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Guidance and manufacturer’s declaration – electromagnetic emissions

The ApexPilot All-In-One 

is intended for use in the electromagnetic environment specified below. 

The customer or the user of the ApexPilot All-In-One should assure that is used in such an 

environment.

Immunity test

IEC60601 test level

Compliance Level

Electromagnetic

environment - guide

Electrostatic

discharge(ESD)

EN 61000-4-2

± 6kV contact

± 8kV air

± 6kV contact

± 8kV 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

± 2 kV for power

supply lines

± 1 kV for input/

Output lines

± 2 kV for power

supply lines

Mains power quality 

should be that of a 

typical commercial or 

hospital environment.

Surge

IEC 61000-4-5

± 1 kV differential

mode

± 2 kV common

mode

± 1 kV differential

mode

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 

IEC 61000-4-11

< 5 % UT

( > 95 % dip in UT)

for 0.5 cycles

40 % UT

( 60 % dip in UT)

for 5 cycles

< 5 % UT

70 % UT

( 30 % dip in UT)

for 25 cycles

< 5 % UT

< 5 % UT

( > 95 % dip in UT)

for 5 s

< 5 % UT

( > 95 % dip in UT)

for 0.5 cycles

40 % UT

( 60 % dip in UT)

for 5 cycles

< 5 % UT

70 % UT

( 30 % dip in UT)

for 25 cycles

< 5 % UT

< 5 % UT

( > 95 % dip in UT)

for 5 s

Mains power quality 

should be that of a 

typical commercial or 

hospital environment. 

If the user of the 

ApexPilot All-In-One 

requires continued 

operation during power 

mains interruptions, 

it is recommended 

that the ApexPilot 

All-In-One be powered 

from an uninterruptible 

power supply or a 

battery.

Power frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m

3 A/m

Power frequency 

magnetic fields 

should be at levels 

characteristic of a 

typical location in a 

typical commercial or 

hospital environment.

NOTE: 

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

Summary of Contents for APEXPILOT ALL-IN-ONE

Page 1: ...Cordless Endodontic Handpiece Built in Apex Locator ApexPilot All In One Instruction for Use ...

Page 2: ...r for endodontic treatment While root canal preparation is made the length determination can be simultaneously carried out Alternatively the stand alone measurement is possible using the separate file clamp for measuring file User Only qualified personnel is allowed to use the unit only in dentistry Prohibition Do not use ApexPilot Endo Motor for formation of an extremely bent root canal Do not us...

Page 3: ...irective Class II equipment Double insulated fulfilling legal requirements of IEC 60601 1 Type B Particular protections against electric shock Refer to the Operation Manual Consult accompanying documents user manual Manufacturer Serial Number Date of manufacture Direct current Authorized representative in the European Community 0197 Symbols ...

Page 4: ...apex locator Control Endo motor mode 4 2 2 Useful tips for accurate length determination 4 2 3 Optional Apical Line 4 2 4 Operation 4 2 5 Root apex locator Demo and self checking 4 3 Running in different modes of rotations and settings 4 4 Torque Speed and Gear rate Settings 4 5 Convenient function 4 5 1 Program 4 5 2 Factory Default Parameters 4 5 3 Calibration 4 5 4 Alarm Sound Setting 4 5 5 Wir...

Page 5: ...formation explanation on operation and performance 1 1 General Warnings and Conditions for Operation Warning CONTRAINDICATION Use of ApexPilot is contraindicated in patients and in users with pacemaker General Warning Use the specified battery for this product Never use any batteries other than Beyes specified High external pressure will cause a liquid leakage or explosion Keep the central unit aw...

Page 6: ...he rotation and speed of the motor If the Central unit has not been used for a long time check it before uses There is electric circuit that controls the torque TORQUE LIMITER Function to prevent files from breaking however files may still break due to metal fatigue if the torque is conditioned to be higher Please check the working instructions of file before use The battery charger must be suppli...

Page 7: ...utomatically start of apex locator to control motor mode without user setting ApexPilot All In One automatically identifies whether the measuring line is inserted Insertion of the measuring line and that means that the user needs to measure and expand the length of the root canal at the same time Endo motor function Quick start User program Auto reverse Reciprocating First press the motor will for...

Page 8: ...attery Charger Adaptor and USB cord Accessories Lip hook Contra angle sleeve Spray nozzle adjust the font size 2 3 Installation contra angle The contra angle can be connected with the central unit at 6 adjustable head positions Align the positioning pins of the contra angle with the positioning slots of the central unit and insert the head until it click When removing the contra angle head pull it...

Page 9: ...nsure that the central unit and the battery charger are placed in dry and clean condition Never use the battery charger for anything other than ApexPilot All In One from Beyes The charging normally takes approx 90 minutes but it depends on battery use conditions battery freshness and ambient temperature etc Under the charging condition the central unit is not allowed to rotate The completely disch...

Page 10: ...ndo motor Select MR model by POWER KEY after power is on for the use of apex locator to control endo motor Apex locator control motor how to rotations POWER Key The POWER key Apex locator controls motor working mode option turn on the power press this key to circle options ON OFF Normal rotation when the power is on Press this key to rotate the motor and then release Press this key again to stop t...

Page 11: ... as other functions LCD panel Root canal length measurement display displayed as the picture on the right Apex locator control motor working mode option Turn on the power press to select M Motor only apex locator will not work MR Motor working for the root canal preparation and apex locator working for the measurement of the root canal length at the same time apex locator will control the preparat...

Page 12: ...ymbol indicates the capacity of battery The symbol will be animated when the battery is being charged The battery is full or nearly full About 30 80 remaining Less than about 30 remaining Battery are drained or the symbol flashing with alarm Please charge the battery at once The symbol indicates the remaining capacity of the battery When load is applied to the file the symbol that indicates the re...

Page 13: ...0N cm Second press the motor will be reciprocating Factory setting 350PRM 3 0N cm Power off Third press Power off Quick Start factory setting Rotation speed 350PRM forward rotate and reciprocating torque 3 0N cm forward rotate and reciprocating Auto Reverse Factory setting auto reverse mode Reciprocating mode rotation direction forward forward about 270 degrees reverse about 30 degrees Working mod...

Page 14: ...to select parameters 2 Press to select arrow direction Fifth step apex locator control motor Press P to select parameters 1 press to select Exit setup Setting parameters will be saved automatically When setting Press ON OFF to enter Quick Start mode and work with parameter settings above Press POWER to enter traditional working mode 4 2 Integrated Apex Locator ApexPilot All In One is equipped with...

Page 15: ...s required in IEC 60601 1 1 Nevertheless in rare cases electrical sensation during the length determination can occur In this case do not continue the treatment with this patient 4 2 1 Modes of Root apex locator Control Endo motor mode There are two types of work mode related to Root Apex Locator Mode Independent Endo motor Apex locator is invalid Mode Apex locator controls motor for rotations Can...

Page 16: ...mpts all apical lines as vertices 4 2 3 Optional Apical Line This feature is convenient for users to make marks of the relative distance from apical point The range of markers is 5 scales from 0 0 to 0 5 According to user labeled apical scale when reaching marker position better visual and sound cues Complete the following steps to change the marks of apical point Turn on the power of main unit Ch...

Page 17: ...f the central unit Insert the lip clip into the connector at the end of the cable Ensure the connection is solid Put the pip clip in the patient s mouth we recommend positioning it on the opposite side of the tooth undergoing therapy For combined length determination 4 2 4 2 Application steps Press POWER to turn on the machine Press POWER key to select the mode of endo motor controlled by the Root...

Page 18: ...ng rotate as setting speed torque Or press ON OFF to drive the file to rotate when the file approaching the apical foramen the root canal relative value will be shown as 0 2 then the motor will automatically slow down the root canal relative value which will be slower and the minimum speed will be 140 PRM When it reaches to the apical foramen the motor will be auto reversed When the file reverse a...

Page 19: ...ce the user s key operation DEMO and the internal detective apex locator will be processed in parallel ApexPilot All In One embedded calibration circuit and there is no need to ration calibration modules Demo animation is the whole process to measure the length of Apex Pilot All In One apex locator Simulation shows that the file enters the root canal reaches the apical beyond the apical the change...

Page 20: ...ex locator testing result apex locator combined with motor testing results Self checking result 1 represent internal detecting result normal 0 represent error please contact with local dealer apex locator testing result 1 represent normal 0 represent error apex locator combined with motor testing results 1 represent normal 0 represent error 4 3 Running in different modes of rotations and settings ...

Page 21: ...or handpiece will stop If you want forward rotate again re press the ON OFF Key or repeat the steps Auto Reverse Off The motor handpiece stops without reverse rotation If you want it to rotate forward rotate again re press the ON OFF Key or repeat the steps Anti clockwise Rotation In general condition the Endo Motor that rotates in counter clockwise is so called as reverse motion The traditional r...

Page 22: ...ersa Notice Under the reciprocating mode only 16 1 or 20 1 is supported The setting must be according to the actual contra angle To set the reciprocating rotation direction please see 5 1 QS Quick Start function settings 4 3 2 Differences in modes of rotation settings Press and hold the SELECT Key for 1 second or longer Enter the Rotation Mode selection the sequence will be Auto Reverse Auto Stop ...

Page 23: ...ng mode by according to personal habits or the order of files all parameters will be saved automatically we recommended users to save the parameters into program 1 5 by according to the conventional order of file more convenient to call 4 5 2 Factory Default Parameters The program can return to the original state that is configured at the time of factory shipment if setup becomes confusing Turn of...

Page 24: ...to its original state If you want to stop this process turn off the power key for more than 1 second Caution This function does not work unless the remaining battery capacity is sufficient Perform calibration after cleaning the contra angle Residuals will affect the calibration Do not attach any rotary files or other when performing calibration Do not shake the motor when performing calibration Th...

Page 25: ...gy to meet the requirements of various radiation indicators There is no more than 5 meters for the transmission distance Display the transmission information in milliseconds to avoid any delays Wireless transmission connection Wireless transmission display features start and off while the power is on long press P to turn on wireless transmission module long press P again to turn off wireless trans...

Page 26: ...reen To initialize the wireless transmission module of connected device for ApexPilot C is to long press wireless transmission key Wait for successful connection as mentioned above Caution The wireless transmission function is designed for one connection does not support multipoint connection When there are multiple devices automatically connected at the same time the connection error may occur Pl...

Page 27: ...lip clip file clamp contra angle sleeve and contra angle mentioned above all other parts for ApexPilot All In One can t be sterilized with high temperature and pressure Items that can be sterilized The lip clip the file clamp the contra angle sleeve and contra angle have biocompatible properties in compliance with EN 10993 1 and can be sterilized in the autoclave put the item in special plastic ba...

Page 28: ... the spray nozzle into the contra angle head insert to the part that connects to the central unit Insert the lubricants spray nozzle to the provided spray nozzle loop inject the lubricants for 1 2 seconds till the outlet liquid from the head of the contra angle is cleaned WARNING Do not lubricate the micromotor in the central unit for any reason because lubricant contamination of the micromotor ca...

Page 29: ...m battery charger WEIGHT 780g POWER TYPE Battery powered 750mAh 3 7VDC BATTERY CHARGER VOLTAGE SUPPLY 100 240VAC VOLTAGE FLUCTUATIONS Max 10 FREQUENCY 47 63Hz BATTERY CHARGER POWER RATING 0 5A TORQUE VARIATION 0 1 4 0 N cm SPEED VARIATION TO MOTOR SHAFT 2000 9000prm ELECTRIC SAFETY CLASS II APPLIED COMPONENT TYPE TYPE B LEVEL OF SAFETY IN PRESENCE OF INFLAMMABLE ANAESTHETIC MIXTURE OR OXYGEN NOT S...

Page 30: ...ean the contra angle head alarm sounds when the motor is working Set to Auto Reverse mode take off contra angle there is NO click sound when working Contact your dealer set to Auto Reverse mode take off contra angle there is click sound Clean the contra angle head There is some residual contamination on the rotating shaft of the contra angle Clean the contra angle head Apex locator no response mea...

Page 31: ...ic length determination do not match This does not mean that your ApexPilot All In One is not working properly or that the X ray image is inaccurate These discrepancies indetermination occur due to the anatomical variation The actual apical foramen may not be located at the radiographic apex 9 Disposing Product Please consuIt with the dealer from whom you purchased in regards to waste disposal The...

Page 32: ...All In One is intended for use in the electromagnetic environment specified below The customer or the user of the ApexPilot All In One should assure that is used in such an environment Emission test Conformity Emission test Conformity Electromagnetic Environment guidance RF Emissions CISPR11 Group 1 The appliance use RF energy only for its internal function Therefore its RF emissions are very low ...

Page 33: ...e 1 kV differential mode 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 IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 cycles 5 UT 70 UT 30 dip in UT for 25 cycles 5 UT 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycles 40 UT 60 dip in UT for 5 c...

Page 34: ...itters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from s...

Page 35: ... to frequency of transmitter in meters Meters m 150 kHz 80 MHz d 1 2 P 80 MHz 800 MHz d 1 2 P 800 MHz 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 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 wh...

Page 36: ...4 20 3514 0949 Email info beyes ca Website www beyes ca Printed in Canada ENI001R2 Federal law restricts this device to sale by or on the order of a dentist physician or any other practitioner licensed by the law of the states in which he or she practices to use or order the use of this device Beyes Dental Canada Inc is not responsible for any typographical errors All brands are holders of their r...

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