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14

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.
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.

Electromagnetic Emissions

Emission test

RF emission – CISPR 11

EN 55011

RF emission – CISPR 11

EN 55011

Harmonic emission – 

IEC 61000-3-2

EN 61000-3-2

Voltage fluctuations

Flicker emission – 

IEC 61000-3-3

EN 61000-3-3

Compliance

Group 1

Class A

Class A

Compliance

Electromagnetic environment – guide

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.

X-CUBE i uses RF energy for internal operation. 

Therefore, its radiofrequency emissions are very low and

are not likely tocause any interference in nearby equipment.

X-CUBE i covers devices for usage in all establishments other than

domestic and that are not directly connectedto a low voltage power

supply network, which supplies 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.

Electromagnetic Immunity

NOTE: 

UT is the a.c. mains voltage prior to application of the test level.

Immunity test

Electrostatic discharge

(ESD)

IEC 61000-4-2

EN 61000-4-2

Electrical fast transients

IEC 61000-4-4

EN 61000-4-4

Surges

IEC 61000-4-5

EN 61000-4-5

Voltage dips,

short interruptions and

voltage variations

IEC 61000-4-11

EN 61000-4-11

Power frequency

(50/60Hz)

magnetic field

IEC 61000-4-8

EN 61000-4-8

IEC 60601 test level

±8kV contact

±15kV air

±2kV for power

supply lines ±1kV for

input/output lines

±1kV differential

mode ±2kV common

mode

0 % UT for 0.5 cycle

at 8 Φ angles

0% UT for 1 cycle

70 % UT for

25/30 cycles

0 % UT for

250/300 cycle

30 A/m

Compliance level

±8kV contact

±15kV air

±2kV for power

supply lines ±1kV for

input/output lines

±1kV differential

mode ±2kV common

mode

0 % UT for 0.5 cycle

at 8 Φ angles

0% UT for 1 cycle

70 % UT for

25/30 cycles

0 % UT for

250/300 cycle

30 A/m

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.

Floors should be wood, concrete or ceramic tile. If floors

are covered with synthetic material, the relative humidity

should be at least 30%.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical
commercial or hospital environment.

Mains power quality should be that of a typical

commercial or hospital environment. If the user

requires continued operation during power mains

interruptions, it is recommended that the X-CUBE i

got power from an uninterruptible power supply or battery.

Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial
or hospital environment.

Содержание Implant X Cube i

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 18: ...18 MEMO...

Страница 19: ...19 MEMO...

Страница 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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