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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          ,            and          .

 

<User>

 Qualified Professional

<Intended use>

 Engine that power the implant handpiece in dental implant procedure.

<Classification of equipment>

 

 

Type of protection against electric shock: Class I equipment

Product Name: Dental Implant Engine Set

               - To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

 Degree of protection against electric shock: Type BF applied part 

 Classification according to the degree of protection against ingress of water as detailed in the current edition of IEC 60529:

    - Control Box: IPX0

    - Foot Controller: IPX8

 Not suitable product to use where there exist flammable anesthetic mixture with air or with oxygen.

 User sterile product (non-sterile product at shipment)

 Classification according to mode of operation: Intermittent ope

- Control Box: Continuous operation

- Handpiece : Non-Continuous operation (Loading time: 1 minute, Resting time: 10 minutes)

ration

 Applied parts: Bur

<Operation & Storage condition>

Operating condition

Transport and storage condition

Temperature (℃

)

Relative humidity (%)

Atmospheric pressure (hPa)

Temperature (℃

)

Relative humidity (%)

Atmospheric pressure (hPa)

10~35

10~80

700~1,060

-20~60

10~90

500~1,060

Summary of Contents for Implant X Cube i

Page 1: ...USER MANUAL www saeshin com...

Page 2: ...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 E...

Page 3: ...a supply mains with protective earth Degree of protection against electric shock Type BF applied part Classification according to the degree of protection against ingress of water as detailed in the c...

Page 4: ...the irrigation tube as a medical waste after use Contact manufacturer if an incorrect display appears on the screen Do not drop or bang the product Do not damage the irrigation tube as it will not wor...

Page 5: ...e Unauthorized modification and dismantling is prohibited Do not use a solvent such as thinner or benzene for cleaning Please use an absorbent or alcohol to wipe the controller box Do not wipe with we...

Page 6: ...on the bur is higher than set torque the motor will stop automatically and an Error message will be displayed To release the overload function release the foot controller Beep sound function When usin...

Page 7: ...reverse direction A beep sound is heard during rotation in reverse direction Memory button Keep pressing this button for 2 seconds after completed setting program program is memorized with beep sound...

Page 8: ...n the device is paused It reaches the set RPM when the foot controller is fully activated 4 Torque display It shows the setup torque value If an actual load is higher than set torque value the set tor...

Page 9: ...w in the connector lock Open the pump roller cover Close the pump roller cover Make sure the irrigation tube is located correctly when close the pump roller cover Make sure the pump roller cover is co...

Page 10: ...he internal and external irrigation are available by the Y connector tube Connect the accessories as in the picture according to the bur using and the surgery type Put the motor cord and irrigation tu...

Page 11: ...controller Irrigation pump operates when the irrigation pump button is on Program setting 1 Press the program button on the control box to select the program number Program number increases each 1 sta...

Page 12: ...over all surfaces with alcohol towelettes 70 Isopropyl Repeat wipe over three times Pay attention to not let water enter the motor Do not submerge the product in detergent It may cause malfunction 3...

Page 13: ...oper action Do not let patient approach or touch the product 3 Please read the notice below after operating the product Do not put any physical pressure on the all cords 4 When the products are not us...

Page 14: ...pplies domestic environment This is a class A product In a domestic environment this product may cause radio interference in which case the user may be required to take adequate measures Electromagnet...

Page 15: ...d 1 2 P 80MHz to 800MHz d 2 3 P 800MHz to 2 7GHz Where P is the maximum output power rating of the transmitter in watt W according to the transmitter manufacturer d is the recommended separation dista...

Page 16: ...nd voltage vvariations on power supply input lines Power frequency 50 60Hz magnetic field Conducted RF Radiated RF Handpiece cord Foot controller cord AC power cord 1 7 M 1 7 M 1 7 M Unshielded Unshie...

Page 17: ...ng Use not recommended consumables or accessories Malfunction after repairing the product at an unauthorized repair shop Normal wear of consumables such as ball bearings gear chuck spindle case assy m...

Page 18: ...18 MEMO...

Page 19: ...19 MEMO...

Page 20: ...uct is the medical device 1639 Tel 82 53 587 2341 Fax 82 53 580 0999 www saeshin com traus saeshin com MERIDIUS MEDICAL EUROPE LIMITED Unit 3D North Point House North point Business Park New Mallow Ro...

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