Related Manuals for Eighteeth Ultra X
Summary of Contents for Eighteeth Ultra X
- Page 1 Ultrasonic Activator Ultra USER MANUAL Changzhou Sifary Medical Technology Co.,Ltd.
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Page 2: Table Of Contents
Symbols Used ............................. 5 Before Use ............................6 Scope of application ......................6 Contraindications ......................6 Setting up the Ultra X ........................8 Installing the sleeve ......................8 Installing the tip ......................... 8 Tip Removal ........................8 Connecting the adapter ....................9 Use Interface ............................. -
Page 3: Scope Of Ultra X
1 Scope of Ultra X Scope of Ultra X Parts Identification Accessories list 1. Tips(6pcs) 2. Wrench 3. Insulating sleeve 4. Ultra X handpiece 5. Adapter 6. Handpiece Base Page 3 / 28... -
Page 4: Components And Accessories
1 Scope of Ultra X Components and Accessories Ultra X handpiece (1pcs) Tip: S21(1 pcs) Tip: G18 (1 pcs) ORDER CODE: 6251001 ORDER CODE: 6251041 ORDER CODE: 6251042 Tip: B18 (1 pcs) Insulating sleeve (1 pcs) Adapter (1 pcs) ORDER CODE: 6251043... -
Page 5: Symbols Used
2 Symbols Used Symbols Used If the instructions are not followed properly, operation may lead to hazards for the product or the user/patient. Additional information, explanation of operation and performance. Serial number Catalogue number Manufacturer Date of manufacture Class II equipment Type B applied part CE marking Direct current... -
Page 6: Before Use
Before Use Scope of application Ultra X is used in endodontic treatment by application of ultrasonic energy. The Ultra X can provide the energy for tip oscillation and vibration in frequency (45KHz+5KHz) required to create sufficient acoustical streaming and cavitation necessary to effectively clean, penetrate, and remove vapor lock. - Page 7 3 Before Use cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Do not charge, operate or store at high temperatures. Comply with the specified operating and storage conditions. 4. Gloves and a rubber dam are compulsory during treatment. 5.
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Page 8: Setting Up The Ultra X
4 Setting up the Ultra X Setting up the Ultra X When you set the tip on the device, the Installing the sleeve tip can be set within a range of 10° , therefore, do not tighten the tip in Always use a silicone sleeve. -
Page 9: Connecting The Adapter
4 Setting up the Ultra X Connecting Handpiece base is recommended to be adapter used to place the Ultra X to protect the tip when the device is not in use. Connect the USB cable to the handpiece power connector, and plug the other end into a power outlet. -
Page 10: Use Interface
LOW OUTPUT POWER MODE Turn Power Off Press to turn off the output during working. The Ultra X will turn off the output and enters the standby state. The Ultra X will shut down after 1 minute of standby automatically. -
Page 11: Operation
6 Operation Operation Charge Power LED light up in “GREEN” Battery power is >50%. Power LED light up in “YELLOW” Battery power is 15%~50%. Battery power is <15%. Power LED light up in “RED” If the power is less than 15%, the device must be recharged within 30 days, otherwise the battery will be damaged. - Page 12 6 Operation Connect the adapter to the handpiece. NOTE Only the original adapter can be used. Charging indication appears on the power LED, and flashes in “YELLOW”(③), when the battery is fully charged or in a state near full charge, the flash will stop and light up in “GREEN”...
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Page 13: Operation
1s during working, you can switch the output power in cycle. Turn off the device: Press on main switch to turn off the device. The Ultra X will turn off the output and enters the standby state. The Ultra X will shut down after 1 minute of standby automatically. - Page 14 In addition, the machine has a timed reminder function, and there is a beep every 5s during the work. Use the Ultra X outside the oral cavity to make sure that the device is functioning properly. Replace the tip on time to avoid file separation within the canal. Tips may separate because of metal fatigue.
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Page 15: Cleaning, Disinfection And Sterilization
Cleaning, Disinfection and Sterilization Foreword For hygiene and sanitary safety purpose, the components (Tips, Wrench, and Insulating sleeve) must be cleaned, disinfected and sterilized before each usage to prevent any contamination. This concerns the first use as well as the subsequent uses. - Page 16 Remove and disconnect the components (Tips, Wrench, and Insulating sleeve) before cleaning. Refer to "Chapter 4- Setting up the Preparation Ultra X" of this manual for disassembly before cleaning instructions. Observe suitable personal protective measures.
- Page 17 min; Cleaning: water temperature 45℃, 5 min; use an enzyme detergent solution (mild and aldehyde free solution) which is suitable used with washer- disinfector, and use in accordance with detergent solution manufacturer; Rinsing: water temperature 45℃, 1 min (rinsing twice). Disinfection: Thermal disinfection at least 5 min at 90℃...
- Page 18 Sterilization Steam sterilization at 134 ℃ at least 6 minutes. Minimum drying time after sterilization: 10 minutes. Use only approved autoclave devices according to EN 13060 or EN 285. Use a validated sterilization procedure according to ISO 17665. ...
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Page 19: Disinfection Components
The instructions provided above have been validated by the manufacturer of the medical device as being capable of preparing a medical device for use. It remains the responsibility of the processor to ensure that the processing, as actually performed using equipment, materials and personnel in the processing facility, achieves the desired result. -
Page 20: Error Warning
Error Warning The device stops working and beeping with Power LED The power is very low. Charge it immediately flashes in red. The main board is broken. Please stop using the Power LED lights up in device immediately and remove the battery. “BLUE”... -
Page 21: Troubleshooting
Troubleshooting When trouble is found, check the following points before contacting your distributor. If none of these are applicable or the trouble is not remedied even after action has been taken, the product may have failed. Contact your distributor. Ref. Problem Cause Solution... -
Page 22: Technical Data
Technical Data Manufacturer Changzhou Sifary Medical Technology Co., Ltd. Model Ultra X Dimensions 22cm x 18cm x 7 cm +1cm (package) Weight 750g+10% Power supply Lithium ion battery: 3.7V, 1500mAh +10% Charger power supply AC100-240V,+10% Charger power output Frequency 50/60Hz,+10% Charger nominal power 5.5VA... -
Page 23: Emc Tables
Guidance and manufacturer’s declaration – electromagnetic emissions The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. Emissions test... - Page 24 Guidance and manufacturer’s declaration – electromagnetic immunity The Ultra X is intended for use in the electromagnetic environment specified below. The customer or the user of the Ultra X should assure that it is used in such an environment. IEC 60601 test...
- Page 25 The Ultra X has been tested with the immunity test level in the below table and meet the related requirements of IEC 60601-1-2:2014. The customer and/or user should help keep a minimum distance between RF wireless communications equipments and the Ultra X as recommended below.
- Page 26 Remark Adapter Cable 2. Use of Ultra X adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Ultra X and the other equipment should be observed to verify that they are operating normally.
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Page 27: Statement
Statement Service Life The service life of Ultra X handpiece is 3 years. Disposal The package should be recycled. Metal parts of the device are disposed as scrap metal. Synthetic materials, electrical components, and printed circuit boards are disposed as electrical scrap. The lithium batteries are disposed as special refuse. - Page 28 Add: NO.99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, 213000 Jiangsu, China Tel: +86-0519-85962691 Fax: +86-0519-85962691 Email: ivy@sifary.com Web: www.eighteeth.com Llins Service & Consulting GmbH Tel: +49 175 4870819 Add: Obere Seegasse 34/2, 69124, Heidelberg, Germany Email： Llins.Service@gmail.com Version: 02 6235001 Issued: Nov.