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Operation  2016-03-07

1. Only fully trained and qualified personnel may operate equipment.

2. Items to be duly noted when installing equipment.

1)  Locate the unit in a place where it will not get wet.
2)  Install the unit in a location where it will not be damaged by air pressure, temperature, humidity, direct sunlight, dust, salts, 

or sulfur compounds.

3)  The unit should not be subjected to tilting, excessive vibrations, or shocks (including during shipping and handling).
4)  Do not install the unit where chemicals are stored or where gas may be released.
5)  Follow all electrical specifications including frequency (Hz), voltage (V), and current capacity (A) (power consumption).
6)  The equipment must be properly grounded.

3. Item to be duly noted before use.

1)  Inspect all switch connections, polarity, dial settings, meters etc. to confirm that the equipment will operate properly.
2)  Confirm that the ground is connected properly.
3)  Confirm that all cords are connected properly.
4) Take into consideration that simultaneous use of more than one instrument or device can create a dangerous situation or 

lead to a mistake in diagnosis.

5)  Reconfirm the safety of external circuits or systems which are connected directly to the patient.

4. Item to be duly noted during use.

1)  Never use the equipment for treatment or diagnosis more than necessary or for longer than necessary.
2)  Maintain a constant vigilance for abnormal conditions in both the equipment and the patient.
3)  Appropriate steps, such as shutting the equipment down, should be devised to protect the safety of the patient in case any 

abnormalities in the equipment or the patient are observed.

4)  Make sure the patient does not handle or manipulate the equipment.

5. Item to be duly noted after use.

1) Turn the power OFF after returning dials, switches etc. back to their original positions in the prescribed order.
2)  Do not use excessive force or pull the cord itself to disconnect cords.
3)  The following items should be considered when storing the equipment:

(1)  The storage area should protect the equipment from getting wet.
(2)  The storage area should protect the equipment from any possible damage due to atmospheric pressure, temperature, 

humidity, wind, direct sunlight, dust or air containing salts or sulfur.

(3)  The equipment should be protected from tilting, vibrations, percussive shocks, etc. (including when it is being moved).
(4)  The storage are should be free of chemicals and gases.

4)  All accessories, cords, guides etc. should be cleaned, properly arranged and carefully put away.
5)  Before storage, the equipment should be cleaned so that it is ready to be used again.

6. In case of a malfunction or defect, the operator should attach a written notice indicating that the equipment is out of order 

without attempting to repair the equipment himself; repairs should be referred to a qualified serviceman.

7. Equipment should not be modified in any way.

8. Maintenance and Inspection

1)  All equipment and components should be inspected regularly.
2) Equipment which has not been used recently should always be inspected to confirm that it functions properly and safely 

before being put back into use.

 

Safety and Accident Prevention for the Opera-

tion of Electrical Medical Devices

Summary of Contents for EndoSync TR-CM BSL

Page 1: ...urchasing the EndoSync For optimum safety and performance read this manual thoroughly before using the unit and pay close attention to warnings and notes Keep this manual in a readily accessible place for quick and easy reference Operation Instructions Brasseler USA ...

Page 2: ... Operation 12 Memory Settings 13 Memory Settings Primary Functions 13 Memory Settings Additional Operation Settings OTR mode 14 Memory Settings Additional Operation Settings Normal mode 15 Memory Settings Other Settings 16 Restore Default Memories 17 3 After Use 17 Take Out File 17 Usage Operation with EndoSync A I 18 Install File Electrode 18 ConnectTransmission Cable 19 Check Operation 19 Meter ...

Page 3: ...r the Operation of Electrical Medical Devices 40 NOTICETO PROTECT INTELLECTUAL PROPERTY US PAT 5897315 JP PAT 3113096 US PAT 5902105 JP PAT 3129888 US PAT 5980248 JP PAT 3223042 US PAT 6929476 JP PAT 3213480 US PAT APPLN 14 485471 JP PAT 3264607 US PAT APPLN 14 489967 JP PAT 3213539 US DESIGN APPLN 29 347684 JP PAT 3676753 DE PAT 19520765 JP PAT 4139809 DE PAT 19549662 JP PAT APPLN 2009 296456 DE ...

Page 4: ...n then operate the equipment with the utmost caution to prevent either damaging the equipment itself or causing bodily injury The following symbols and expressions indicate the degree of danger and harm that could result from ignoring the in structions they accompany This alerts the user of important points concerning operation or the risk of equipment damage The user e g the hospital clinic etc i...

Page 5: ...eler USA and other than in their original condition 5 operating the equipment in ways other than the operating procedures described in this manual or resulting from the safety precautions and warnings in this manual not being observed 6 workplace conditions and environment or installation conditions which do not conform to those stated in this manual such as improper electrical power supply 7 fire...

Page 6: ...OFF Instruments which produce considerable electrical noise such as electric scalpels can cause the EndoSync to operate abnor mally Turn the EndoSync OFF before using any instruments that produce electrical noise Do not use this instrument on patients who have a pacemaker or an Implantable Cardioverter Defibrillator ICD It could cause the pacemaker or the Implantable Cardioverter Defibrillator ICD...

Page 7: ...ut Apical Reverse or Stop The motor reverses or stops when the tip of the file reaches a preset position inside the ca nal ApicalTorque Reduction The automatic torque reverse value is reduced as the file tip approaches the apex These controls can be used if the EndoSync is connected to the EndoSync A I Normal Mode If the file torque is less than the set value the file will keep rotating in the for...

Page 8: ...Minus Switches Power Supply Cord Charge LED orange Power LED green Charger Motor Handpiece Charger Switch Parts Identification and Accessories Standard Accessories Optional Accessories Parts Identification Accessories Power Supply Cord 1 LS Oil 1 Guide Bur 1 Handpiece Rest 1 Transmission Cable 1 ...

Page 9: ...tion Conditions for Main unit and Charger Charge the battery as soon as the battery power indicator gets down to its last bar If the orange charge LED goes OFF immediately or doesn t light up when the motor handpiece is put into the charger the battery is probably fully charged To make sure take the motor handpiece out and put it back in again Make sure the contact areas for the motor handpiece an...

Page 10: ...up the marks Approx 290 Do not force the contra angle to rotate beyond its limit The rotation range of the contra angle is about 290 Set it so that it reaches the treatment area and the dis play is easy to see Line up the match marks and push the contra angle onto the motor handpiece until there is an audible click The contra angle must be lubricated with LS Oil before using for the first time Ref...

Page 11: ...way into the latch Release the file release button Before using right after purchase whenever the motor handpiece or contra angle has been replaced or if the motor alternates between forward and reverse rotation outside the canal calibrate the instrument in the following way 1 Make sure the battery is fully charged three bars are displayed 2 Put a commonly used file into the contra angle 3 Turn th...

Page 12: ...ck Nickel titanium file may suddenly snap depending on the curvature and shape of the canal stop using the file if you notice or feel anything amiss Files will eventually break due to metal fatigue and should be replaced before they reach this point Electric noise or a malfunction could interfere with the motor control Do not depend entirely on the unit controlling itself always watch the display ...

Page 13: ...le the switch is held down and stop when the switch is released You can temporarily change the torque reverse setting while the motor is running by pressing the Plus or Minus switch Normal mode only The color of the backlight changes depending on the load applied to the file The backlight starts blinking when the load approaches the torque reverse setting While the OTR is triggered the back light ...

Page 14: ...TR Standby Display Rotation Mode Speed Torque Reverse These functions are available only when connected to the EndoSync A I If the torque limit is too high the file could jam inside the canal and break The torque settings must be changed depending on the root canal condition and the file If the torque reverse seems to be activated too frequently increase its value When the OTR mode motor runs back...

Page 15: ... the standby display if 5 seconds initial setting elapses without a switch being pressed Standby Display Apical Action Function When this is turned ON Apical Reverse or Stop function be activated Apical Reverse or Stop The file will reverse or stop when the file tip reaches the Flash Bar When Apical Action Function is turned OFF this display will be skipped Auto Start Stop When this is turned ON t...

Page 16: ...ivated Apical Reverse or Stop The file will reverse or stop when the file tip reaches the Flash Bar When Apical Action Function is turned OFF this display will be skipped Auto Start Stop When this is turned ON the file starts rotating when it is inserted and stops when it is taken out of the canal Apical Slow Down When this is turned ON the file slows down as it approaches the apex ApicalTorque Re...

Page 17: ...Beeper Volume Press Plus or Minus switch to set beep volume used for switch operation and alarms at OFF Low or Big Auto Power OFFTime The time lapse for automatic shut OFF when the unit is not used can be set from 1 to 15 min utes Press Plus or Minus switch to set the time Positive Negative Display Set display for black on white background or vice versa Right or Left Handed Set display for right o...

Page 18: ...peration 3 Wait unit the Finished display appears and then press the Main switch to go to the standby display Take care not to injure your fingers when inserting and removing files Never insert or remove files without holding down the button this will damage the chuck Make sure the unit is turned OFF before inserting or removing files 1 Hold down the Select switch and press the Main switch to turn...

Page 19: ...ed with this electrode Also the files noted below cannot be used To use these types of files do not clip on the electrode and use the motor in manual mode Those with a file diameter of more than 1 2 mm Those with chuck shanks that are not perfectly round Gates Glidden Drills Those that have cutting sections with large diameters such as largo burs Do not use files shanks larger than the ISO standar...

Page 20: ...go straight in After insertion give plugs a light tug to make sure they are securely connected Otherwise data may not be transmitted accurately Do not bump the plugs or drop anything on them when they are plugged in Use only the special cable provided Other cable could be electrically risky and result in damage or injury Make sure the file goes all the way in Give the file a light tug to make sure...

Page 21: ...t is not always possible especially in cases of abnormal or unusual root canal morphology always take an X ray to check the measure ment results If the meter does not move when the file is inserted the unit may be malfunctioning and must not be used Do not use an ultra sonic scaler while the contrary electrode is hooked in the patient s mouth noise from the scaler could cause the motor to start ru...

Page 22: ...stained beep will sound when this happens If the unit is set for Apical Reverse the motor will run back wards after it stops If the load on the file exceeds the setting for torque re verse the motor will stop and then reverse its rotation A rapid repeated three toned beep will sound when this happens The motor will stop when the file is taken out of the ca nal Gradually increase the size of the fi...

Page 23: ...the electrode to remove any remaining mois ture Rotor Axle and Built in Electrode Cleaning If the bars flicker during use or if all the bars in the meter do not light up when the file touches the contrary electrode clean the rotor axle and the built in electrode in the following way Do not bend or deform the electrode Always use the guide bur and make sure it will not come out If the guide bur is ...

Page 24: ... must be lubricated with LS Oil Refer to page 24 Tighten the screw up securely and then hold down the push button and pull out the guide bur Rotor Axle and Built in Electrode Cleaning Make sure the screw is tight enough Otherwise it might come out and be swallowed Also measurements might not be accurate Contact is too high OK No Good ...

Page 25: ...lization pouch Minimum drying time after sterilization 30 minutes Never autoclave the motor handpiece Autoclaving and drying temperatures must never exceed 135 C 275 F Take the file out of the contra angle before autoclaving it Clean everything thoroughly before autoclaving Any chemicals or foreign debris left on instruments could cause them to malfunction or could cause discoloration For steriliz...

Page 26: ...alin cresol FC and sodium hypochlorite as they are quite strong Wipe up any chemical spills immediately Some chemicals may leave traces even if wiped up immediately Use only Ethanol for Disinfection Ethanol 70 to 80 vol and OPTI CIDE 3 Surface Wipes for cleaning Any other cleaning chemical or products should not be used including but not limited to the following cleaning products and similar clean...

Page 27: ...over and its screw Turn power OFF Remove the screw and slide the battery cover off Take out the old battery and disconnect it Replace the battery when it starts to loose power relatively quickly after being fully charged The battery will last for approximately 1 year under normal circumstances and use Be careful not to pinch the battery cord when replacing the cover Do not tighten the cover screw ...

Page 28: ...r inserted this could damage the instrument Take out the screw and then take out the built in electrode Hold the push button and slide the guide bur straight in as shown in the illustration Then rotate it left and right Put a little Ethanol for Disinfection Ethanol 70 to 80 vol on a brush and clean the rotor axle with it Slide the built in electrode onto the guide bur and line up the screw holes B...

Page 29: ...ew up securely and then hold down the push button and pull out the guide bur 1 2 Operation 2016 03 07 Built in Electrode Replacement Make sure the screw is tight enough Otherwise it might come out and be swallowed Also measurements might not be accurate Contact is too high OK No Good ...

Page 30: ... 45 C 14 to 113 F Relative Humidity 10 to 85 RH without condensation Atmospheric Pressure 700 to 1 060 hPa Do not expose to direct sunlight frequently or for long times If the unit has not been used for a long time make sure it works properly before using Always remove the battery prior to storing or shipping the unit ...

Page 31: ... held down 3 Check that pressing the Plus and Minus switches changes the memory number from M1 through M6 4 Check that the settings for each memory can be changed 5 Make sure the connection end of the motor handpiece is not damaged or dirty 6 Make sure that the connection end of the contra angle is not damaged or dirty and that it can be securely connected to the motor handpiece Make sure that the...

Page 32: ...ee for one year beginning from the date of purchase Within this period any defect that is due to faulty manufacturing or material will be remedied by repair or replacement at the judgment of the manufacturer or its dis tributor 2 Warranty repair and service In the event of a claim under this guarantee the device is to be sent to Brasseler USA For customers in the U S call 1 800 841 4522 For custom...

Page 33: ...th Is Apical Action Function setting turned OFF Turn Apical Action Function setting ON Is Auto Start Stop turned OFF Turn Auto Start Stop setting ON Has the meter gone past the Flash Bar Set the Apical Stop or Reverse for Reverse REV Motor starts but then stops right away Did you hold down the Main switch for more than 1 second If you hold the Main switch down for more than 1 second the motor runs...

Page 34: ...setting tuned ON When this is turned ON the motor slows down as the file approaches the apex Refer to page 15 for how to turn this setting ON and OFF Is Torque Slow Down setting tuned ON When this is turned ON the motor slows down as the torque increases Refer to page 15 for how to turn this setting ON and OFF Unit turns OFF ON its own Was the unit no used for a long time Auto power OFF was probab...

Page 35: ... Fitting Length of Shank 9 0 mm Maximum Overall Length of Rotary Instrument 28 0 mm Type of Shank Type 1 according to ISO 1797 1 Type of Coupling TR CM Type BSL coupling It can be used only with TR CM Type BSL motor handpiece Gear Ratio 1 88 1 Chuck Type Push Button Latch Charger Rated Input voltage A C 100 240 V Frequency 50 60 Hz Power Consumption 13 VA Name EndoSync Model TR CM Type BSL Classif...

Page 36: ...ec trode and File Holder Type BF applied part Class II Equipment Autoclavable up to 135 C Rating Label Contra Angle Operation Instructions cTUVus certification mark for the U S and Canadian Model Type Alternating Current Supply Frequency Rated Input Voltage Input Power Distributor Caution U S Federal law and Health Canada Medical Device Regulations restrict this device to sale by or on the order o...

Page 37: ...PERATURE LIMITATION Attention consult accompanying documents THIS WAY UP Package Caution U S Federal law and Health Canada Medical Device Regulations restrict this device to sale by or on the order of a physician or properly licensed practitio ner Symbols ...

Page 38: ...c environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 2 4 6 kV contact 2 4 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic mate rial the relative humidity should be at least 30 Electrical fast tran sients bursts IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 0 kV for power sup ply lines 2 Mains p...

Page 39: ...uld be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip ment 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 be absorption and reflec tion from structures objects and people Power frequency magnetic ...

Page 40: ...tions equipment transmitters and the TR CM as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 11 80 MHz to 800 MHz d 800 MHz to 2 5 GHz d 2 0 01 0 11 0 1 0 2 0 1 0 35 0 32 0 63 1 1 11 1 2 10 3 51 3 16 6 32 100 11 11 10 20 For transmit...

Page 41: ...wn should be devised to protect the safety of the patient in case any abnormalities in the equipment or the patient are observed 4 Make sure the patient does not handle or manipulate the equipment 5 Item to be duly noted after use 1 Turn the power OFF after returning dials switches etc back to their original positions in the prescribed order 2 Do not use excessive force or pull the cord itself to ...

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Page 44: ...PUB M8084 EA Brasseler Printed in Japan One Brasseler Boulevard Savannah GA 31419 U S A ...

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