TTBIO Vigor Series User manual

Indications for Use: The air motor powered by air supplied by a dental unit, designed to transform
energy to drive the low speed handpiece.
Use environment/Intended user: This device is to be connected to dental low speed handpiece
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. (*Air motor to be used with handpiece)
Contraindications: N/A
The clinical benefits of our air motor enable to transform the air supplied by a dental unit to drive
the low speed handpiece.
* Spray Air Pressure must be greater than Water Pressure and both values need to be set at the same time
1. The Vigor Air Motor are intended only for use within dentistry as part of dental treatment;
any form of misuse or modifications to the product are prohibited and may cause danger.
2. Once air motor is damaged (i.e. deformed cause by hit) or improperly used (i.e. sterilized
above suggested temperature), be sure not to continue using them.
3. Before operation, always make sure the product and its accessories meet the specified
requirements (i.e. air pressure, water pressure).
4. It is the duty of the user to use only faultless tools, for the correct purpose, and protect
patients and third parties from all dangers.
5. Higher temperature might cause the sense of oral surface tissue unadaptable. Stop using the
handpiece if overheated.
6. Read this Operation Manual before use to fully understand the product functions.
◼Forward: Turn the FWD/REV Switch Ring to "F" Mode.
◼Reverse: Turn the FWD/REV Switch Ring to "R" Mode.
◼When FWD/REV Switch Ring is positioned in the middle
between "F" and "R", the air motor stops operating.
1. Vigor A65:
◼When water is required at the bur, connect the spray tube attachment to the water supply
nozzle of the motor and connect the other end to the water supply nozzle of the Straight or
Contra-angle Handpiece.
◼Trim the tube to the required length.
◼The spray tube attachment for Straight handpiece is an option (※0PL0227)
2. Vigor A68:
◼When water is required, connect relevant Straight or Contra-angle Handpiece.
◼When water leak after long use, replace the O-ring (※0PL0300)
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
Air motor with thermal disinfection mark may be cleaned by a washer-disinfector which
comply with EN ISO 15883-1.
6.1 Manual cleaning
1. Using a soft-bristled brush, brush the external surfaces of the entire device under running
utility (tap) water.
2. Prepare a detergent bath using a mild enzymatic detergent (such as “METREX“EmPower
Instrument Cleaner) with the ratio of 1 oz “METREX” EmPower Instrument Cleaner per
gallon of warmed distilled water.
3. Using a lint-free cloth soaked in the detergent solution, wipe the devices thoroughly to
remove any visible soil.
4. Use a soft bristled brush moistened with the detergent solution to clean any remaining
debris from the Vigor series handpiece. Brush device for at least 1 minute and 30 seconds.
5. Rinse the air motor under running tap water for 30 seconds.
6. Wiped dry the air motor with lint-free clothes.
6.2 Automated cleaning
1. TTBIO recommends to place the air motor 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)
2. Dry the handpiece with a lint-free cloth. If any visible soil is still found, please repeat step 1.
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. Be sure to lubricate the handpieces prior to sterilization and run the handpieces for 20~30
seconds to emit residual oil and dirt.
3. After unpacking and prior to first use, be sure to lubricate
with oil and run the handpiece in low rotation speed for
30 seconds and in full speed for 10~20 seconds to emit
residual oil.
◼Air motor:
1. Put Shaft Spray Nozzle(※0PL0044) into nozzle of the
lubrication oil can.
2. Inject the oil into the drive air pipe for 2~3 seconds, at the
back end of the motor.
1. Before sterilization, the air motor 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 air motor 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 air motor or
cartridge/rotor into chemical sterilant, otherwise could damage the air motor 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.
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.
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. Any serious incident that has occurred in relation to the medical device should be reported
to the manufacturer and the competent authority.
5. eIFU use the ref on https://www.ttbio.com/download.php.
Air motor
Vigor A65 / Vigor A68
Hose connection
ISO 9168
Instrument connection
ISO 3964
Max. speed (rpm)
20,000
Water flow rate (ml/min)
> 50
Water pressure (bar)
1.5 –2.5*
Air pressure (bar)
2.0 –3.0*
Fig.1
Fig.2
Fig. 3

Manufacturer
Caution
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
0JL0129EU1 V1
2022.10