AeroPro Directions for Use Rev 4

Table of Contents

Section 1

Section 5

General Information... 1

System Information... 17

1.1 Introducing – Premier® AeroPro™ Cordless Prophy System... 1

5.1 Specifications... 17

1.2 Overview... 1

5.3 Symbol Identification... 18

5.2 Classifications... 18

1.3 User and Indications for Use... 1 Section 6 Section 2 Cautions for Handling and Operating... 2

Maintenance, Safety Features, Troubleshooting and Frequently Asked Questions (FAQ)... 19

2.1 Contraindications... 2

6.1 Periodic Maintenance, Replacing O-rings... 19

2.2 Warnings... 2 2.3 Precautions for Handling and Operations... 3

6.2 Safety Features of AeroPro™ Cordless Prophy System... 19

2.4 Adverse Events... 4

6.3 Troubleshooting... 20 6.4 Frequently Asked Questions... 22

Section 3

6.5 Disposal of AeroPro™ Components... 23

Your AeroPro™ Cordless Prophy System... 5 3.1 Your System Components... 5

Section 7

3.2 Component Description... 6

Electromagnetic Compatibility Information... 24

3.3 Assembled Handpiece Features... 7 Section 4

Section 8 Part Numbers... 28

Using AeroPro™ Cordless Prophy System... 8

Section 9

4.1 Setting up the System... 8

Limited Warranty... 29

4.2 Unlocking the Handpiece...8 4.3 Pre-Operational Checks...9 4.4 Operating your AeroPro™ Handpiece... 10 4.5 Changing Speed Modes... 11 4.6 Charging the Battery, ChargeSMART™ and Sleep Mode... 11 4.7 Locking the Handpiece... 13 4.8 Infection Prevention Procedures... 13

Section 1

1.1

General Information

Introducing – Premier® AeroPro™ Cordless Prophy System Congratulations! You’ve made a smart choice in purchasing Premier’s AeroPro Cordless Prophy System. We thank you for your trust in us and encourage you to read this manual to ensure proper operation and maintenance of the handpiece. We suggest that you keep the manual available for future reference. Please take a few minutes to register your Premier AeroPro cordless handpiece as instructed in the warranty section of this manual (Section 9). By registering the unit, you ensure prompt and accurate service and support should your unit need to be repaired or replaced during the warranty period. Register at premierdentalco.com/aeroprowarrantyregistration

1.2

Overview The Premier AeroPro cordless prophy system has been designed to provide the clinician with an ergonomic handpiece that provides independence from heavy cord-drag, complete control and operator comfort during prophylaxis procedures. This system was engineered with ChargeSMART™ technology to provide the clinician a full-day battery life. Premier’s handpiece provides the flexibility of using Premier’s 2pro® prophy angle or most other preferred disposable prophy angles (DPA) on the market. In compliance with the CDC’s sterilization and infection control guidelines, to protect the clinician and the patient, the sterilizable outer sheath has been designed to be steam autoclavable. Premier suggests the clinician acquires enough sheaths to cover the number of procedures during one shift between sterilization cycles. Per FDA guidelines, Premier has custom-designed a disposable polyethylene barrier to cover the motor component (handpiece) after properly disinfecting the system between patients.

1.3

User and Indications for Use 1.3.1 User Licensed Dental Professional

1.3.2 Indications for Use The Premier AeroPro Cordless Prophy System is a high performance cordless prophylaxis handpiece with a centralized control button for use with disposable prophylaxis angles to perform cleaning and polishing procedures on teeth.

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Section 2

2.1

Cautions for Handling and Operating

Contraindications None known.

2.2

Warnings }} Check items received and do not use if items are missing or damaged. (Section 3.1) }} Do not use if labels are illegible, smudged, damaged or lost. }} Use only components and accessories in Section 3 of this manual. Failure to do so will void the warranty, may decrease system performance, may lead to unsafe operation, may negatively affect electromagnetic compatibility (EMC) performance and result in non-compliance. }} Failure to follow recommendations for environmental operating conditions (Section 5.1) could result in injury to patients or users. }} Charge the cordless handpiece using only the AeroPro charging station and the supplied AC adapter. Failure to use the supplied AeroPro AC adapter might cause a malfunction and result in a void of your warranty. }} The autoclavable outer sheath must be steam autoclave sterilized before first use and between patients to prevent patient cross-contamination. See Section 4.8 for the Infection Prevention Procedures. }} To prevent bodily injury and damage to the device, do not sterilize the motor component, charging station, AC adapter, or DPA. Disinfect the motor component, charging station or AC adapter using only the tested and approved disinfectants listed in Section 4.8.2, under Infection Prevention Procedures. }} The motor component, charging station and AC adapter 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. }} Do not spray disinfectant or other fluids directly onto the motor component, charging station, or AC adapter in order to avoid liquid from pooling on these system components. The user should spray solution onto a cloth or use a wipe to disinfect these items per the instructions in Section 4.8.2. }} It is the responsibility of the Licensed Dental Professional to determine the appropriate uses of this product and to understand:

2

•

the general health status of each patient

•

the dental procedures being undertaken

•

applicable industry and governmental agency recommendations for infection prevention in dental healthcare settings

•

requirements and regulations for the safe practice of dentistry

•

the Directions for Use in their entirety

}} Inspect the cordless handpiece system before each use for worn, loose or damaged parts. Do not attempt to operate unless the DPA is properly installed. A loose DPA could separate from the cordless handpiece causing bodily injury. Reinstall the DPA or replace any damaged parts as necessary such as the O-rings. (Section 6.1) }} Never insert a DPA into the cordless handpiece while it is operating. }} The DPAs are designed for single-patient use only and should never be used more than once. DPAs are not autoclavable or designed to withstand disinfection solutions. The risks of reuse of a DPA are damage to equipment and patient cross-contamination. Install a new DPA between each patient. }} Dispose of Premier’s 2pro (or other brand) prophy angles after each patient according to CDC Guidelines for Infectious Waste and Federal, State and Local regulations. }} There are no user-serviceable items in the motor component, AC adapter, sterilizable outer sheath, or charging station. Opening the motor component or any unauthorized modification of any of these units may result in unsafe operation and will void the warranty. }} Per FCC Part 15.21, changes or modifications not expressly approved by the party responsible for compliance (i.e., the manufacturer) could void the user’s authority to operate this equipment. }} If the battery fluid leaks and adheres to the skin or clothing, immediately wash it off with clean water. This may cause skin irritation. }} 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.)

2.3

Precautions for Handling and Operations Before using this product, carefully read and follow all instructions and retain it for future reference. Observe all precautions and warnings. }} As with all dental procedures, use universal precautions (i.e., wear face mask, eyewear, or face shield, gloves and protective gown). }} AeroPro’s motor located inside the motor component is designed to be lube-free. Lubrication may cause damage to the cordless handpiece motor component. }} Oil and/or dirt may damage the motor, electronics and battery located inside the motor component. Take care to prevent external objects from entering the handpiece system. }} The lithium-ion battery is not user replaceable. When needed, the unit should be returned to Premier for service. }} Do not place the system on or next to a radiator or any other heat source. Excessive heat may damage the system’s electronics. }} 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 undesirable operation.

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}} 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. }} This Class A digital apparatus complies with Canadian ICES-003. }} FCC ID: 2AQ77-2018-AP }} IC: 24334 - AEROPRO }} Model # AP-18-PDPC* }} Product Marketing Name: AeroPro System

2.4

Adverse Events There are no known adverse reactions.

*Refer to Section 8 for Item Numbers for Product Ordering 4

Section 3

3.1

Your AeroPro™ Cordless Prophy System

Your System Components Confirm the AeroPro Cordless Prophy System by the REF# on the packaging and verify the following components and accessories are included. If an item is missing, call Premier Customer Experience at 888-670-6100 or 610-239-6000.

Basic Kit - #5500500

Complete Package - #5500510

1 Motor Component

1 Motor Component

1 Autoclavable Outer Sheath

3 Autoclavable Outer Sheaths

1 Charging Station

1 Charging Station

1 AC Adapter

1 AC Adapter

1 Stand

1 Stand

1 Box of 500 Disposable Barriers

1 Box of 500 Disposable Barriers

1 Bag of 48 Units 2pro® Disposable Prophy Angles (Short/Soft)

2 Bags of 144 Units 2pro® Disposable Prophy Angles (Short/Soft)

3 Extra Set of O-rings and Tool for Maintenance

3 Extra Set of O-rings and Tool for Maintenance

(6 Small O-rings for the Outer Sheath and 3 Large O-rings for Motor Component)

(6 Small O-rings for the Outer Sheath and 3 Large O-rings for Motor Component)

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3.2

Component Description

Part Name

Picture

Infection Prevention

Motor Component The motor component houses the motor, gear box, power supply (lithium-ion battery) and five indicator lights. The motor component of AeroPro is not sterilizable and is to be used only with AeroPro disposable barriers.

Disinfect

Charging Station The charging station uses an induction charge mechanism, allowing the handpiece to be placed into the charger without regard to any particular alignment.

Disinfect

AC Adapter Converts AC current into DC current required for charging the AeroPro handpiece.

Autoclavable Outer Sheath The outer sheath is a sterilizable protective cover that acts as a barrier to the internal handpiece component (motor component). It also houses the bearings and acts as an interface between a DPA and the motor component. The autoclavable outer sheath features an on-board user control button (ON/OFF/MODE) for power and rotation speed control. Stand Provides a passive support for the AeroPro handpiece on the tray when not in use. It is fully steam autoclavable. NOTE: Do not confuse the autoclavable Stand for the non-autoclavable Charging Station.

AeroPro™ Disposable Barrier Placed over the motor component (under the outer sheath) for infection prevention.

Disinfect

Autoclave

Autoclave

N/A Disposable

2pro® Disposable Prophy Angle (DPA) N/A Disposable

O-rings and Replacement Tool O-rings on the motor component and the outer sheath can be replaced as needed. A pack of O-rings and a replacement tool are included in the package.

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Follow instructions per component after replacement

3.3

Assembled Handpiece Features

Special Friction Grip Nose Cone Design Positioning pin is not required allowing prophy angle to swivel. Dimpled Silicone Grip Improves tactile feel while preventing slippage.

ON/OFF/SPEED MODE One Quick Touch button provides total control

Easy-to-Read Indicator Lights • Displays Battery Power • Charging Process Status • Speed Mode Change Charging Station with ChargeSMART™ Technology Induction Charging System: • Safe and convenient • Preserves battery life • No need for prongs alignment • Prevents overcharging the unit

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Section 4

4.1

Using AeroPro™ Cordless Prophy System

Setting up the System The system is packaged non-sterile. Refer to Section 4.8 for Infection Prevention Procedures. }} Do not use if labels are illegible, smudged, damaged or lost. }} Check items received and do not use if items are missing. (Section 3.1) Note: AeroPro is provided partially charged (charge level 50–70%), locked and in 2-speed mode.

4.1.1

Plug the power supply (AC Adapter) into the outlet of a surge protector and insert the connector into the back of the charging station. PRECAUTION: To prevent electrical failure/damage connect to single-phase AC power 100-240V power only.

4.1.2

The handpiece must be charged and unlocked prior to operation. Follow the initial charging instructions described below.

4.1.3

Charging for the first time - Prior to first use, fully charge the handpiece using the AeroPro AC

adapter provided. Failure to use the supplied AC adapter might cause malfunction and result in a void of your warranty. 1)

Be sure to plug in AC adapter into appropriate electrical outlet

2) Sit the motor component on the charging station connected to the AC adapter 3) (Optional: Assemble the autoclavable outer sheath on the motor component) 4) Charge for at least 2 hours 5) After fully charged, follow instructions for unlocking your AeroPro handpiece

4.2

Unlocking the Handpiece 4.2.1

Your AeroPro handpiece is factory shipped in a “Locked” position to prevent damage while in transit. The handpiece must be “Unlocked” prior to initial use.

4.2.2

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The unit will stay unlocked until it is relocked by the user.

4.2.3

To unlock the handpiece, ensure that the motor component has been charged for at least 2 hours for initial use. Remove the motor component from the charging station. The unit cannot be unlocked while in charging station.

4.2.4

Assemble the outer sheath onto the charged motor component; press and hold ON/OFF/MODE button for 3 seconds. The handpiece will beep 6 times and all the indicator lights will flash simultaneously 6 times to indicate that the system is unlocked.

4.3

*Beep 6x

Pre-Operational Checks PRECAUTION: The operator and the patient must wear safety glasses and the operator should wear the proper Personal Protective Equipment.

4.3.1

Ensure that the outer sheath has been steam autoclave sterilized according to the Infection Prevention Procedure (Section 4.8).

4.3.2

Insert the motor component into the AeroPro™ custom-fitted disposable barrier. Ensure that the nose of the motor component is fully aligned to the opening of the disposable barrier. (See images below.)

PRECAUTION: Check the AeroPro™ disposable barrier for integrity before use; DO NOT use the barrier if it is damaged. Do not insert the covered motor component into the outer sheath without ensuring the AeroPro™ disposable barrier is clear of the motor component nose. Do NOT apply the AeroPro™ disposable barrier around the outer sheath. The protective outer sheath is designed to be sterilized before each use.

✓

4.3.3



Install the motor component covered with the disposable barrier into the outer sheath.

4.3.4

Attach a 2pro or equivalent DPA into the cordless handpiece. Due to the special friction grip nose cone design, no position pin is needed. So the handpiece can be operated by both right and left handed users. 9

NOTE: AeroPro is compatible with most DPAs. PRECAUTION: Make sure motor is off before inserting the DPA.

4.3.5

Verify that all parts of the AeroPro system are securely attached before use.

Fully assembled CDC compliant handpiece

4.3.6

Before use, operate the product outside the patient’s mouth and check that the DPA rotates properly. If abnormal vibration, noise or overheating is detected during testing or use, immediately stop use and contact Premier Dental Customer Experience at 888-670-6100 or 610-239-6000.

4.4

Operating your AeroPro™ Handpiece 4.4.1

Before turning on the AeroPro Cordless Handpiece, make sure it is fully charged and unlocked.

4.4.2

The AeroPro Cordless Handpiece can operate at three different speeds and has two (2) optional Speed Modes:

Speeds and Speed Modes Operating Speeds

2-Speed Mode

3-Speed Mode

Low

500 rpm

500 rpm

Medium

-

1500 rpm

High

2800 rpm

2800 rpm

(factory setting)

The 2-Speed Mode allows the operator to go from low to high speed with one button touch (factory setting) or, if a greater range of speeds is preferred, the 3-Speed Mode can be selected by following the “Changing Speed Modes” instructions in 4.5.

4.4.3

Using the Assembled Handpiece: Press the ON/OFF/MODE button once quickly using your thumb. The DPA tip will begin to rotate at low speed of 500 rpm. Note: The handpiece always goes to 500 rpm speed upon powering on from off state.

4.4.4

Use the low speed for dipping the DPA into the prophy paste. Press the cup of the DPA into the prophy paste, applying a downward force and light pressure. The low speed can also be used for very light stains and pedodontic patients.

4.4.5

Insert the handpiece into the patient’s mouth and, if desired, change to high speed (2800 rpm) by pressing ON/OFF/MODE button again quickly and start polishing.

4.4.6 10

To turn handpiece off: To turn off the DPA rotation, press and hold ON/OFF/MODE button for 1 second.

4.4.7

4.4.8

After completion of treatment, turn off the handpiece and remove the DPA. 4.4.7.1

To turn handpiece off: Press and hold ON/OFF/MODE button for 1 second.

4.4.7.2

To remove DPA: Pull straight on the DPA to remove.

Disassemble the handpiece for infection prevention procedure. (See Section 4.8 for instructions) 4.4.8.1

Remove outer sheath for sterilization by steam autoclaving.

4.4.8.2 Remove the AeroPro barrier from the motor component and discard it as medical waste. 4.4.8.3 Disinfect the motor component and charging station. (See Section 4.8)

4.4.9

4.5

Place disinfected motor component back into the charging station.

Changing Speed Modes 4.5.1

To change the speed mode, first turn off the handpiece, as per step 4.4.6.

4.5.2

From 2-speed to 3-speed mode: The factory setting is the 2-speed mode (low to high speed). To change the speed mode from 2-speed to 3-speed, press and hold ON/ OFF/MODE button for 3 seconds. Three green indicator lights flash and beep three times and the handpiece is switched to 3-speed mode.

4.5.3

From 3-speed to 2-speed mode: To change the speed mode from 3-speed to 2-speed, press and hold ON/OFF/MODE button for 3 seconds. Two top green indicator lights flash and beep two times and the handpiece is switched to 2-speed mode.

*Beep 3x

*Beep 2x

4.5.4

Once the speed mode is selected, press and release ON/OFF/MODE button to go from one speed to another: •

2-speed mode: Press once to go from Low to High and again to go from High back to Low. (L ’ H ’ L ’ H)

•

3-speed mode: Press once to go from Low to Medium, press again to go from Medium to High, and again to go from High back to Low. (L ’ M ’ H ’ L)

4.5.5

4.6

The selected speed mode will be saved until a new speed mode selection is made.

Charging the Battery, ChargeSMART™ and Sleep Mode 4.6.1

Charge the battery prior to operation by placing the motor component into the charging station. The charging station uses an induction charge mechanism allowing the handpiece to be placed into the charger without regard to any particular alignment. NOTE: In order to provide the charge to the handpiece, the charging station must be plugged into the power source via the AC adapter included with the system. PRECAUTION: Remove the barrier from the motor component before placing the handpiece into the charging station after use.

4.6.2

The handpiece is fully charged when all 5 indicator lights are on. The disinfected handpiece can be put back into the charging station after each use. 11

NOTE: A smart charging management system, ChargeSMART™, allows for multiple charging throughout the day without the danger of premature battery decay. ChargeSMART™ senses when the unit is at 100% capacity and will stop the charging process to prolong battery life. RECOMMENDATION: For maximum battery life avoid running battery to empty. The handpiece can perform up to 10 polishing cycles on a fully charged battery.

4.6.3

Do not place the handpiece in charger while motor is running. Although the handpiece stops operating during charging, this is not recommended. NOTE: If ON/OFF/MODE button is pressed while the handpiece is in the charging station, it will not turn on. However, as soon as the handpiece is picked up from the charging station and ON/OFF/MODE button is pressed, it will start rotating at low speed.

4.6.4

During charging, the indicator lights blink in sequence from bottom to top: solid red, blinking yellow, 3 blinking green until charging is completed. If no indicator lights are blinking, check position of motor component and reseat in the charging station. (See Table 1 below)

4.6.5

The lights stop blinking in sequence when charging is completed. When the battery is fully charged, all five indicator lights will display in a steady state (one red, one yellow and three green). NOTE: Allow 2 hours to fully charge the battery.

4.6.6

Indicator lights represent available power usage, as per Table 2 below:

Charge Status: Cordless Handpiece Charge Level Table 1 (unit is in charging base)

Table 2 (unit is outside charging base)

Charge Indicator Color

Battery Indicator Color

Light Functional Description

Battery Fully Charged Five Solid Lights: 1 red, 1 yellow, 3 green

Five Solid Lights: 1 red, 1 yellow, 3 green

Cordless Handpiece Charge is between 80% - 100%.

Battery charging in progress

Four Solid Lights: 1 red, 1 yellow, 2 green

Cordless Handpiece Charge is between 60% - 79%.

Three Solid Lights: 1 red, 1 yellow, 1 green

Cordless Handpiece Charge is between 40% - 59%.

Two Solid Lights: 1 red, 1 yellow

Cordless Handpiece Charge is between 20% - 39%. Recharge is recommended.

Flashing Red Light

Warning indicator comes on - Cordless Handpiece Charge is less than 20%. Unit will soon shut off automatically, charge immediately.

No Color

Cordless Handpiece is • turned off (locked mode) • in sleep mode • battery is fully discharged

• Solid Red Stays on • 1 yellow, and 3 green lights are blinking in sequence from bottom segment to top segment

Charge indicator lights always stay on while the handpiece is in the charging station. If no lights are blinking, reseat motor component in charging station.

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4.6.7

All the green indicator lights disappear when the handpiece has less than 40% power remaining. Although the handpiece is able to perform normal operations, it is suggested to recharge the motor component immediately.

4.6.8

When the yellow light disappears and remaining red light begins flashing, the handpiece will shut off automatically to avoid damage to the motor, control system, and battery. At this point, the handpiece should not be operated and should be connected to the charging station immediately. NOTE: When the battery power is very low (below 10%), the indicator lights will not display. The indicator lights will turn back on when the battery returns to a safe power reserve level.

4.6.9 Sleep Mode (if cordless handpiece is not in a powered charging station) 4.6.9.1 Your AeroPro handpiece has been optimized with a sleep mode technology to improve the life of your battery. After 20 continuous seconds of non-use, the cordless handpiece will automatically enter the sleep mode phase and the indicator lights will turn off. The Indicator lights will illuminate again once you press the ON/OFF/MODE button. 4.6.9.2 If the handpiece is left in ON position (the motor is running) after 10 minutes of inactivity (ON/ OFF/MODE button is not pressed) the motor will automatically turn off and the indicator lights will turn off.

4.7

Locking the Handpiece In the event the AeroPro cordless handpiece needs to be transported, it must first be set into the “Locked” position. The handpiece should only be locked when the indicator lights show 4 indicator lights or less Important: To lock the handpiece; it must be placed into the charging station.

4.7.1

Place the assembled handpiece into the charging station, then press and hold the ON/OFF/MODE button for 3 seconds. NOTE: Make sure that the charging station is plugged into a power source.

4.7.2

The handpiece will beep 6 times and all indicator lights will flash 6 times to indicate the system is going through the locking process.

*Beep 6x

4.7.3

Remove the handpiece from the charging station. The handpiece is now “Locked” and all indicator lights are turned off. NOTE: If the handpiece is left in the charging station, the indicator lights will not go off, however, the handpiece will stay locked.

4.7.4

The system will remain in the selected speed mode setting that was used before locking the handpiece, and will restore to this mode upon unlocking.

4.8

Infection Prevention Procedures The objective of the information provided in this section is to reduce the potential for patient cross contamination when using the AeroPro Cordless Prophy System during routine dental care. Please follow all Infection Prevention Procedures as recommended by your governing regulatory agency.

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The AeroPro™ system consists of the following parts:

Part

Infection Prevention

Motor Component

Disinfect

Charging Station

Disinfect

AC Adapter

Disinfect

Autoclavable Outer Sheath

Autoclave

Stand

Autoclave

Disposable Barriers

N/A Disposable

2pro® Disposable Prophy Angles (Soft Short)

N/A Disposable

O-rings

Follow instructions per component after replacement

O-ring Replacement Tool

Autoclave

NOTE: Sterilize the outer sheath and the stand prior to each use. Additional outer sheaths and stands are available for purchase to accommodate uninterrupted patient procedures.

4.8.1

Instructions for Steam Autoclave Sterilizing of the Outer Sheath & Stand

Instructions for Steam Autoclave Sterilizing of the Outer Sheath and Stand Warning

These instructions are for use ONLY on the outer sheath and the stand. All other components of the system should be disinfected according to the procedures in the “Instructions For Disinfecting” (Section 4.8.2) The outer sheath and the stand in the AeroPro™ Cordless Prophy System are not sterile upon receipt and must be steam autoclave sterilized prior to use in accordance with the following instructions. Do not use an automatic washer/disinfector for the outer sheath and the stand. Discoloration of material will occur. Repeated cleaning and autoclave cycles have minimum effect on the outer sheath and the stand. End of life is normally determined by wear and damage due to use.

Limitations of Reprocessing

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 and the stand in an ultrasonic bath. Remove excess soil with disposable cloth or paper wipe.

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Point of Use

It is recommended to reprocess the outer sheath and stand reasonably soon following use.

Containment and Transportation

Protect the outer sheath and the stand from contact with other dental instruments that may cause damage.

Instructions for Steam Autoclave Sterilizing the Outer Sheath and the Stand 1. Disassemble by removing the disposable prophy angle (DPA) from the Outer Sheath, and the Outer Sheath from the Motor Component. 2. Prepare enzymatic solution per manufacturer’s recommendation.

Preparation for Decontamination and Pre-Sterilization Cleaning: Manually

3. Using a lint-free cloth dampened with the prepared detergent, thoroughly wet the Outer Sheath/ Stand with the prepared detergent. 3.1 Using a soft bristled brush, brush the Outer Sheath/Stand until all visible soil is removed, paying attention to the disposable prophy angle area. 4. Rinse the Outer Sheath/Stand under potable running tap water for a minimum of 30 seconds to remove detergent residue. 5. Dry the Outer Sheath/Stand using a clean lint-free cloth. 6. Visually inspect each Outer Sheath/Stand for visible soil. If soil is seen, repeat the cleaning procedure.

Disinfection

Do not use a disinfectant solution on sterilizable outer sheaths.

Packaging

Place each Outer Sheath/Stand in a separate paper/plastic steam-sterilizing pouch. If using a sterilizing cassette, ensure that the sterilizer’s maximum load is not exceeded. Place bagged Outer Sheath/Stand into a steam autoclave, per the autoclave manufacturer’s instructions. Gravity Steam Sterilization - Outer Sheath/Stand

Steam Autoclave Sterilization

Full Cycle: 135°C (275°F) for 10 minutes Pre-vacuum Steam Sterilization - Outer Sheath/Stand Full Cycle: 132°C (270°F) for 4 minutes Alternate Method: Place non-bagged outer sheath into the steam autoclave and run at the above listed cycles. NOTE: Outer sheath should remain bagged until ready for use.

Drying

To dry, use the drying cycle of the steam autoclave. Set cycle for 20 to 30 minutes. Do not exceed 137°C (278°F). Visually inspect to ensure that all contamination has been removed.

Maintenance

Check for distortion, damage or wear. Discard damaged, worn or corroded Outer Sheath/Stand.

Storage

To maintain sterility, Outer Sheath/Stand should remain bagged until ready for use.

Manufacturer Contact

In the United States, contact Premier Dental Customer Experience at 1- 888-670-6100. For areas outside the United States call 1-610-239-6000, contact your local Premier Dental representative.

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4.8.2

Instructions for Disinfecting the Motor Component, Charging Station, and AC Adapter

Warnings

The charging station, motor component, and AC adapter 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. Recommended Disinfectant: The following tuberculocidal disinfectant has been found to be effective in achieving a desired level of disinfection, CaviWipes® Surface Disinfectant or equivalent CDC intermediate level disinfectant. Do not immerse in liquid.

Limitations of 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 steam 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

Using a CaviWipe or equivalent CDC intermediate level of disinfectant wipe, wipe charging station, motor component, and AC adapter. Discard used wipe. Dry with a clean cloth.† † - when choosing to use a spray delivery disinfectant, spray disinfectant solution on a clean cloth to wipe the charging station, motor component and AC adapter. Discard used cloth. Dry components with a clean cloth.

Disinfection

Drying

Using a second, new CaviWipe, wipe charging station, motor component and AC adapter. Discard used wipe and allow disinfectant to air dry.‡ ‡ - when choosing to use a spray delivery disinfectant, generously spray disinfectant solution into a second clean cloth and wipe the charging station, motor component and AC adapter components and let air dry.

When cleaning, wipe surfaces dry with a clean cloth. To achieve disinfection, allow surfaces to air dry. Visually inspect to ensure that all contamination has been removed.

Maintenance Visually inspect power supply and cord for damage.

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Storage

Temperature range: -10°C to 50°C/14°F to 122°F Relative humidity range: 45 - 95% (non-condensing)

Manufacturer Contact

In the United States, contact the Premier Dental Customer Experience Team at 888-670-6100. For areas outside the United States call 1-610-239-6000 or contact your local Premier Dental representative.

®CaviWipes is a registered trademark of Metrex Research, LLC.

Section 5

5.1

System Information

Specifications

Adapter Power Supply Manufacturer: Power Supply Model Number:

Shenzhen Ri Hua Da Electronic Co., Ltd RHD20W12010000U

AC Input Voltage

Continuous (100-240V)

AC Input Current

Less than 0.35A

AC Input Phases

Single

AC Input Frequency

50-60 Hz

DC Output Power

12W

DC Output Voltage and Current

12VDC at 1A

Output Regulation

+/- 10%

Induction Charging

Transmitting input voltage 12 VDC Receive module output voltage 5VDC Receive output 5V/400-500mA Coil inductance 10uH

Weight

Handpiece with Outer Sheath = 121 g

Dimensions

Handpiece with Outer Sheath L = 159 mm, W = 27 mm

Operating Environment

Ambient temperature: Relative Humidity: Atmospheric Pressure: Altitude:

10°C-40°C/50°F to 104°F 45-95% (non-condensing) 80-106 kPa ≤ 2,000 meters

Transport and Storage Conditions

Temperature: Relative Humidity: Atmospheric Pressure: Altitude:

-10°C to 50°C/14°F to 122°F 45-95% (non-condensing) 50-106 kPa ≤ 5,000 meters

Handpiece Performance Speeds

High Speed Medium Speed Low Speed Max Torque

2800 rpm 1500 rpm 500 rpm 14 mNm

Handpiece Performance Modes

2-speed Mode (factory setting) 3-speed Mode

500 rpm and 2800 rpm 500 rpm, 1500 rpm and 2800 rpm

IPX (Water Ingress Index)

Motor Component Charging Station AC Adapter

IPX3 IPX0 IPX0 17

5.2

Classifications

Type of protection against electric shock

Class II

Degree of Protection against electric shock

Type B applied part

According to medical device directive

IIA (Rule 9) (IEC 60601) UL 60601-1

Mode of operation for handpiece (Duty Cycle)

Non-continuous: 5 minutes ON, 30 minutes OFF

Degree of safety of application in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide

Equipment NOT suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide

Method of sterilization or disinfection

Refer to Section 4.8: Infection Prevention Procedures

Degree of protection against ingress of water as detailed in the current edition of IEC 60529

Motor Component: IPX3 Charging Station: IPX0

Pollution Degree Classification

Pollution Degree 2

Overvoltage Category

Category II (connected to wall outlet)

5.3

Symbol Identification Protection Class IPX3 - IPX3 Classification of ingress of water for Motor Component - Protected against falling spray.

Class II Equipment Type B applied part Medical equipment with respect to electric shock, fire and mechanical hazards only in accordance with UL 60601-1CAN/ CSA-C22.2 No. 601.1, ANSI/AAMI ES60601-1 (2005, 3rd ed.), CAN/CSA-C22.2 No. 60601-1 (2008),13VA Consult instructions for use

13 5 °

30 min

Duty Cycle for handpiece 5 minutes ON 30 minutes OFF Serial Number Lot Number

12 V-1000mA

13 5 °

Direct Current (DC) supply. 12 Volts, 1000 milliamps Do Not Autoclave (Motor Component, Charging Station, or AC Adapter)

Sterilize up to temperature specified Do not reuse (for DPAs) and AeroPro disposable barriers

WEEE

5 min

Dispose of in accordance with the Waste Electrical and Electronic Equipment Directive 2002/96/EC for product and accessory disposal. Protection Class IPX0 - IPX0 Classification of ingress of water for Charging Station – not protected

Date of Manufacturing Year - Month

This product meets UL safety standard requirements. Electromagnetic interference from the device is under limits approved by the Federal Communications Commission. For indoor use only Efficiency level

18