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15. 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 effected

by electromagnetic interference Avoid using the device in high electromagnetic

environment.

Technical Description Concerning Electromagnetic Emission

Table 1: Declaration - electromagnetic emissions

Guidance and manufacturer’s declaration - electromagnetic emissions

The model ApexPilot G1 is intended for use in the electromagnetic environment

specified below. The customer or the user of the model ApexPilot G1 should

assure that it is used in such an environment.
Emissions test

Compliance

Electromagnetic environment -

guidance

RF emissions

CISPR 11

Group 1

The model ApexPilot G1 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 ApexPilot G1

is suitable for used in all

establishments, including

domestic establishments and

those directly connected to

the public low-voltage power

Harmonic

emissions

lEC 61000-3-2

Class A

Guidance & Declaration — electromagnetic immunity

The model ApexPilot G1 is intended for use in the electromagnetic environment

specified below. The customer or the user of the model ApexPilot G1 should

assure that It is used in such an environment.
Immunity test

IEC 60601

test level

Compliance level

Electromagnetic

environment -

guidance

Technical Description Concerning Electromagnetic Immunity

Table 2: Guidance & Declaration - electromagnetic immunity

Содержание ApexPilot G1

Страница 1: ...Endo Motor Instruction for Use ...

Страница 2: ...ot canals or measuring canal length 1 3 Contraindication Patient or doctor with a pacemaker Patient with hemophilia Patient with heart disease Pregnant women or young Table of Contents 1 Product Introduction 2 2 Warning and Safety 4 3 Installation 5 4 Operation 7 5 Screen Display 9 6 Automatic Reverse Function 10 7 Troubleshooting 12 8 Cleaning Disinfection and Sterilization 13 9 Maintenance 15 10...

Страница 3: ...3 1 4 Package includes Motor handpiece Contra angle Charging base Lubricator Power adapter 1 5 Diagram of components and control buttons ...

Страница 4: ...ns causing harm to the patient Only use original power adapter Other power adapter will result in damage to lithium battery and control circuit The motor handpiece cannot be autoclaved Use disinfectant of neutral pH value or ethyl alcohol to wipe its surface Do not remove contra angle before motor stops Doing so may cause damage to handpiece and contra angle Secure the file before starting Set tor...

Страница 5: ...ct after usage on each patient Sterilize under 134 C 2 0 2 3bar 0 20 0 23MPa Contra angle in this package only fits ApexPilot G1 This will not fit other handpieces Installation of contra angle Align the pin of the contra angle with one of the holes on the motor handpiece and push in the contra angle until there is an audible click A click sound indicates that the installation is in place Note Ther...

Страница 6: ... Do not insert or remove files without holding down the push button this will damage the chuck Removal of file 1 Press the push button 2 Pull out the file Warning Stop motor before plugging and pulling out the file Removing files without holding the push button may damage contra angle chuck Warning After installation give the contra angle a light tug to make sure that it is securely attached befor...

Страница 7: ... operation Press ON OFF to start and stop motor Standby Running 4 3 Store setting on M1 9 M1 M9 is a memory program used to store Operation mode and parameter settings Press to change standby screen to select memory location between M1 to M9 press and hold to speed up screen selection change Standby Interface Press S to enter parameter setting ...

Страница 8: ...F R Change parameter and operating mode Press on each screen to change the parameter Press S to next parameter Note Only available parameters for the operating mode can be changed Example Forward mode Speed and Rev Torque can be changed Keep pressing S to cycle the display screen to different setting options The display screen will go back to Standby display when 5 seconds elapses without a switch...

Страница 9: ...ween forward and reverse rotation outside the canal calibrate the unit in the following way Press S and and hold for 2 seconds to start calibration After calibration is complete the display screen will show succeed and will then return back to Standby Display initial display Note Plug in original contra angle without file Warning Use original contra angle only Any load applied to contra angle will...

Страница 10: ...1000 step 50 Rev Torque Ncm 0 6 5 0 step 0 1 100 1000 step 50 Rev Torque Ncm 0 6 5 0 step 0 1 Note Device beeping M3 F REV TORQUE 3 0 _ DIR M3 R R REV TORQUE 3 0 _ DIR M3 M3 F SPEED SPEED 300 300 _ _ TRQ TRQ 6 Automatic Reverse Function Automatic reverse function is only available in CW mode During operation the motor is in clockwise rotation If the load at file exceeds the preset torque motor wil...

Страница 11: ...wise resume Warning In low battery motor cannot execute automatic reverse It is advised that the handpiece should always be charged If automatic reverse is triggered frequently in the same operation motor will overload and stop If this occurs please turn off device and allow motor to cool down ...

Страница 12: ... oil injection Handpiece heating Extended usage in Reciprocating Motion Mode a Normal phenomenon b Stop use Use after the temperature of handpiece drops After plugging the handpiece into charging base the wireless charging indicator light does flash a The handpiece is not seated in place b The handpiece is fully charged Reseat the handpiece in place The time of endurance becomes shorter after char...

Страница 13: ...user is responsible for the sterility of the product for the first cycle and each further usage as well as for the usage of damaged or dirty instruments where applicable after sterility 8 2 7 The water quality has to be convenient to the local regulations especially for the last rinsing step or with a washer disinfector 8 2 8 Do not sterilize the motor handpiece the AC adapter or the base After ea...

Страница 14: ...infector Ao value 3000 or at least 5 min at 90 C 194 F Avoid any contact between the contra angle and any instruments kits supports or container Follow instructions and observe concentrations given by the manufacturer see also general recommendations Use only approved washer disinfector according to EN ISO 15883 maintain and calibrate it regularly Make sure contra angle is dry before moving to the...

Страница 15: ...gle in sterilization packaging in a dry and clean environment Sterility cannot be guaranteed if packaging is open damaged or wet Check the packaging and the contra angle before using it packaging integrity no humidity and validity period 9 Maintenance 9 1 General This device do not include accessories for repair usage the repair should be carried out by an authorized person or authorized after ser...

Страница 16: ...eaning and disinfection but before sterilization 1 Screw injecting nozzle into jet of oil bottle Around 1 to 3 circles 2 Plug nozzle into the end part of contra angle 3 Spray oil into the contra angle for 2 3 secs until the oil flows out of contra angle head 4 Purge excess oil from the end part of contra angle using air or keep contra angle in a vertical position for gravity draining Warning Motor...

Страница 17: ...y period 13 1 SCOPE OF WARRANTY BEYES Dental Canada Inc warrants to the original retail purchaser that it will be at BEYES option to repair or replace components of the dental products manufactured by BEYES except for components not warranted under Exclusions that are defective in material or workmanship under normal use and service BEYES obligation under this limited warranty is limited to the re...

Страница 18: ... 12 Products that would otherwise by covered under Sections 1 and 2 of this limited warranty but are acquired i from a person or entity that is not BEYES or one of its authorized dealers or ii from a BEYES dealer that is not authorized to sell the product at issue in the geographic territory where the purchaser is located or is not authorized to sell the product at issue within the medical animal ...

Страница 19: ...Power supply Class II Input 100V 240V 50Hz 60Hz Output DC5V 1A Battery capacity 3 6V 750mAh Torque 0 6 5 Ncm Speed 100 1000 rpm Environmental parameters Working Storage Temperature 5 C 40 C 20 C 55 C Humidity 30 75 10 93 Air pressure 70kPa 106kPa 70kPa 106kP Warning Do not store device in extreme temperature and humidity ...

Страница 20: ...ent guidance RF emissions CISPR 11 Group 1 The model ApexPilot G1 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 ApexPilot G1 is suitable for used in all establishments including domestic establishments and those directly connected to the public ...

Страница 21: ...ariations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 250 cycles 5 UT 95 dip in UT for 0 5 cycle 5 UT 95 dip in UT for 1 cycle 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 250 cycles Voltage should be that of a typical commercial or hospital environment If the user of the m...

Страница 22: ...ndo Smart including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P1 2 d 2 P1 2 d 1 2 P1 2 80 MHz to 800 MHz d 2 3 P1 2 800 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter In watts W according to the transmitter manufacturer and d Is the recommended separ...

Страница 23: ...ntended for use in electromagnetic environment in which radiated RF disturbances is controlled The customer or the user of the model ApexPilot G1 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the model ApexPilot G1 as recommended below according to the maximum output power of the communicatio...

Страница 24: ...naplein 10 Ie Verd 2595AA The Hague Netherlands Tel 31645171879 English 31626669008 Dutch Email info beyes ca Website www beyes ca Printed in Canada ENI034 Rev 1 13 04 21 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 0197 ...

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