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X-CUBE User Manual Rev1

This instruction manual provides essential guidelines for the safe and effective use of a medical device intended for dental procedures, including user qualifications and operational protocols. It outlines product features, components, and maintenance requirements, emphasizing patient safety and proper handling. Users are advised to follow specific instructions regarding electrical safety, sterilization, and operational procedures to ensure optimal performance and compliance with regulations.

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ardiless.manuel
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0% found this document useful (0 votes)
15 views28 pages

X-CUBE User Manual Rev1

This instruction manual provides essential guidelines for the safe and effective use of a medical device intended for dental procedures, including user qualifications and operational protocols. It outlines product features, components, and maintenance requirements, emphasizing patient safety and proper handling. Users are advised to follow specific instructions regarding electrical safety, sterilization, and operational procedures to ensure optimal performance and compliance with regulations.

Uploaded by

ardiless.manuel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 28

INSTRUCTION MANUAL

www.saeshin.com
CONTENTS

· INTRODUCTION

· USER GUIDELINES

· PRODUCT FEATURES & ADVANTAGES

· PRODUCT COMPONENTS

· PART NAME OF CONTROL BOX

· BUTTONS ON THE OPERATION PANEL

· LCD WINDOW

· BUTTONS ON THE FOOT CONTROLLER

· CONNECTION OF EACH PART

· OPERATION PROCESS

· MAINTENANCE OF THE PRODUCT

· ATTENTION

· PRODUCT SPECIFICATION

· ELECTROMAGNETIC COMPATIBILITY INFORMATION

· WARRANTY

· SYMBOL
INTRODUCTION

This product is medical device.

Make sure to read this user manual before using.

This user manual is to assure proper installation and use.

Pay attention to read this user manual in order to making the best use of this product and to assure the

prolonged lifespan before using.

Specially, pay attention the contents with marks such as , and

<User>

· Qualified Professional

<Intended purpose>

· Engine that power the implant handpiece in dental implant procedure.

· 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>

· Type of protection against electric shock: ClassⅠ equipment

· Degree of protection against electric shock: Type B applied part

· 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.

· User sterile product (non-sterile product at shipment)

· Classification according to mode of operation : Intermittent operation

· Applied parts : Bur

<Use time>

· Loading time: 2 minutes

· Resting time: 15 minutes

1
USER GUIDELINES

CAUTION

● Please pay attention to the use considering the patient’s safety first of all.

● Check condition of the product before use.

● Stop to use and inspect the product when an abnormal sign such as calescence, vibration or noise occurs

before or during operation.

● 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

head of the angle handpiece.

● Change or insert bur after the motor is completely stopped. Otherwise, inside of the angle could be

damaged by bur, and it could cause an accident.

● Please sterilize and lubricate the angle handpiece right after use. Otherwise, the product could be damaged

due to coagulation of blood inside the product.

● The control box and foot controller are not steam sterilization objects.

● The input power is available at AC 100-120V / 220-240V


(Check input voltage before connecting the AC power.)

● Dispose the irrigation tube as a medical waste after use.

● Contact manufacturer if incorrect display is on the screen.

● Do not drop or give a strong impact to the product.

● 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.

● The product is designed to be used indoor, do not use outdoor.

● Do not use the product in humid or dusty environment.

● 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.

● Specification and design of product can be changed to improve quality of product.

● User has responsibility to operate and maintain the product.

● The company did not sterilize the product. Please be sure to sterilize before operation. (User sterilization)

● US Federal law restricts this device to sale by or on the order of a dentist.

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.

● Do not damage or drop the LCD part of the control box.

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.

● Unauthorized modification and dismantling is prohibited.

● Do not use the solvent such as thinner or benzene for cleaning.


※ Be careful not to drop liquid on control box.
※ Do not wipe the control box (membrane) with wet fabric.

● 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.

● Be sure to use designated bur by ISO 1797.

● Follow the instruction manual by manufacturer of bur to use bur.

● 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

<BLDC motor designed by SAESHIN’s own technology and know-how>

- 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

<Program memory function>

- 9 programmable memories for setting speed, gear ratio, torque, rotating direction, irrigation pump.

<Automatic overload protection function>

- 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.

<Realtime RPM, TORQUE view system>

- Actual RPM and Torque value are displayed on the screen. It makes user can do more delicate operation.

<Ergonomic foot controller>

- Foot controller is designed ergonomically to control all the functions. And it provides high convenience.

<Motor Auto-calibration function>

- 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

* Please check all components are included.

1 9

2 10

3 11

4 12

5 13

6 14

7 15

No. Component No. Component


1 CONTROL BOX 9 INTERNAL SPRAY NOZZLE(Option)

2 ANGLE HANDPIECE 10 MOTOR CAP (For sterilization of motor)

3 BLDC MOTOR 11 SPANNER FOR ANGLE

4 FOOT CONTROLLER 12 TUBE HOLDER


5 MOTOR STAND 13 TUBE CLAMP
6 HANGER 14 AC POWER CORD
7 IRRIGATION TUBE 15 Y-Tube (Option)
8 A-SLEEVE

- Saline solution is not included in a set.


- Irrigation tube and Y-Tube are disposable, Do not use them again.

5
PART NAME OF CONTROL BOX

Hanger

Irrigation pump

Foot controller connector


Motor connector
Main power
Switch

Fuse box

Gear ratio button Operation direction


button Main power socket
Irrigation pump button

Memory button
Speed button

Program button Torque 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.

Gear ratio button


: Use for setting the gear ratio of the angle handpiece.

Operation direction button


: Use for selecting the forward or reverse direction. The beep sound is heard during
rotation in reverse direction.

Irrigation pump button


: Use for setting the irrigation volume in 5 levels (from 0 to 75ml).

Irrigation level Water Pump


0 0 ml/min
1 abt. 45 ml/min ±20%
2 abt. 55 ml/min ±20%
3 abt. 65 ml/min ±20%
4 abt. 75 ml/min ±20%

7
LCD WINDOW

1. Irrigation volume display


: It shows the selected irrigation level. There are 5 levels. Level 0 is no volume and level 4 is
maximum 75ml/min.

2. Program number display


: 9 programmable programs set from 1 to 9. And it shows program 1 at every power on.

3. Gear ratio display


: It shows the selected gear ratio number.

4. Direction display
: It shows the selected direction.

5. Speed / Torque display


: It shows preset RPM and preset Torque when Motor is stopped. It shows running RPM and running
Torque when Motor is running.
Motor stops running automatically and occurs error when running Torque reaches preset torque.
For releasing the overload function, release the foot controller.

* 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.

2. Not in use currently

3. Operation direction button


: Select the operation direction.

4. Irrigation pump button


: Set the irrigation volume. Each press increases 1 stage.

5. Speed control pedal


: Press and release the foot controller to control the motor speed.

9
CONNECTION OF EACH PART

* When connect the motor and foot controller, please make sure the power is off.
(Otherwise, it might cause malfunction.)

Motor Cord Connection

Please insert the motor connector. Check the hole and pins of motor
connector are in place. Then screw the Connector Lock.

Connector Lock

Foot Controller Connection

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

Insert the power cord into the power socket in the


back of control box.

Irrigation Tube 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.

Turn the knob counter clockwise ( ) until closing pump cover.

11
Bottle Setting

Put the hanger into the hanger hole in the back of control box.
Hang the saline solution pack on the hanger.

6 Irrigation Tube Insertion

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.

Irrigation tube needle

Please operate product after put the irrigation tube into


lrrigation Stopper Breather needle the groove on the bottom of control box.

Do not install the irrigation tube on the control box or beside of the membrane.
It may cause the damage of product.

(O) (X)

Correct installation Incorrect installation

12
Irrigation Nozzle Connection

Y-connector tube
Tube clamp
Internal spray nozzle

External 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.

Tube Holder Connection

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

(1) Turn on the main switch.


Product remains as standby mode having memory in Program 1 like below picture when power on.

(2) Choose the program.


Press the bottom of the left side button on the foot controller or button on the control box,
the program changes by 1 stage. Select the program that user want to use.
If press the button on the foot controller when the program is selected program 9,
it returns to program 0.

(3) Check the setting.


Check the display on LCD box to make sure the setting is correct.

(4) Start the Operation.


The motor starts to rotate after press the speed control pedal. It runs at low speed with light press and
at high speed with heavy press by the set speed in max. If the irrigation mode is on, the irrigation pump
operates too.

(5) Overload protection function.


If the load exceeds the set torque during the operation, the overload protection function works not to
generate the extra torque.

(6) Stop the operation.


The operation is stopped when user takes foot off the speed control pedal.

(7) Change the operation direction.

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

X-CUBE has 9 programmable memories in conditions below


Set the gear ratio – speed – torque – operation direction – irrigation pump. And press the memory button.

ex)

Complete
Complete

Error and Remedy

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.

Indication Cause & Remedy

· In case that the actual torque reaches preset torque and


Warning! keeps it more than 2 seconds.
Torque LIMIT.
- Remedy: Release the foot controller.

· In case that the motor is not connected properly.


Warning! - Remedy: Make sure to connect Motor properly.
Motor Connect Check! Press the foot controller.
If the remedy does not work, contact the manufacturer.

· In case that the foot controller is not connected properly.


Warning!
Foot Switch Check! - Remedy: Make sure to connect the foot controller.
Press the foot controller.
If the remedy does not work, contact the manufacturer.

15
MAINTENANCE OF THE PRODUCT

Fuse Change

Check the fuse if the control box doesn’t work. Contact your dealer.

Fuse box
Fuse

Cleaning / Sterilization / Lubrication

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.

② Disconnect the angle handpiece to 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.

※ Pay attention to not enter the water into the motor.

16
2. Sterilization

Sterilization part list


· Angle handpiece
· Motor (assembling with the motor cap)

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.

Sterilization Temperature Time Dry


Moist heat sterilization 132℃ 4 minutes 30 minutes

* Maximum sterilization number is 250 times.


* Make sure to use the sterilization bag and seal tightly.
* Make sure to dry the applicable products before sterilization.
* Motor could be damaged in sterilization because of the moisture inflow or else, so should be
careful to handle it.
* Sterilizing the angle handpiece with blood or other remains may cause the breakage of the angle
handpiece. Therefore, it is necessary to clean the angle handpiece before sterilization.
* Irrigation tube and Y-connector are disposable. Do not use them again.

3. Lubrication

Lubrication product list


· Angle handpiece

Lubrication method
- Refer the angle handpiece manual.

* Do not insert the oil into the motor. It damages the bearing or causes fever.

ATTENTION

1. Please read the notice below before operating X-CUBE.


1) Check the connection of every cords and correct operation when power-on.
2) Check the earth connection is safe.
3) Make sure to check the contact part to patient.
4) Check the voltage.
5) Check the sterile condition of autoclavable parts.

2. Please read the notice below during X-CUBE use.


1) Check the status of product and patient constantly during the surgery.
2) When product or patient has any problem, stop the operation in condition of patient’s safety or take
proper action.
3) Do not let patient to approach the product.

3. Please read the notice below after operating X-CUBE.


1) Do not put any physical pressure on the power cord, motor cord and foot controller cord.

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

Lever type Button type

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

Bur replacement type Lever type Button type

Bur dimension CA bur (Ø 2.35)

Coupling dimension Standard dimension of dental handpiece (ISO 3964)

3. Motor

Model name FORTE 100αEI

RPM 50,000

4. Foot controller

Model name X-CUBE 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

User’s misuse or improper use and treatment


Use the product with incorrect input voltage (AC voltage)
Drop the device during setting, moving, using
Use the not recommended consumables or accessories
Malfunction after repairing the product at the not recommended repair shop
Normal wear of the consumables such as ball bearing, gear, chuck, spindle case ass’y, rotator etc.
Faulty by Act of God

Foreign Language Manual Support

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.

1) The translated manual will be supplied by manufacturer on demand.


2) We will send the translated manual with English manual to the import company to
check the translated manual.
3) After we get the feedback from the import company, we will offer final version of
the manual.

Temperature (℃) 10~35

Operating condition Relative humidity (%) 10~80

Atmospheric pressure (hPa) 700~1,060

Temperature (℃) -20~60

Transport and Relative humidity (%) 10~90


Storage condition
Atmospheric pressure (hPa) 500~1,060

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.

(1) Electromagnetic Emissions

Emission test Compliance Electromagnetic environment - guide

X-CUBE uses RF energy for internal operation.


RF emission – CISPR 11 Group 1 Therefore, its radiofrequency emissions are very low and are
EN 55011 not likely to cause any interference in nearby equipment.

RF emission – CISPR 11
EN 55011 Class A

Harmonic emission – X-CUBE is suitable to use in all establishments,


IEC 61000-3-2 Class A including domestic establishments and those directly
EN 61000-3-2 connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Voltage fluctuations
Flicker emission –
IEC 61000-3-3 Compliance
EN 61000-3-3

(2) Electromagnetic Immunity

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

<5% UT (>95% dip <5% UT (>95% dip


in UT) for 0.5 cycle in UT) for 0.5 cycle
Mains power quality should be that of a typical
Voltage dips, 40% UT (60% dip 40% UT (60% dip commercial or hospital environment. If the user
short interruptions and in UT) for 6 cycles in UT) for 6 cycles requires continued operation during power mains
voltage variations interruptions, it is recommended that the
IEC 61000-4-11 70% UT (30% dip 70% UT (30% dip
in UT) for 30 cycles in UT) for 30 cycles X-CUBE got power from an uninterruptible
EN 61000-4-11 power supply or battery.
<5% UT (>95% dip <5% UT (>95% dip
in UT) for 5s in UT) for 5s
Power frequency (50/60Hz)
Power frequency magnetic fields should be at levels
magnetic field
3A/m 3A/m characteristic of a typical location in a typical
IEC 61000-4-8
commercial or hospital environment.
EN 61000-4-8

20
(3) ELECTROMAGNETIC IMMUNITY / RADIOFREQUENCY MOBILE EQUIPMENT

Portable and mobile RF communicationsequipment should be used


Conducted RF rms no closerto any part of the X-CUBEincluding cables,than the
IEC 61000-4-6 rms recommended separation distancecalculatedfrom the equation
EN 61000-4-6 applicableto the frequencyof the transmitter.

Recommended separation distance


d = 1.2 √P
d = 1.2 √P 80MHz to 800MHz
d = 2.3 √P 800MHz to 2.5GHz

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

Micromotor with Motor cord 2M


Foot controller with cord 1.8M
1.6M
: IEC 61000-3-3 / EN 61000-3-3

: IEC 61000-4-8 / EN 61000-4-8

21
SYMBOL

Memory Button Program Button

Gear Ratio Button Speed Button

Operation Direction Button Torque Button

Irrigation Pump Button Operation Direction Button

Program Button Irrigation Pump Button

Manufacturer Consult Instruction for Use

EC Representative General Caution Sign

SN Serial Number General Warning Sign

132℃
Autoclave
General Prohibition Sign

Type B
Foot Controller

This product should not be mixed CE Certificate Logo


with other commercial waste for 1639
disposal

NON Non sterile


STERILE

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

SOM-S040S-E Rev.1 2023-05-19

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