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Views: 0 Author: Emit Dental Publish Time: 2024-10-28 Origin: Site
1 Description of device
1.1 Description
Ultrasonic Scaler Handpiece is the accessory of scalers, it is the handheld energy transformation part of ultrasonic piezo scaler, by using piezoceramics to transfer electric energy to mechanical energy to eliminate the dental calculus.
1.2 Product structure
The handpiece is composed of cover and ultrasonic transducer.
1.3 Scope of application
The handpiece is used for dental calculus elimination and root canal cleaning.
1.4 Contraindication
1.4.1 The hemophilia disease patient is not allowed to use this handpiece.
1.4.2 Patients with heart pacemaker are forbidden to use this handpiece.
1.4.3 Doctors with heart pacemaker are forbidden to use this handpiece.
1.4.4 The heart disease patient, pregnant woman and children should be cautious to use this handpiece.
1.5 The classification of the device
1.5.1 Operating mode: Continuous operation
1.5.2 Protection degree against water (used on the pedal): IPX1
1.5.3 Degree of safety of application in the presence of a Flammable Anesthetic Mixture with air or with Oxygen or Nitrous Oxide. Scaler handpiece is not suitable for being used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
1.6 The main technical specifications
1.6.1 Power source Input: 190V AC-230V AC
1.6.2 Output primary tip Vibration excursion: < 200um
1.6.3 Output tip Vibration frequency: 28kHz + 5kHz
1.6.4 Output half-excursion force: 0.5N-5N
1.6.5 Tip's output power: 3W-20W
1.6.6 Water pressure: 0.01MPa-0.5MPa
1.7 Working condition
1.7.1 Environmental temperature: +5°C - +40°C
1.7.2 Relative humidity: 30% - 75%
1.7.3 Atmospheric pressure: 70kPa - 106kPa
2 Installation of the product
2.1 Installation of handpiece
2.1.1 Open the packing box, make sure that all the parts and accessories are complete according to the packing list.
2.1.2 Keep dry the handpiece connector and cable plug socket before installing the handpiece.
2.1.3 Make sure that the bottom jack point is at the plug, make the handpiece fixed to the cable correctly. (Picture 1)
2.2 Installation of tips
2.2.1 Fix the tip to handpiece by torque wrench. (Picture 2)
2.2.2 Please use Manufacturer’s brand scaling tips.
Notes: The detachable handpiece is a high-tech device which should be used carefully. Don't use too much torque force to screw the tips.
In order to avoid the vibration by stepping on the foot switch by accident, unscrew the scaling tips after each operation.
3 Product function and operation
3.1 Scaling function
3.1.1 Connect the handpiece and the connector of cable correctly and adjust the water and vibration intensity to a suitable level.
3.1.2 The handpiece can be handled in the same gesture as a pen in hand.
3.1.3 Select a suitable scaling tip as you need, screw it on the handpiece tightly by the torque wrench.
3.1.4 During the clinical treatment, don't make the end of tip touch the teeth vertically.
3.1.5 Don't make the tip overexert on the surface of the teeth in case of hurting the teeth and damaging the tip.
3.1.6 After finishing operation, keep the machine working for 30 seconds on the water supply condition in order to clean the handpiece and the scaling tip.
3.2 Endo function
3.2.1 Usage process
a) Fix endo chuck to handpiece by endo wrench.
b) Unscrew the screw cap on the endo chuck.
c) Put the ultrasonic file into the hole in the front of endo chuck.
d) Screw down the screw cap with endo wrench to tight up the ultrasonic file.
e) Press option key, turn to endo root canal cleaning function.
f) Press option key, turn the water and vibration intensity to a suitable level.
g) Put the ultrasonic file into the patient's root canal slowly step on the foot pedal, then make endo root canal cleaning.
During the treatment, turn up the power gradually according to the needs.
3.2.2 Notes
a) When fixing endo chuck, it must be screwed down.
b) The screw on the endo chuck must be screwed down.
c) Don't press it too much when the ultrasonic file in root canal.
d) Don't start up the foot pedal until the ultrasonic file in root canal.
e) The power range is supposed to be from 1st to 5th grade.
f) Please sterilize the endo chuck and handpiece after operation.
3.3 Instruction for main components of detachable handpiece
3.3.1 Nipple: The nipple can be removed, for easy cleaning
3.3.2 Light pipe: light guide, can be autoclaved under high temperature and pressure.
3.3.3 LED lamp: illuminate the oral area, detachable and sterilized.
3.3.4 Handpiece: The main part of the whole handpiece can be autoclaved under the high temperature and pressure.
Picture 3
4 Notes
4.1 Don't knock or rub the handpiece.
4.2 Don't screw or unscrew the scaling tip and endo chuck when stepping on the foot pedal.
4.3 The handpiece, scaling tip, torque wrench, endo wrench and endo chuck must be sterilized before treatment.
4.4 The internal screw thread of the scaling tips produced by some manufactures is coarse, rusty and collapsed. This will damage the external screw thread of the handpiece irretrievably. Please use Manufacturer' brand scaling tips.
4.5 We are only responsible for the safety on the following conditions: The maintenance, repair and modification are made by the manufacturer or the authorized dealer.
5 Trouble shooting
Fault | Possible Causes | Solutions |
Handpiece doesn’t work | The tip is loosened | Tighten it |
Something wrong with the handpiece | Take out the handpiece and send it back for repair | |
Something wrong with the cable | Contact us | |
The connect plug between the cable and circuit board is loosened | Contact us | |
There is no spray when getting through the electricity | The water control switch is not on | Turn on the water control switch |
No pressure or low pressure | Check the pressure | |
There is no water when getting through the electricity | The water control switch is not on | Turn on the water control switch |
There is impurity in the solenoid valve | Contact us | |
Water way clogs | Clean the water line by three-way syringe | |
Low vibration
| The tip hasn't been screwed on the handpiece tightly | Screw the tips tightly by torque wrench |
The tip is shaken loose by vibration | Screw on the tip tightly | |
The coupling between the handpiece and the cable is not dry | Dry it, especially the water between handpiece and connector | |
The tip is worn out or deformed | Change another tip | |
The handpiece generates heat | The water control switch is in a low setting | Turn the water control switch to a higher grade |
LED light doesn't work | Poor contact | Contact tightly |
Something wrong with LED light | Change a new one | |
LED lamp installed backwards | Please install the “+” of the LED lamp to the “+” of the handpiece | |
There is water seeping from the coupling between the handpiece and the cable | The waterproof "O" ring is damaged | Change a new "O" ring |
If the problem still can't be solved, please contact us.
6 Cleaning, disinfection and sterilization
1. For cleaning and disinfection, use disinfectant ethanol or disinfectant isopropanol that does not contain any additives (any quaternary ammonium salts).
Use of other disinfectants may cause discoloration or cracking.
* For details, contact the manufacturer of the disinfectant.
* In this operation manual, disinfectant ethanol or disinfectant isopropanol that does not contain any additives (any quaternary ammonium salts) is called "disinfectant alcohol".
2. Remove the cap, light conductor, and LED lamp before cleaning, disinfection and sterilization (Picture 3).
3. The maximum cleaning, disinfection and sterilization cycles of Ultrasonic Scaler Handpiece are identified as 300 cycles.
6.1 Beginning work
6.1.1 Please read these operating instructions carefully as they explain all the most important details and procedures.
Please pay special attention to the safety precautions.
Always keep this instruction close at hand.
6.1.2 To prevent injury to people and damage to property, please heed the corresponding directives.
6.1.3 The instructions in this manual are only applicable to the product which it was delivered with.
6.2 Introduction
6.2.1 These reprocessing instructions provide instructions for cleaning, disinfection, sterilization and packaging of manufacturer reusable products intended to be reprocessed in medical facilities.
6.2.2 The goal of reprocessing reusable products is to reduce bioburden and to achieve sterility of those products in order to eliminate the risk of product reuse related infection.
Decisions regarding cleaning, disinfecting or sterilizing manufacturer's medical and dental instruments are based on the potential risk of infection associated with their use.
6.2.3 lt is recommended to use steam sterilization.
6.2.4 Remember that sterilization or high-level disinfection cannot be achieved unless the elements of the assembly are cleaned first.
6.2.5 lf you find that the reprocessing instructions from the manufacturer seem to be inadequate, please inform the manufacturer about those inadequacies.
6.2.6 We encourage adverse events related to device reprocessing be reported directly to the manufacturer.
6.3 Reprocessing -instructions for reusable products
6.3.1 The instructions are binding for the reprocessing of all reusable products (Here after called "product") of manufacturer. When necessary, additional product-specific instructions are included with the product to provide additional information.
lmportant: before use, carefully read the operating instructions of the manufacturer instrument and devices with which the product will be used.
6.3.2 Reusable product must be cleaned, disinfected and sterilized prior to first use. Reprocessing procedures have only limited implications to this device.
The limitation of the numbers of reprocessing procedures is therefore determined by the function / wear of the device.
From the processing side there is no maximum number of allowable reprocessing.
The device should no longer be reused in case of signs of material degradation.
In case of damage the product should be reprocessed before sending back to the manufacturer for repair.
6.4 Preparation-basic principles
6.4.1 lt is only possible to carry out effective sterilization after the completion of effective cleaning and disinfection.
Please ensure that, as part of your responsibility for the sterility of products during use, only sufficiently validated equipment and product-specific procedures are used for cleaning/disinfection and sterilization, and that the validated parameters are adhered to during every cycle.
6.4.2 Please also observe the applicable legal requirements in your country as well as the hygiene regulations of the hospital or clinic. This applies especially with regard to the additional requirements for the inactivation of prions.
6.5 Preparation at the point of use
Disconnect product. Remove gross soiling of the scaler handpiece with cold water (<40'C) immediately after use. Don't use a fixating detergent or hot water (>40°C) as this can cause the fixation of residuals which may influence the result of the reprocessing process.
Store the scaler handpiece in humid surroundings.
6.6 Transportation
Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.
6.7 Preparation for decontamination
The scaler handpiece must be reprocessed in a disassembled state, as far as possible.
6.8 Pre-cleaning
Do a manual pre-cleaning, until the products are visually clean. Submerge the products in a cleaning solution and flush the lumens with a water jet pistol with cold tap water for at least 10 seconds. Clean the surfaces with a soft bristle brush.
6.9 Cleaning
Regarding cleaning/disinfection, rinsing and drying, it is to distinguish between manual and automated reprocessing methods. Preference is to be given to automated reprocessing methods, especially due to the better standardizing potential and industrial safety.
Automated Cleaning:
Use a washer-disinfector (WD) meeting the requirements of the lS0 15883 series.
Put the scaler handpiece into the machine on a tray. Connect the products with the WD by using suitable adapter and start the program:
4 min pre-washing with cold water (<40°C);
Emptying
5 min washing with a mild alkaline cleaner at 55°C;
Emptying
3 min neutralizing with warm water (>40°C);
Emptying
5 min intermediate rinsing with warm water (>40°C);
Emptying
The automated cleaning processes have been validated by using 0.5% nourisher MediClean forte (Dr. Weigert).
Acc. to EN IS0 17664 no manual reprocessing methods are required for these devices.
lf a manual reprocessing method must be used, please validate it prior to use.
6.10 Disinfection
Automated Thermal Disinfection in washer/disinfector under consideration of national requirements regarding A0 value (see EN 15883).
A disinfection cycle of 5 min disinfection at 93°C has been validated for the product to achieve an A0 value of 3000.
6.11 Drying
Automated Drying:
Drying of outside of products at 40°C, 5 min through drying cycle of washer/disinfector.
lf needed, additional manual drying can be performed through lint free towel. Insufflate
cavities of scaler handpiece by using sterile compressed air.
6.12 Functional testing, maintenance
Visual inspection for cleanliness of the scaler handpiece and reassembling if required. Functional testing according to instructions of use. lf necessary, perform reprocessing process again until scaler handpiece is visibly clean.
Before packaging and autoclaving, make sure that the scaler handpiece has been maintained according to manufacturer's instruction.
6.13 Packaging
Pack the scaler handpiece in an appropriate packaging material for sterilization.
The packaging material and system refer to EN ISO 11607.
6.14 Sterilization
Sterilization of scaler handpiece by applying a fractionated pre-vacuum steam sterilization process (according to EN 285/EN 13060/EN IS0 17665) under consideration of the respective country requirements.
Minimum requirements: 3 min at 134°C (in EU: 5 min at 134°C)
Maximum sterilization temperature: 138°C
Drying time:
For steam sterilization, we recommend a drying time of 15 to 40 minutes.
Choose a suitable drying time, depending on the autoclave and load.
Refer to the autoclave's instructions for use.
After sterilization:
a. Remove the scaler handpiece from the autoclave.
b. Let the scaler handpiece cool down at room temperature for at least 30 minutes.
Do not use additional cooling. Check that the sterilization wraps or pouches are not
damaged.
* Flash sterilization is not allowed on lumen products.
* The manufacturer assumes no responsibility for the use of other sterilization procedures (e.g. ethylene oxide, formaldehyde and low temperature plasma sterilization). In such cases, please observe the respective valid standards (EN ISO 14937/ANSI AAMI ISO 14937 or the procedure-specific standard) and verify the suitability and effectiveness in principle of the procedure (if necessary, including investigations on sterilizing agent residue), considering the specific product geometry as part of the validation.
Maximum sterilization temperature 138°C.
Storage of sterilized products in a dry, clean and dust free environment with a relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to 106KPa, and a temperature of-20°C to + 55°C; refer to label and instructions for use.
After sterilization, the product should be packaged in a medical sterilization bag or a clean sealing container and stored in a special storage cabinet.
The storage time should not exceed 7 days. lf it is exceeded, it should be reprocessed before use.
6.16 Service life
The scaler handpiece has been designed for many sterilization cycles. The materials used in their manufacture were selected accordingly.
However, with every renewed preparation for use, thermal and chemical stresses will result in aging of the devices. lf the number of permissible re-sterilization cycles is restricted; this will be pointed out in the product specific instructions.
The use of ultrasound baths and strong cleaning and disinfection fluids (alkaline pH>9 or acid pH<5) can reduce the life span of devices.
The manufacturer accepts no liability in such cases.
The scaler handpiece may not be exposed to temperatures above 138°C.
It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel can reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly.
7 Transportation, Storage and Maintenance
7.1 Transportation
7.1.1 Excessive impact and shaking should be prevented during transportation. Lay it carefully and lightly and don't invert it.
7.1.2 Don't put it together with dangerous goods during transportation.
7.1.3 Avoid solarization and getting wet in rain or snow during transportation.
7.2 Storage
7.2.1 Don't store the machine together with the articles which are combustible, poisonous, caustic, or explosive.
7.2.2 This equipment should be stored in a room where the relative humidity is 10%-93%, atmospheric pressure is 70kPa-106kPa, and the temperature is -20°C-+55°C.
7.3 Maintenance
The scaler handpiece 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.
8 Environmental Protection
There is not any harm factor in our scaler handpiece. You can deal with it based on the local law.
9 After Service
We offer one year's free repair to the scaler handpiece according to the warranty card. The repair of the equipment should be carried out by our professional technician. We are not responsible for any irretrievable damage caused by the non-professional person.
10 Symbol instruction (Picture 4)
11 Statement
All rights of modifying the product are reserved to the manufacturer without further notice. The pictures are only for reference. The final interpretation rights belong to the manufacturer. The industrial design, inner structure, etc. have been claimed for several patents by manufacturer, any copy or fake product must take legal responsibilities.
Before installing the handpiece, make sure that the handpiece connector and the cable plug socket are completely dry.