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Electromagnetic Immunity

Note 1: 

At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: 

These specifications may not be applicable in all situations. 

             E lectromagnetic 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 d

etermined 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.

Immunity test

Conducted RF

IEC 61000-4-6

EN 61000-4-6

IEC 60601 test level

3 Vrms

150 k

Hz to 80 MHz

6 Vrms

In ISM bands from

150 kHz to 80 MHz

Compliance level

Electromagnetic environment – guidance

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.

Portable and mobile RF communications equipment
should be used no closer to any part of the X-CUBE i
including cables, than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

d = 1.2 √P

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

distance (m).

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: 

3 Vrms

150 k

Hz to 80 MHz

6 Vrms

In ISM bands from

150 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

EN 61000-4-3

3 V/m

80 MHz to 2.7 GHz

3 V/m

80 MHz to 2.7 GHz

Recommended separation distances between portable and mobile RF communications equipment and the X-CUBE i

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.

For transmitters rated at a maximum output power not listed above, the recommended separation distance ‘d’ in 

meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Rated maximum output

Power of transmitter

(W)

Electromagnetic environment – guidance

The X-CUBE i is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the X-CUBE i can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the X-CUBE i as
recommended below, according to the maximum output power of the communications equipment

0.01

0.1

1

10

100

150 kHz ~ 80 MHz

d = 1.2 √P

0.12

0.38

1.2

3.8

12

80 MHz ~ 800 MHz

d = 1.2 √P

0.12

0.38

1.2

3.8

12

800 MHz ~ 2.7 GHz

d =

 2.3 √P

0.23

0.73

2.3

7.3

12

15

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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