TTBIO EVO 500 Series User manual

Intended purpose: The EVO 500 series High Speed Handpieces are designed for removing carious
material, reducing hard tooth structure, cavity preparation, and finishing tooth
reparations/restorations.
Use environment/Intended user: This device is to be connected to dental unit and operated by
qualified professional (dentist) in the clinic.
Patient population: Any patient (except babies). The user’s discretion is required prior use.
Indications: Removing carious material, reducing hard tooth structure, cavity preparation, and
finishing tooth preparations/restorations.
Contraindications: N/A
The clinical benefits of our handpieces enable dentists to operate effectively in removing carious
lesions and hard dental tissues, preparing cavity for restoration and finishing after treatment.
Model
500
T/TL/
M/ML
500K
T/TL/
M/ML
500Y
T/TL/
M/ML
500N
T/TL/
M/ML
500W
T/M
500B
T/M
500MR
T/TL/
M/ML
Connection
TTBIO®
EZclick
TTBIO®
EZclick-KL/
KaVo®
MULTIflex®
YOSHIDA®
Quick
Coupling
TTBIO®
Zclick-NL/
NSK®
PLT-CL®
W&H®
Quick
Coupling
Bien-Air®
Quick
Coupling
MORITA®
Quick
Coupling
Rotating speed
(rpm)
T：300,000 ~ 360,000
M：360,000 ~ 440,000
Bur size(mm)
diameter/length
Ø 1.59~1.60 /T(19~25) ;M(16~21) ISO 1797 Type3
Drive air pressure
(bar)
2.6 ~ 3.0
3.0 ~ 3.7
Suggested drive
air pressure (bar)
2.8
3.2
(Blcok
pressure)
Water flow rate
(ml/min)
>50
Water pressure
(bar)
0.8 ~ 2.0
Air pressure (bar)
1.0 ~ 3.0
-
Light system
Glass Rod
-
Glass Rod
Transportation
and Store
Environment
Temperature: -10~50˚C
Humidity: 30~85%
Atmospheric Pressure: 700~1,060hPa
※Air pressure must be higher than water pressure. ※T: torque head M: mini head
※Pressure values are measured by multi gauge.
1. Once handpiece is damage (i.e. deformed caused by hit) or improperly use (i.e. sterilized above
suggested temperature), be sure not to continue using it.
2. Before operation, always make sure the product and its accessories meet the specified
requirements (i.e. drive air pressure, chip air pressure, water pressure, illumination), check the
head cap is firmly tightened, water spray normally. Also check for handpiece vibration, noise
and overheating outside the patient's oral cavity.
3. Please contact our dealer or us with proof of purchase, whenever you have problems such as
abnormal vibration, exceeding temperature or unusual noise, etc.
4. Avoid contacting between the instrument head and soft tissue (risk of burning due to the press
button heating up).
5. Be sure it is functioning correctly before using on a patient.
6. Read this Operation Manual before use to fully understand the product functions.
To install or strip handpiece, please follow the steps illustrated from Fig. 1 to Fig. 3
(Please refer to the coupling manufacturers' instructions.)
1. Follow the arrowhead direction show in Fig.4 to take off or install the bur.
2. Put on protective gloves to reduce the risk of interactive inflection, especially not
to touch the used burs without proper protection.
3. Make sure bur is tightly secured before operation according to ISO 1797,
otherwise risks of injury to doctors, patients or the third party may occur.
4. Bur must be complied with ISO requirement. Burs not in good conditions such as
being bent and damaged, or are deviated from ISO standards and in improper
length may decrease the lifetime of the handpiece or even cause severe
consequence such as injury to people.
5. Do not press the button while bur is rotating, otherwise it could harm internal parts.
1. Please contact local dealers and let the technicians replace the rotor.
2. Do not use unsuitable rotors or spare parts, otherwise could damage the handpiece and result
in severe consequence during treatment.
1. Internal cleaning waterlines must be conducted through the
main dental unit by connecting to handpiece connector and
follow the instruction for handpiece and hose waterlines
disinfection of the main dental unit. (It is recommended to use
Waterline Maintenance Tablets for main dental unit, it is the
simple way to maintaining clean dental unit waterlines.)
2. Do not remove attached handpiece from the connecting cable
during internal waterlines cleaning and disinfection procedure.
3. Hold the handpiece over the cuspidor or over a waterproof container on main dental unit with
sufficient capacity and press the purging key on the main dental unit. Setting time to clean and
disinfect the waterlines base on manual instruction of main dental unit. (Fig.5)
Evidence of the medical device’s basic suitability for effective manual cleaning and automated
cleaning were provided by an independent test laboratory.
Manual cleaning OR Automated cleaning
Handpiece with thermal disinfection mark may be cleaned by a washer-disinfector which
comply with EN ISO 15883-1.
8.1 Manual cleaning
1. If included, remove the cutter or grinder.
2. Using a soft-bristled brush, brush the external surfaces of the
entire device under running (30±5°C) utility (tap) water.
3. If spray nozzle is blocked with debris clean the spray nozzle with
the nozzle cleaner needle. (See Fig.6)
4. Prepare a detergent bath using a mild enzymatic detergent (such as Enzol®) per the vendor’s
recommendation of 1 oz/gal using warm tap water.
5. Using a lint-free cloth soaked in the detergent solution, wipe the devices thoroughly to remove
any visible soil.
6. Use a soft bristled brush moistened with the prepared detergent to clean any remaining debris
from the EVO 500 series handpiece. Brush device for 1 minute and 30 seconds.
7. Rinse the EVO 500 series handpiece under running tap water for 30 seconds.
8. Dry the EVO 500 series handpiece with a lint-free cloth.
8.2 Automated cleaning
1. If included, remove the cutter or grinder.
2. If spray nozzle is blocked with debris clean the spray nozzle with the nozzle cleaner needle. (See
Fig.6)
3. TTBIO recommends to place the handpiece in a cassette or container prior to wash in "Miele
G7883" washer-disinfector, by switching the preprogrammed mode to "Vario TD". The
recommended cleaning agent is alkaline detergent, such as “neodisher® mediclean” and the
neutralizing agent is acid neutralizer, such as “neodisher® Z”.
※Operate washer-disinfector according to user manual provided by the original manufacturer.
The automated cleaning will be processed by pressing one “Vario TD” button and the
preprogrammed procedures and parameters set by “Miele G7883” are shown as
below:
Pre-wash
Main wash
Rinse
Rinse
Final rinse
Drying
Cold water
Cold water;
55°C for 5 minutes
(Default);
Alkaline detergent
(neodisher® mediclean is
recommended)
Hot water;
Acid neutralizer
(neodisher® Z is
recommended)
Hot water
Deionized
Water;
93°C for 5
minutes
(Default)
10 minutes
(Default)
4. Dry the handpiece with a lint-free cloth. If any visible soil is still found, please repeat step 3.
1. Use dental handpiece lubrication oil for maintenance, any unspecified oil not intended for
lubricating handpieces could shorten the lifetime and harm human body.
2. To lubricate EVO 500 series handpiece, put Spray Nozzle into nozzle of the lubrication oil can
(Fig.7). Connect handpiece with the nozzle (Fig.8) and inject lubrication oil for 2~3 seconds.
3. Be sure to lubricate the handpieces prior to sterilization and run the handpieces for 20~30
seconds to emit residual oil and dirt.
4. To lubricate handpiece chucks, put Shaft Spray Nozzle into nozzle of the lubrication oil can and
inject lubrication oil into the chuck (Fig.9) for 1 second. It’s recommended to lubricate chuck at
least once a week and then proceeds step 2.
5. After unpacking and prior to first use, be sure to lubricate with oil and run the handpieces in low
rotation speed for 30 seconds and in full speed for 20~30 seconds to emit residual oil.
Fig.7
Fig.8
Fig.9
1. Before sterilization, the handpiece must be placed into a legally marketed disposable
sterilization pouch made by a combination of plastic film and material which can allow
penetration of steam (e.g. paper).
2. Sterilization must be in compliance with ISO 17665-1 (choose ONE from the following methods):
i. Gravity-displacement steam sterilization: place in autoclave in accordance with: ANSI/AAMI
ST55 at 132°C for 15 minutes and drying duration is 30 minutes.
ii. Dynamic-air-removal steam sterilization:place in autoclave in accordance with EN13060 at
134°C for 4 minutes and drying duration is 15 minutes.
3. Always perform complete drying process and remove the handpiece from steam sterilizer once
the sterilization cycle is completed as the user manual of sterilizer manufacturer.
4. Chemical sterilization is NOT applicable. DO NOT immerse the entire handpiece or
cartridge/rotor into chemical sterilant, otherwise could damage the handpiece or harm the
users or patients (e.g. allergic contact dermatitis, asthma, mucosal damage and so forth).
We recommend a regular service for the TTBIO handpiece after 250 reprocessing cycles.
Fig.5
Fig.6
Fig.4
7. Cleaning for Dental Unit Tubing

Follow your local and national laws, directives, standards and guidelines for disposal.
-Medical device
-Packaging
Remove the dental bur from the handpiece, and dispose it according to the user manual
provided by the original manufacturer to eliminate the biohazard and physical hazards.
1. Information in this operation manual has been carefully reviewed. We will not take any liability
for any damage arising from improper use of the handpiece or misuse of this manual.
2. Products are subject to change without notice.
3. Please refer to the bar code on the packing box for manufacturing and expiry date.
4. The product can be reused only if it is reconditioned under the responsibility of the
manufacturer to comply with the general safety and performance requirements.
※KaVo® & MULTIflex® are the registered trademarks of Kaltenbach & Voigt GmbH CO., Germany.
※NSK® & PLT-CL® are the registered trademarks of NAKANISHI INC. Japan.
※Bien-Air® amd Unifix® are the registered trademarks of Bien-Air Dental S.A., Switzerland.
※W&H® & RotoQuick® are the registered trademarks of W&H Dentalwerk Burmoos GmbH., Austria.
※MORITA® are the registered trademarks of J. MORITA CORP. Japan
Any serious incident and adverse event (e.g. bur detached accidentally and poor clamping) caused
by device deficiency must be reported to the manufacturer, the authorized representative and the
local competent authorities.
1. All of our products have passed strict QC procedures before delivery.
2. Please note that improper use or not using the recommended parts and accessories or
modifying our products without our approval may shorten the lifetime of the product or cause
damage.
3. Please contact us or dealers with proof of purchase for consultation whenever you have any
questions.
4. eIFU use the ref on https://www.ttbio.com/download.php.
Manufacturer
Date of manufacture
CE mark
(European Conformity)
Serial number
Authorized representative in
the European Community
Sterilizable up to the temperature
specified
Data Matrix Code for product
information including UDI
(Unique Device Identification)
Washer-disinfector for thermal
disinfection
Instructions for use
Caution
0JL0158EU1 V1
2022.12
13. Reporting
14. Quality and Service
15. Symbol