REFINE RF-UST-M004 Ulltrasonic Scaler Tip Instruction Manual

Contraindications

1. The hemophilia patient is forbidden to use this equipment.
2. The patients or doctors with heart pacemaker are forbidden to use this equipment.
3. The heart disease patient, pregnant woman and children should be cautious to use the equipment.

Compatibility Descriptions

1. Gx, GxT (x: 1-999)Female screw series for Scaling .
2. Px, PxL, PxR, PxLT, PxRT, PxLDT, PxRDT, PxLD, PxRD, PxD, PxT, PxDT (x: 1-999) Female screw series for Perio.
3. Ex, ExD, ExT, ExDT (x: 1-999) Female screw series for Endo .
4. GDx, GDxT (x: 1-999) Female screw series for Scaling.
5. PDx, PDxD, PDxT, PDxL, PDxR, PDxLT, PDxRT, PDxLDT, PDxRDT, PDxLD, PDxRD, PDxDT (x: 1-999) Female screw series for Perio.
6. EDx, EDxD, EDxT, EDxDT (x: 1-999) Female screw series for Endo.
7. GSx (x:1-999) Male screw series for Scaling.
8. PSx, PSxD (x:1-999) Male screw series for Perio.
9. ESx, ESxT, ESxD, ESxDT (x: 1-999)Male screw series for Endo
10. GCx, GKx (x: 1-999)Male screw series for Scaling.
11. EKx (x:1-999) Male screw series for Endo.
12. Ax, AxT (x:1-999)Amdent series of scaler tip.
13. SBx, SBxT, SBxR, SBxL, SBxRT, SBxLT(x: 1-999) Female screw series for Cavity Preparation.
14. SBDx, SBDxT, SBDxR, SBDxL, SBDxRT, SBDxLT(x: 1-999)Female screw series for Cavity Preparation. 15.SBSx(x: 1-999),SBSL, SBSR: Male screw series for Cavity Preparation.
15. USx, USxL, USxR , ULx , UCx , UPx , UEx , Ulx (x: 1-999) Oral Surgery series tips.
16. 201, 202, 203:Female screw series for Scaling.
17. ETx (x: 1-999)Female screw series for Endo .
18. ExD-S(x: 1-999)Female screw series for Endo.
19. Sx (x: 1-999)Female screw series for Scaling.
20. PCx(x: 1-999)Female screw series for Scaling, .

Instructions of Use

1. Scaling,Cavity Preparation tips should work with Scaling function on the Ultrasonic Scaler. Perio tips should work with Perio function on the scaler. Endo tips should work with Endo function on the scaler.
2. Select suitable tip according to operation needs, install on the handpiece tightly by torque wrench.
3. Turn on the Ultrasonic scaler for operation. During operation, do not let the scaler tip contact the teeth surface with vertical direction, do not press too hard in case of damaging the teeth or damaging the tip.
4. After operation, rinse the tip and handpiece by letting the scaler work 30 seconds with water, uninstall the tip and handpiece for sterilization.

Precautions

1. Make sure the tip installed on the handpiece tightly and spray well during operation.
2. Scaler tip must be cleaned, disinfected and sterilized before each use, please conform to the recommendations of the manual in attachment 1″Reprocessing Instructions of Cleaning, Disinfecting And Sterilizing”.
3. The following sterilizing methods are forbidden: -Boil in water. -Dip in iodine, alcohol and glutaraldehyde. -Bake in oven or microwave oven.
4. The maximum cleaning, disinfection and sterilization cycles of Ultrasonic Scaler Tip are identified as 300 cycles.
5. Do not bend nor polish the tip.
6. After the golden color coated tips have contacted with Oxidizing solution such as H202 or NaClO, please use clean water to rinse the tip.

< Storage>
The tip should be stored in a clean, dry, ventilated, relative humidity of 10% to 93%, atmospheric pressure of 70kPa 106kPa, temperature of -20°C +40°C non-:orrosive gas indoor environment.
< Environmental protection>
The product doesn’t contain battery or toxic substances. And there are no components which should be removed specially from the main unit for disposal and scrapping. After the device is out of its service life, you must not discard it in domestic household waste. Please comply with the Waste Electrical and Electronic Equipment (WEEE) directives and the medical waste disposal regulations of your country.
Tips, end chuck, torque wrench, endo wrench and iandpiece, those which could easily contact to the oiological sources and cause biological hazards, shall De detached from the main unit and reprocessed fore the disposal and scrapping. Tips and endochucks are sharp instruments and easy to scratch people. Should you dispose it in the medical waste containers for sharp instruments.

Symbol instruction

| Caution
---|---
| Refer to instruction manual/booklet
| Manufacturer
| Date of manufacture
| Handle with care
| Keep dry
| For indoor use only
| Con be autoclaved

| Recovery
| Atmospheric pressure for storage 70kPa-106kPa
| Temperature limitation -20° C-+40° C
| Humidity limitation 10%-93%
| lot number
| Medical device
| CE marking with identification number of the Notified Body
| Authorized representative in the European Community
| Green: No Wear-Tip is OK Tip replacement is not necessary
| Yellow: Wear of 1mm-Tip is showing some wear Tip replacement is not necessary
| Red: Wear of 2 mm-Tip is badly worn Tip replacement is necessary
| Effective length

Attachment 1 (Reprocessing instructions of cleaning, disinfecting and sterilizing)

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

2. Introduction
   2.1 These reprocessing instructions provide instructions for cleaning, disinfection, sterilization and packaging of manufacturer reusable products intended to be reprocessed in medical facilities.
   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.
   2.3 It is recommended to use steam sterilization.
   2.4 Remember that sterilization or high-level disinfection cannot be achieved unless the elements of the assembly are cleaned first.
   2.5 If you find that the reprocessing instructions from the manufacturer seem to be inadequate, please inform manufacturer about those inadequacies.
   2.6 We encourage you to report adverse events related to device reprocessing. Report such events directly to manufacturer.

3. Reprocessing – instructions for reusable products
   3.1 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. Ab,
   Important: Before use, carefully read the operating instructions of the manufacturer instrument and devices with which the product will be used.
   3.2 Reusable products 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. et In case of damage the product should be reprocessed before sending back to the manufacturer for repair.

4. Preparation – basic principles
   4.1 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.
   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.

5. Preparation at the point of use Disconnect product. Remove gross soiling of the products with cold water (<40 ° C) immediately after use. Dorf 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.

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

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

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.

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 15015883 series. Put the products 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% neodisher MediClean forte (Dr. Weigert). &Am. to 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.

10. 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.

11. Drying Automated Drying: Drying of outside of products at 40 °C , 5 min through drying cycle of washer/disinfector. If needed, additional manual drying can be performed through lint free towel. Insufflate cavities of products by using tercile compressed air.

12. 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 products is visibly clean. Before packaging and autoclaving, make sure that the products have been maintained acc. to manufacturer’s instruction.

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

14. 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 o suitable drying time, depending on the autoclave and load. Refer to the autoclave’s instructions for use.
    After sterilization:
    a. Remove the product from the autoclave.
    b. 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. Z6,
    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.
    Maximum sterilization temperature 138° C

15. Storage 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. If it is exceeded, it should be reprocessed before use.

16. 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 (alkaling 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 °C. 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.

GUILIN REFINE MEDICAL INSTRUMENT CO.,LTD.
No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, 541004 Guilin, Guangxi, PEOPLE’S REPUBLIC OF CHINA

Tel:+86-773-7796686
Fax: +86-773-7796686
E-mail: refine@refine-med.com
Website: http://www.refine-med.com
MedNet EC-REP C Ilb GmbH Borkstrasse10,48163Minster,Germany
Service life: 5 years
RF-UST-M004 Version:1.7 20240308
https://www.alandental.com

References

• Dental Instruments Australia |Dental Equipment Supplies For Sale - Alandental.com

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