according to region
2
Only 120 V
3
These are not on photo above.
4
3
)
)
)
4 1 2 2
-
­3
2. Name and Function of each part
Front side
Water Volume Knob
Back side
(
Control Unit With Control Unit Holder
Handpiece Cord Holder
Power Indicator
Output Indicator
DC Connector
)
Power/Volume Knob
Control Unit Holder
This Holder can move back and forth.
Handpiece Cord Holder
English
Foot Control Connector
3. Prior to Operating System
3-1 Set the AC Adaptor
Insert each plug into appropriate connector.
Insert the Plug Head into the Adapter Body as
shown in the right figure.
Slide the Plug Head on to the Adaptor Body.
To release, push the Release Button shown on the right figure and remove the Plug Head from the Adaptor Body.
Handpiece Cord
Water Tube Connector
Release Button
Adaptor Body
5
Plug Head
3-2 Connecting
Insert each plug into appropriate connector. (Fig.1
Align the " " Mark on the Foot Control Connector and Foot Control Plug and connect those firmly into
Foot Control Connector.
Connect Water Tube Connect AC Adaptor into DC Connector.
Foot Control Plug
Insert each plug and tube firmly into the connector. If connection is incomplete, it may cause
CAUTION
a malfunction.
Ensure Power is OFF on the Control Unit during the AC Adaptor Connection.
Do not connect the cord in wall outlet before connecting DC Connector.
Do not pull the AC Adaptor forcibly.
Do not disconnect the AC Adaptor while pressing on the Foot Control.
(Non-Filter Side,
Mark
• Turn OFF the power to connect or disconnect the cords and plugs.
)
refer to Fig. 23 for detail) firmly into Water Tube Connector.
Fig.1
3-3 Disconnecting
3-3-1 DC Plug and Foot Control Plug
Simply pull out plugs from the Control Unit.
3-3-2 Water Tube (Fig.2
Depress the white ring to remove the water tube.
Shut off the main valve of the water injection, and then remove the tube.
CAUTION
It requires the water removal before the water tube disconnection.
)
Water Tube
PULL
PUSH
White Ring
Fig.2
6
3-4 Handpiece Holder
The handpiece holder attached to the Control Unit keeps the handpiece in place when it is not in use. To mount the Handpiece Holder on a vertical surface follow the procedures below.
1) Make a 3 mm hole in the Double-Face tape behind the screw hole in handpiece holder. (Fig. 3)
2) On the vertical surface make a 3.2~3.5 mm hole in the plate where the holder will be mounted. Align the hole with the screw hole on the holder. Make certain the surface is clean then adhere the holder to the plate, and attach. Insert the Set Screw through the two holes on the holder and the plate. Fasten the Set Screw with the Nut from the rear of the plate. (Fig. 4)
Handpiece Holder
Screw hole
Double-Face Tape
Handpiece Holder
Nut
English
Set Screw
Make a hole after a screw hole (about 3.0mm in diameter)
Fig. 3
3-5 Handpiece Cord Holder and Control Unit Holder
The Control Unit can be attached to the chair unit using
the control unit holder.
1) Make two 3.2~3.5mm holes in the mounting
surface. Insert the set screw in the hole from the holder side and secure it with the nut.
2) Align the chaser and Slide the Control Unit into the Control Unit Holder.
3) Tuck the Handpiece Cord into Handpiece Cord Holder.
Do not pull or bend the handpiece cord forcibly as it might cause damage to the handpiece,
CAUTION
and result in improper water flow.
You can mount Control Unit Holder on a top surface or bottom surface.
Control Unit
Holder
Chaser
Nut
Set Screw
Chaser
Drill a hole (3.2~3.5mm in diameter)
Drill a hole (3.2~3.5mm in diameter)
Handpiece
Cord Holder
Handpiece
Cord
Fig. 4
Fig. 5
7
3-6 Rubber Pad
To prevent the control unit from slipping apply rubber pads.
1) Clean bottom of the Control Unit.
2) Fit the Rubber Pad appropriate place as shown
on the Fig. 6.
Control Unit Holder is not necessary when rubber pads are applied.
Rubber
Pad
CAUTION
4. Sterilization before first time use
NSK Varios components are not sold sterile and should be sterilized prior to first time you use. Autoclave sterilization is recommended. Please note the following when sterilize components.
Follow your local directives, standards, and guidelines. Sterilize components in a U.S. FDA-cleared sterilization pouch, complaint to ISO 11607-1. Ensure that you only remove dry sterile goods from the sterilizer. Store sterile goods dust-free and dry.
Fig. 6
NOTE
• 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 the medical device regulations
specific to your location.
Autoclave Procedure
1) Pick a tip up from the tip case. Take handpiece out of the packing bag before sterilization.
2) Insert sterilizable components into a U.S. FDA-cleared sterilization pouch, complaint to ISO 11607-1. Seal the pouch.
3) Autoclave conditions are below: < When sterilizing a Tip>
Steam Sterilization Cycle
Type Gravity Displacement Pre-Vacuum (Dynamic Air Removal) Minimum Temperature 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.
<When sterilizing components except for a Tip>
Type Gravity Displacement Pre-vacuum Minimum Temperature
Full Cycle Time 20 minutes 15 minutes 10 minutes 10 minutes Minimum Dry Time 10 minutes 10 minutes 10 minutes 15 minutes
132°C 135°C 132°C 134°C* 135°C
Steam Sterilization Cycle
121˚C 132˚C 135˚C 135˚C
8
• Do not exceed 138˚C during sterilization.
CAUTION
4) Keep the components in the autoclave pouch until ready to use.
5) 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.
5. Mounting and Removing the Handpiece
English
Align the Dots on the Handpiece and the Handpiece Cord. Push
handpiece into connector.
To detach the handpiece, grip the Handpiece and plug of the
handpiece cord and separate in a straight motion. (Fig. 7
To avoid Electrical Shock Do not touch the handpiece backend electrical contacts.
)
Handpiece Handpiece Cord
Dots
Handpiece backend
WARNING
Always confirm that the handpiece is correctly seated and locked into place.
CAUTION
Do not use a Handpiece other than that supplied with this device.
6. Mounting and Removing Tip
Turn TIP lightly by hand, and install it. Tip will insert from the bottom hole of Tip Wrench. Align the four corner of the Tip base area into the four corner of Tip
Wrench. And turn it clockwise until it clicks.
Do not touch the top part of TIP to avoid an injury.
To remove the Tip, turn it counterclockwise with the Tip Wrench.
Tip Wrench
Loosen
Fig. 7
Tighten
Tighten
Loosen
Fig. 8
9
CAUTION
for Tip Usage
• Check the Tip before use. (Flush, Damage, Bending or Rust)
• Do not exceed Maximum Power Level for Tip. Damage to tooth structure and Tip may result.
• Do not hit metal or prosthetic crown etc. except when removing them. Tip could break and
fall into mouth.
• Do not hit gingival, mucosa and/or skin directly. It could cause damage and/or burn injury.
• During its operation, the whole tip vibrates due to ultrasonic waves. 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.
• The “dry tip* ” (a tip which does not require coolant water) utilizes heating to some extent for effective treatment. During or after its operation, the whole of such tip could be overheating. Do not bring any part of the tip into contact with soft tissue, gums or skin. Ensure that the power setting of the Control Unit does not exceed the maximum power written on the Tip Case label. Adjust the power from the lowest level. During use of the tip, ensure that burn injury does not occur in or around the treatment area. Also ensure that the tip does not affect
the treatment area and oral cavity.
* E5, E6, E7, E8, G21, G22, G28
• Do not sharpen and/or bend the Tip. Tip may damage and not generate enough vibration
during scaling.
• During cutting, Tip will gradually wear away, as the Tip wears the stroke will get smaller and decrease cutting efficiency. When level drops too far, change the Tip. (Tip Card check)
• DO ENSURE when securing Tip to use the Tip Wrench as supplied, inefficient cutting will
result.
• DO ENSURE before attaching Tip, Cleanliness of the tip screw, inefficient cutting will result.
• To avoid personal injury ENSURE Tip is removed prior to disconnecting the handpiece from
the handpiece cord.
• If you feel the Tip is not vibrating, remove it from an operative site, and press the Foot Control again. If this does not improve the condition, Ensure the Tip is secure, turn the power off and
restart it.
• When mounting the Tip, always use groves and Tip Wrench as supplied.
• Turn water off when using Tip that does not require water.
• Tip Wrench is consumable For reliable operation replace annually.
10
7. Operating Procedures
7-1 Power On (Fig. 9)
Connect the AC Cord to the wall outlet. Rotate the Power/ Volume Knob on the Control Unit. (Power indicator will
)
light.
O F F
Power
Indicator
7-2 Power Level Setting
DO ENSURE Power setting does not exceed the recommended Power Level (Tip-Power Guide or Tip case label (Fig.10) included in the package.) Set the power level with the Power/Volume Knob on the Front Panel. Make sure the power level is set in the appropriate range for the attached Tip.
O N
English
Fig. 9
Power Level for each mode
NOTICE
Model
Maximum Power
Fig. 10
• Rotate the Power/Volume Knob to increase or decrease the Power Level.
• If the Power Level is set to 0 (zero), Tip will not oscillate but water comes out from the
handpiece.
11
11
7-3 Operate Varios 370 / 370 Lux
Tip vibration will begin when the Foot Control is depressed. Also, Output Indicator will light. (For Varios2 Lux, Handpiece LED will illuminate.
7-3-1 Water Supply Volume Adjustment
Turn the Water Adjustment Knob clockwise
gradually to increase the supply volume. (Fig. 11
During the Handpiece operation :
Possible: Power Level and Water Volume adjustment.
)
DecreaseIncrease
)
7-4 After the Treatment
Release the Foot Control and Power off the Control Unit. Close the dental unit's water valve.
How to drain the inside of the Handpiece
1) Shut off the water main valve.
2) With the Tip and Handpiece attached, turn the Power/Volume Knob to its lowest setting and then continue stepping on the Foot Control until water stops coming from the Tip.
3) Remove the Tip and Handpiece.
Fig. 11
NOTICE
• LED of the handpiece will remain ‘On’ for approx 5 seconds after Foot Control is released. (
Varios2 Lux
)
7-5 Protection Circuit
The Varios 370 has an internal Protection Circuit to prevent overheating. If the internal temperature of the Varios 370 becomes hot, such as when the device is used for more than 10 minutes with the power level set higher than G7, the output of the device will be reduced automatically to G7. The device will continue to operate at this reduced level until the internal temperature has reduced to below the protection circuit threshold. During this period, the maximum output setting that can be used is G8 and to increase output from G7 to G8, output must first be reduced to G5 or lower, then increased to the maximum of G8. Maximum output can be restored by turning the device off for 15 minutes or longer.
NOTICE
• During Protection Circuit function, the Control Unit can not increase the Power Level more
than 8.
12
8. Provided Scaler Tips
G4
The end of the Tip is thin and for supragingival fine scaling and interdental scaling. The round cross-section allows tooth surfaces to be finished without causing damage.
English
Apply the top of the Tip on the tooth plane and move it sideways finely in the same way as G8 Tip. (Fig. 12
G6
Insert the top of the Tip into the periodontal pocket and move it slowly. The top of the Tip is sharp so that it could remove tartar
on long coroner and retracted gingival. (Fig. 13 Clean periodontal pocket at low power. (Set the level less than
“Power 5” at P mode.
)
G8
)
Removal of supra and subgingival calculus. It provides easy access to interdental
spaces and narrow pockets.
)
Removal of supragingival and interdental calculus. This Tip can be used in all
quadrants and is very useful for the removal of hard calculus.
Fig. 12
Fig. 13
Apply the top of the Tip on the tooth plane and move it sideways
finely along the neck of tooth. (Fig. 14
)
• Tip is article of consumption. We recommend periodical replacement. About time of
CAUTION
replacement, check the Tip Card.
• Additional Tips and accessories are available for order in the catalog.
13
Fig. 14
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