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26 

 

14.

 

EMC-Declaration of conformity  

The device has been tested and homologated in accordance with EN 60601-1-2 for EMC. This 

does not guarantee in any way that this device will not be affected by electromagnetic 

interference Avoid using the device in high electromagnetic environment.  

14.1

 

Technical Description Concerning Electromagnetic Emission  

Table 1: Guidance & declaration - electromagnetic emissions 

The model Rooter

®

 X3000 is intended for use in the electromagnetic environment specified below. The customer 

or the user of the model Rooter

®

 X3000 should assure that it is used in such an environment.  

Emissions test  

Compliance  

Electromagnetic environment - guidance  

RF emissions  

CISPR 11  

Group 1  

The model Rooter

®

 X3000 uses RF energy only for its internal 

function. Therefore, its RF emissions are very low and are not 

likely to cause any interference in nearby electronic equipment. 

RF emissions  

CISPR11  

Class B  

The model Rooter

®

 X3000 is suitable for used in all 

establishments, including domestic establishments and those 

directly connected to the public low-voltage power supply 

network that supplies buildings used for domestic purposes.  

Harmonic emissions  

lEC 61000-3-2  

Class A  

Voltage fluctuations 

/ flicker emissions  

lEC 61000-3-3  

Complies  

14.2

 

Technical Description Concerning Electromagnetic Immunity  

Table 2: Guidance & Declaration - electromagnetic immunity 

The model Rooter

®

 X3000 is intended for use in the electromagnetic environment specified below. The customer 

or the user of the model Rooter

®

 X3000 should assure that It is used in such an environment.  

Immunity test  

IEC 60601  

test level  

Compliance level  

Electromagnetic environment - 

guidance  

Electrostatic 

discharge (ESD)  

lEC 61000-4-2  

±8kV contact  

±2, ±4, ±8, ±15kV air  

±8kV contact  

±2, ±4, ±8, ±15kV air  

Floors should be wood, concrete or 

ceramic tile. If floors are covered with 

synthetic material, the relative 

humidity should be at least 30 %.  

Electrical fast 

transient/burst  

IEC 61000-4-4  

±2kV for power 

supply lines  

±1kV for Input/ 

output lines  

±2kV for power supply 

lines  

Mains power quality should be that of 

a typical commercial or hospital 

environment.  

Surge  

lEC 61000-4-5  

±0.5, ±1kV line to line  

±0.5, ±1, ±2kV line to 

earth  

±0.5, ±1kV line to line  

±0.5, ±1, ±2kV line to 

earth  

Mains power quality should be that of 

a typical commercial or hospital 

environment.  

Voltage dips, short 

interruptions and 

voltage variations on 

power supply input 

lines  

<5 % UT  

(>95% dip in UT.)  

for 0.5 cycle  

<5 % UT  

(>95% dip in UT.)  

for 0.5 cycle  

Mains power quality should be that of 

a typical commercial or hospital 

environment. If the user of the models 

Rooter

®

 X3000 requires continued 

operation during power mains 

Summary of Contents for Rooter X3000

Page 1: ...User Manual...

Page 2: ...1...

Page 3: ...and display interface 11 3 1 Motor modes 11 3 2 Apex locator Operation mode 12 3 3 Combined Motor and Apex locator Operation mode 12 3 4 Display interface 13 4 Device operating instructions 14 4 1 Se...

Page 4: ...ment of the battery 23 8 Storage 24 9 Transportation 24 10 Environmental protection 24 11 After sales service 24 12 Symbol instruction 24 13 Statement 25 14 EMC Declaration of conformity 26 14 1 Techn...

Page 5: ...l apex locator It can be used as an endo motor for preparation of tooth root canals or as an apex locator device to help to determine the root canal working length It can also be used to prepare the c...

Page 6: ...8 971 00 003 FK 4 Spray noozle 08 971 00 004 FK 5 Measuring wire 08 971 00 005 FK 6 File clip 08 971 00 006 FK 7 Lip hook 08 971 00 007 FK 8 Touch probe 08 971 00 008 FK 9 Protective silicone cover 08...

Page 7: ...handpiece refer to Chapter 2 2 e Do not connect or disconnect the contra angle while the motor is running f Do not disconnect the instrument while the motor is running g Be sure to be able to power OF...

Page 8: ...temperature of applied part 46 6 C 1 7 Environmental parameters a Operating ambient temperature 5 C 40 C b Operating relative humidity 30 75 c Operating atmospheric pressure 70kPa 106kPa 1 8 User qual...

Page 9: ...n may damage the chuck of the contra angle c Be careful when manipulating files to avoid injury to fingers d Make sure the file is well connected and locked before to start the motor handpiece e Do no...

Page 10: ...x locator setup 2 3 1 Warnings a In Apex locator mode the file clip must properly hold the file b In case of bad or wrong connection signal replace the measuring wire c In apex locator mode it is sugg...

Page 11: ...working length determination To be informed about the Apex locator limitations refer to Chapter 4 8 2 3 2 Connecting apex locator wires 1 Connect the measuring wire to the motor handpiece USB socket a...

Page 12: ...e Operation modes and display interface 3 1 Motor modes 3 1 1 CW Operation Mode Clockwise continuous rotation mode In this mode the motor handpiece rotates in clockwise direction only forward directio...

Page 13: ...t torque limit 3 2 Apex locator Operation mode 3 2 1 EAL Operation Mode Electronic Apex Locator This mode is intended for working length determination only In this mode the motor handpiece does not ru...

Page 14: ...ay scale Ncm Combined Motor and Apex locator Operation interface a File progression indication bar b File progression indication number The numbers 1 0 2 0 3 0 a and numbers 00 16 b do not represent a...

Page 15: ...interface according to the program used For example 3 To stop the motor press the Main button again The device goes back in stand by state 4 To power OFF the device hold down the Setting button P and...

Page 16: ...ng speed can be adjusted from 100rpm to 3 300rpm 50rpm increments In REC mode the working speed can be adjusted for 100rpm to 500rpm 50rpm increments In ATR mode the working speed can be adjusted for...

Page 17: ...on Apical reference point The apical reference point flash bar can be set from 2 to AP Apical foramen 0 5 indicates that the file tip is located very near the physiological apical foramen Apical Actio...

Page 18: ...e parameters according to FKG recommendation the most popular FKG File Systems are already preset in the device 1 To select a preset FKG File System from the stand by state long press the Setting butt...

Page 19: ...YES YES n a n a R Motion All Files YES YES YES YES NO 4 6 Set device parameters To set the device parameters 1 To access the device parameters from the power OFF state hold down the Setting button P a...

Page 20: ...7 1 Warnings a In reciprocation motion mode REC when the load value is higher than the torque limit i if the Forward angle is greater than the Reverse angle the motor automatically switches to counter...

Page 21: ...the electrical signal Broken crown If the crown is broken and a section of the gingival tissue intrudes into the cavity surrounding the canal opening the contact between the gingival tissue and the fi...

Page 22: ...ntact local distributor No sound Beeper Volume set to 0 Vol 0 Mute Set Beeper Volume to 1 2 3 4 The continuously rotating file is stuck at the root canal Incorrect specification setting Too high load...

Page 23: ...eneral recommendations Use only approved washer disinfector according to EN ISO 15883 maintain and calibrate it regularly Make sure accessories contra angle lip hook file clip and touch probe protecti...

Page 24: ...et go the redundant oil under gravity via the end part 7 2 1 Warnings a Use original oil injection nozzle only b Motor handpiece shall not be filled with oil 7 3 Charging of the battery 1 Insert the p...

Page 25: ...e device in case of long period storage 9 Transportation a Avoid excessive shocks during transportation b Don t store together with dangerous goods during transportation c Avoid sun rain and snow expo...

Page 26: ...t further notice The pictures are only for reference The final interpretation rights belong to GUILIN WOODPECKER MEDICAL INSTRUMENT CO LTD The industrial design inner structure etc have claimed for se...

Page 27: ...icker emissions lEC 61000 3 3 Complies 14 2 Technical Description Concerning Electromagnetic Immunity Table 2 Guidance Declaration electromagnetic immunity The model Rooter X3000 is intended for use i...

Page 28: ...t Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF lEC 61000 4 6 Conducted RF lEC 61000 4 6 Radiated RF lEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 6 Vr...

Page 29: ...oretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in wh...

Page 30: ...nsmitter W Separation distance according to frequency of transmitter m 150kHz to 80MHz d 1 2 P1 2 80MHz to 800MHz d 1 2 P1 2 800MHz to 2 7GHz d 2 3 P1 2 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1...

Page 31: ...30...

Page 32: ...mation Industrial Park Guilin National High Tech Zone Guilin Guangxi 541004 P R China Sales Dept 86 773 5873196 Http www glwoodpecker com E mail woodpecker glwoodpecker com MedNet EC Rep GmbH Borkstra...

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