8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Cavitron RF Combination System Ultrasonic Scaler and Air Polishing Prophylaxis System Directions for Use -Draft FormRev-1 04/26/05 Rev-2 06/27/05 Rev-3 06/29/05 Rev-4 07/14/05 Rev-5 07/18/05 Rev-6 07/22/05 Rev-7 07/25/05 Rev-8 08/01/05 Page 1 of 18
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Introduction Welcome to the world of ultrasonic scaling and air polishing as experienced with a Cavitron® combination ultrasonic scaling and air polishing prophylaxis system, the original brand of ultrasonic scaling and air polishing systems. Your decision to add the Cavitron® JET RF™ system from DENTSPLY Professional to your practice represents a wise investment in good dentistry.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Technical Support There are no user serviceable parts in this device except for filter maintenance. Refer to Section 9.0 System Care for Maintenance Instruction. Refer all service to a qualified service repair facility. For technical support and repair assistance in the U.S., call the DENTSPLY Professional Cavitron CareSM Factory Certified Service at 1-800-989-8826, Monday through Friday, 8:00 A.M. to 5:00 P.M. (Eastern Time).
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT • It is the responsibility of the Dental Healthcare Professionals (DHCP) to determine the appropriate uses of this product and to understand the health of each patient, the dental procedures being undertaken, and industry and governmental agency recommendations, requirements, and regulations for safe practice of dentistry.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 3.3 Precautions for Air Polishing Procedures • Only set the air polishing powder flow control to the maximum position (H) when it is necessary to remove particularly difficult stains. Return the powder flow control to the medium position upon the completion of the procedure. • Avoid use on restorative dental materials. • Avoid prolonged use on cementum or dentin. • Avoid prolonged use on polished metal surfaces as a matte finish may result.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 5.2 Water Line Requirements • A water supply line with user-replaceable filter is supplied with your system. See Section 9.0 System Care for replacement instructions. • Incoming water supply line pressure to the system must be 20 psi (172kPa minimum) to 40 psi (275kPa maximum). If your dental water system’s supply line pressure is above 40 psi, install a water pressure regulator on the water supply line to your Cavitron® RF™ Combination System.
8/17/2005 • • CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT The Cavitron® RF™ Combination System is designed for a level surface. Be sure unit is stable and resting on four feet. Placing unit in direct sunlight may discolor plastic housing. 5.7 Power Cord/Power Connection (Picture) • Verify the main Power Control ON/OFF switch, located at the center front underside of the system, is set to the OFF position before proceeding.
/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 3. 4. 5. 6. 7. 8. 9. Maintain a distance of no more that 10 feet between the system base and footswitch during the synchronization process. Turn the main Power Control switch to the ON position and wait for the Information Center graphics (refer to Section 6.2) to light. While all graphics are lit, press the Purge button, also located on the Information Center.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Power – (Display) Lights when the Power ON/OFF Control Switch is ON. Low Battery – (Display) Lights when the footswitch battery power is approaching end of life. Replace batteries as instructed in Section 5.8. Service – (Display) Lights when the system is not functioning properly. This display has two distinct modes. A blinking light indicates an incorrect set-up in the system, such as a missing handpiece.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Insert Tip Shape and size of tip determines access and adaptation. Insert Marking Manufacturer, Date (YYMM), Frequency, Insert Type (E.g. DENTSPLY 0508 30K FSI-SLI-10S) • • Hold the handpiece in an upright position. Activate the Foot Control to bleed any air bubbles that might be trapped inside the handpiece. Lubricate the O-ring on the insert with water before placing it into the handpiece. Fully seat insert with a gentle push-twist motion.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 7. 8. 9. 10. Cavitron® DualSelectTM Dispensing system Cavitron® JET Air Polishing Insert Cavitron® JET Nozzle Cleaning Tool JetShield® Aerosol Reduction Device 7.2 User Replaceable Part Kits 1. Powder Bowl Cap O-ring, Part Number 628052001 2. Powder Bowl Cap, Part Number 81728 3. Cavitron Insert Replacement O-ring 12/Pack, Part Number 62351 4. Handpiece Cable O-ring , Part Number 79357 5. Jet-Mate Handpiece Nozzle Grip, 81717 6.
8/17/2005 • • CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Applying excessive pressure. Use a very light grasp and pressure, with a soft tissue fulcrum whenever possible, especially on exposed cementum. If sensitivity persists, decrease power setting and/or move from the sensitive tooth to another and then return. 8.4 Air Polishing Powder bowl • • • Use only Cavitron® Prophy Powder in your Cavitron® RF™ Combination System.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 5. 6. Place ejector tube clip around ejector tube and handpiece cable such that the cables drape together for patient and clinician comfort. (Optional)Place handpiece clip such that the clip is holding the JetShield ™ evacuation tube in place along handpiece as shown in applicable Figure 3. After completion of each procedure,remove JetShield ™ cup assembly and dispose of according to applicable regulations.
8/17/2005 • • CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Do not aim directly at the soft tissue. Avoid prolonged use on polished metal surfaces as a matte finish may result. 8.8 Proper Angulation of the Air Polishing Insert without JetShield™ • Recommended angulation on the anterior teeth is 60o with the tip aimed at the middle third of the tooth surface. • Recommended angulation to occlusal surfaces is 90o.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 6. 7. 8. 9. Inspect the handpiece cable for any breaks or tears. If using a closed water supply or DualSelect Dispensing System, check for adequate fluid volumes for next procedure. Check the powder bowl for sufficient powder for the next procedure.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT 4. 5. Install the replacement filter onto the water hose fittings. The filter should be positioned to match up with the correct hose fitting. Hand tighten the two hose fittings in a clockwise direction. Reconnect the water supply line, turn the system ON and operate lavage flow to bleed the air and test for leaks. 9.4 Air Supply Line Air Filter Maintenance Water build up in the air supply line filter should be drained.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Symptom – System operates: (No insert cavitation) 1. 2. 3. 4. 5. 6. 7. 8. Check that the Ultrasonic Power Control knob is not in rinse mode. Check that the Low Battery light is not lit. Turn the system’s main power switch OFF. Wait 5 seconds and turn the system back ON. If problem still exists, replace both “AA” batteries in footswitch with new “AA” batteries. Refer to Section 5.8.
8/17/2005 CavitronRF Combo - DFU Draft 08-01-05 Rev8doc DRAFT Section 12: Specifications (Include required symbols) Electrical Voltage Current Frequency Water Pressure Air Pressure Flow Rate Weight Dimensions Footswitch Operating Environment Continuous (100-240 VAC) 1.0 Amperers, Maximum 50/60 Hertz 20-40 psig 65-100 psig Minimum Setting (CCW) < 15 ml/min Maximum Setting (CW) > 55 ml/min 4.4 lbs (2 Kg) Height 6 in (15,24 cm) Width 9.5 in (24,13 cm) Depth 8 in (20,32 cm) Handpiece Cable length: 6.5 ft.
