X-CUBE User Manual Rev1
X-CUBE User Manual Rev1
www.saeshin.com
CONTENTS
· INTRODUCTION
· USER GUIDELINES
· PRODUCT COMPONENTS
· LCD WINDOW
· OPERATION PROCESS
· ATTENTION
· PRODUCT SPECIFICATION
· WARRANTY
· SYMBOL
INTRODUCTION
Pay attention to read this user manual in order to making the best use of this product and to assure the
<User>
· Qualified Professional
<Intended purpose>
· The X-CUBE is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics
for treatment of dental hard tissue and mechanical rotating root canal preparation.
<Classification of equipment>
· Classification according to the degree of protection against ingress of water as detailed in the current
edition of IEC 60529
- Control Box : IPX 0
- Foot Controller : IPX 8
· Not suitable product in the atmosphere that exist flammable anesthetic mixture with air or with oxygen.
<Use time>
1
USER GUIDELINES
CAUTION
● Please pay attention to the use considering the patient’s safety first of all.
● Stop to use and inspect the product when an abnormal sign such as calescence, vibration or noise occurs
● Please contact manufacturer if cannot find reason of problem, or cannot solve the problem.
● Prepare extra consumables before use for safety because blood or physiological saline might flow into the
● Change or insert bur after the motor is completely stopped. Otherwise, inside of the angle could be
● Please sterilize and lubricate the angle handpiece right after use. Otherwise, the product could be damaged
● The control box and foot controller are not steam sterilization objects.
● Do not give any damage to irrigation tube, it will not work normally due to the tube is broken or taken off.
● Do not insert oil into BLDC motor. It will damage bearing or cause calescence.
● Use the regulated products and consumables by manufacturer. Otherwise there might be a risk of an
accident or failure.
● Replace the motor cord immediately when it is worn out or damaged to prevent electric shock for user or
patient.
● The company did not sterilize the product. Please be sure to sterilize before operation. (User sterilization)
2
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 angle handpiece. In case of malfunction, dropping, or dropping in water, do not
use it and contact the manufacturer. (It may cause vibration of bur, overheating, or damage of the bearings.)
● The equipment is automatically stopped when the machine load is higher than Torque value.
PROHIBITION
● Do not use damaged or broken power cord, plug, and outlet. It may cause fire and electric shock.
● When unplug the power cord, hold the plug and do not touch with wet hand.
Do not use loose power cord, it may cause electric shock and fire.
● Do not damage to power cord (do not bend too hard, do not put heavy objects on it). It may cause
electric shock and fire.
● Do not place the product near heat equipment, and do not put candles or cigarette on it.
● Please use a grounded plug. Contact to electrician or manufacturer to ask how to grounding.
● Keep the recommended speed limit by manufacturer of bur to use bur. If exceed the speed limit, it might
cause an accident.
● The product must be used by specialist or expert. If not, patient might get burn or damage by improper use.
● Do not use the product to patient with cardiac pacemaker because the product may disturb the performance
of cardiac pacemaker.
● If patient is taking antibiotics, patient needs to consult with doctor before operation.
● Keep away from fire or heat when using spray containing flammable material.
● Manufacturer does not have any responsibility for defects or loss of property in cases below.
1. User did not follow the instruction manual to use the product.
2. Used the product in the place of unregulated wire condition.
3. Unauthorized person repaired or assembled the product.
4. Did not follow the instruction manual to keep the product.
3
PRODUCT FEATURES & ACVANTAGES
- Provide the optimized performance by BLDC motor (0~50,000rpm) and Angle handpiece of several kinds.
* RPM
1:4 1:5 1:1 16:1 20:1 27:1 32:1 64:1
200,000rpm 250,000rpm 50,000rpm 3,100rpm 2,500rpm 1,850rpm 1,560rpm 780rpm
* The free-running speed of the handpieces shall be in accordance with the manufacturer’s instructions
at a tolerance of ±10 % as specified. (Refer to ISO 14457)
* Torque
1:4 1:5 1:1 16:1 20:1 27:1 32:1 64:1
**N·cm **N·cm **N·cm 5~50N·cm 5~55N·cm 5~60N·cm 5~65N·cm 5~65N·cm
* Gear Ratio: 1:4, 1:5, 1:1, 16:1, 20:1, 27:1, 32:1, 64:1
- 9 programmable memories for setting speed, gear ratio, torque, rotating direction, irrigation pump.
- If the load on the bur is higher than set torque, the motor is stopped automatically.
- For releasing the overload function, Release the foot controller.
- Actual RPM and Torque value are displayed on the screen. It makes user can do more delicate operation.
- Foot controller is designed ergonomically to control all the functions. And it provides high convenience.
- Motor auto-calibration function is that control box check the angle handpiece status to reconcile speed
and torque that user wants with angle handpiece for accurate and safe operation.
1. Set the program number at ‘0’. The program changes to calibration mode.
2. Push the foot controller to the end. The calibration starts and the display show the calibration process.
3. During normal operation, the calibration will be completed after 5~10 seconds with ‘Success! Calibration OK’
on the screen and beep sounds.
4. When it is completed, Use the product.
* The function is set up when the product is released by manufacturer and Use the function when
user repair or change the product.
* Program 0 is the only for auto-calibration function, so the memory function or other setting
value does not work.
4
PRODUCT COMPONENTS
1 9
2 10
3 11
4 12
5 13
6 14
7 15
5
PART NAME OF CONTROL BOX
Hanger
Irrigation pump
Fuse box
Memory button
Speed button
6
BUTTONS ON THE OPERATION PANEL
Program button
: Use for selecting the set program number. (+) button for 1 stage up and (-) button
for 1 stage down.
Speed button
: Use for setting the speed (RPM).
(+) button for 1 stage up and (-) button for 1 stage down. Keep pressing speed button
to change the stage rapidly.
* The setting range of speed is different from the gear ratio.
Torque button
: Use for setting the torque according to the various use such as drilling or tapping.
(+) button for 1 stage up and (-) button for 1 stage down.
* The setting range of torque is different from the gear ratio.
Memory button
: Keep pressing memory button after completed setting. Then the condition is memorized
with beep sound.
7
LCD WINDOW
4. Direction display
: It shows the selected direction.
* Impact to device and drop the device may cause breakage of LCD.
8
BUTTONS ON THE FOOT CONTROLLER
1. Program button
: Select the program. Each press increases 1 stage.
9
CONNECTION OF EACH PART
* When connect the motor and foot controller, please make sure the power is off.
(Otherwise, it might cause malfunction.)
Please insert the motor connector. Check the hole and pins of motor
connector are in place. Then screw the Connector Lock.
Connector Lock
Please insert the foot controller connector. Check the hole and pins of
foot controller connector are in place. Then screw the Connector Lock.
Connector Lock
10
Power Cord Connection
Turn the open-close knob clockwise in the back of control box, and pump cover
opens and can see the space between the covers. Then insert the irrigation tube
into the space.
11
Bottle Setting
Put the hanger into the hanger hole in the back of control box.
Hang the saline solution pack on the hanger.
Insert the irrigation tube needle to the bottle in place with the bottle downward.
Lock the irrigation stopper and put it between the irrigation tube needle and bottle.
* If the pump operates while the tube is bent or the water does not come out,
the tube may be broken or damaged.
Do not install the irrigation tube on the control box or beside of the membrane.
It may cause the damage of product.
(O) (X)
12
Irrigation Nozzle Connection
Y-connector tube
Tube clamp
Internal spray nozzle
The internal and external irrigation are available by the Y-connector tube.
Connect the accessories like the picture according to the using bur and surgery type.
* If the user did not remove the internal spray nozzle and press the button or
open the lever when replace the bur, the nozzle may be damaged.
Irrigation tube
Put the motor cord and irrigation tube
together with tube holders.
Tube Holder Insert the tube holder to the motor cord
and then put the irrigation tube for easy
Motor cord work.
13
OPERATION PROCESS
Press the button on the foot controller or button on the control box to reverse direction.
In reverse direction mode, the device will sound beep sound, and it continues during the operation.
(If one more press the button, it is changed to forward direction mode.)
14
Program Setting
ex)
Complete
Complete
If the motor is stopped due to the overload, user’s error and etc., circuit safety system cuts the power
supply and shows an error code on LCD window.
15
MAINTENANCE OF THE PRODUCT
Fuse Change
Check the fuse if the control box doesn’t work. Contact your dealer.
Fuse box
Fuse
1. Cleaning
■ Angle Handpiece
① Rotate the head in a tap water about 10 seconds with maximum speed to remove the remains
(blood, physiologic saline solution, etc.) and rinse.
※ Do not put the tap water in the motor.
③ Remove contaminants on the angle handpiece using a nylon brush after soaking for 20 minutes
in Enzymatic Detergent.
④ Rinse the angle handpiece using the tap water for 3 minutes to remove Enzymatic Detergent.
⑤ Wash the angle handpiece for 10 minutes in the ultrasonic cleaner containing Enzymatic
Detergent.
⑥ Rinse the angle handpiece for 3 minutes in the ultrasonic cleaner containing purified water
repeatedly subjected 3 times. (Change the purified water each time.)
⑦ Wipe using dust-absorbent after the product soaked in alcohol(70%) for 30 seconds.
■ Motor
Wipe the surface of motor with alcohol swab or paper towel after removing the dirt.
16
2. Sterilization
Sterilization method
① Dry the applicable products completely after cleaning.
② Put the applicable products in a sterile bag and seal tightly.
※ Make sure to assemble the motor cap for autoclave on the motor. 132
※ Do not disassemble the motor and motor cord when sterilizing.
③ Put the sterile bag in the sterilizer and sterilization for 4 minutes with 132℃, and let it dry for
30 minutes.
3. Lubrication
Lubrication method
- Refer the angle handpiece manual.
* Do not insert the oil into the motor. It damages the bearing or causes fever.
ATTENTION
17
PRODUCT SPECIFICATION
1. Control box
Model name X-CUBE
Input AC 100-120V / 220-240V
Fuse 5A / 2A
Frequency 50 / 60 Hz
Output 48VA
Maximum
Max. 75 ㎖/min ± 20%
irrigation volume
2. Handpiece
Name ACL-41I ACL-42I ACL-43I ACL-45I ACL(B)-41I ACL(B)-42I ACL(B)-43I ACL(B)-45I ACL(B)-61I ACL(B)-62I ACL(B)-63I ACL(B)-65I
Gear ratio 20:1 16:1 64:1 32:1 20:1 16:1 64:1 32:1 20:1 16:1 64:1 32:1
3. Motor
RPM 50,000
4. Foot controller
Classification according
to the degree of protection
IPX 8
against ingress of water
(IEC 60529)
18
WARRANTY
SAESHIN guarantees out product for 1 year from invoice date, and product warranty means that
SAESHIN has responsibility of defective material or operation failure. The product warranty does not
cover user’s misuse, wrong installation, inappropriate maintenance and repair, and normal wear of
consumables such as bearings, spindle, gear, and rotator. To check the warranty requires the operating
condition, environment information, serial number of the product and stamped invoice. The warranty will
be performed as repairs or exchanges by manufacturer’s judgement and analysis of product.
Exception of warranty
This manual is basically offered in Korean and English. But, if other countries need
manual with their own language, we can offer the manual with relevant language.
19
ELECTROMAGNETIC COMPATIBILITY INFORMATION
In IEC 60601-1-2:2014/AMD1:2020. 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. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following
measures:
- Reorient or relocate the receiving device.
- Increase the separation between the equipment.
- Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
- Consult the manufacturer or filed service technician for help.
RF emission – CISPR 11
EN 55011 Class A
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge
Floors should be wood, concrete or ceramic tile. If
(ESD) ±6kV contact ±6kV contact
floors are covered with synthetic material, the
IEC 61000-4-2 ±8kV air ±8kV air
relative humidity should be at least 30%.
EN 61000-4-2
Electrical fast transients ±2kV for power ±2kV for power Mains power quality should be that of a typical
IEC 61000-4-4 supply lines ±1kV supply lines ±1kV commercial or hospital environment.
EN 61000-4-4 for input/output lines for input/output lines
Surges ±1kV differential ±1kV differential Mains power quality should be that of a typical
IEC 61000-4-5 mode ±2kV common mode ±2kV common commercial or hospital environment.
EN 61000-4-5 mode mode
20
(3) ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT
Where ‘P’ is the maximum output power rating of the transmitter in watt
(W) according to the transmitter manufacturer, and ‘d’ is the recommended
Radiated RF
separation distance (m).
IEC 61000-4-3
EN 61000-4-3 The electromagnetic field strength of fixed radiofrequency emitters, which is
determined by an electromagnetic environment measurement (a), must be
less than the compliance level in each frequency range (b).
Interference may occur near equipment marked with the symbol below:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These specifications may not be applicable in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and persons.
(a): The electromagnetic field strength of fixed radiofrequency emitters, such as base stations
for mobile telephones (cellular / cordless), mobile radio, AM/FM radio broadcasts and TV
broadcasts cannot be determined exactly by theory.
To assess the electromagnetic environment due to fixed radiofrequency emitters, an
electromagnetic environment measurement must be made. If the measured radiofrequency field
strength in the immediate environment where the product is used exceeds the compliance level
specified above, the performance of the product must be tested to verify whether it conforms
to the specification. If abnormal performance is observed, additional measures may be necessary,
such as reorienting or relocating the product.
(b): In the 150 kHz to 80 MHz frequency range, the electromagnetic field strengths must be
less than 3V/m.
Maximum length
21
SYMBOL
132℃
A u t o c l a v e
G e n e r a l P r o h i b i t i o n S i g n
T y p e B
F o o t C o n t r o l l e r
22
MEMO
23
MEMO
24
MEMO
25
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
Tel. 82-53-587-2341 / Fax. 82-53-580-0999
+353 212066448
www.saeshin.com / traus@saeshin.com