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5.3.2 Manual disinfection
Tools: containers for disinfectant, water guns, air guns, trays
Place the handpieces and its accessories in a disinfectant (e.g.75% medical alcohol or 2% glutaraldehyde solution) for at least the
time specified by the manufacturer.
Remove the handpieces and its accessories from the disinfectant and rinse it with purified water, distilled water or deionized water
for at least 5 times for not less than 60
seconds of each time.
Dry the handpieces and its accessories with filtered compressed air (maximum pressure: 3 bar).
After the program is finished, remove the handpieces and its accessories from the washer-disinfector, inspect (refer to section
Inspection and Maintenance) and packaging (refer to chapter Packaging). Dry the handpieces and its accessories repeatedly if
necessary (refer to section Drying).
Verification of the fundamental suitability of the handpieces and its accessories for effective manual cleaning and disinfection was
provided by a verified testing laboratory.
Precautions:
1) The disinfectant used to configure the disinfectant must be compatible with the handpieces and cleaning agent, and must be tested
effective (e.g., DGHM, FDA approved or CE certified).
2) The disinfectant must be used in accordance with the concentration and contact
time specified by manufacturer.
3) The disinfectant used must be freshly prepared solutions and no foaming is allowed.
5.4 Drying
If your cleaning and disinfection process does not have an automatic drying function, dry it after cleaning and disinfection.
Methods:
1) Spread a clean white paper (white cloth) on the flat table, point the handpieces and its accessories against the white paper (white
cloth), and then dry the handpieces and its accessories with filtered dry compressed air (maximum pressure 3 bar). Until no liquid is
sprayed onto the white paper (white cloth), the drying is completed.
2) It can be dried directly in a medical drying cabinet (or oven). The recommended drying temperature is 80 - 120 and the time
should be 15 - 40 minutes.
Precautions:
1) The drying of product must be performed in a clean place.
2) The drying temperature should not exceed 138;
3) The equipment used should be inspected and maintained regularly.
5.5 Inspection and maintenance
1) Check the handpieces and its accessories. If there is still visible stain on the handpieces and its accessories after cleaning/
disinfection, the entire cleaning/disinfection process must be repeated.
2) Check the handpieces and its accessories. If it is obviously damaged, smashed, detached, corroded or bent, it must be scrapped
and not allowed to continue to be used.
3) Check the handpiece. If the structural parts (O-ring, LED light, light guide, etc.) are broken, please replace it before use. But the
replaced parts must be cleaned, disinfected and dried.
4) If the service time (number of times) of the Ultrasonic handpiece reaches the specified service life (number of times), please
replace it in time.
5) Do not use the machine when the machine is being cleaned/disinfected/sterilized.
5.6 Packaging
The disinfected and dried handpieces and their accessories are assembled and quickly packaged in a medical sterilization bag (or
special holder, sterile box).
Precautions:
1) The package used conforms to ISO 11607;
2) It can withstand high temperature of 138 and has sufficient steam permeability;
3) The packaging environment and related tools must be cleaned regularly to ensurecleanliness and prevent the introduction of
contaminants;
4) Avoid contact with parts of different metals when packaging.
5.7 Sterilization
Use only the following steam sterilization procedures (fractional pre-vacuum procedure*) for sterilization, and other sterilization
procedures are prohibited:
The steam sterilizer complies with EN13060 or is certified according to EN 285 to comply with EN ISO 17665;
The highest sterilization temperature is 138;
The sterilization time is at least 4 minutes at a temperature of 132 / 134 and a pressure of 2.0 bar - 2.3 bars.
Allow a maximum sterilization time of 20 minutes at 134.
Verification of the fundamental suitability of the products for effective steam sterilization was provided by a verified testing
laboratory.
Precautions:
1) Only products that have been effectively cleaned and disinfected are allowed to be sterilized;
2) Before using the sterilizer for sterilization, read the Instruction Manual provided by the equipment manufacturer and follow the
instructions.
3) Do not use hot air sterilization and radiation sterilization as this may result in da mage to the product;
4) Please use the recommended sterilization procedures for sterilization. It is not recommended to sterilize with other sterilization
procedures such as ethylene oxide, formaldehyde and low temperature plasma sterilization. The manufacturer assumes no
responsibility for the procedures that have not been recommended. If you use the sterilization procedures that have not been
recommended, please adhere to related effective standards and verify the suitability and effectiveness.
Fractionation pre-vacuum procedure: a procedure for steam sterilization by repeating pre-vacuum, the procedure used here is steam
sterilized by three pre-vacuums.
6 Transport, storage and maintenance
6.1 Transpor
6.1.1 Excessive impact and shake should be prevented during transport. Lay it care fully and lightly.
6.1.2 Do not put it together with dangerous goods during transport.
6.1.3 Avoid being exposed to sun, rain, and snow during transport.
6.2 Storage
6.2.1 The device should be handled carefully and lightly. Be sure that it is far from the vibration, and installed or kept in a cool, dry,
and ventilated place.
6.2.2 Do not store the machine together with articles that is poisonous, combustible, caustic, or explosive.
6.2.3 This machine should be stored in a room where the relative humidity is 10% - 93%, atmospheric pressure is 70kPa - 106kPa, and
