DENTALEZ 511-265993 iStar Cordless Prophylaxis Handpiece Instruction Manual

DENTALEZ 511-265993 iStar Cordless Prophylaxis Handpiece

USER AND INDICATIONS FOR USE

User: Licensed Dental Professionals
Indications for Use: iStar is a cordless prophylaxis handpiece for use with disposable prophylaxis  angles in hygiene operatory to perform cleaning and polishing procedures on teeth.

WARNING:

• Do not use this product in the vicinity of explosive substances and flammable materials.
•  It is the responsibility of the Dental Healthcare Professional to determine the appropriate uses of this product and to understand applicable industry and governmental agency recommendations for infection control in dental healthcare settings.

FOR AVAILABLE LANGUAGE TRANSLATIONS VISIT
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CAUTIONS FOR HANDLING AND OPERATION

• Please read these instructions carefully and use only for intended purpose.
• Safety instructions are intended to avoid potential hazards that could result in personal injury or damage to the device.
• Safety instructions are classified as follows in accordance with the degree of risk.

instructions are

not followed.

 WARNING| Hazard that could result in serious injury or damage to the device if the safety

instructions are not followed.

 CAUTION| Hazard that could result in moderate injury or damage to the device if the

safety instructions are not followed.

NOTICE| General product specification information highlighted to avoid product

malfunction and reduction in performance.

DANGER

•  Do not attempt to disassemble or tamper with the product or tamper with the mechanism except as specified by StarDental in this Operation Manual. Unauthorized modification or repairs may cause injury, electric shock, or fire.
•  Do not handle the AC adapter with wet hands. Wet hands coming into contact with electricity may result in electric shock.
•  Do not wet the handpiece motor with a disinfectant solution or other fluids. The protective function of the rechargeable battery may become damaged which may result in overheating, rupture, or explosion due to the abnormal current or voltage to the battery.
•  Should the rechargeable battery leak or the motor casing become deformed or discolored, immediately stop use and contact your Authorized StarDental Dealer for service. Using the handpiece under these abnormal conditions may cause injury or damage to property.
•  Should battery fluid leak and get into patient’s or user’s eyes, immediately flush eyes thoroughly with clean water and seek medical attention. If left untreated this condition may result in blindness.
•  Do not charge, use or store the product in direct sunlight, a vehicle, fire, stove, or other location where temperatures may be outside the range shown in this manual. This may result in overheating, smoking, reduction in performance or reduction in the life of the rechargeable battery.
• Never use an AC adapter other than the one supplied for this product. This may cause the product to fail.
•  Do not heat the handpiece motor or dispose of in a fire. This may cause overheating, smoking, rupture, or explosion due to melting of the insulator in the internal battery, damage to the gas relief valve or safety mechanism, or ignition of the battery fluid.
•  Do not pierce the handpiece motor, hit it with a hammer, or step on it. This may cause overheating, smoking, rupture, or explosion due to an internal short-circuit as a result of rupture or deformation to the internal battery.
• If the battery leaks or a strange smell comes from the handpiece, immediately discontinue use and keep the handpiece away from fire and combustible materials. This may cause smoking, rupture, or explosion due to battery fluid catching fire.

WARNING

• The product may malfunction when used in the presence of electromagnetic interference. Do not use the product in the vicinity of any device which emits electromagnetic waves. Turn off the Main Power Switch of the product if an ultrasonic oscillation device or an electrode knife is being used nearby.

WARNING

•  Using a handpiece motor, AC adapter, or accessories other than those provided by StarDental may reduce the electromagnetic compatibility performance of this product (EMC) (An emission increase or immunity decrease may occur).
•  iStar should not be used adjacent to, or stacked with, other equipment. If adjacent or stacked use is necessary, iStar should be observed to verify normal operation in the configuration in which it will be used.
•  Make sure to check the product before use by attaching Disposable Prophy Angle (DPA) and operating it outside the patient’s mouth. If any abnormality is detected, immediately stop use and contact your Authorized StarDental Dealer.
•  If any abnormal vibrations, overheating, noise or low power are perceived before or during use, immediately stop using the product and contact your Authorized StarDental Dealer.
•  If the cause of the abnormality is a part that cannot be easily replaced or the cause of the abnormality is unknown, contact your Authorized StarDental Dealer.
•  Keep away from explosive substances and flammable materials. Do not use the product on or near patients being treated with a flammable anesthetic (nitrous oxide).
•  If the battery fluid leaks and adheres to the skin or clothing, immediately wash it off with clean water. This may cause skin irritation.
•  This product cannot be sterilized. Do not attempt to sterilize this product.

CAUTION

• This product is intended for those who have received training and are licensed as a healthcare professional such as dentists and dental hygienists. This product is designed for use in clinical settings such as dental clinics, hospitals and for visiting dental professionals.
• Read this Operation Manual before use to fully understand the product functions.
•  Always consider the safety of the patient when operating this product.
•  Connect or disconnect the disposable prophy angle only after rotation of the handpiece has completely stopped. This may cause injury or cause damage to the connecting portion of the disposable handpiece.
•  Do not drop or strike the product. This may cause electric shock or failure.
•  Always install a handpiece sleeve before use to prevent contamination of the handpiece motor.
•  Clean the handpiece motor immediately after use and before storage by wiping down with isopropyl alcohol solution. Wipe all surfaces including the chuck, buttons, and bottom charge area, as all of these locations may become contaminated during use. Compliance with cleaning procedures is critical to patient safety. Information on proper maintenance of this handpiece is included in this manual.
•  Do not lubricate the handpiece motor. This may cause overheating or a failure.
•  Should an antiseptic solution, water, saline or other fluid come in contact with the handpiece motor or Stand, turn off the power immediately and thoroughly remove the fluid with an absorbent cloth.
• Do not clean the product with any solvent such as a paint thinner or benzene.
•  Do not recharge or use near combustible materials. Heat generated during charging or use may cause ignition of combustible items.
•  Do not use the product in a place where static electricity may be generated. This may damage the protection circuitry and cause the battery to leak.
•  The rechargeable battery has a limited use. If you feel the operating time becomes shorter or the power becomes weaker the rechargeable battery should be replaced with a new one. Contact your Authorized StarDental dealer.
• The maximum surface temperature of the handpiece might reach 45°C depending on use.
•  Extended continuous use may cause overheating of the handpiece motor which may result in an accident. Do not exceed 3 minutes of continual use and leave the handpiece off for at least 5 minutes before using again.
•  This product is rated Medical Electrical equipment. Electromagnetic compatibility (EMC) is described in the enclosed documentation.
•  Installation and use of this product requires special precautions regarding EMC. Refer to the enclosed EMC information.
•  Portable and mobile RF communications equipment can affect Medical Electrical equipment. Do not use RF equipment near the product.
•  During operation this product may interfere with computers, LAN cables in vicinity of use or could cause noise in radio receivers nearby.
•  U.S. Federal law restricts this device to sale by or on the order of a licensed physician.

NOTICE

• Turn off the switch after using the product. When the product is not used for a long period, disconnect the AC adapter from the outlet.
•  The AC adapter is a fast way to cut off the commercial power supply. Therefore, install the AC adapter in such a way that it can be quickly disconnected from the outlet in an emergency. Do not place any object within 6 inches of the AC adapter.
•  When disconnecting the AC adapter, be sure to hold the adapter body. Disconnecting by pulling on the cord may damage the cord.
•  Refer to the disposable prophy angle operation manual for the specific disposable prophy angle being used for handling and disposal information.
•  Do not store the product in a place exposed to strong direct sunlight. This may cause discoloration of the handpiece body.
•  Users are responsible for the operational control, maintenance and continual inspection of this product.
•  If the product is not used for a long period check for vibration, noise and overheating before using on a patient.
•  Repairs of this product are only to be performed by authorized service technicians according to StarDental requirements. Contact your Authorized StarDental Dealer if repairs are necessary.
• No special training is required prior to using this device.
•  The end user shall be responsible for any judgment on use of this product on a particular patient.
• The maximum rotation speed of the handpiece motor is 2,500rpm (in the full charge state).
•  The speed of the handpiece motor may get slower than the preset speed when the battery capacity lowers during use.

PACKAGE CONTENTS

SET COMPONENTS

COMPONENT NAMES

Keys on operation panel

1. POWER key
   Used to turn the power on and off. Pressing and holding down switches the power between ON and OFF.

2. SPEED key
   Used to set the speed of the motor. Every time is pressed the speed increases one step. After the speed reaches the maximum setting and the button is pressed again the handpiece returns to the lowest speed.
   The setting range is 500 to 2,500rpm ( Refer to the SPEED lamp on the operation panel).

3. ON/OFF key
   Pressing the key activates the handpiece motor and pressing it again stops the rotation. (Alternate operation)
   Alternatively, pressing and holding down the ON/OFF key rotates the handpiece motor while the button is being pressed. Releasing the ON/OFF key stops rotation. (Temporary rotating operation)

Indicators on operation panel

• (A) SPEED lamp
  The speed is indicated by lamps.
  

• (B) Battery charge indicator
  This indicator lamp lights up during battery charging.

• (C) Battery indicator
  Battery power is low. Charge the rechargeable battery when this indicator lamp lights up.

SETUP

CONNECTING THE STAND

Insert the AC adapter plug into the connector on the back of the Stand until it stops (Fig. 1).
When disconnecting the AC adapter plug, hold the Stand firmly and pull out straight.

CONNECTING THE DISPOSABLE HANDPIECE (DISPOSABLE PROPHY ANGLE)

NOTICE

•  Only use a disposable prophy angle.
•  Any commercially available disposable prophy angle compatible to ANSI/ADA N. 85-1:2004 can be used with the iStar.
•  Always wear safety glasses and dust mask during use.

1. Connecting

1. Turn off the handpiece motor
   Cover the handpiece with the supplied single-use handpiece sleeve (Fig. 2
   Connect the disposable prophy angle firmly to the handpiece. Check that the connection is secure by running the handpiece outside of the patient’s mouth.(Fig. 3, 4).

2. When operation is complete, turn off device and disconnect the disposable prophy angle.

1. Turn off the handpiece motor by depressing the Power button until the speed lights turn off.
2. Pull straight on the disposable handpiece (disposable prophy angle) to remove.

WARNING:

• The disposable prophy angle and handpiece sleeve are disposable items intended for a single patient use only. Do not use the same prophy angle or handpiece sleeve for more than one patient. Handle the used disposable prophy angle and handpiece sleeve as contaminated patient care items. Dispose of these items according to your specific state and local medical waste regulations.
• Make sure to install a new single-use handpiece sleeve before every use to prevent contamination of the handpiece motor.

PREOPERATIONAL CHECKS

Before use operate the product outside the patient’s mouth and check that the disposable handpiece head rotates properly. If abnormal vibration, noise or overheating is detected during testing or use immediately stop use and contact your Authorized StarDental Dealer.

OPERATION

Charging the Battery

1. Insert the AC adapter plug into a commercial AC power outlet.
2. Insert the handpiece motor into the Stand. The battery charge indicator lamp lights up and charging starts.
3. When the battery charge indicator lamp turns off charging is completed.

The lamp lights up when remaining battery power becomes low. When the  lamp is illuminated immediately charge the battery.

CAUTION

• Do not insert the plug into any outlet other than the one for commercial power supply.
•  Turn off the handpiece motor before charging.
•  The standard charging time is Approx. 90 minutes. This may vary depending on the battery condition, age, temperature and other factors. With older batteries the charging time and operating time may become significantly shorter.
•  Only use the supplied AC adapter.
• Gently place the handpiece motor into the Stand. A strong impact may cause handpiece failure.
• When placing the handpiece motor into the Stand pay attention to the insertion direction. Excessive force is not required and it may cause damage to the handpiece. The handpiece may also be damaged if dropped.
•  Remove the handpiece sleeve from the handpiece motor before placing it on the battery charger.
•  The handpiece battery charging Stand is exclusively for the iStar handpiece motor. Never use the Stand for any other purpose.
•  The battery will get warm during charging, but this is not a failure. Inserting or removing the plug at short intervals (approx. 5 minutes) may generate heat and interfere with charging. Charge the handpiece for at least 10 minutes.
•  If not used for a long period charge the battery prior to use. If not charged periodically the battery will become fully discharged and will not charge properly. If this occurs contact your authorized StarDental dealer to purchase a new battery.
•  Use the handpiece battery charging Stand for the iStar handpiece only. Do not put any other handpiece or object (e.g., wire safety pin, etc.) into the Stand.
•  Do not charge, use or store the product in direct sunlight, a vehicle in the sun, near fire or a stove, or other location where temperatures are outside the range shown in the specification table in this manual. This may result in overheating, smoking, reduction in performance or reduction in the life of the rechargeable battery.
• Battery charge may not start in the following cases:
  – The battery temperature is too low or too high (less than approx. 10°C (50°F) or above approx. 40°C (104°F)).
  – The battery voltage is too low.
  – The battery voltage is abnormal.

NOTE:

• The rechargeable battery discharges electricity gradually even in the charged and unused state. It is recommended to charge the battery immediately before using the product.
•  This product automatically turns off the power by detecting a reduction in battery voltage. However, the low voltage may not be immediately detected if the product is left under the low voltage condition before turning on the power. This is due to the properties of the battery and is not a failure.

POWER SUPPLY

Press and hold down the POWER key to turn on the power. The SPEED lamp will light up on the operation panel.

SPEED SETTING

Speed is adjusted by pressing the SPEED key . Every time you press the key the speed increases one step. After the speed reaches the maximum setting and the button is pressed again it returns to the lowest speed setting. SPEED can be adjusted during operation.
The SPEED can be selected from the following 5 settings:

OPERATION

1. When the ON/OFF key is pressed and released the handpiece motor will rotate until the key is pressed again to stop the rotation (Alternate operation).
   The handpiece motor continues to rotate while pressing and holding down the ON/OFF key. Release the ON/OFF key to stop rotation (Temporary rotating operation).

2.  After completion of treatment, press and hold down the POWER key to turn off the power.

AUTO POWER-OFF FUNCTION

When approximately 10 minutes have elapsed with no operation of the ON/OFF key the power is automatically turned off to save energy and prevent accidental operation. The power is NOT turned off while the handpiece motor is rotating.

LAST MEMORY FUNCTION

The current setting (last memory) is always memorized when turning off the handpiece motor.

MAINTENANCE

After every patient maintain the product as follows.

CLEANING THE HANDPIECE MOTOR AND STAND

1. Carefully remove the handpiece sleeve. Wipe down the handpiece motor with isopropyl alcohol solution. Be sure to wipe all surfaces including the chuck, buttons, and bottom charge area, as all of these locations may become contaminated during use.
2. Disconnect the AC adapter plug from the Stand.
3.  Wipe the surfaces with a lightly moistened cloth then wipe with alcohol.

WARNING:

• Be sure to clean the handpiece motor after every patient by wiping down with isopropyl alcohol solution. Wipe all surfaces including the chuck, buttons, and bottom charge area, as all of these locations may become contaminated during use. Compliance with cleaning procedures is critical to patient safety.
• Do not lubricate the handpiece motor.
• Do not use any solvents such as benzene or thinner to clean the handpiece motor.
• This product cannot be sterilized. Do not sterilize it.

NOTICE

• The use of r ubbing alcohol (ethanol) with its alcohol content of 76.9-81.4%(containing isoprpanol) is recommended.

7 RECHARGEABLE BATTERY

This product is rechargeable but the battery pack (lithium-ion battery) has a limited life which varies depending on use. When a shorter charging time, shorter operating time, or weaker power is observed the battery should be replaced. Contact your authorized StarDental dealer for replacement.

MOUNTING AND REMOVING THE AC ADAPTER PLUG HEAD

When attaching the Plug Head to the Adapter body, follow the procedure below.

1. Set the Plug Head on the Adapter body ( ).
2.  Slide the Plug Head to the direction of the arrow ( ).

To remove, push the Release Button shown on the right figure, then remove the Plug Head from the Adapter Body.

PERIODIC MAINTENANCE

Perform periodic maintenance checks every three months according to the check sheet below. If any abnormalities are found, contact your Authorized StarDental Dealer for repair.

abnormal

rotation, vibration, noise, and overheating.

OVERLOAD PROTECTION

PROTECTION CIRCUIT

When the product is operated under a load exceeding the allowable limit of protection, the circuit operates to stop the motor and prevent a hazard or damage. The corresponding lamp flashes on the operation panel to display the error.

ERROR DISPLAY

Where the handpiece motor stops due to an abnormality caused by a failure, overloading, breakage, misuse and other factors, the handpiece motor will display an error code on the display. When an error is displayed, turn the power off and on again to check whether the error persists. If the error is displayed again follow the solutions recommended in the table below.

During rotation

| The SPEED

lamp flashes.

| Outside the

range of working temperatures

| The use

temperature is significantly low.

| Use the product within

allowable temperatures. To reset the error turn off the power.

The use

temperature is significantly high.

During battery charge

| The battery

charge indicator and battery indicator flash.

| Battery voltage error| The voltage of the

battery pack is high.

| Contact your Authorized

StarDental Dealer for repair service.

The battery

charge indicator flashes.

| Outside the

range of working temperatures

| Outside the

range of working temperatures of the battery pack (10°C or less, 40°C or more) or thermistor failure in the rechargeable battery.

| Use the product within

allowable temperatures.

TROUBLESHOOTING

When malfunctions occur, check the items below prior to requesting repair services. If no item is applicable or the trouble is not eliminated after following the recommended actions contact your Authorized StarDental Dealer for repair services.
<Handpiece motor, Stand, AC adapter>

No battery

charge (The CHARGE lamp does not light up).

| The AC adapter is not

connected to the Stand.

| Check the power connection.
The AC adapter plug is not

inserted into the outlet or no electricity is provided to the outlet.

Poor connection between

the Stand and handpiece motor.

| Contact your Authorized StarDental Dealer.
Rechargeable battery in the

full charge state or close to it.

| No problem.
The temperature of the

battery pack is low.

| The battery is not charged when the temperature

of the battery pack is less than approx. 10°C (50°F). Charge the rechargeable battery at room temperature (Be careful of condensation).

The temperature of the

battery pack is high.

| The battery is not charged when the temperature of

the battery pack is approx. 40°C (104°F) or higher. Charge the rechargeable battery within permissible temperatures.

SPECIFICATIONS

< Stand>