TTBIO EVO 500 Series Operation 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.
500 500K
Model T/TL/ T/TL/
M/ML M/ML
TTBIO®
TTBIO® EZclick-KL/
Connection
EZclick KaVo®
MULTIflex®
Rotating speed
(rpm)
Bur size(mm)
Ø 1.59~1.60 /T(19~25) ;M(16~21) ISO 1797 Type3
diameter/length
Drive air pressure
(bar)
Suggested drive
air pressure (bar)
Water flow rate
(ml/min)
Water pressure
(bar)
Air pressure (bar)
Light system Glass Rod
Transportation
and Store
Environment 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.
7. Cleaning for Dental Unit Tubing
500Y 500N
500W 500B
T/TL/ T/TL/
T/M T/M
M/ML M/ML
TTBIO®
YOSHIDA® W&H® Bien-Air®
Zclick-NL/
Quick Quick Quick
NSK®
Coupling Coupling Coupling
PLT-CL®
T：300,000 ~ 360,000
M：360,000 ~ 440,000
2.6 ~ 3.0
2.8
>50
0.8 ~ 2.0
1.0 ~ 3.0
-
Temperature: -10~50˚C
Humidity: 30~85%
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
500MR
the nozzle cleaner needle. (See Fig.6)
T/TL/
M/ML 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.
MORITA®
5. Using a lint-free cloth soaked in the detergent solution, wipe the devices thoroughly to remove
Quick
Coupling
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.
3.0 ~ 3.7
8.2 Automated cleaning
3.2
1. If included, remove the cutter or grinder.
(Blcok
2. If spray nozzle is blocked with debris clean the spray nozzle with the nozzle cleaner needle. (See
pressure)
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.
Glass Rod
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
Cold water Cold water;
55°C for 5 minutes
(Default);
Alkaline detergent
(neodisher® mediclean is
recommended)
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
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
Fig.4
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.6
Rinse Rinse Final rinse
Hot water; Hot water Deionized
Acid neutralizer Water;
(neodisher® Z is 93°C for 5
recommended) minutes
(Default)
Fig.8 Fig.9
Fig.5
Drying
10 minutes
(Default)