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Guidance and manufacturer statement - Electromagnetic Immunity 

The device is intended for use in the electromagnetic environment specified below. The customer or the user 

of the device shouId assure that is used in such an environment. 

Immunity test 

IEC 60601 test level 

Compliance Level 

Electromagnetic environment - guide 

 

 

 

Portable and mobile RF communications 
equipment  should be used  no closer  to 
any  part  of  apex  locator,  including 
cables, 

than 

the 

recommended 

separation  distance  calculated  from  the 
equation  applicable  to  the  frequency  of 
the transmitter. 
Recommended separation distance 
 

Conducted RF 

GB/T17626.6 

3V(Effective value) 

150kHz~80MHz 

3V(Effective value)  d=1.2

√𝑝

 

Radiated RF 

GB/T17626.3 

3V/m 

80MHz~2.5GHz 

3V/m 

d=1.2

√𝑝

                80MHz~800 MHz 

d=2.3

√𝑝

                800 MHz~2.5GHz 

 

 

 

P——Where  P  is  the  maxi  mum  output 
power  rating  of  the  transmitter  in  watts 
(W)  according  to  the  transmitter 
manufacturer;   
d——d  is  the  recommended  separation 
distance in meters (m) 
  Field 

strengths 

from 

fixed 

RF 

transmitters  as  determined  by  an 
electromagnetic  site  survey,  shouId  be 
less  than  the  compliance  level  in  each 
frequency range.     

NOTE: U

T

 is the ac. mains voltage prior to application of the test level. 

NOTE 1:    At 80 MHz and 800 MHz, the higher frequency range applies. 
NOTE  2:  These  guidelines  may  not  apply  in  at  I  situations.  Electromagnetic  propagation  is  affected  by 
absorption and reflection from structures objects and people. 

a) Field strengths from fixed transmitters, such as base stations for radio (celIular/ cord less) telephones and 
land  mobile  radios,  amateur  radio,  AM  and  FM  radio  broadcast  and  TV  broadcast  cannot  be  predicted 
theoretically  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 which the 
device is used exceeds the applicable RF compliance level above, the device should be observed to verify 
normal operation. If abnormal performance is observed, additional measures may be necessary, such as 
re-orienting or relocating the device. 
b)Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. 

Содержание iRoot apex

Страница 1: ...Operation Manual for iRoot apex Apex locator Read this Operation carefully before use Keep this Operation Manual for future reference...

Страница 2: ......

Страница 3: ...sification of Device Classification by type of protection against electric shock Class devices Classification by degree of protection against electric shock Applied part type B Degree of protection ag...

Страница 4: ...ooth Function 7 2 4 Gyroscope 8 2 5 Charging and USB introduction 8 3 Installation 9 3 1 Connect the measurement line 9 3 2 Demo function 10 3 3 Battery charging 10 4 Product operation 11 4 1 Operatio...

Страница 5: ...ce measurement technology automatic calibrating ensures the measurements are accurate c Equipped with high precision gyroscope switch the display mode according the state of display d Bluetooth wirele...

Страница 6: ...2 1 3 Components 1 3 1 Picture of main unit 1 3 2 Main accessories Picture 2 a Picture 2 b Picture 3 a Picture 3 b Picture 3 c Picture 1 Power Adapter USB cable Measuring cable File clip Lip hook...

Страница 7: ...cceptable 1 4 Application scope The product is used for the measurement of root canal length 1 5 Contraindication 1 5 1 The product cannot be used for treatment other than implantation or other root c...

Страница 8: ...2 1 Interface display introduction 2 1 1 Icon introduction Battery charging status display Battery power status indicator 0 25 50 75 100 Bluetooth has been built to connect Bluetooth open when chargin...

Страница 9: ...t canal file did not reach near the root tip the entire root apex area is gray When the needle slowly close Display the torque N cm of connected device when the Bluetooth is on Display the rotation sp...

Страница 10: ...ea with accompanying alarm Picture 5 c is the position of the apical region of the root The position of red arrows point is preset root tip when the red arrow is located at a scale the red arrows are...

Страница 11: ...n it s off Enter demo mode e Click or press in demo mode Exit demo mode 2 3 Bluetooth Function Bluetooth of this product can establish a wireless signal transmission with our endo motor In the connect...

Страница 12: ...urn on sequence For the device has been connected turn on Bluetooth again and will only be able to connect to the last connected Bluetooth slave device please take 2 3 1 for reference to connect a new...

Страница 13: ...eep it stable avoid hit II Measurement can t be proceeded without the complete Insertion of the plug 3 1 2 Insert the file clip and lip hook respectively into the two socket of the measuring wire Pic...

Страница 14: ...ower key again to exit the demo mode 3 3 Battery charging When the battery becomes red on the screen it indicates that the battery is not enough and it needs to be charged in time 3 3 1 The charging l...

Страница 15: ...t 4 1 5 Please choose the file matched with the diameter of the root canal if use a small file in a big root canal the digital on the screen will be instability 4 1 6 Line link test must be performed...

Страница 16: ...so necessary to get rid of the pulp and necrosis tissue 4 2 8 The following cases are not suited for a normal measurement a The size of the root similar to the size of apical foramen In this case the...

Страница 17: ...acy when the endo file touches metal crown Pic 15 Sometimes the results of the Apex Locator and X Rays do not meet each other which is neither because the machine is not normal nor the photo is incorr...

Страница 18: ...p hook Pic 9 this icon appears on the screen means the connection is normal the measurement can be start 4 3 3 Please press the volume key to set the volume 4 3 4 Hang the lip hook on the lip make sur...

Страница 19: ...measure the length of the root canal due to the improper force the front of the root canal pin is easy to wear 4 3 6 When the file reaches the apex adjust the rubber piece set on the endo file to the...

Страница 20: ...Display Calibration failure If turn on unit normally and display Calibration failure please press power to exit if not the device can be used normally Please note if in this situation there must be so...

Страница 21: ...uids inside the root canal but it will return to normal as it approaches the apex Is the tooth surface covered with cutting debris or chemical solutions Clean entire tooth surface Is the file touching...

Страница 22: ...amen Is root canal blocked Canal length indicator will return to normal when the file reaches apical constriction Is root canal extremely dry Moisten the root canal with hydrogen peroxide or a saline...

Страница 23: ...roduct should be handled with care away from the source and stored in a dry ventilated place b Not mixed with toxic corrosive flammable and explosive materials c The product should be stored in a spac...

Страница 24: ...on the warranty card we will repair this equipment free of charge if there s quality problem Please refer to the warranty card 10 Symbol instruction This conforms to CE European Directive Follow the w...

Страница 25: ...romagnetic Environment guidance RF Emissions CISPR 1 Group 1 The appliance use RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer...

Страница 26: ...ospital environment Surge IEC 61000 4 5 1 kV differential mode 1 kV differential mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruption...

Страница 27: ...ransmitters as determined by an electromagnetic site survey shouId be less than the compliance level in each frequency range NOTE UT is the ac mains voltage prior to application of the test level NOTE...

Страница 28: ...ications equipment Rated maximum output power of transmitter Watts W Separation distance according to frequency of transmitter in meters Meters m 150 KHz 80 MHz d 1 2 80 MHz 800 MHz d 1 2 p 800 MHz 2...

Страница 29: ...cked use is necessary you should observe and verify it works normally Using the specified peripherals Avoid to use not specified equipment otherwise it may cause the lower performance of EMC Check the...

Страница 30: ...26...

Страница 31: ...________________________________________________ ________________________________________________________________ Trouble Description ________________________________________________________________ _...

Страница 32: ...28...

Страница 33: ...QUALIFIED CERTIFICATE INSPECTOR DATE...

Страница 34: ......

Страница 35: ......

Страница 36: ...ad West Taihu Science Technology Industrial Park Changzhou City Jiangsu China Website www bomedent com Tel 86 0519 88991980 Landlink GmbH Address Dorfstrasse 2 4 79312 Emmendingen Germany Tel 0049 764...

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