DentalEZ StarDental 430 SWL Flex Instruction Manual

StarDental® Instruments
430 SWL® Flex
430 SWL® Torque Flex
High-Speed Handpiece
Instruction Manual
Includes Lubricated and LubeFree
Caution: Federal law restricts this device to
sale by or on the order of a dentist.
Non-Sterile
Medical Device
0344
EC REP
StarDental® Emergo Europe
1816 Colonial Village Lane 1816 Colonial Village Lane
Prinsessegracht 20 Prinsessegracht 20 Prinsessegracht 20
Lancaster, PA 17601 U.S.A. Lancaster, PA 17601 U.S.A.
2514 AP The Hague 2514 AP The Hague 2514 AP The Hague
Printed in the U.S.A.
The Netherlands The Netherlands The Netherlands
©2019 DentalEZ, Inc.
866.DTE.INFO (383.4636)
www.DentalEZ.com
064363 L Date of Issue 2019-03-31 Date of Issue 2019-03-31
DO NOT USE FOR ORAL SURGERY
BEFORE OPERATING THE HANDPIECE, CAREFULLY READ AND FOLLOW ALL OF THESE INSTRUCTIONS.
SAVE THESE INSTRUCTIONS FOR FUTURE REFERENCE AND OBSERVE ALL WARNINGS AND CAUTIONS.
Indications For Use
The 430 SWL ®
Flex High Speed Dental Handpieces are pneumatically driven, hand-held devices intended for use
by trained dental professionals for drilling in the oral cavity. Procedures include, but are not limited to, caries
removal, restorative work and crown preparations.
Any serious incident occurring from the use of this device should be reported to StarDental immediately.
NOTICE
If incident occurred in a EU Member State the Competent Authority must be notifi ed.
Contents
• Specifi cations • Safety Instructions • Cleaning & Ster i l i za t ion
• Handpiece Installation • Lubrication - For Lubricated • Troubleshooting
Handpieces ONLY
• Handpiece Op e r a t ion • Turbine Replacement
Specifi cations
®
430 SWL Flex High-Speed Handpiece is designed to fi t a 6-pin Flex
standard ISO Type C (6-pin Tubing) fi ber optic tubing.
430 SWL Flex Type: High speed fi ber optic with a Flex Swivel and replaceable autochuck turbine.
(Swivel sold sep a rate ly.)
Operating Air Pressure: 40 to 42 psi
Air Consumption: 1.9 SCFM @ 40 psi
No Load Speed: 385,000 rpm Flex
340,000 rpm Torque Flex
Connection: 360° 6-pin Flex Swivel with ISO Type C (6 pin Tubing)
confi guration and fi ber optics.
Power: 26 watts @ 42 PSI Flex
135°C
31 watts @ 42 PSI Torque Flex
Weight: 60g
*
Multifl ex Lux ® is a registered trademark of Kavo corporation.
Handpiece Installation
Note: Filter air and water supplies, recommended fi ltration: 25 microns. Soften and deionize water. Be sure fi lters
operate effi ciently.
Air and Water Adjustment
1. Air Pressure –
NOTICE To prevent premature damage to the turbine, do not exceed recommended pressure (see Specifi cations)
when using a Flex Swivel.
Using an air pressure gauge, StarDental
If more torque is desired, increase air pressure to a maximum of 42 psi.
If a gauge is not available, set pressure at delivery head allowing 1 psi pressure loss for every foot of tubing. (See
Specifi cations for recommended operational pressure.)
For example, if you want to operate at 40 psi and you are using either 5 feet or 12 feet of tubing, then the pressure
should be set at the delivery head to compensate for the air pressure losses.
2. Water Pressure –
Adjust water volume and coolant air pressure at the delivery head to obtain a satisfactory spray mist.
3 Chip Air Pressure–
Adjust to 40 PSI to obtain a satisfactory spray mist.
Handpiece Operation
Use standard length concentric diamond and carbide burs with .0628" nominal
diameter friction grip shanks designed for high speed handpieces. Every
StarDental Diamond Bur meets the specifi cations at right for recommended
lengths. Contact your dealer for a complete list of StarDental Diamond Burs.
StarDental autochuck turbines have the following bur requirements:
Use only burs with hardened, tempered steel shanks or carbide shanks. Every
StarDental Diamond Bur maintains required hardness. Before use, verify
concentric rotation by operating handpiece outside the oral cavity in a safe place.
Note: Do not use burs that produce excessive noise or do not run concentrically. Do not use burs that are
eccentrically designed, or are bent or
Autochuck Bur Changing System
1. Insert bur into autochuck until resistance is felt.
2. Depress autochuck end cap button and continue to feed-in bur until it clicks and stops.
3. Release end cap button.
This will help set the chucking mechanism for initial start up.
on bur after it has been installed to confi rm that it is secured).
1. To remove,
and push until a slight 'click' is noticed.
2. Pull bur straight out.
3. Release end cap.
Never depress the autochuck end cap button or rest the end cap against any part of the oral anatomy
CAUTION
during handpiece operation. Depressing the end cap while a bur is rotating can activate the chuck mechanism and
result in end cap heat-up and/or loss of bur retention.
• R eplacement P art N umbers
SAFETY
• Warranty
INSTRUCTIONS
To minimize risk of serious injury:
• A lways insert bur the full length of the chuck. If you attempt to extend it from the chuck, the bur may dislodge during
*
®
Multifl ex Lux swivel. The swivel connects to
use and possibly injure you or your patient.
To minimize risk of injury or damage to handpiece or auto chuck:
• Replace turbine when handpiece does not run at full speed or runs noisily.
• U se only recommended burs. An improperly clamped or bent bur, usually indicated by sudden high-pitched sound
or increased vibration during use, may dislodge injuring you or your patient.
• Follow these safety instructions:
- Confi rm bur is secure by tugging on it after it is loaded
- Verify concentric rotation by operating handpiece outside oral cavity. Do not use if it does not run concentrically
or runs with excessive noise.
Sterilizable up to 135°C
- Do not operate handpiece without an installed bur.
- Always use burs with overall length of less than 24mm. Shank length must be at least 7.3 mm. This includes most
short shank burs. (see Handpiece Operation)
- When using autochuck, never depress end cap while bur is rotating.
6-pin Flex Swivel
Tubing
Coupler
430 SWL Flex
Handpiece
Tubing
Snap 430 SWL ® Flex handpiece onto 6-pin Flex Swivel.
®
Part #262591 for 4/6-Line, set pressure to 40-42 psi.
5 feet tubing 40 psi + 5 psi = 45 psi
12 feet tubing 40 psi + 12 psi = 52 psi
Autochuck Bur Changing System
Shank Length
'soft' (non-heat treated) shanks.
Now, apply light inward force to the dental bur.
(Always tug
grasp handpiece fi rmly so your thumb touches the end cap
WARNING
CAUTION
Lubrication
- For Lubricated Handpieces ONLY
For maximum turbine life do not exceed recommended pressure.
Note: Lubricate handpiece daily with Handpiece Lubricant, StarDental Part #264183, and prior to
each sterilization procedure.
1. Disconnect handpiece.
2. Shake lubricant can well before using.
3. Thread 430 SWL Flex Lubricated Lubricant Tip onto can nozzle.
4. Press handpiece onto 430 SWL Flex Lubricated Lubricant Tip until handpiece stops.
5. Place rag around handpiece.
6. Holding fi rmly, press spray button on can for one second.
7. Remove handpiece from 430 SWL Flex Lubricated Lubricant Tip.
Note: Never operate handpiece without bur in place.
8. With bur in place connect handpiece to tubing, operate for 20 seconds to expel excess lubricant.
9. Wipe off excess lubricant from handpiece.
LubeFree Handpieces Contain A LubeFree Ceramic Bearing Turbine -
NOTICE
This turbine uses a sophisticated ceramic bearing design and, therefore, requires no lubrication. To ensure the life
of, and to prevent damage to, this turbine - do not lubricate it. If it gets lubricated even once, it MUST then continue
to be lubricated for the rest of its life.
Cleaning & Sterilization
It is the responsibility of the user to use only FDA compliant sterilizing equipment and
CAUTION
accessories that are capable of meeting the manufacturers recommendations below.
Do not exceed 135°C
CAUTION
To prevent damage to the bur, use an autoclavable bur block.
Do not use:
Limits On Reprocessing Repeated processing has minimal effect on this handpiece. End of life is normally
determined by wear and damage due to use.
INSTRUCTIONS
Clean and sterilize handpieces and burs as soon as practical before fi rst use and after each patient.
WARNING
Containment and It is recommended that handpieces are reprocessed as soon as is reasonably practical
Maximum
transportation: following use.
24.0 mm
OVERALL LENGTH
Preparation for cleaning: Remove handpiece from swivel. No further disassembly is required.
Cleaning - Automated: Washer-disinfectors are not recommended.
Minimum
Cleaning - Manual: Cleaning Handpieces:
7.3 mm
modifi ed,
Cleaning Diamond Burs:
•
•
•
Lubrication: Lubricate - For Lubricated Handpieces ONLY - See 'Lubrication' instruction section
Disinfection: Use steam sterilization exclusively for complete sterility as outlined below.
Maintenance: Use Junk-Out High Speed Chuck Cleaner Kit (263790) once a week prior to sterilization
to ensure optimum working condition of the chuck. Instructions for cleaning the chuck are
included in the Junk-Out kit.
See Turbine Replacement section of this manual for additional information.
Handpiece should be routinely maintained, checked for corrosion, worn parts, etc. and
should be replaced on an as needed basis.
Inspection & function testing: See Handpiece Operation or Troubleshooting sections of this manual.
Packaging: Single: A standard sterilization packaging material must be used. Ensure that the pack is
large enough to contain the handpiece without stressing the seals.
In sets: Handpieces may be loaded into dedicated instrument trays or general purpose
sterilization trays. Ensure that cutting edges are protected and do not exceed the tray
manufacturer's limit per tray. Wrap the trays using appropriate packaging materials and methods.
Wrapped Instrument Gravity Type Autoclave:
Sterilization:
Pre-Vacuum Autoclave:
Do not exceed 135° C
Drying: Dry the handpiece for 30 minutes minimum using the sterilization dry cycle and allow the
handpiece to cool to room temperature in bag prior to use. If moisture is present, increase
your sterilizer dry cycle appropriately.
Storage: Store in bag after sterilization until ready to use.
Additional information: Do not exceed the sterilizer manufacturer's guidelines for load capacity.
Manufacturer contact: See front or back panels of this manual.
264147
• dry heat sterilizer • cold sterilizers • ultrasonic cleaners
• chemical disinfectors • immersion techniques • surgical milk
• surface wipes • hand soaps • detergents
• sterilizer bags •surface sprays
containing disinfectants
Remove debris from external surfaces using a
Optical Surface
small brush and isopropyl alcohol. Clean
(1 of 2)
internal surfaces of the handpiece at the swivel
connection location using a small brush and
isopropyl alcohol. Optical surfaces can be
cleaned with a cotton swab soaked in isopropyl
alcohol. Dry thoroughly. Repeat after each
Internal Surface
patient.
After each use, clean the diamond bur by running it against a wet diamond cleaning stone.
To mechanically clean, the diamond bur should be held in a solution of either enzymatic
presoak, Sparkl® Dental Instrument Cleaner StarDental Part# 205472, or water.
Rinse the bur thoroughly and allow it to dry, then Sterilize – See Sterilization.
• Minimum of 15 minutes at 132°C.
• Minimum of 30 minutes at 121° C
• Minimum of 4 minutes at 132° C