Ultradent Ultrapro TX Cordless User manual

Instructions for Use

Contents

1 Preface ............................................................................................5
2 Product Description.........................................................................5
3 Indications for Use/Intended Purpose .............................................5
4 Contraindications.............................................................................6
5 Warnings and Precautions...............................................................6
6 Stepwise Instructions.......................................................................7
7 Maintenance ...................................................................................9
8Processing ....................................................................................10
9 Storage and Disposal ....................................................................15
10 Technical Considerations ............................................................15
11 Miscellaneous Information .........................................................21
12 Symbol Instruction .....................................................................22

4
Disposable prophy
angle
Centralized control
button
Outer sheath
Motor component
Battery indicator Disposable sleeve
Power adapter
Foot pedal
Charging station
Charging indicator

5

Thanks for purchasing the Ultradent Ultrapro™Tx Cordless hygiene handpiece. For the discerning dental professional
who values an untethered alternative to cleaning and polishing, the Ultrapro Tx Cordless handpiece cuts the cord and
allows the user to perform prophylaxis exibly while providing the patient a comfortable and high-quality cleaning
experience. It is recommended that you read the accompanying documentation to take full advantage of the features
and benets of the Ultrapro Tx Cordless handpiece.

The Ultrapro Tx Cordless handpiece has an ergonomic and lightweight design for maximum clinician comfort and
use. It is equipped with an on/o button and a wireless foot pedal used for dental prophylaxis procedures and is
compatible with nearly all disposable prophy angles on the market.

1 – Motor component
3 – Autoclavable outer sheaths
1 – Charging station
2 – Power adapters
1 – Foot pedal
100 – Disposable sleeves
4 – Disposable prophy angles
6 – Black O-rings
2 – Green O-rings

The manufacturer accepts no liability for any damage resulting from the improper use of this unit and/or any
purpose other than those covered by these instructions.
For all products described, carefully read and understand all instructions in this manual and SDS information
prior to use.

The Ultrapro Tx Cordless handpiece is a cordless prophylaxis handpiece equipped with a control button and a
wireless foot pedal. It is intended for use with disposable prophy angles in the hygiene operatory to perform
cleaning and polishing procedures on tooth surfaces and llings.

6

• Doctors with a pacemaker are prohibited from using this device.
• Patients with a pacemaker (or other electrical equipment) who are warned not to use small appliances (such as
Electric razors, hair dryers, etc.) are prohibited from using this device.
• Hemophilia patients are prohibited from using this device.
• For patients with heart disease, pregnant women and young children, cautiously use this device.
For patients or users with allergy concerns, refer to product allergen document available at www.ultradent.com. If
allergic reaction is observed, rinse exposed area thoroughly with water and have the patient consult their physician.

• Do not place device near a heat source.
• Operate and store device in a safe dry place.
• Do not use lubrication on the motor component.
• Use caution for patients with heart conditions, pregnant women, and children.
• This device requires special precautions regarding electromagnetic compatibility (EMC) and must be in strict
accordance with the EMC information for installation and use. Do not use this equipment near uorescent lamps,
radio transmitting devices, remote control devices, handheld or mobile high-frequency
communication devices.
• Long term use of equipment may result in overheating of the motor handpiece and should be left to cool until
next use. Please contact Ultradent if any issues arise.
• To avoid damage or malfunction of device, use the original charging base.
• Any changes to the device may violate safety regulations, causing harm to patients. The manufacturer will not
accept any liability for a modied device.
• To avoid damage to lithium battery and control circuit, use original power adapter.
• If you think a battery replacement is necessary, please contact Ultradent. Do not attempt to replace the battery.
• To avoid damage, ensure that the device is in the o position before removing or installing the outer sheath or
disposable prophy angle.
• To avoid damage to the handpiece and disposable prophy angle, only use disposable prophy angles compatible
with this device and be sure that they are correctly installed before starting the handpiece.
• Wireless charging will generate heat. The surface temperature of the charging station and motor handpiece will rise.
• According to IEC 60601-1/UL60601-1, this device must not be used in the presence of a ammable anesthetic gas
mixed with air, oxygen, or nitrous oxide. (NOTE: Nitrous oxide by itself is not a ammable anesthetic gas.)
• Do not use handpiece while charging.

7


Ensure that the foot pedal is fully charged before rst use. If the handpiece is turned on, the Bluetooth will be
paired automatically. The Bluetooth indicator will ash while the handpiece and the foot pedal are connecting.
If the connection has failed, the Bluetooth indicator will keep ashing. There may be a 3-second delay to the
handpiece when the foot pedal is activated. If there is no response to the handpiece after depressing the foot pedal,
check the battery and recharge if necessary. After ensuring full connection, step on the foot pedal to control the speed
of the handpiece.

1. Plug the power adapter into an appropriate electrical outlet.
2. Place the motor component on the charging station connected to the power adapter.
3. When the device is charging, the indicator light on the charging station and foot pedal will ash green. Once fully
charged, the battery indicator light will illuminate green.

• Handpiece and foot pedal are provided partially charged (charge level 50%–70%).
• Do not depress the foot pedal while charging.

1. Install disposable sleeve onto the motor component.
2. Install the sterilized outer sheath onto the motor component covered with the disposable sleeve.
: Before installation, check whether the disposable sleeve is intact. Do not use if damaged.
3. Attach the disposable prophy angle onto the cordless handpiece.

1. Press the button on the handpiece once to turn device on. Depress wireless foot pedal to control speed
of motor handpiece.
 There may be a 3-second delay during the Bluetooth connection of the foot pedal and handpiece.
2. Use according to clinical need.
3. After use, discard the disposable prophy angle and disposable sleeve. Disinfect and sterilize outer sheath between
each use. Do not immerse sheath in disinfection solution or ultrasonic bath. Only disinfect the motor component,
do not sterilize.

8
INDICATOR PICTURE CHARGE LEVEL LED COLOR
Battery full charged 3 green
Charged 2/3 2 bottom indicators green and 1 top indicator o
Charged 1/3 1 bottom indicator green and 2 top indicators o
Battery low
1 bottom indicator orange and 2 top indicators
o. Unit will soon shut o automatically, charge
immediately.
Bluetooth Indicator
Charging Socket
Battery Indicator
BATTERY INDICATOR’S COLOR BATTERY OF FOOT PEDAL STATUS
Green light ashes Charging
Green light illuminates Fully charged or the battery is sucient for operation
Orange Low battery, unit will soon shut o automatically, charge immediately.

The handpiece will automatically shut down once placed on the charging station or after 5 minutes of device
not being in use.

9


1. Do not use if product or accessories are damaged, smashed, detached, corroded, or bent.
2. This device does not include accessories for repair usage. Please contact Ultradent for repairs.
3. Repairs are only to be performed by authorized service personnel.

• Keep the equipment in a dry storage area.
• Do not throw, beat, or shock the equipment.
• Contact Ultradent if the battery needs repair or replacement.


The O-ring should be replaced regularly every 6 months or sooner if needed.
• Remove the disposable prophy angle and outer sheath from the handpiece.
• Hold the O-ring between your thumb and index nger and apply rm pressure to disengage the ring
from the metal channel.
• Pull the old O-ring o and replace with a new O-ring.

Ultradent hereby warrants that this instrument shall, for a period of 2 years*, conform in all material respects to the
specications therefore as set forth in Ultradent’s documentation accompanying the product and be free from any
defects in materials/or workmanship. This warranty applies solely to the original purchaser and is not transferable.
All defective products are to be returned to Ultradent. There are no user service components of the Ultrapro Tx
Cordless handpiece. Tampering with Ultrapro Tx Cordless handpiece will void its warranty. The Ultrapro Tx Cordless
handpiece warranty does not cover customer damage. For example, if an Ultrapro Tx Cordless handpiece is misused
or dropped and breaks, the customer would be responsible for paying for any necessary repairs.
*With sales receipt indicating the date of sale to the dentist.

10

The objective of the information provided in this section is to reduce the potential for patient cross contamination
when using the device. Please follow all cleaning, disinfection, and sterilization procedures as recommended.
• Sterilize the outer sheath prior to each use. Additional outer sheaths are available for purchase to accommodate
uninterrupted patient procedures.
• Do not place the outer sheath in a disinfectant solution or in an ultrasonic bath.
• Do not use bleach or chloride disinfectant materials.
• For your own safety, please wear personal protective equipment (gloves, glasses, mask).
• The user is responsible for the sterility of the product for the rst cycle and each further usage as well as for the
usage of damaged or dirty instruments where applicable after sterility.
 


Prophy angle that helps clinician easily access hard-to-reach areas of the mouth quickly for
optimal dental hygiene.
Single use
Discard after use

The outer sheath is a sterilizable protective cover that acts as a sleeve to the internal motor
component. It also houses the bearings and acts as an interface between DPA and the
motor component. The outer sheath features an on-board user centralized control button
for power of the device.
Manual cleaning followed by
steam autoclave

The disposable sleeve is designed to protect the motor component from debris.
Single use
Discard after use

The motor component house, the motor, power supply (lithium-ion battery), and 3
indicator lights. The motor component is not sterilizable and is to be used to provide
speed and torque.
Manual cleaning and
disinfection