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Summary of Contents for SAESHIN Implant X Cube i
- Page 1 USER MANUAL www.saeshin.com...
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Page 2: Table Of Contents
CONTENTS - INTRODUCTION - USER GUIDELINES - PRODUCT FEATURES & ADVANTAGES - PRODUCT COMPONENTS - PART NAME OF CONTROL BOX - BUTTONS ON THE OPERATION PANEL - LCD WINDOW - CONNECTION OF EACH PART - OPERATION PROCESS - MAINTENANCE OF THE PRODUCT - ATTENTION - PRODUCT SPECIFICATION - ELECTROMAGNETIC COMPATIBILITY INFORMATION... -
Page 3: Introduction
INTRODUCTION This product is medical device. Please make sure to read this manual before using. This manual is to assure proper installation and usage. Pay attention when reading the manual in order to properly use this product and to assure prolonged lifespan of the product. Specifically, pay attention to the contents with marks such as <User>... -
Page 4: User Guidelines
USER GUIDELINES CAUTION ● Please pay attention when using to consider the patient’s safety most importantly. ● Check the condition of the product before use. ● Stop using and inspect the product when an abnormal sign occurs such as calescence, vibration or noise before or during operation. ●... - Page 5 WARNING ● Please watch old person, children, or disabled person near the place that the product is installed. If so, do not let them alone. ● Do not drop or damage the motor. In case of malfunction, dropping or falling in water, do not use it and contact the manufacturer. ●...
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Page 6: Product Features & Advantages
PRODUCT FEATURES & ADVANTAGES <DC motor designed by SAESHIN’s own technology and know-how> - Provide the optimized performance by DC motor and standard angle handpiece. * RPM: 30 ~ 1,500 rpm - The free-running speed of the handpieces shall be in accordance with the manufacturer’s instructions at a tolerance of ±10 % as specified. -
Page 7: Part Name Of Control Box
PART NAME OF CONTROL BOX IRRIGATION PUMP HANGER FOOT CONTROLLER CONNECTOR MAIN POWER SWITCH LCD DISPALY FUSE BOX MAIN POWER SOCKET MOTOR CONNECTOR OPERATION DIRECTION BUTTON PROGRAM BUTTON MEMORY / GEAR BUTTON SPEED BUTTON IRRIGATION BUTTON TORQUE BUTTON BUTTONS ON THE OPERATION PANEL Program button : This is used for selecting the memorized program number. -
Page 8: Lcd Window
LCD WINDOW 1. Program number display : It shows current set of program number. It display PRG:1 to PRG:3 and can save 3 programs. After restart the device, it displays the last selected program. 2. Operation direction display : It shows the selected direction •... - Page 9 1. Motor cord connection 2. Foot controller connection 3. Power cord connection Insert the motor connector. Insert the foot controller connector. Insert the power cord into the power Check if the holes and pins of motor Check if the holes and pins of foot socket in the back of the control box.
- Page 10 6. Irrigation tube insertion 5. Hanger setting : Put the hanger into the hanger : Insert the irrigation tube needle into the bottle and place with the bottle downward. hole on the top side of the Lock the irrigation stopper and put it between the irrigation tube needle and bottle. control box.
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Page 11: Operation Process
OPERATION PROCESS 1. Turn on the main switch. When you turn on the device, the last program you used is set in the standby mode. 2. Press the operation direction button ( ) on the control box to select the operation direction. Operation direction is forward and reverse. -
Page 12: Maintenance Of The Product
■ Fuse replacement - Check the fuse if the control box doesn’t work. - If necessary contact your dealer. MAINTENANCE OF THE PRODUCT 1. Cleaning 1) Angle handpiece ① Rotate the head in tap water for about 10 seconds with maximum speed to remove the remains (blood, physiologic saline solution, etc.) and rinse. -
Page 13: Attention
ATTENTION 1. Please read the notice below before operating the product. ① Check the connection of all cords and correct operation when powering-on. ② Check if the ground connection is safe. ③ Make sure to check any contact part to patient. ④... -
Page 14: Electromagnetic Compatibility Information
ELECTROMAGNETIC COMPATIBILITY INFORMATION In IEC/EN 60601-1-2 4th edition. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generate, use and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. - Page 15 Electromagnetic Immunity The X-CUBE i is intended for use in the electromagnetic environment specified below. The customer or the user of the X-CUBE i should assure that is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment –...
- Page 16 Cables and accessories Maximum length Shield Complies with Handpiece cord 1.7 M Unshielded RF emissions, CISPR11 Class A / Group 1 Foot controller cord 1.7 M Unshielded IEC 61000-3-2 Harmonic emissions EN 61000-3-2 AC power cord 1.7 M Unshielded IEC 61000-3-3 Voltage fluctuations / flicker EN 61000-3-3 emissions...
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Page 17: Warranty
1) The translated manual will be supplied by manufacturer on demand. 2) Saeshin will send the translated manual with an English manual to the import company to review the translated manual. 3) After getting feedback from the import company, Saeshin will offer a final version of the manual. - Page 18 MEMO...
- Page 19 MEMO...
- Page 20 This product is the medical device. 1639 MERIDIUS MEDICAL EUROPE LIMITED Unit 3D, North Point House North point Business Park New Mallow Road CORK, T23AT2P, Ireland +353 212066448 Tel. 82-53-587-2341 / Fax. 82-53-580-0999 SOM-S044S-E Rev.0 2023-01-31 www.saeshin.com / traus@saeshin.com...
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