REFINE DS7 Ultrasonic Scaler Instruction Manual

REFINE DS7 Ultrasonic Scaler

Product Information

Specifications:

• Model : CE 1434
• Manufacturer: Guilin Refine Medical Instrument Co., LTD.
• Version : RF-D7L-M002 Version 1.7
• Shelf Life : 10 years
• Website: http://www.alandental.com

Product Usage Instructions

Section 1: Introduction
Thank you for choosing the CE 1434 Ultrasonic Scaler. This instruction manual provides detailed information on how to operate the scaler effectively and safely. Please read this manual thoroughly before using the product to ensure proper usage and to avoid any potential risks.

Section 2: Safety Precautions
Before using the ultrasonic scaler, it is important to follow these safety precautions:

• Only trained professionals should operate the scaler.
• Do not use the scaler near flammable substances.
• Ensure the power supply is properly grounded.
• Do not immerse the scaler in water or other liquids.
• Keep the scaler away from children and unauthorized individuals.

Section 3: Operating Instructions
To operate the CE 1434 Ultrasonic Scaler, please follow these steps:

1. Connect the scaler to a power source using the provided power cord. Ensure the power source meets the voltage requirements specified in the product manual.
2. Attach the appropriate scaler tip to the handpiece. Ensure the tip is securely fastened.
3. Turn on the power switch located on the scaler’s control panel.
4. Adjust the power intensity using the intensity control knob. Start with a lower intensity and gradually increase it as needed.
5. Gently place the scaler tip on the desired tooth surface or area to be treated.
6. Maintain a consistent and controlled motion while scaling the teeth. Avoid applying excessive pressure.
7. After use, turn off the power switch and disconnect the power cord from the electrical outlet.

Section 4: Maintenance and Cleaning
Proper maintenance and cleaning of the ultrasonic scaler are essential for its longevity and optimal performance. Follow these guidelines:

• Regularly clean the handpiece and scaler tips with an appropriate disinfectant solution.
• Do not autoclave the handpiece or scaler tips.
• Inspect the power cord for any signs of damage and replace if necessary.
• Store the scaler in a clean and dry environment when not in use.

Frequently Asked Questions (FAQ)

• Q: Can this scaler be used on all types of teeth?
  A: Yes, the CE 1434 Ultrasonic Scaler can be used on all types of teeth, including natural teeth, crowns, and veneers.

• Q: What is the recommended frequency for scaling procedures?
  A: The recommended frequency for scaling procedures may vary depending on individual patient needs. It is best to consult with a dental professional for personalized recommendations.

• Q: Can the scaler be used on patients with pacemakers?
  A: It is not recommended to use the ultrasonic scaler on patients with pacemakers. Consult with a healthcare professional for alternative treatment options.

Safety precautions

WARNING : If you neglect these safety precautions, you may cause personal injury such as electric shock, fire or damage to the product.

1. Use a separate, grounded power outlet. Never use wet hands to unplug the power cord.
2. Please put the power plug into the socket easy to pull out, to make sure it can be pulled out in emergency. Please do not use other than the specified voltage.
3. Do not damage, modify, pull, over bend or twist the power cord, do not place heavy objects on the power cord.
4. Do not place the product on unstable workbenches, such as shaky tables, bevels, or vibrations.
5. Keep the scaler clean before and after operation. The scaling tip, wrench and handpiece (detachable) must be sterilized before each treatment.
6. The tip must be tightened to the handpiece with torque wrench. While scaler is working, the heat of scaling tip may become higher if there is no water flowing out, make sure the irrigation is good.
7. Don’t twist or rub the tip. Change a new one when the tip is damaged or worn excessively.
8. Don’t screw the scaling tip while stepping on the foot switch.
9. Don’t use impure water source, and be sure not to use normal brine instead of pure water source.
10. If use the water source without hydraulic pressure, the water surface should be one meter higher than the head of the patient.
11. Don’t knock or rub the handpiece. Do not pull the cable while the device is working, to avoid damage to the cable.
12. After operating, turn off electrical source, and then pull out the plug.
13. The screw thread of the scaling tips produced by other manufacturers is maybe coarse, rusty and collapsed, which will damage the screw thread of the handpiece irretrievably. Please use our scaling tip.
14. This equipment is only applicable to the corresponding type of power adapter produced by our company.
15. As a professional manufacturer of medical instruments, 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.
    • The changed components are original of our company and operated correctly according to instruction manual.
16. This product is intended for use in hospitals and dental clinics only. The user must be professionally trained and qualified dentists.
17. Indicator light: Other colours: Meaning other than red, yellow, or green, indicated the device ready for use.
18. Statement: the third conductor in the POWER SUPPLY CORD is only a functional earth.

Symbol instruction

Product introduction

1. Product Overview
   Guilin Refine Medical Instrument Co.,Ltd. is a professional manufacturer to research, develope, produce and sell ultrasonic scalers. The product is used for teeth cleaning and also an important device for teeth disease prevention and treatment. The Ultrasonic scaler is composed of main unit, handpiece, cable, water pipe, tip, torque wrench, foot switch, and power supply.
   The ultrasonic scaler has following features:

2. Detachable handpiece can be autoclaved under 134°C and 0.22 Mpa.

3. Automatic frequency tracking ensures that the device always works on the best frequency, stable and efficient performance.

4. Intended use
   Ultrasonic Scaler is used for cleaning and shaping the surface and root area on the teeth.

5. Contraindications:

6. The hemophilia patient is forbidden to use this equipment.

7. The patients or doctors with heart pacemaker are forbidden to use this equipment.

8. The heart disease patient, pregnant woman and children should be cautious to use the equipment.

9. Intended patient population
   Adults and Pediatrics.

10. Intended user
    The Ultrasonic Scaler is intended to be operated by professionally trained and qualified dentist.

11. Equipment safety classification

12. Operating mode: Continuous operation

13. Type of protection against electric shock: Class II

14. Degree of protection against electric shock: Type B applied part

15. Applied part of the equipment: Tip

16. Degree of protection against harmful ingress of water: Ordinary equipment

17. Degree of protection against harmful ingress of water: Protection degree against water (used on foot switch ): IPX1

18. Degree of safety of application in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide: Equipment can not be used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide

Model and technical parameters

Note 1: In addition to the above, the electronic components used to clarify their electrical properties are exactly the same.
Note 2: Function Annotation: “G”means “Scaling mode” ; “P”means “Periodontal mode” ; “E”means “Endodontic mode”
Note 3: Do not replace the fuse of main unit nor the power supply, to avoid safety risks.

Working condition

1. Environment temperature: +5°C-+40°C
2. Relative humidity: 30%-75%
3. Atmosphere pressure: 70kPa-106kPa
4. Temperature of the water at the inlet: not higher than +25°C

Installation and ad·ustment

1. Product installation steps
2. Unpack the package, make sure that all the parts and accessories are complete according to the packing list, take the main unit out of the box, and put it on the stable plane facing to the operator.
3. Insert the plug of the foot switch to the socket.
4. Connect the handpiece (detachable) to the cable.
5. Install the tip on the handpiece and turn on the power switch to start operation.
6. The function instructions and the connection diagram
7. Power adjustment: The models with a potentiometer are adjusted by potentiometer, turn on/off the potentiometer to adjust the power; for the models with touch panel, power can be adjusted by finger touch.
8. Water adjustment: Water is adjusted by touch panel.

Instruction for main components of handpiece (showed in picture 2).

Instruction for using the wrench to install tip

a) The torque wrench’s structure is designed in special way which can control the strength of the scaling tip installation properly and correctly. It also can guarantee the operator screw or unscrew the scaling tip effectively and keep their hands away from being scratched.
b) Operation
Take the tip into the torque wrench then install or uninstall the scaling tip as picture 3 showed.
· Installation: Hold the handpiece and turn the tip toward clockwise direction with the torque wrench. Turn one more circle when the tip stops, then the tip is installed.
· Uninstallation: Hold the handpiece, turn the wrench toward anti-clockwise direction.

Note: The connection of handpiece (detachable) and the plug must be kept dry.

Function and operation

1. Scaling & periodontal treatment function

2. Turn on the power switch, the power indicator lighted and the machine is ready for work.

3. Choose the scaling tip according to the requirement, and fix the scaling tip with the wrench. ( see picture 3) Please select a suitable power when using different type of tips (refer to “TABLE OF OPERA TING POWER OF THE TIPS”).

4. The handpiece can be handled in the same gesture as a pen in hand.

5. Vibrating intensity: Adjust the vibrating intensity according to your need, usually adjust to the middle grade, and adjust the vibrating during the clinical treatment according to the patient’s sensitivity and the rigidity of the tartar.

6. Step on the foot switch, the tip begins to vibrate, and the LED lamp (model with LED) on the top of the handpiece lights up. Release the foot switch, the LED lamp keep shining for 10 seconds.

7. Under normal working condition, the frequency of the tips is very high, light touch and a certain to-and-fro motion will eliminate the tartar without obvious heating, overexertion and overstay are forbidden.

8. Water volume adjustment: Step on the foot switch, and the tip begins to vibrate, then turn the water control switch to fine spray to cool down the handpiece and clean the teeth.

9. After finishing operation, keep the machine working for 30 seconds with the water supply to clean the handpiece and the tip. 3.1.9 Unscrew the scaling tip and sterilize it.
   Note : Be sure not to make the end of the tip touch the teeth vertically, and not use too much force when the tip touching the surface of the teeth, in case of hurting the teeth and damaging the tip.
   Note : Don’t screw the scaling tips when stepping on the foot switch, while the machine is working.
   Note : When the water is lower than water level lower limit, please open the lid, fill the bottle with adequate purified water and cover the lid.

10. Endo function (root canal treatment)

11. Fix endochuck to handpiece by endo wrench (See Picture 4).

12. Unscrew the screw cap on the endochuck.

13. Put the ultrasonic file into the hole in the front of endochuck.

14. Screw the screw cap with endo wrench to tighten up the ultrasonic file.

15. Press option key, turn to endo function.

16. When ultrasonic scaler turns into endo function, only the first power indicator is on and the power is at the 1st grade. Put the ultrasonic file into the patient’s root canal slowly, step on the foot switch to start endo treatment. During the treatment, turn up the power gradually according to the needs.

Note:

• When fixing endochuck, it must be screwed down.
• The screw cap on the endochuck must be screwed down.
• Don’t press it too much when the ultrasonic file in root canal.
• Don’t step on the foot switch until the ultrasonic file is in root canal.
• The power range of endo treatment is advised from the 1st to the 5th grade.

Instruction for main components of detachable handpiece (Showed in

picture 2)

• Cap : The cap can be removed. You can screw out the cap and clean the pole with alcohol termly.
• Decorative ring: can be disassembled and cleaned with alcohol regularly, can be autoclaved under the high temperature and pressure.
• Handpiece : The main part of the whole hand piece, can be autoclaved under the high temperature and pressure.
• Symbol : Autoclaved (134°C, 0.22MPa)
• The connector of the cable : Connect the handpiece with the water source and power supply of the main unit.
• LED lamp, Light conductor (The models that the handpiece with LED lamp): Clean them with purified water and sterilize them under the high temperature of 134°C and high pressure of 0.22Mpa.
  Note: The connection of handpiece and the plug must be kept dry.

Cleaning, disinfection and sterilization

1. Please conform to the recommendations of the manual “Reprocessing Instructions of Cleaning, Disinfecting and Sterilizing” delivered with your product regarding the procedure of cleaning, disinfecting, sterilizing and packing of the components.

2. The handpiece (detachable), scaling tips, endo chuck, torque wrench, endo wrench, LED lamp and Light conductor (the handpiece with LED lamp) can be sterilized.
   Notice:

   • Clean the handpiece (detachable) with compressed air before sterilization.
   • Be sure that the scaling tip has been unscrewed from the handpiece and it cannot be sterilized with others.
   • Please notice whether the outer of the hand piece is damaged during the treatment and sterilization. Don’t smear any protective oil on the surface of handpiece.
   • There are two waterproof “O” rings at the end of the handpiece. Please lubricate them with dental lube frequently, as sterilization and repeated pulling and inserting will reduce their using life. Change a new one once it is damaged or worn excessively.
   • The following sterilizing methods are forbidden:
   • Boil in water.
   • Dip in iodine, alcohol and glutaraldehyde.
   • Bake in oven or microwave oven.
   • Notice : We are not responsible for any damage caused in the above items.

Trans ortation, stora e and maintenance

1. Transportation
2. Excessive impact and shake should be prevented in the transportation. Lay it carefully and lightly and don’t invert it. 6.1.2 Don’t put it together with dangerous goods during transportation.
3. Avoid solarization and getting wet in rain or snow during transportation.
4. Storage
5. Don’t store the machine together with the articles that are combustible, poisonous, caustic or explosive.
6. 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 – +40°C.
7. Maintenance
8. The equipment 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.
9. Please turn off the electrical source if not use it, if not use for a long time, please make the machine get through to the power and water once 3 months for five minutes.

Troubleshooting

If the problem still can’t be solved, please contact with local dealer or manufacturer.

Environmental protection

Please dispose according to the local laws.

EMC – declaration of conformit

Instructions for use
The ME EQUIPMENT or ME SYSTEM use in hospitals or dental clinics.

• Warning : Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• Warning : Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• Warning : Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Warning : Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  Note : The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

List of all cables

Replaceable accessories

Performance of the me equipment
Ultrasonic Scaler is used for cleaning and shaping the surface and root area on the teeth. If the measured field strength to which the ultrasonic scaler is located is above the applicable RF compliance level, the ultrasonic scaler should be observed to verify if the performance is in proper operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or repositioning the ultrasonic scaler.
When the me equipment’s essential performance is ineffective or degraded due to em disturbances, the doctor should immediately stop using it to ensure that there is no treatment error. And then remove the source of disturbances or adjust the direction or position of me equipment to ensure me equipment can be used in normal performance condition.

Technical description

1. Portable and mobile RF communications equipment may affect the performance of equipment , use of equipment should be avoided strong electromagnetic interference, and do not closer to mobile phone, microwave oven, etc.
2. Use of equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
3. Except for the cables sold by manufacturers of as spare parts of internal components, the use of accessories and cables other than those specified or provided by the manufacturer may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
4. Use of accessories, transducers and cables other than those specified or provided by the manufacturer together with equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Table 1

Table 2

Table 3

Table 4

Attachment 1. Table of operating power of the tips (Compatible with SATELEC)

Attachment 2. Reprocessing instructions of cleaning, disinfecting and sterilizing

Beginning work

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.
2. To prevent injury to people and damage to property, please heed the corresponding directives.
3. The instructions in this manual are only applicable to the product which it was delivered with.

Introduction

1. These reprocessing instructions provide instructions for cleaning, disinfection, sterilization and packaging of manufacturer reusable products intended to be reprocessed in medical facilities.
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 products are based on the potential risk of infection associated with their use.
3. It is recommended to use steam sterilization.
4. Remember that sterilization or high-level disinfection cannot be achieved unless the elements of the assembly are cleaned first.
5. If you find that the reprocessing instructions from the manufacturer seem to be inadequate, please inform manufacturer about those inadequacies.
6. We encourage you to report adverse events related to device reprocessing. Report such events directly to manufacturer.

Processing – instructions for reusable products
The instructions are binding for the reprocessing of all reusable products (Here after called “products”) of manufacturer. When necessary, additional product-specific instructions are included with the product to provide additional information. Important: Before use, carefully read the operating instructions of the manufacturer instrument and devices with which the product will be used. Reusable products must be cleaned, disinfected and sterilized prior to first use. They must be replaced after the number of operations specified by the manufacturer. Disposable products (single use) cannot be reused.

Preparation – basic principles

1. It 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.
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.
   Reprocessing procedures have only limited implications to this product. The limitation of the number of reprocessing procedures is therefore determined by number of operations specified by the manufacturer. From the processing side there is no maximum number of allowable reprocessing.

ln case of damage the product should be reprocessed before sending back to the manufacturer for repair.

Preparation at the point of use
Disconnect product. Remove gross soiling of the instrument 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 products in a humid surrounding.

Transportation
Safe storage and transportation to the reprocessing area to avoid any damage and contamination to the environment.

Preparation for decontamination
The products must be reprocessed in a disassembled state, as far as possible.

Pre-cleanin
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.

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 ISO 15883 series.
Put the instrument into the machine on a tray. Connect the instrument with the WO 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% neither MediClean forte (Dr. Weigert).

Acc. ta EN ISO 17664 no manual reprocessing methods are required for these devices. If a manual reprocessing method has to be used, please validate it prior to use.

Disinfection
Automated Thermal Disinfection in washer/disinfector under consideration of national requirements in regards to AO value (see EN 15883).
A disinfection cycle of 5 min disinfection at 93°C has been validated for the product to achieve an AO value of 3000.

Dring
Automated Drying:
Drying of outside of instrument through drying cycle of washer/ disinfector. If needed, additional manual drying can be performed through lint free towel. insufflate cavities of products by using sterile compressed air.

Functional testing, maintenance
Visual inspection for cleanliness of the products and reassembling if required. Functional testing according to instructions of use. If necessary, perform reprocessing process again until the instrument is visibly clean.
Before packaging and autoclaving, make sure that the products have been maintained acc. to the manufacturer’s instructions.

Packaging
Pack the products in an appropriate packaging material for sterilization. The packaging material and system refer to EN ISO 11607.

Sterilization
Sterilization of products by applying a fractionated pre-vacuum steam sterilization process (according to EN 285/EN 13060/EN ISO 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:

• Remove the product from the autoclave.

• Let the product 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), taking into account the specific product geometry as part of the validation.

Storage
Storage of sterilized products in a dry, clean and dust free environment at modest temperatures, refer to label and instructions for use.

Service life

• The products have been designed for a large number of 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. If 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 devices may not be exposed to temperatures above 138 oc.
• It is the duty of the user to ensure that the reprocessing processes including resources, materials and personnel are capable to reach the required results. State of the art and often national law requiring these processes and included resources to be validated and maintained properly.

Note: We reserve the rights to change the design of the equipment, the technique, fittings, the instruction manual and the content of the original packing list at any time without notice. If there are some differences between blueprint and real equipment, take the real equipment as the norm.

• Shelf life : 10 years, the date of manufacture see product label.
• Website : http://www.alandental.com

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