Dentsply Professional Division 7334761248 MIDWEST RDH Freedom Cordless Prophy System Foot Pedal User Manual 90714 Rev 2 07 11 with Translations indd
Dentsply Professional Division MIDWEST RDH Freedom Cordless Prophy System Foot Pedal 90714 Rev 2 07 11 with Translations indd
final manual
Cordless Prophy System DIRECTIONS FOR USE Mode d’emploi Instrucciones de uso Gebrauchsanweisung Istruzioni per l’uso Указания по применению Please read carefully and completely before operating unit. Prière de lire attentivement et complètement avant la première utilisation de l’appareil. Por favor lea cuidadosamente y en su totalidad antes de operar la unidad. Bitte vor Inbetriebnahme der Einheit sorgfältig und vollständig durchlesen. Si prega di leggere attentamente e completamente prima di utilizzare l’apparecchio. Пожалуйста, внимательно и полностью прочтите перед использованием устройства. ENGLISH • 1 TABLE OF CONTENTS OVERVIEW . . . . . . . . . . . . . 1. INDICATIONS FOR USE . 2. CONTRAINDICATIONS . 3. WARNINGS . . . . . . . . . . . . . . . .3 . . . . . . .3 . . . . . . .3 . . . . . . .3 4. PRECAUTIONS . . . . . . . . . . . . 5. ADVERSE REACTIONS . . . . . . 6. MIDWEST® RDH FREEDOM™ CORDLESS PROPHY SYSTEM DESCRIPTION . . . . . . . . . . . . 7. UNPACKING THE SYSTEM . . . 8. INFECTION CONTROL PROCEDURES . . . . . . . . . . . 9. SYSTEM SETUP . . . . . . . . . . . 10. CHARGING THE HANDPIECE AND FOOTPEDAL . . . . . . . . . . 11. SYNCHRONIZING THE HANDPIECE AND FOOT PEDAL . . . . . . . . . . . . . . . . . . 12. PREPARATION FOR USE . . . . . 13. OPERATION . . . . . . . . . . . . . . 14. HANDPIECE INDICATOR LIGHTS (WHEN IN USE) . . . . . 15. SPECIFICATIONS . . . . . . . . . . 16. CLASSIFICATIONS . . . . . . . . . 17. SYMBOL IDENTIFICATION. . . . 18. DISPOSAL OF UNIT. . . . . . . . . 19. TROUBLESHOOTING . . . . . . . . 20. ACCESSORIES . . . . . . . . . . . . 21. LIMITED WARRANTY . . . . . . . ENGLISH • 2 . .4 . .4 . .5 . .6 . .6 . .9 . .9 . 10 . 11 . 12 . 12 . 13 . 13 . 14 . 15 . 15 . 17 . 17 Overview The MIDWEST® RDH Freedom™ Cordless Prophy System offers a cordless design that eliminates cord drag and allows clinicians easy access and comfort during prophylaxis procedures. Quieter than traditional hygiene and low speed handpieces, the system offers all-day battery life while delivering the same performance you would expect from a corded handpiece. The system includes an autoclavable outer sheath for infection control. 1. Indications for Use 2. Contraindications The Midwest RDH Freedom is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth. None Known. Safety Conventions in This Document WARNING Use care to prevent personal and / or patient injury PRECAUTION Use care to prevent product damage and ensure safe and effective product use 3. Warnings • Sterilizing the inner module will cause component damage to the handpiece and the sterilizing equipment, and may cause personal bodily injury. • The outer sheath must be steam sterilized before first use and between patients to prevent cross contamination. See Section 8 for the Infection Control Procedures. • The Disposable Prophy Angles are designed for single-patient use only and should never be used more than once. Disposable Prophy Angles are not autoclavable or designed to withstand disinfection solutions. The risk of reuse of a Disposable Prophy Angle are damage to equipment and cross-contamination. Install a new Prophy Angle before each use. • • Failure to follow recommendations for environmental operating conditions (see Section 15 for Specifications) could result in injury to patients or users. • Inspect the handpiece system before each use for worn, loose or damaged parts. Do not attempt to operate unless the Disposable Prophy Angle (DPA) is properly installed. A loose DPA could eject from the handpiece causing bodily injury. Reinstall the DPA or replace any damaged parts as necessary. • Operating the Disposable Prophy Angle at an excessive speed or with excessive force may cause heating of the tooth and temporary discomfort to the patient. • To prevent bodily injury and damage to the device, do not sterilize the disposable prophy angle, inner module, charging base, foot pedal or power supply. Disinfect the inner module, charging base, foot pedal and power supply using only the tested and approved disinfectants listed in Section 8, Infection Control Procedures. • The inner module, foot pedal, charging base and power supply are not waterproof. To prevent damage to the equipment, contamination or bodily injury, do not immerse any of these components in water or a chemical solution. • Use only components and accessories listed in Section 7 of this manual. Failure to do so will void the warranty, may decrease system performance and may lead to unsafe operation. • Never mount a Disposable Prophy Angle to the handpiece body while it is operating. It is the responsibility of the Dental Healthcare Professional to determine the appropriate uses of this product and to understand: • the health of each patient • the dental procedures being undertaken • applicable industry and governmental agency recommendations for infection control in dental healthcare settings • requirements and regulations for safe practice of dentistry • these Directions for Use in their entirety • Per FCC Part 15.21, changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. ENGLISH • 3 • • There are no user-serviceable items in the inner module, power supply, outer sheath, foot pedal or charging base. Opening any of these units may result in unsafe operation and will void the warranty. • Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.) is not more than that necessary for successful communication. • This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: According to IEC 60601-1/UL60601-1, this device must not be used in the presence of a flammable anesthetic gas mixed with air, oxygen, or nitrous oxide. (Note: nitrous oxide by itself is not a flammable anesthetic gas.). 4. Precautions • Before using this product, carefully read and follow all instructions and save them for future reference. Observe all precautions and warnings. • The handpiece system can only be used with NUPRO® Freedom™ Disposable Prophy Angles. • Do not place the system on or next to a radiator or other heat source. Excessive heat may damage the system’s electronics. • As with all dental procedures, use universal precautions (i.e., wear face mask, eyewear, or face shield, gloves and protective gown). • The inner module motor is designed to be lubefree. Lubrication may cause damage to the inner module. • This Class B digital apparatus complies with Canadian ICES-003.” Oil and/or dirt may damage the motor, electronics and battery located inside the handpiece inner module. • To prevent damage, charge the handpiece using only the charging base provided. • The batteries are not user replaceable. When needed, the units should be returned to the listed repair center for replacement. • Inadvertent system shutdown may occur in the presence of strong non-compliant radio frequencygenerating components. • This device complies with part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance (i.e. the manufacturer) could void the user’s authority to operate the equipment. ENGLISH • 4 • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 5. Adverse Reactions There are no known adverse reactions. 6. MIDWEST® RDH Freedom™ Cordless Prophy System Description NUPRO® Freedom™ Disposable Prophy Angle Removable, Autoclavable Outer Sheath Removable, Replaceable Color Ring Inner Module Charging Base (See Section 10) LED Indicator Lights (Charging - See Section 10) (Operation - See Section 14) Handpiece Tray Cradle - Autoclavable Wireless Rechargable Foot Pedal (Charging - See Section 10) (Syncronization - See Section 10) ENGLISH • 5 7. Unpacking the System As you unpack your MIDWEST® RDH Freedom™ Cordless Prophy System, verify that the following components and accessories are included: Basic System: 1- Handpiece Inner Module 1- Handpiece Outer Sheath 1- Charging Base 1- WIreless Foot Pedal 1- Power Supply 1- Double-ended extension cable (not shown) 20- NUPRO Freedom Disposable Prophy Angles (DPAs) 1- Disposa-Shield Trial Pack (25) 1- Handpiece Cradle 1- Handpiece Outer Sheath Color Bands Package (3pk) Premium System: 1- Handpiece Inner Module 3- Handpiece Outer Sheaths 1- Charging Base 1- WIreless Foot Pedal 1- Power Supply 1- Double-ended extension cable (not shown) 20- NUPRO Freedom Disposable Prophy Angles (DPAs) 1- Disposa-Shield Trial Pack (25) 1- Handpiece Cradle 1- Handpiece Outer Sheath Color Bands Package (3pk) 1- Carrying case 8. Infection Control Procedures The objective of the information provided in this section is to reduce the potential for cross contamination when using a MIDWEST® RDH Freedom™ Cordless Prophy System during routine dental care. In the event any regulatory agency disagrees with this information, the agency requirements take precedence. NOTE: Outer sheaths and handpiece cradle must be steam-autoclave sterilized prior to each use. Additional outer sheaths and handpiece cradles are available for purchase. ENGLISH • 6 Instructions for Sterilizing The Outer Sheath And Handpiece Cradle WARNINGS These instructions are for use ONLY on the outer sheath and handpiece cradle. All other parts of the system should be disinfected according to the procedures in the “Disinfection” section. The outer sheath and handpiece cradle for the MIDWEST® RDH Freedom™ Cordless Prophy System are not sterile upon receipt and must be sterilized prior to use in accordance with the following instructions. LIMITATIONS ON REPROCESSING Repeated cleaning and sterilization cycles have minimum effect on these instruments. End of life is normally determined by wear and damage due to use. Do not use chemical disinfectants prior to sterilization or rapid deterioration of the material may occur. Cold liquid disinfection/sterilization, chemical vapor sterilization, and dry heat sterilization methods have not been tested or validated for efficacy and are not recommended for use. Do not immerse the outer sheath or handpiece cradle in an ultrasonic bath. POINT OF USE Remove excess soil with disposable cloth or paper wipe. It is recommended that instruments are reprocessed as soon as is reasonably practical following use. CONTAINMENT AND TRANSPORTATION Protect the outer sheath and handpiece cradle from contact with other dental instruments that may cause damage. PREPARATION FOR DECONTAMINATION Remove the outer sheath from the inner module of the handpiece. Only the outer sheath, color ring of the handpiece, and handpiece cradle may be steam-autoclave sterilized. CLEANING: MANUAL Rinse the instruments with running water to remove any gross debris. DISINFECTION Disinfection of the instruments is not necessary prior to steam - autoclave sterilization. PACKAGING Place each instrument in a separate paper or paper/plastic steam-sterilization pouch. If using a sterilizing cassette, ensure that the sterilizer’s maximum load is not exceeded. STERILIZATION Use a steam autoclave. Place bagged instruments into the steam autoclave, paper side up when using a paper/plastic pouch. Gravity Steam Sterilization Full Cycle:135°C (275°F) for 3.5 minutes Pre-vacuum Steam Sterilization Full Cycle:132°C (270°F) for 3 minutes Alternate Method: Place non-bagged instruments into the steam autoclave and run at the listed cycles. NOTE: Instruments sterilized unbagged should be used immediately. DRYING To dry, use the drying cycle of the autoclave. Set cycle for 20 to 30 minutes. Do not exceed 137°C. ENGLISH • 7 Instructions For Sterilizing The Outer Sheath And Tray Cradle, Cont. MAINTENANCE Visually inspect to ensure that all contamination has been removed. Check for distortion, damage or wear. Discard damaged, worn or corroded instruments. STORAGE To maintain sterility, instruments should remain bagged until ready for use. MANUFACTURER CONTACT In the United States, contact DENTSPLY Professional Customer Service Technical Support at 800-989-8826. For areas outside the United States, contact your local DENTSPLY Division. Instructions For Disinfecting All Other Parts (Charging Base, Inner Module, Foot Pedal and Power Supply) WARNINGS The charging base, inner module, foot pedal, power supply and extension cable (not shown) are not sterilizable by autoclave, but can be disinfected following the procedures listed below. Only use water based non-immersion type disinfectant solutions. Per the Centers for Disease Control and Prevention (CDC), chemical germicide registered with the EPA as a “hospital disinfectant” and labeled for “tuberculocidal” (i.e., mycobactericidal) activity is recommended for disinfecting surfaces that have been soiled with patient material. These intermediate-level disinfectants include phenolics, and chlorine-containing compounds. The following tuberculocidal disinfectants are safe for use on the components listed above: • Phenolics (Dual Water-Based) such as Birex SE Concentrate or Disinfectant Wipes (Manufactured by Biotrol) • Phenolics (Dual Alcohol-Based) such as Cavicide Spray or Wipes (Manufactured by TotalCare) • Quarternaries (Dual or Synergized Plus Alcohol) such as Lysol IC Disinfectant Spray (Manufactured by Sultan Heathcare) • Sodium Hypochlorite such as Clorox Germicidal Spray or Wipes (Manufactured by Harry J. Bosworth Company) • Sodium Bromide & Chlorine (Microstat Tablets) 2 tablets/quart of water LIMITATIONS ON REPROCESSING Repeated cleaning has minimum effect on these instruments. End of life is normally determined by wear and damage due to use. Do not use disinfectant solution on sterilizable outer sheaths. Refer to sterilization procedures for sterilizable outer sheaths. POINT OF USE Remove excess soil with disposable cloth or paper wipe. Discard wipe after use. CONTAINMENT AND TRANSPORTATION Handle with care. CLEANING Generously spray disinfectant solution on a clean cloth. Wipe the outer surfaces of the charging base, inner module, foot pedal, power supply and cords. Discard used cloth. Wipe dry with a clean cloth. DISINFECTION Generously spray disinfectant solution on a clean cloth. Wipe the outer surfaces of the charging base, inner module, foot pedal, and the power supply and its cord. Discard used cloth. Allow disinfectant to air dry. ENGLISH • 8 Instructions For Disinfecting All Other Parts (Charging Base, Inner Module, Foot Pedal and Power Supply), Cont. DRYING When cleaning, wipe surfaces dry with a clean cloth. To achieve disinfection, allow surfaces to air dry. MAINTENANCE Visually inspect to ensure that all contamination has been removed. Visually inspect power supply and cords for damage. STORAGE Ambient temperature range: -20˚C to 50˚C Relative humidity range: 45 - 95% (non-condensing) MANUFACTURER CONTACT In the United States, contact DENTSPLY Professional Customer Service Technical Support at 800-989-8826. For areas outside the United States, contact your local DENTSPLY Division. The instructions provided above have been validated by DENTSPLY as being capable of preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing is actually performed using equipment, materials and personnel in the processing facility to achieve the desired result. This requires validation and routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences. 9. System Setup Power supply connector Both the handpiece and footpedal must be charged prior to first use. Charge the handpiece and foot pedal for at least 90 minutes. (See Section 10, Charging the Handpiece and Foot Pedal). 10. Charging the Handpiece and Foot Pedal When the corresponding indicator light is orange, the handpiece and/or foot pedal must be charged. Handpiece charge indicator 10.2 Plug the power supply into a wall outlet. NOTE: The green power-on indicator on the back of the charging base illuminates when the charging base is successfully connected. Foot-pedal charge indicator Power Indicator 10.1 An extension cable has been supplied that allows you to charge both the inner module and the foot pedal at the same time. Plug the female onto the Power Supply Cable plug and plug the male ends into the charging base and foot pedal. PRECAUTION: Connect to single phase AC power 100240V power only. Otherwise, malfunction will occur. Do not unplug the power supply by pulling on the cord. You can also charge the inner module and the foot pedal individually using the power supply cable alone. ENGLISH • 9 10.3 Place the inner module or handpiece on the charging base, aligning the charging contacts on each. Charging Contacts 10.4 Refer to the figure and table below to determine the charging progress for the inner module. Indicator Lights Degree of Charge Scrolling orange Less than 50% Scrolling green 50-90% Solid green Greater than 95% NOTE: • After one week of non-use, both the handpiece and the foot pedal enter an enhanced battery-saving mode. • Place the handpiece inner module into an energized charging base for 5 seconds to restore normal functions. • Connect the footpedal to the power supply for 5 seconds to restore normal functions. 11. Synchronizing the Handpiece and Foot Pedal NOTE: Follow this procedure when: • the foot pedal or handpiece inner module is replaced for any reason • the handpiece and foot pedal do not seem to be communicating properly 11.1 Place the foot pedal within 10 feet of the charging base. 11.2 Invert the foot pedal and remove the screw and the access door. Indicator lights Access Door Screw NOTE: • The handpiece should be recharged after each full day’s use. • If necessary, the handpiece may be “quick charged” for a single use in 15 minutes. 10.5 The foot pedal should be recharged monthly. A fully discharged foot pedal will need approximately 90 minutes to fully recharge. The foot pedal may be operated while charging. NOTE: • The middle LED light on the inner module denotes the degree of the charge in the foot pedal battery. A solid green light means greater than 30%. A solid orange light means less than 30%. ENGLISH • 10 11.3 Remove the inner module from the outer sheath of the handpiece. 11.4 Place the inner module on the charging base, ensuring that the three indicator lights are scrolling or all are solid green. 11.5 Invert the inner module and place it on the charging base as shown. The LED shown below will blink green if the position is correct for synchronization. LED 12. Preparation for Use 12.1 Position the foot pedal for use, ensuring that the floor is level. 12.2 Ensure that the outer sheath has been sterilized according to the Infection Control Procedures (section 8). 12.3 When it is sufficiently charged, insert the inner module into a Disposa-Shield®, piercing the shield just enough to expose the tip. 11.6 When the indicator lights display a scrolling green and orange pattern, press the red button in the bottom compartment of the foot pedal within 15 seconds. PRECAUTION: The Disposa-Shield protects the inner module from debris and splatter. Do NOT apply the Disposa-Shield to the outer sheath, which must be sterilized before each use. 12.4 Install the inner module into the outer sheath by aligning the swoops on each and snapping in place. Aligned correctly NOTE: • The LED beside the synchronization switch of the foot pedal flashes orange to indicate that the foot pedal is in synchronization mode. 12.5 Attach a NUPRO Freedom Disposable Prophy Angle to the handpiece by aligning the swoops on each and snapping in place. 11.7 If the synchronization was successful, the three indicator lights on the handpiece and the LED in the foot pedal will flash green several times. 11.8 If all three handpiece indicator lights, and the footpedal LED flash orange, the syncing was unsuccessful. Return the inner module to an upright position in the charging base and repeat the procedure. 12.6 Verify that all parts of the handpiece are securely attached before use. Aligned correctly Fully-Assembled Handpiece ENGLISH • 11 13. Operation 13.1 The handpiece powers up when it detects motion, i.e. when the user picks it up. If not in use, it will shut down again after a minute. 13.2 Load the DPA with prophy paste and depress the foot pedal slowly to avoid splatter. The DPA (motor) will only rotate in one direction. 13.3 Adjust pressure on the foot pedal to control the rotation speed of the DPA throughout the procedure. 13.4 Follow standard prophylaxis procedures as you would with any corded prophy device. 13.5 Applying excessive force to the polishing surface may slow or stop the rotation of the DPA and result in ineffective polishing. 13.6 The Handpiece Cradle should be placed on the instrument tray so that the Handpiece may be placed in it to avoid the handpiece possibly rolling and falling off the tray during a prophylaxis procedure. 14. Handpiece Indicator Lights (when in use) The MIDWEST® RDH Freedom™ Cordless Prophy System handpiece has three LEDs. Whenever the handpiece is in normal operational mode (i.e., not being charged or synchronized) the handpiece indicator lights display information about the system according to the table below: Degree of Charge Color Light Functional Description Handpiece charge indicator Orange Handpiece charge less than 50% Green Handpiece charge greater than 50% Foot-pedal charge indicator Orange Temperature indicator light Foot pedal charge less than 30% Green Foot pedal charge greater than 30% Orange Illuminates when the internal temperature of the handpiece is higher than normal. The light will turn off when the temperature returns to normal. Operator should refrain from using the handpiece for several minutes until the indicator light goes out. If the temperature indicator light persists, call tecnical support. Handpiece charge indicator Foot-pedal charge indicator Temperature indicator light ENGLISH • 12 NOTES: • If the handpiece seems to be losing power, recharge as soon as possible. • If the handpiece battery is completely discharged, the three LEDs will blink and the unit will shut down. The handpiece must be put in the charging base before it’s able to operate again. 15. Specifications Power Supply manufacturer: Power Supply model number: Ault (SL Power) MW170KB0502B3 AC Input Continuous (100-240 VAC) AC Input Current Less than 0.7A AC Input Phases Single AC Input Frequency 50-60 Hz DC Output Power 8W DC Output Voltage and Current +5VDC at 0-1.6A Output Regulation +/- 10% Weight Handpiece with metal sheath = 120 g Foot pedal = 200 g Dimensions Handpiece with sheath & disposable angle L = 190 mm, W = 30 mm Foot pedal W = 118 mm H = 40 mm Foot Pedal Protection Class IPX1. Not for operating theatres. Remote Communication Frequency: Power: Channels: 2405-2480 MHz 1mW 16 Operating Environment Ambient temperature: Relative Humidity: 10°C-40°C 45-95% (non-condensing) Transport and Storage Conditions Ambient temperature: Relative Humidity: Atmospheric Pressure: -20°C to 50°C 45-95% (non-condensing) 500-1060 hPa Handpiece Performance Protection Class IPX3. Max Cup Speed Max Torque 3000 rpm 10 mNm 16. Classifications Type of protection against electric shock: Class II Degree of protection against electric shock: Type B Applied Part Mode of operation for handpiece: Intermittent: 5 minutes ON, 25 minutes OFF Mode of operation for foot pedal: Continuous 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 flammable mixtures According to medical device directive: IIA (Rule 9) (ISO/IEC 60601) ENGLISH • 13 17. Symbol Identification The following standard symbols appear on the device label. Class II Equipment Class II Equipment Type B applied part MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL-2601-1/60601-1, CAN/CSA C22.2 NO.601.1 Consult instructions for use Sterilizable up to the temperature specified 135 Do not re-use (For DPAs) Do not re-use Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/ EC of the European Parliament and the Council of the European Union IPX0 Protection Class IPX0 IPX0 Classification of ingress of water for Charger – not protected IPX1 Footswitch not for operating theatres Protection Class IPX1 IPX1 Classification of ingress of water IPX3 Protection Class IPX3 IPX3 Classification of ingress of water for Inner Module - Protected against falling spray. 5 min 25 min Duty Cycle for handpiece: 5 minutes ON 25 minutes OFF Serial Number LOT Batch Code/Lot Number Manufactured by This symbol is a mandatory marking for devices entering the European market to indicate conformity with the essential health and safety requirements set out in European Directives. The symbol may be accompanied by a four-digit identification number of the notified body. The vertical dimensions may not be less than 5 mm high. ENGLISH • 14 18.Disposal of Unit U.S. - Dispose of the system components in accordance with state and local laws. EU - Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC of the European Parliment and the Council of the European Union. 19. Troubleshooting Problem Solution DPA is not revolving 1. Ensure the outer sheath and the DPA are snapped together securely. 2. Ensure that the Inner Module and the Outer Sheath are snapped together securely. 3. Verify the handpiece is powered up and properly charged. If the handpiece lights do not illuminate, place the handpiece in the charging base for a minimum of 5 seconds, and then remove it to use. 4. Verify the foot pedal is not in battery saving mode or discharged. This is done by connecting the power supply to the footpedal. The footpedal will operate while charging. 5. Ensure the DPA is not damaged by removing the DPA and spinning the cup between your fingers. The cup should spin freely. 6. Ensure that the sheath is not damaged by removing the inner module from the sheath, leaving the DPA connected, and spinning the DPA cup between your fingers. The cup should spin freely. If the cup does not spin freely, place 1-2 drops of MIDWEST Lubricant into the sheath nose and try to spin again. If the cup still does not spin freely, call Technical Support. 7. If DPA still does not spin freely, remove the sheath from the inner module and verify the inner module motor spins when the foot pedal is depressed. If the inner module motor does not spin, resynchronize the foot pedal with the inner module as per instructions contained in this manual. 8. Resynchronize the units. See Section 11 Synchronizing the Handpiece and Foot Pedal 9. If the synchronization is not successful and/or the handpiece still does not spin, call Technical Support. Excessive noise or vibration during operation 1. Ensure that the outer sheath is aligned correctly with the inner module. 2. Check the components for gross debris or contamination and adhere to all infection control procedures. 3. Check for damaged, worn or broken components. 4. Call Technical Support if necessary. Foot pedal does not charge 1. Ensure that the power cord is securely attached to the wall outlet and the foot pedal 2. Remove the foot pedal access door and look in the compartment; ensure that the LED in the bottom compartment is illuminated. If not, return the foot pedal to Technical Support for professional battery replacement. ENGLISH • 15 Difficulty removing outer sheath from inner module 1. Check the components for gross debris 2. Hold the handpiece outer sheath securely and twist the inner module 3. Inspect parts for wear 4. Call Technical Support if necessary Charging base does not drain liquids Clear any debris from the hole at the bottom of the charging base. Handpiece does not charge 1. Clean the charge contacts on the handpiece and charging base, using one of the approved cleaning solutions described in section 8. 2. Verify that the power supply is properly connected to the charging base and that the green LED on back lights up. 3. Verify that the handpiece is able to properly sit inside the charging base, and that there are no foreign obstructions. 4. If still not charging, return the handpiece to Technical Support for professional battery replacement. Handpiece does not hold charge 1. Verify that the handpiece properly charges (LEDs scroll when in the charger). 2. Return the handpiece to Technical Support for professional battery replacement. Orange Service Light in handpiece illuminates 1. Handpiece is heating up due to excess ON time or load. Do not use handpiece for several minutes and allow it to cool down. 2. If LED still illuminates even after allowing handpiece to cool down, set aside and call Technical Support. Power supply overheating Immediately unplug the unit and call Technical Support. Power cords are frayed or damaged in any way Do not use. Call Technical Support. NOTE: For current Technical Support contact information, see “Manufacturer contact“ in the infection control procedures (section 8). ENGLISH • 16 20. Accessories MIDWEST RDH FREEDOM Item Description DENTSPLY Part Number Outer Sheath 9070301 Inner Module, Lavender 9070402 Inner Module, Pink 9070404 Charging Base, Lavender 9070502 Charging Base, Pink 9070504 Wireless Foot Pedal 9070601 Power Supply-Domestic 9070701 Power Supply, with Adapter Plugs - International 9070702 Handpiece Cradle 9070801 Carrying Case 9070901 Color Bands, Sheath-Multi Colored Package 9071001 NUPRO FREEDOM DISPOSABLE PROPHY ANGLES Item Description DENTSPLY Part Number NUPRO Freedom DPA, Lavender Soft Cup – Box/100 96570001 NUPRO Freedom DPA, Lavender Firm Cup – Box/100 96570101 NUPRO Freedom DPA, Lavender Brush Cup – Box/100 96570201 NUPRO Freedom DPA, Pink Soft Cup – Box/100 96570601 NUPRO Freedom DPA, Pink Firm Cup – Box/100 96570701 NUPRO FREEDOM PROPHY PACKS (only available with lavender soft cup DPA) Item Description DENTSPLY Part Number NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste Mint Flavor, Medium Grit • NUPRO Freedom DPA with Soft Cup 96571001 NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste Mint Flavor, Coarse Grit • NUPRO Freedom DPA with Soft Cup 96571101 NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste Razzberry Flavor, Medium Grit • NUPRO Freedom DPA with Soft Cup 96571201 NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste Razzberry Flavor, Coarse Grit • NUPRO Freedom DPA with Soft Cup 96571301 96571401 NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste BubbleExtreme Flavor, Medium Grit • NUPRO Freedom DPA with Soft Cup NUPRO Freedom Prophy Pack – Box/100 • NUPRO Prophy Paste BubbleExtreme Flavor, Coarse Grit • NUPRO Freedom DPA with Soft Cup 96571501 ENGLISH • 17 21. Limited Warranty The DENTSPLY Professional MIDWEST® RDH Freedom™ Cordless Prophy System is designed exclusively for dental use and this warranty is not applicable to other uses. This warranty extends to Midwest RDH Freedom system purchased from an authorized DENTSPLY distributor, and only to the original purchaser. The system is made up of four significant assemblies, the Inner Module, Metal Outer Sheath, Charging Base and Wireless Foot Pedal. All are warranted against defects arising from faulty materials and workmanship. All components of the Midwest RDH Freedom Cordless Prophy System, except the Disposable Prophy Angle, which is a single use only item, are warranted for (1) year from the date of purchase with (1) free battery replacement for the inner module within the first three years. Parts will be repaired or replaced at the discretion of DENTSPLY Professional provided that the system has been operated and maintained as prescribed in these instructions and has not been subjected to apparent misuse, abuse or accident. Claims covered by this warranty will be honored when presented through your DENTSPLY Professional distributor within thirty (30) days from discovery of defect within the applicable warranty period. THERE ARE NO WARRANTIES, EXPRESS OR IMPLIED, WHICH EXTEND BEYOND THE DESCRIPTION ON THE FACE HEREOF. DENTSPLY neither assumes, nor authorizes any person to assume for it, any other liability in connection with the sale or use of its products. DAMAGES ARE LIMITED STRICTLY TO REPAIR OR REPLACEMENT OF PARTS. DENTSPLY EXPRESSLY DISCLAIMS LIABILITY FOR INCIDENTAL AND CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF THE PRODUCTS. ENGLISH • 18 Manufactured by: DENTSPLY Professional DENTSPLY International 1301 Smile Way York, PA 17404-1785 USA DENTSPLY DeTrey GmbH De-Trey-Str. 1 78467 Konstanz Germany Imported and Distributed by: DENTSPLY Canada Woodbridge, Ontario L4L 4A3 PN: 90714 Rev.2 (07/11) ENGLISH • 104
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.6 Linearized : Yes Encryption : Standard V1.2 (40-bit) User Access : Print, Modify, Copy, Annotate, Fill forms, Extract, Assemble, Print high-res Page Mode : UseNone XMP Toolkit : Adobe XMP Core 4.0-c321 44.398116, Tue Aug 04 2009 14:24:39 Create Date : 2011:08:05 10:49:56-04:00 Metadata Date : 2012:01:09 14:59:11-06:00 Modify Date : 2012:01:09 14:59:11-06:00 Creator Tool : Adobe InDesign CS4 (6.0.4) Thumbnail Format : JPEG Thumbnail Width : 256 Thumbnail Height : 256 Thumbnail Image : (Binary data 9410 bytes, use -b option to extract) Instance ID : uuid:903e5783-d1a0-46c0-b4b4-d0b23dda4178 Document ID : xmp.did:048011740720681195FEDF6F74D41921 Original Document ID : xmp.did:01801174072068119948C8F6B2BD08BC Rendition Class : proof:pdf Version ID : 1 History Action : created, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, saved, 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xmp.iid:BE64144814206811A03CE86B4B895EEC, xmp.iid:BF64144814206811A03CE86B4B895EEC, xmp.iid:C064144814206811A03CE86B4B895EEC, xmp.iid:C164144814206811A03CE86B4B895EEC, xmp.iid:C264144814206811A03CE86B4B895EEC, xmp.iid:C364144814206811A03CE86B4B895EEC, xmp.iid:C464144814206811A03CE86B4B895EEC, xmp.iid:5EB3D96C1E206811A03CE86B4B895EEC, xmp.iid:5FB3D96C1E206811A03CE86B4B895EEC, xmp.iid:60B3D96C1E206811A03CE86B4B895EEC, xmp.iid:61B3D96C1E206811A03CE86B4B895EEC, xmp.iid:62B3D96C1E206811A03CE86B4B895EEC, xmp.iid:63B3D96C1E206811A03CE86B4B895EEC, xmp.iid:64B3D96C1E206811A03CE86B4B895EEC, xmp.iid:65B3D96C1E206811A03CE86B4B895EEC, xmp.iid:66B3D96C1E206811A03CE86B4B895EEC, xmp.iid:67B3D96C1E206811A03CE86B4B895EEC, xmp.iid:68B3D96C1E206811A03CE86B4B895EEC, xmp.iid:60C1DBEE20206811A03CE86B4B895EEC, xmp.iid:61C1DBEE20206811A03CE86B4B895EEC, xmp.iid:62C1DBEE20206811A03CE86B4B895EEC, xmp.iid:63C1DBEE20206811A03CE86B4B895EEC, xmp.iid:65C1DBEE20206811A03CE86B4B895EEC, xmp.iid:66C1DBEE20206811A03CE86B4B895EEC, xmp.iid:67C1DBEE20206811A03CE86B4B895EEC, xmp.iid:68C1DBEE20206811A03CE86B4B895EEC, xmp.iid:69C1DBEE20206811A03CE86B4B895EEC, xmp.iid:6AC1DBEE20206811A03CE86B4B895EEC, xmp.iid:1A2CA53325206811A03CE86B4B895EEC, xmp.iid:1B2CA53325206811A03CE86B4B895EEC, xmp.iid:1C2CA53325206811A03CE86B4B895EEC, xmp.iid:1D2CA53325206811A03CE86B4B895EEC, xmp.iid:1E2CA53325206811A03CE86B4B895EEC, xmp.iid:1F2CA53325206811A03CE86B4B895EEC, xmp.iid:202CA53325206811A03CE86B4B895EEC, xmp.iid:212CA53325206811A03CE86B4B895EEC, xmp.iid:222CA53325206811A03CE86B4B895EEC, xmp.iid:232CA53325206811A03CE86B4B895EEC, xmp.iid:242CA53325206811A03CE86B4B895EEC, xmp.iid:D8AAE45234206811A03CE86B4B895EEC, xmp.iid:0A8011740720681195FEDF32FC4180A5, xmp.iid:74CEDD922220681195FEDF32FC4180A5, xmp.iid:75CEDD922220681195FEDF32FC4180A5, xmp.iid:76CEDD922220681195FEDF32FC4180A5, xmp.iid:78CEDD922220681195FEDF32FC4180A5, xmp.iid:79CEDD922220681195FEDF32FC4180A5, xmp.iid:7ACEDD922220681195FEDF32FC4180A5, xmp.iid:7BCEDD922220681195FEDF32FC4180A5, xmp.iid:7CCEDD922220681195FEDF32FC4180A5, xmp.iid:7DCEDD922220681195FEDF32FC4180A5, xmp.iid:018011740720681195FEDF6F74D41921, xmp.iid:028011740720681195FEDF6F74D41921, xmp.iid:038011740720681195FEDF6F74D41921, xmp.iid:048011740720681195FEDF6F74D41921, xmp.iid:0580117407206811B8B882262A33C28C, xmp.iid:0880117407206811B8B882262A33C28C, xmp.iid:0980117407206811B8B882262A33C28C, xmp.iid:0A80117407206811B8B882262A33C28C History When : 2010:10:13 14:41:31-04:00, 2010:10:13 15:01:16-04:00, 2010:10:13 15:01:16-04:00, 2010:10:13 15:27:48-04:00, 2010:10:14 13:15:06-04:00, 2010:12:30 10:15:17-05:00, 2011:04:07 15:35:12-04:00, 2011:04:07 15:36:44-04:00, 2011:04:07 15:38:59-04:00, 2011:04:07 15:41:52-04:00, 2011:04:07 15:43:46-04:00, 2011:04:07 15:48:43-04:00, 2011:04:07 15:51:28-04:00, 2011:04:07 15:52:56-04:00, 2011:04:07 15:53:56-04:00, 2011:04:07 16:16:36-04:00, 2011:04:07 16:18:28-04:00, 2011:04:07 16:20:18-04:00, 2011:04:07 16:27:49-04:00, 2011:04:08 11:35:13-04:00, 2011:04:11 14:01:50-04:00, 2011:04:11 14:09:31-04:00, 2011:04:11 14:14:29-04:00, 2011:04:11 14:18:53-04:00, 2011:04:11 14:19:26-04:00, 2011:04:11 14:22:52-04:00, 2011:04:11 14:47:28-04:00, 2011:04:11 14:53:25-04:00, 2011:04:11 14:59:20-04:00, 2011:04:11 14:59:37-04:00, 2011:04:11 15:01:25-04:00, 2011:04:11 15:03:29-04:00, 2011:04:11 15:07:26-04:00, 2011:04:12 09:43-04:00, 2011:04:12 09:45:15-04:00, 2011:04:12 09:49:15-04:00, 2011:04:12 09:52:18-04:00, 2011:04:12 09:54:10-04:00, 2011:04:12 09:57:47-04:00, 2011:04:12 09:59:09-04:00, 2011:04:12 10:00:08-04:00, 2011:04:12 10:01:21-04:00, 2011:04:12 10:04:41-04:00, 2011:04:12 10:06:09-04:00, 2011:04:12 10:08:32-04:00, 2011:04:12 10:09:10-04:00, 2011:04:12 10:13:08-04:00, 2011:04:12 13:51:03-04:00, 2011:04:12 13:53:07-04:00, 2011:04:12 13:54:06-04:00, 2011:04:12 13:54:31-04:00, 2011:04:12 14:54:17-04:00, 2011:04:12 15:03:11-04:00, 2011:04:12 15:06:16-04:00, 2011:04:12 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InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0, Adobe InDesign 6.0 History Changed : /, /metadata, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, /, 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/;/metadata, /, /, /, / Derived From Instance ID : xmp.iid:038011740720681195FEDF6F74D41921 Derived From Document ID : xmp.did:028011740720681195FEDF6F74D41921 Derived From Original Document ID: xmp.did:01801174072068119948C8F6B2BD08BC Derived From Rendition Class : default Manifest Link Form : ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream, ReferenceStream Manifest Placed X Resolution : 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00 Manifest Placed Y Resolution : 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00, 72.00 Manifest Placed Resolution Unit : Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches, Inches Manifest Reference Instance ID : uuid:0474f156-13c0-1645-a260-34abd60bf18b, uuid:355c0371-7b87-0f47-b772-41c7f35a0acb, uuid:e9478f28-69e7-1c40-8a51-fa1b2bc18a54, uuid:7c0ba551-f2cf-5040-9ecf-c75bcbc935a7, uuid:c7dd1975-47c3-8a4c-8af1-9a469e707b9a, uuid:cde69fab-2984-6542-a2a5-970eff8c221a, uuid:5f57242a-fd9d-1441-99e8-0dea7805e89e, uuid:8ab3944e-841e-3642-aa08-2ae12957e3c8, uuid:5c49db8e-f4d6-9241-90cf-8506fd8a9931, uuid:614704d2-4ef2-df4a-aa17-417c077fd3b5, uuid:fe579a43-607b-7946-90a5-14b3986b9634, uuid:21436663-44a7-2440-8396-260b8819314e, 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uuid:5f57242a-fd9d-1441-99e8-0dea7805e89e, uuid:8ab3944e-841e-3642-aa08-2ae12957e3c8, uuid:5c49db8e-f4d6-9241-90cf-8506fd8a9931, uuid:614704d2-4ef2-df4a-aa17-417c077fd3b5, uuid:fe579a43-607b-7946-90a5-14b3986b9634, uuid:21436663-44a7-2440-8396-260b8819314e, uuid:314856e2-d668-e343-8b54-af6aaae12652, uuid:0474f156-13c0-1645-a260-34abd60bf18b, uuid:355c0371-7b87-0f47-b772-41c7f35a0acb, uuid:e9478f28-69e7-1c40-8a51-fa1b2bc18a54, uuid:7c0ba551-f2cf-5040-9ecf-c75bcbc935a7, uuid:c7dd1975-47c3-8a4c-8af1-9a469e707b9a, uuid:cde69fab-2984-6542-a2a5-970eff8c221a, uuid:5f57242a-fd9d-1441-99e8-0dea7805e89e, uuid:8ab3944e-841e-3642-aa08-2ae12957e3c8, uuid:5c49db8e-f4d6-9241-90cf-8506fd8a9931, uuid:614704d2-4ef2-df4a-aa17-417c077fd3b5, uuid:fe579a43-607b-7946-90a5-14b3986b9634, uuid:21436663-44a7-2440-8396-260b8819314e, uuid:314856e2-d668-e343-8b54-af6aaae12652 Manifest Reference Document ID : xmp.did:FDE2E2D7612168119109B023A3C03AAA, xmp.did:09801174072068119D1BC9698932DBAF, 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