Cordless Endodontic Handpiece. Manual Revision Date: July 2005 OPERATION MANUAL

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Luke Walton
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1 LightSpeed EndoPAL TM Powerful and Long-Lasting Cordless Endodontic Handpiece Manual Revision Date: July 2005 OPERATION MANUAL Thank you for choosing the EndoPAL (Powerful And Long-lasting) cordless batterypowered handpiece. The EndoPAL provides mechanical assistance to complete root canal therapy quicker and with less fatigue. It is designed to work in conjunction with rotary nickel-titanium root canal instruments. Be certain that the specifications of the EndoPAL (Instructions for Use, Page 3) are compatible with the instrument manufacturer's requirements before using. Read all safety instructions carefully and understand them before attempting to operate this device. Keep this manual for future reference. Be sure to also read instructions for charging unit before attempting to charge the handpiece. Caution: Federal law restricts this device to sale by or on the order of a dentist. This device is powered by a rechargeable, recyclable Lithium-Ion battery pack.

2 2 Important Safety Descriptions Safety instructions are classified as follows in accordance with the seriousness of this risk. Class Danger Warning Caution Degree of Risk Existence of a hazard that could result in death or serious injury, if the safety instructions are not followed. Existence of a hazard that could result in bodily injury or damage of the device, if the safety instructions are not followed. Possibility of a hazard that could result in light or medium degree of bodily injury or damage of device, if the safety instructions are not followed. Danger Never disassemble or alter the handpiece or charging unit. Never use this handpiece or charger in an area with combustible liquids or gases. Never plug anything, other than the supplied charger, into the charging port on the rear of the handpiece. Doing so will void the warranty. Warning Do not attempt to replace batteries. Opening this device will void warranty. Return to service center for all repairs and service. Never allow water or other liquids to spill or seep into the handpiece as it could cause damage to the handpiece and void warranty. Do not use handpiece if any liquid leaks from inside the handpiece and report leak immediately to service center. Immediately wash clothes or part of the body in water if you come in contact with battery fluid. Caution This cordless handpiece is only to be used by licensed dental practitioners or hygienists for rotary root canal treatments or polishing. Charging should be done in a dry place at 0 to 40 C (32 to 104 F) ambient temperature. Battery life may be shortened when left uncharged for an extended period of time. Never use a bent, damaged, deformed or non-iso conforming instrument in this handpiece. Do not use or leave this device in a high heat environment such as direct sun, near fire or heater. Do not drop or impact these devices. Warming of the handpiece casing is not normal. and contact us immediately. If you feel it become warm, stop using the device Looseness, vibrations or rattling noises are not normal. If you feel or hear such, stop using the device and contact us immediately. Never attempt to sterilize the handpiece body itself. Only the heads may be sterilized. Handpiece body may be cleaned only with alcohol.

3 General Instructions for Use 3 On/off Switch Head Main Body Charging Port Figure 1. Handpiece Instructions Turn handpiece on by sliding on/off switch forward; turn handpiece off by sliding on/off switch back. The handpiece has only one setting and when using a 1:1 head the speed is ~2600 RPM at ~5.0 oz-in (360 g-cm) torque. Check with your instrument manufacturer for their recommended speed and torque settings before using this handpiece. It is good to charge the handpiece before the first use. A fully charged battery should be capable of 6-8 hours of continuous operation before additional charging is necessary. When using the handpiece, cover handpiece body with a FDA cleared barrier sheath. Wipe down handpiece body with alcohol taking care not to soak or damage labels. Warnings DO NOT attempt to open handpiece body for any reason at any time. Return to service center if service is required. DO NOT autoclave the handpiece body. DO NOT ultrasonic the handpiece body.

specifically for the LightSpeed EndoPAL handpiece. Failure to do so will void the warranty. Please follow the contra angle maintenance and sterilization instructions between each patient use.

4 4 Contra Angle Head Maintenance and Installation Latch Push Button Figure 2. Latch Head Collar Collar Figure 3. Push Button Latch Head Head Maintenance Only use the contra angle head provided with the cordless handpiece or one that is sold by LightSpeed Technology Inc. specifically for the LightSpeed EndoPAL handpiece. Failure to do so will void the warranty. Please follow the contra angle maintenance and sterilization instructions between each patient use. Steam autoclaving is the only acceptable sterilizing method. Remove from handpiece and autoclave between patient uses. Sterilize between 121 C and 132 C for 15 to 20 minutes at 15-PSI minimum pressure. Follow manufactures directions of the unit you are using for autoclaving. Never autoclave with an instrument in head. Allow head to cool to room temperature before use. You may use rubbing alcohol to wipe off the head but this is not a sufficient sterilization process. Lubricate the head with handpiece oil between each use and prior to autoclaving. Clean off any excess oil that could seep into handpiece body, damage its components or get into the patient s mouth. Attaching and Removing Heads Turn collar portion only: clockwise to tighten, counterclockwise to loosen. Use caution not to strip threads or attempt to turn any portion of the head other than the contra angle collar. Open the latch before removing or attaching the head as the latch gets in the way of turning the collar. Ensure head is properly connected before attempting to use handpiece.

handpiece body. Plug charging unit into AC outlet according to Fig 6a or 6b.

The charger may take slightly longer to charge the handpiece due to the actual room temperature and other charging

You may leave the handpiece connected to the charger for longer than the specified time, such as leaving it charging

Battery Charging Unit Figure 6a. Model 1: 120 Volt 60 Hz., with USA type plug Figure 6b.

5 Charging and Batteries 5 Figure 4. Charging Position Place handpiece in cradle on its side as shown in Figure 4 then insert charger plug into back of handpiece body. Plug charging unit into AC outlet according to Fig 6a or 6b. Normal charging cycle is minutes (1-2 hours). The charger may take slightly longer to charge the handpiece due to the actual room temperature and other charging variables. You may leave the handpiece connected to the charger for longer than the specified time, such as leaving it charging over the weekend. You may also use the cradle as a stand as shown in Figure 5. Figure 5. Storage Position Figure 6. Battery Charging Unit Figure 6a. Model 1: 120 Volt 60 Hz., with USA type plug Figure 6b. Model 2: 230 Volt 50 Hz, with Euro type plug The battery charger has a lighted charge indicator as shown in Figure 6. A red light indicates that your battery is being charged. A green light indicates charging is complete, is not needed, or that the charger is not connected to handpiece. DO NOT attempt to replace the batteries yourself. Return the handpiece to LightSpeed Technology, Inc. to replace the battery pack. Please call for pricing and a Return Authorization number.

6 6 Troubleshooting If trouble is found, please refer to the following chart before consulting your dealer. If none of the following scenarios are applicable or the solution does not remedy the problem, a more serious problem is suspected. Contact your dealer. Problem Likely Causes Solution Battery has fully discharged. Recharge the battery. Abnormal battery. (Are the batteries hot?) Cool the handpiece for a while and turn it on. If handpiece keeps overheating, call for a return authorization number (RA#). Handpiece will not turn on. The contra angle (CA) is not making connection with the handpiece gears Remove the CA, turn on handpiece and visually check to see if the gears are turning. If not, call for RA#. Handpiece turns on but will not rotate the contra angle. The CA is jammed and not allowing the motor to spin. Handpiece or CA has been damaged or drive shaft has loose gear connections. Remove the CA, autoclave and oil, reinsert CA and check for rotation. If still jammed, try to spin the CA gears by hand and check for rotation. If still jammed, call for RA#. Turn handpiece on without CA and look inside front of handpiece to confirm gear is moving. If gear is moving, reinsert contra angle and try again. If this still doesn t work or if gear is not moving call for RA#. The handpiece torque is noticeably weaker. The battery has become weak. Recharge the battery. The speed of the handpiece is low. The battery has become weak. Recharge the battery. The battery charger light does not turn on. The battery charger is not plugged into the wall chord or the wall chord is not plugged into the charger. Plug the battery charger or wall chord in. Handpiece unit has come apart. Joint connections have failed. Call for RA#. Contra angle won t fit onto handpiece. Handpiece or contra angle has been damaged. Call for RA#.

7 Electrical Characteristics and Specifications 7 Battery Charger Input rating nominal VAC/47-63Hz Switch frequency khz Leakage current from battery Operating temperature ºc - +40ºC Ripple < 100 mv p-p Insulation class class II Insulation voltage vac (primary) / 5640VDC (secondary) Electrical safety approvals ul , EN 60950, EN , EN EMC standards en (Medical), EN (Emission), EN (Immunity) Reliability (MIL-GDBK-217F) MTBF > 250,000 hours at 30ºC and full load Input connection pin IEC 320 Output connection mm x 5.5mm x 9mm barrel plug, center positive Dimensions/weight x 1.77 x 1.26 (90 x 45 x 32mm) /.25 lbs. (115g) Battery Pack Cell Type Rechargeable Lithium-Ion Cylindrical Cell Cell Dimensions Diameter 18mm Height 50mm Nominal Voltage V (4.2V max) Rated Capacity mAh nominal Charging Time A Cycle Life % after 300 cycles Weight g

8 8 Warranty and Repairs One-year parts and labor warranty for handpiece body and internal components (excluding the battery), heads and charging unit. Warranty is void if units are opened for any reason. Warranty may be void if handpiece is used without protective moisture barrier or dropped. Before units are returned for repair or service a return authorization number must be obtained. Shipping to our repair facility must be prepaid if unit is out of warranty period. Only use the contra angle provided with the cordless handpiece or one that is sold by LightSpeed Technology Inc. specifically for the LightSpeed EndoPAL handpiece. Failure to do so will void the warranty. Instructions, warranty and repairs are subject to change without notice. Notice: Always contact us BEFORE returning your handpiece for service or repair. Phone: Fax: Website: info@lightspeedusa.com Address: 403 E. Ramsey, Suite 205 San Antonio, TX 78216

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