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Schlumbohm 110 0607, Руководство пользователя

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Pilot²

 

 

Doc. No. 610 2221 v07

 

- 11 -       

(*applicable with the ultrasonic extension module)

 

1.  Notes 

1.1. 

Symbols used 

 

 

Symbol 

Title,  Description / Explanatory Text,  Standard / Reference No. of Symbol 

 

 

The product complies with the requirements of EU Regulations / No. of notified body 

 

Caution 

Indicates the need for the user to consult the instructions for use for important cautionary 

information such as warnings and precautions that cannot, for a variety of reasons, be 

presented on the medical device itself. 

ISO 15223-1:2016 / Ref. 5.5.4 

 

Type BF Applied Part 

To identify a type BF applied part complying with IEC 60601-1 

IEC 60601-1: 2005+Cor.:2006+Cor.:2007+A1:2012 / Ref. Table D1 / 20 

 

 

 

Waste Collection 

Separate collection for waste of electrical and electronic equipment. 

EN 50419 - Marking of electrical and electronic equipment in accordance with article 11(2) of Directive 

2002/96/EC 

 

 

Do not re-use 

Device intended for single use only and not to be re-used 

ISO 15223-1:2016 / Ref. 5.4.2

 

 

Non-sterile 

A medical device not subjected to sterilization 

ISO 15223-1:2016 / Ref. 5.2.7 

 

 

UDI of the device, Data-Matrix-Code (GS1-Code)   

 

 

UL Component Recognition Mark 

indicates compliance with Canadian and U.S. requirements 

 

EU representative  

EU authorised representative 

ISO 15223-1:2016 / Ref. 5.1.2

 

 

automated processing in the thermal disinfector 

 

Steam sterilization up to the indicated temperature 

 

Batch Code 

Batch code so the lot or batch can be identified 

ISO 15223-1:2016 / Ref. 5 

 

 

2021 

Manufacturer/ Date of Manufacture 

Indicates the medical device manufacturer / 

Indicates Date of Manufacturer 

ISO 15223-1:2016 / Ref. 5.5.1 /5.1.3

 

 

Содержание 110 0607

Страница 1: ...610 2221 v07 25 01 2021 EndoPilot User manual Schlumbohm ...

Страница 2: ...Pilot 2 Illustration 1 Control unit Basic device LED 1a Right side of the device 1b 1c 1d Rear side with microSD card 1e 1f Left side of the device ...

Страница 3: ... Illustration 4 4a 4b 4c 4d 4e 4f Illustration 4e contact wire housing spring threaded bush knob contact You can dismantle the patented file clamp 4e for reprocessing cleaning disinfection and sterilization A universal key for ultrasonic tools can be used as a tool for assembly with a wrench size of 3 2 mm ...

Страница 4: ...Pilot 4 Illustration 5 Illustration 6 Illustration 7 7a 7b Illustration 8 Illustration 9 Ill 10 Ill 11 Illustration 12 12a 12d 12b Illustration 13 12c Illustration 14 Illustration 15a Illustration 15b ...

Страница 5: ...processing instructions At the end of assembly firmly tighten the contact again Caution Check if the device is functioning properly Loose parts may fall out and enter the patient s mouth 4f Retainer for apex cable mounted on the device A2 A1 A1 A1 A1 A1 5 109 0126 Contra angle for apex measurement Fully insulated 1 1 gear tools coupling ISO 14457 2017 and ISO E motor coupling ISO 3964 2016 Amd 1 2...

Страница 6: ...n Thermal protector 4 pcs Order no 110 1043 Heat insulator protects against thermal damage Obtura Spartan Obtura Multi Tool for shaping and for screwing on and unscrewing the BackFill needles Obtura Spartan Not part of the Set Standard Gutta percha pellets From the US market see Obtura Spartan box with 100 pcs Obtura Cleaning brushes 2 brushes to clean the BackFill gun Obtura Spartan Obtura Cleani...

Страница 7: ...lec Suprasson Order no 109 3102 A6 18 109 3132 Rinsing adapter Attachment to a standard syringe for flushing the Acteon Satelec Suprasson handpiece A1 19 F00406 Wrench Order no 109 3113 Acteon Satelec universal wrench for ultrasonic tips A6 20 109 3122 Ultrasonic handpiece cable Acteon Satelec highly flexible supply cable with plug A6 21 109 2351 Optional Twin wireless foot switch Pedal I Start Pe...

Страница 8: ...able a locking clamp keeps the cables in place Illustration 16a Ultrasonic module Bottom compartment with the connection for the ultrasonic cable Illustration 17 Illustration 18 Illustration 19 Rinsing sleeve for cleaning Illustration 20 lllustration 21 ...

Страница 9: ...apex locator EndoPilot plus REF 110 0609 Endo motor with apex locator DownPack and BackFill EndoPilot ultra REF 110 0610 Endo motor with apex locator and ultrasonic extension EndoPilot ultra plus REF 110 0611 Endo motor with apex locator DownPack BackFill ultrasonic This user manual describes the EndoPilot comfort EndoPilot plus EndoPilot ultra and EndoPilot ultra plus Devices with less function a...

Страница 10: ...n 23 4 Motor system 24 4 1 Favorites 24 4 2 Selection of the file systems 24 4 3 Preparation 25 4 4 MyFile file system 25 4 5 Setup motor 26 4 5 1 File data 26 4 5 2 Reciprocal function 27 4 5 3 Apex functions during motor operation 28 4 5 4 Calibrate 29 5 Obturation 30 5 1 DownPack 30 5 2 BackFill 30 6 Ultrasonic function 31 6 1 Operating instructions 31 6 2 Setting the ultrasonic power output 32...

Страница 11: ...ction for waste of electrical and electronic equipment EN 50419 Marking of electrical and electronic equipment in accordance with article 11 2 of Directive 2002 96 EC Do not re use Device intended for single use only and not to be re used ISO 15223 1 2016 Ref 5 4 2 Non sterile A medical device not subjected to sterilization ISO 15223 1 2016 Ref 5 2 7 UDI of the device Data Matrix Code GS1 Code UL ...

Страница 12: ...60601 1 2005 Cor 2006 Cor 2007 A1 2012 Ref Table D1 9 Consult Instructions for Use Indicates the need for user to refer to instructions for use IEC 60601 1 2005 Cor 2006 Cor 2007 A1 2012 Ref Table D2 10 Wireless connection Fragile handle with care Indicates a medical device that can be broken or damaged if not handled carefully ISO 15223 1 2016 Ref 5 3 1 Temperature Limit Indicates temperature the...

Страница 13: ... patients which needs root canal treatment 1 3 Device Description The EndoPilot is a device that combines the functions 1 3 1 Apex locator The apex locator determines the file position in the root canal This length determination can either be performed manually without a motor by using the file clamp or during preparation using the contra angle integrated length determination with a motor 1 3 2 Mo...

Страница 14: ...sonic module Use safety goggles The patient should also wear safety goggles The use of ultrasound may release aerosols and germs into the air You must therefore always use a surgical mask 1 4 1 Contraindications No contraindications have been identified The device must not be used on patients or by clinicians with an active implant cardiac pacemaker etc 1 4 2 Operating instructions Use The EndoPil...

Страница 15: ...d application in the event of device failure will likely be impossible This failure will not endanger the patient s life Make sure that the treatment can also be completed in the event of device failure Device components and accessories The power supply has a safety relevant function Only use the supplied medically approved original power supply unit Follow the file manufacturer s instructions for...

Страница 16: ...Obtura Young Innovations Ultrasonic module Ultrasonic tips You can use all US registered endo instruments from Satelec Acteon Warning do not use non FDA registered accessories General information Keep this user manual and all information safe on the device Keep the documents for the entire product life cycle The operator is obliged to report all incidents within the meaning of the current regulati...

Страница 17: ...w the assembly instructions provided separately Ultrasonic module A double holder is mounted on the extension module for the ultrasonic handpiece and the motor 2 3 Connection All connections are plugged in and must not be twisted Care must be taken to ensure that the plug s groove fits into the socket s groove The Push and Pull connections for the handpieces are color coded the numbers refer to th...

Страница 18: ...atteries is displayed in the service menu see chapter 11 Spare batteries should always be available for uninterrupted operation Battery replacement Please open the battery compartment under the foot switch s base plate Remove the used batteries Insert new batteries Pay attention to the prescribed pole direction Correctly dispose of the old batteries Model Location Battery type Single foot switch U...

Страница 19: ...tery Charge the battery regularly If the device is not used for a prolonged period of time the device automatically switches to sleep mode and the display illumination switches off The sleep mode is indicated by slow flashing of the blue LED in the display By briefly pressing the foot switch or the touch display the device switches on again The last menu used is displayed again After a long waitin...

Страница 20: ...que DownPack D Pack Connect the DownPack handpiece 7 to the blue socket 1f on the left side of the EndoPilot Only use the handpiece holder provided on the EndoPilot for storage Note that the tip becomes very hot It can reach a surface temperature of over 400 C without a thermal load without heating up the gutta percha Do not use the tip in the air without thermal load without cooling Do not press ...

Страница 21: ...area of the gun reaches temperatures of over 200 C This is necessary as a matter of principle but requires careful handling Always use a heat thermal protector 11 to avoid burns Always put on the thermal protector shortly before application so that it does not heat up Remove the thermal protector from the gun after applying the gutta percha If necessary change the protector during work to have a c...

Страница 22: ...p function is reached during mechanical preparation The manufacturer has already set the marker The user if desired can however change the setting directly on the display by moving the bar by tapping on it with the finger With this function it is possible to transfer the X ray verified position of a pilot instrument to the display The marker s setting remains unchanged until the device is switched...

Страница 23: ...ion the canal should be rinsed briefly with physiological saline solution The canal input must then be dried e g with a cotton pellet to avoid leakage current and as a consequence incorrect measurements Protective gloves should be worn during the length determination so that the measuring current has no power dissipation For the manual measurement the file is connected to the file clamp below the ...

Страница 24: ...activation the file systems that are saved as favorites are displayed here This will speed up the selection of the file system in the future This example shows F360 and F6 SkyTaper The MyFile system is initially an empty system Here the user can create his or her own sequences by copying files See chapter 4 4 4 2 Selection of the file systems Select the file systems to be displayed in the Favorite...

Страница 25: ...Otherwise incorrect measurements may occur during the length determination using the contra angle By pressing the ultrasonic icon you can switch to the ultrasonic menu if the ultrasonic extension module is mounted You can switch the integrated apex measurement off and on again during preparation by pressing the green apex icon at the right edge of the screen 4 4 MyFile file system The MyFile syste...

Страница 26: ...facturers The File setup menu offers a variety of setting options The device allows all parameters such as speed torque operating mode etc to be changed individually Please contact the file manufacturer first if you want to change the Parameters Parameters that differ from the instrument manufacturer s specifications may lead to file breakage and other damage Under the Movement menu item you can s...

Страница 27: ...Select the function in the File Setup menu of the file under Movement The parameters are set using the or button and saved with Save During your work please ensure a constant removal of chips Remark The torque is also monitored in this operating mode However since this technique does not have a distinct start up phase when the motor is started the torque control can already be triggered at high sp...

Страница 28: ... the motor does not stop automatically Check the apex cable and the correct connection by briefly touching the lip clip with the clamped file The Short circuit error message must be displayed see chapter 14 A convenient function of the EndoPilot is the length determination during the mechanical preparation In principle all instructions already mentioned in chapter 3 Manual apex length determinatio...

Страница 29: ...n the cutting direction 2 Apex functionApex stop off The position or propulsion of the file in the root canal is displayed on the apex image on the display during preparation and the manual probing An acoustic signal sounds when the horizontal line is crossed The motor does not stop and the torque is not reduced either Note An electronic length determination is only possible with conductive tool s...

Страница 30: ...r 40 seconds at the latest Do not press several times in quick succession This will make the needle hotter than desired During the heating process the connected BackFill gun is switched off for a short time Please also refer to chapter 5 2 5 2 BackFill You can select the temperature of the gun s heating in this menu The BackFill gun must be connected The temperature column is set to the desired te...

Страница 31: ...ts in an appropriate manner Ensure that a contamination or an infection is prevented If possible cool the instrument with external cooling to prevent it and the treatment site from heating up Always use sterile water when working in the root canal Please note that freely vibrating thin instruments may also break without an external load which is solely due to the ultrasonic vibration Flying splint...

Страница 32: ...iological effects are not to be expected To keep heating to a minimum operation should be limited to 1 minute at maximum power and to 4 minutes at minimum power Ensure adequate cooling times 1 minute operation at maximum power 3 minutes cooling time 4 minutes operation at minimum power 6 minutes cooling time The instrument s working end may also heat up due to friction Ensure adequate cooling of t...

Страница 33: ...tch press it The foot switch is added with the Save button The green Detected message appears when the added foot switch is pressed again On the right side you will find the battery voltage of the switch Low voltage under 1 4V will lead to an interruption and a loss of function Keep fresh batteries in stock and replace low batteries immediately You can use the keypad to activate further functions ...

Страница 34: ...nce 7 Medizin Produkte Betreiber Verordnung in accordance with the international standard IEC 62353 Medical electrical equipment Recurrent test and test after repair of medical electrical equipment resp DIN EN 62353 VDE 0751 1 The scope of testing should include the following test steps Is the power supply unit the original power supply unit REF number matches the number in the user manual Caution...

Страница 35: ...le down in a vertical position The contra angle should be oiled with oil spray for contra angles immediately after application before reprocessing to remove penetrated treatment fluids such as sodium hypochlorite Before operating the ultrasonic handpiece check for damage to the insulation and check whether the oscillator s axis is firmly anchored in the housing before each application Do not use a...

Страница 36: ...Li Ion battery This may lead to fires and injuries if handled incorrectly e g overheating mechanical damage use of liquids and short circuit Please do not dismantle the control unit yourself Avoid falls and unnecessary damage Disposal in the EU Pursuant to EU directives WEEE and RoHS this device may not be disposed of along with general household waste Please observe the applicable national laws a...

Страница 37: ... connection and the plugs for damage Check whether the motor runs without the contra angle Contra angle damaged Check whether the axis can rotate freely Apex locator No measurement possible Signal missing or weak and interrupted Contact problems Are the lip clip and the measuring cable connected correctly Are the lip clip and the file clamp immaculately clean Check if a short circuit is indicated ...

Страница 38: ... for firm clamping BackFill No gutta percha at the tip of the needle Handpiece too cold Has the waiting time been adhered to Is the heating chamber perceptibly warm Pellet is used up Is the piston fully pressed in Insert a new pellet Lock in slips Turn the rotary knob clockwise as far as possible see 11d Piston is blocked cannot be pulled back during cleaning Gutta percha residues The residues sti...

Страница 39: ...ent of the entire device or individual parts The decision whether to replace or repair is entirely up to the manufacturer In the event of an alleged defect during warranty the customer has to inform the Schlumbohm customer service immediately The customer service will give further instructions Normally you will be asked to return the complete unit The costs of returning the product are at the send...

Страница 40: ...minimum power 6 minutes cooling time forced shutdown after 1 90 seconds depending on the selection DownPack 5 seconds operation at the maximum temperature 5 seconds cooling time forced shutdown after 5 30 seconds depending on the power setting BackFill 15 minutes operation at the maximum temperature 5 minutes Cooling time forced shutdown after 15 minutes of continuous operation 200 1000 rpm 10 Max...

Страница 41: ... vicinity It may be necessary to take suitable remedial actions such as a new orientation or a new arrangement of the device The EndoPilot device may be impaired in its function due to interference from other devices The device does not contain any life supporting functions The continued application in the event of device failure will likely be impossible This failure will not endanger the patient...

Страница 42: ...3 Complies Guidelines and manufacturer s declaration Electromagnetic immunity The EndoPilot Device is intended for use in the electromagnetic environment specified below The customer or the user of the Device should assure that it is used in such an environment Immunity test IEC 60601 1 2 2014 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 ...

Страница 43: ... fields should be at levels characteristics of a typical location in a typical commercial or hospital environment Conducted RF According to IEC 61000 4 6 V1 3 V 150 kHz 80 MHz V1 6 V 150 kHz 80 MHz 80 AM 1 kHz Portable and mobile communications equipment should be used no closer to any part of the EndoPilot Device including cables than the recommended separation distance calculated from the equati...

Страница 44: ...ps 609 2112 For Items from other original manufacturers look at the individual reprocessing instructions These instructions are also delivered with the device or could be downloaded from our website see below For direct information contact the original manufacturer A4 DownPack E Q heating tips Meta Biomed Homepage www meta biomed com or http www endopilot de edp2 6102244v00 pdf 610 2244 A5 BackFil...

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