Schlumbohm EndoPilot,EndoPilot Comfort Plus,EndoPilot Comfort,CoPilot User Manual

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Schlumbohm

609 2x01- v07 All data is subject to change. Misprints, errors, innovations and changes excepted.

Gebrauchsanweisung

User Manual

Mode d’emploi

ITITModo di uso

Modo di uso

Podręcznik

Modo oe Utilizacion

Ο∆ΗΓΙΕΣ ΧΡΗΣΗΣ ΓΙΑ

EndoPilot

1a 1b 1c 1d

11a

11b

11d

11c

7 8

EndoPilot

Description of the individual components

Picture Component Description

Control-Unit Ref.-No: 109 2010

Power Supply Ref.-No: 109 232.1

Foot Switch Ref.-No: 109 233.4

Apex-cable set Ref.-No: 109 2311

Contra-angle Ref.-No: 109 0126

Motor Ref.-No: 109 0112

D-Pack Heating Tip Ref.-No: 109 0152 - ...56

D-Pack Ref.-No: 109 0151

BackFill Needle Ref.-No: 109 0149

Heat insulator Ref.-No: 109 0143

BackFill Gun Ref.-No: 109 0141

(Backfill cable) Ref.-No: 509 0142

Multi-tool Ref.-No: 109 0147

Control unit with touch screen, incl. 4 connecting sockets (1a, 1b, 1c, 1d) and tripod nut on the backside

AC/DC converter with Euro-prime plug Input: 100 – 240 V/AC Output: 12 V/DC 1,25 A

Start/stop, cable-connected foot switch with connection to the power supply

4a – Measuring cable with plug Ref.-No: 109 2312 4b – Cable with file clamp Ref.-No: 109 2313 4c – Lip clip Ref.-No: 109 2314

For the Apex-measuring / fully isolated/ transmission 1:1, with ISOE fitting

Motor with Apex-measuring contact, LED performance display and ISO-E connection

Heating Tips - 5 different sizes are available

DownPack handpiece with LED display

The Gun Needle Starter Set encloses 3X25ga und 3X 23ga Different sizes are available

Offers protection from thermal damaging

For the thermo-plastic filling of the root canal (cable: no illustration) 11a – Release button 11b – Piston 11c – Lever 11d – Cylinder with knurled knob

For forming as well as screwing on and off the BackFill Needles

*related to the additional module “CoPilot” - 1 - 609 2201 v12 www.schlumbohm.de

Guttapercha Ref.-No: 109 0142

Cleaning Set Ref.-No: 109 0148

Base with equipment Holder Ref.-No: 109 2306

Protective Foil Ref.-No: 109 2397

Wireless foot switch Ref.-No: 109 2360

Pellets made of Guttapercha for the BackFill Gun Gutta Percha Bar encloses 100 Pellets

Brushes for the cleaning of the BackFill Gun The Cleaning Set encloses 2 brushes

Tray for the entire equipment (see illustration on page 2)

Foil for protection of the display (optional, no illustration) Can be ordered from the manufacturer

Special accessories: wireless foot switch with one pedal (single) incl. receiver module (optional, no illustration )

19a

15d

15e

15c

15a

15b

Supplementary module CoPilot *

Picture Component Description

Control unit incl. 4 connecting sockets (15a -15d), connecting plug to the EndoPilot (15e) and integrated battery as well as wireless module 15a – Update – Connection 15b – Power supply – Connection in combination with 15c – Additional connection DownPack 15d – Ultrasonic handpiece - connection

With Satelec® compatible screw thread EMS ® compatible version also available on request

Additional module CoPilot Ref.-No: 109 32.07

Ultrasonic handpiece Ref.-No: 109 3102

EndoPilot

Rinsing adapter Ref.-No: 109 3132

Handpiece cable Ref.-No: 109 3122

Base CoPilot Ref.-No: 109 2306

Wireless twin foot switch Ref.-No: 109 2351

Torque wrench Ref.-No: 109 3112

Adapter cable Ref.-No: 509 0410

Mounting screws Ref.-No: 360 0413

Adapter for standard syringe for the cleaning of the ultrasonic handpiece

Highly flexible connection with handpiece plug

Rack for the handpieces with double holder (19a) Ref.-No: 109 2309 for ultrasonic handpiece and motor (3 countersink screws for the mounting at the device casing are attached) Pedal I = Start Pedal II = Select / to select the functions Incl. 2x 1,5V batteries, type AA

Mounting tool for ultrasonic tips with torque limiter

Connecting cable to charge the CoPilot with the power supply of the EndoPilot

To mount the CoPilot to the EndoPilot (3x) Countersunk screw DIN 7991 M4x12

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EndoPilot

CoPilot

EndoPilot

Congratulations!

We are glad you have decided to purchase the EndoPilot. You have made a good choice. For more than 40 years, the family-owned company Schlumbohm® has been successful on the dental industry market. These long-standing experiences as well as excellent contacts to specialists nationally and internationally permit the company Schlumbohm® to design outstanding devices, enabling the patient as well as the dentist to achieve an optimal treatment result. Each development has, in addition to the self-evident optimal treatment result strived for, the focus on an easy and convenient handling. With the EndoPilot and usability, it meets even the highest demands.

Attention: the device is available in several extension versions

Depending on the extension version, the device offers various functions:

• EndoPilot Comfort : Endo-Motor and Apexfinder

• EndoPilot Comfort Plus : Endo-Motor and Apexfinder, DownPack and BackFill

• Additional module CoPilot : offers additional ultrasonic, battery-operation and a wireless foot switch

This instruction of use describes the basic device EndoPilot Comfort Plus, from firmware 50 (see Setup chap. 8). All extra functions of the additional module „CoPilot“ are marked with „* “.

Manufacturer:

Schlumbohm GmbH & Co. KG Klein Floyen 8-10 D-24616 Brokstedt Germany

www.schlumbohm.de post@schlumbohm.de

Telephone +49-4324 - 8929 - 0 Telefax +49-4324 - 8929 – 29

WEEE-Reg.-Nr. DE 88116129

you acquired a product which was developed and tested with utmost care. With regard to function

Edition 04-2013

The manufacturer reserves the right to change indications and data of this operating manual also without prior notice. Upon request, the operating manual is available in several languages. This operating manual was prepared with utmost care. However, as mistakes can never be fully excluded, we are always thankful for each hint. Please contact us directly in such an event. Also, should you have any further questions, please do not hesitate to contact us.

*related to the additional module “CoPilot” - 5 - 609 2201 v12 www.schlumbohm.de

EndoPilot

Table of contents Page

1. Remarks .................................................................................................................... 7

1.1. Symbols ................................................................................................................................................................ 7

1.2. Proper Usage........................................................................................................................................................ 8

1.2.1. Apexlocator........................................................................................................................................................... 8

1.2.2. Motor..................................................................................................................................................................... 8

1.2.3. DownPack-Handpiece with Heating Tip................................................................................................................ 8

1.2.4. BackFill Gun.......................................................................................................................................................... 8

1.2.5. Ultrasonic Handpiece * ......................................................................................................................................... 8

1.3. General Precautions ............................................................................................................................................. 8

1.3.1. Contra-Indications................................................................................................................................................. 8

1.3.2. General Conditions of Operating........................................................................................................................... 8

2. First Steps............................................................................................................... 10

2.1. Installation........................................................................................................................................................... 10

2.2. Base with Equipment Holder............................................................................................................................... 10

2.3. Connection.......................................................................................................................................................... 10

2.4. Touch-Display ..................................................................................................................................................... 11

2.5. Foot Switch ......................................................................................................................................................... 11

2.6. Switch on, Standby, Switch off, Battery-Operation* ............................................................................................ 12

2.7. Preparation of the Root Canal – Motor and Contra-Angle .................................................................................. 12

2.8. Filling Technique - DownPack (D-Pack) ............................................................................................................. 13

2.9. Filling Technique - BackFill (B-Fill)...................................................................................................................... 13

3. Manual Root Length Measurement ....................................................................... 14

3.1. Advice for an accurate Measurement ................................................................................................................. 15

4. Motor system .......................................................................................................... 15

4.1. Favorites ............................................................................................................................................................. 15

4.2. Selection of a file system .................................................................................................................................... 16

4.3. MyFile System .................................................................................................................................................... 16

4.4. Selection of a sequence / file .............................................................................................................................. 17

4.5. Preparation ......................................................................................................................................................... 17

4.6. File Parameters (F. Data) ................................................................................................................................... 18

4.6.1. Reciprocal Function ............................................................................................................................................ 18

4.6.2. File Management / Selection of a Box ................................................................................................................ 19

4.7. Options ............................................................................................................................................................... 20

4.7.1. Apexlocator – Root Canal Measurement during Preparation.............................................................................. 21

5. Obturation ............................................................................................................... 22

5.1. DownPack........................................................................................................................................................... 22

5.2. BackFill ............................................................................................................................................................... 22

6. Ultrasonic Function* .............................................................................................. 23

6.1. Selection of the Ultrasonic output level*.............................................................................................................. 24

6.2. Selection of Run-Time* ....................................................................................................................................... 24

6.3. Ultrasonic-Instrument-Selection.......................................................................................................................... 24

7. Contra-angle calibration ........................................................................................ 25

8. Setup CoPilot / Wireless foot switch* ................................................................... 25

9. Reset........................................................................................................................ 26

10. Setup / Updates / Tones........................................................................................ 26

11. Maintenance............................................................................................................ 26

12. Trouble Shooting.................................................................................................... 27

13. Error Messages ...................................................................................................... 28

14. Warranty / Liability ................................................................................................. 28

15. Technical Data ........................................................................................................ 28

16. Cleaning, Disinfection, processing of devices .................................................... 28

16.1. procedural instruction part I : Control-Unit, Contra-angle and Motor................................................................. 29

16.2. Procedural Instruction part II: Apex-cable, D-Pack-handpiece and BackFill-gun ............................................... 31

16.3. Procedural Instruction Part III: 1. CoPilot device 2. Ultrasonic cable and 3. Ultrasonic handpiece .................... 33

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EndoPilot

1. Remarks

1.1. Symbols

Description of the symbols used in this operating manual.

Symbol Description

The product complies with the requirements of the EU Directive 93/42

Warning: Consult the operating manual! If the instructions are not followed properly, operation may result in damages of the device or in the injury of the user or the patient.

Special protection against electric shock (Usage part)

This medical product may not be disposed off in the normal garbage. The national disposal regulations for electrical and electronic equipment have to be adhered to. WEEE Directive (Directive 2002/96/EC)

Single use only

contains Guttapercha

contains silver

use before

EU authorized representative

Mechanic processing in the thermo disinfector

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Steam sterilisation

Production LOT

Manufacturer

EndoPilot

1.2. Proper Usage

The EndoPilot is an „all-in-one“ device concept for the mechanical root canal treatment. It is exclusively determined for the usage in dentistry and may not be combined with other devices. The EndoPilot was especially designed for the endodontic. The EndoSystem is intended for the following usage only:

1.2.1. Apexlocator

By the Apexlocator, the file position in the root canal is determined. This length determination can either be done manually by using the file clamp (without motor) or parallel to the preparation of the root canal (integrated length determination with motor).

1.2.2. Motor

Mechanical root canal preparation in combination with the preprogrammed nickel-titanium files with standard settings, with optional integrated length determination. Basically, the actual parameters of the manufacturer files should be used.

1.2.3. DownPack-Handpiece with Heating Tip

Vertical thermoplastic condensation of Guttapercha in the root canal as well as cutting off of Guttapercha sticks.

1.2.4. BackFill Gun

Final thermoplastic filling of root canals with Guttapercha.

1.2.5. Ultrasonic Handpiece *

*CoPilot: The CoPilot was developed as supplementary module for the EndoPilot. It provides the ultrasonic function for the execution of professional endodontic treatments. Possible scope of application: Activation of a rinsing solution in the root canal, revisions, preparations of the canal with ultrasonic instruments and removal of pins. In addition, the device is equipped with a battery and a wireless foot switch.

1.3. General Precautions

Please read the operation manual precisely and completely! This is the only way to assure a maximum of security. Most of the problems in operating and maintenance result from the insufficient attention being paid to basic safety precautions and the fact that the possibility of accidents is not foreseen. The user and his team have to be familiar with the device prior to the first usage. Always use a cofferdam to prevent inhalation or swallowing of small parts!

If you have any questions or note any problems, please contact your supplier immediately.

Do not use the device if your patient or you are having an active implant (pacemaker, etc.)!

*CoPilot: Use safety goggles. Aerosols and germs may be released when using ultrasonic, therefore, please always use a mask.

1.3.1. Contra-Indications

Using Guttapercha in combination with the Backfill function on patients with a known allergy to latex, silver or copper may result in allergic reactions. These reactions may cause irritations of eyes, lips and the face. They may also cause breathing problems. Patients should be instructed to immediately indicate any complaints occurring.

1.3.2. General Conditions of Operating

Operating

• The EndoPilot may only be used by approbated specialists.

• The device parts have to be used sterile, please observe the disinfection- and processing-instruction in the

appendix.

• Prior to usage, please check the device for damages.

• Use the device only for its intended purposes.

• Do not combine the device with other devices, like, for example, Endo-devices from other manufacturers.

• Do not alter the device in any way. Schlumbohm® declines any and all responsibility in case of alteration or

modification of the device.

• *CoPilot: the device may only be used with Satelec®, resp. EMS® compatible ultrasonic tips.

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EndoPilot

Conditions of the Location

• The device may not get in contact with liquids or be installed in damp places.

• Do not expose the device to direct or indirect heat sources.

• The use of the device in a place with free oxygen, explosive or flammable gases and fluids is not admitted.

• In order not to influence to correct length determination, the EndoPilot should not be installed near devices

emitting electro-magnetic radiation.

• Do not cover the device with cloth or foils. Inflammable materials may be damaged or even ignited upon unintended activation of the DownPack function.

• *CoPilot: Regarding the usage of several wireless foot switches: The signal is transmitted encoded; this technique enables a safe synchronization of foot switch and receiving module. It also prevents from an unintended usage of one device with the foot switch of another device. For the simultaneous usage of several devices in a confined space (e.g. training sessions), different transmitting frequencies are additionally available, please contact us if needed.

• *CoPilot: Do not use any mobile phones or other devices with a strong electro-magnetic radiation near the device. In some cases, this may cause a disturbance of the wireless foot switch’s function.

Device Parts and Accessories

• The power supply has a safety-relevant function. Use only the permitted original medical-power-supply supplied with the device!

• Follow the manufacturer’s instructions for use and disposal of the endodontic files.

• The accuracy of the length determination, the torque and the speed is only ensured when using the EndoPilot

1:1 contra-angle.

• In case of abnormal or unusual canal morphology (blocked or fractured canal), an exact length determination may not always be possible.

• The tolerance of torque and speed is 10%.

• The DownPack-handpiece and the BackFill Gun become hot; there is a risk of burns, of damaging the

surroundings and of fire.

• In order to avoid the induction of separate source voltage, the hand pieces shall not be put down on electrically conducting surfaces.

• Guttapercha is a natural rubber, which may cause allergic reactions (latex-cross-allergy).

• *CoPilot: do not use any deformed or worn instruments.

At first, always use a very low ultrasonic power level and increase the energy only if necessary. The ultrasonic device is intended for intermittent (interrupted) usage. In order to avoid a heating to the extent possible, the usage at maximum output level should be limited to 2 minutes and at minimum power level to 4 minutes.

• *CoPilot: Please note that the ultrasonic instruments heat up during usage, therefore, please provide, if necessary, for adequate, external cooling.

Compatibility

• Endo Files: All commercially available NiTi-Endo-Files with standard ISO shaft can be used..

The values for speed, torque and the operation mode must follow the data from the file-manufacturer.

The manufacturer of the instruments may change the values. Prior to the usage please check if the selected values are conform with the current data from the manufacturer.

• DownPack Heating Tips: Only use the original tips which are available from the manufacturer.

• BackFill Needles: Only use the original needles which are available from the manufacturer.

• *CoPilot Ultrasonic-Tips: All commercially available instruments with Satelec® or EMS® compatible thread can

be used. (Depending on your ultrasonic handpiece, also EMS ® compatible instruments)

General

• Store this operating manual and all information at the device.

• Keep the documents for this device for the entire product shelf-life.

• The user is obliged to report all incidents according to MDD 93/42/EWG as well as any indications of risks to the

manufacturer.

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EndoPilot

2. First Steps

2.1. Installation

At first, please compare the components delivered with the attached shipping documents and the corresponding serialresp. LOT-numbers. Please check if the display-glass is damaged (1).

Please note that all components are delivered unsterile and not disinfected (s. chap.16). Following conditions should be considered when installing the device:

• The space for the device must be horizontal.

• The device may not be installed in damp places.

• Do not expose the device to direct or indirect heating. Direct sunlight has to be avoided.

• The temperature in the environment should not be below 15°C and not above 40°C.

• The device shall not be installed near free oxygen, flammable gas-mixtures or liquids.

• In order not to influence the correct length determination, the EndoPilot should not be installed near devices

emitting electro-magnetic radiation.

Place the foot switch in such a way that it will be easy to use.

• *CoPilot: If you would like to use two devices with wireless foot switch simultaneously and close to each other, please contact the manufacturer; different transmission modules are available.

• *CoPilot: please take care that the foot switch may not be activated unintentionally.

• Place the machine so that the power supply cable can be pulled out of the unit if necessary.

2.2. Base with Equipment Holder

The base offers a secure stand for the device and the operating tools. Thanks to the recessed grip in the upper part, the stand can be transported single-handedly. The surfaces are easy to clean and skid-proof feet ensure optimal stability. For the mounting of the base as well as the arrangements of the hand pieces, please read the mounting instructions (delivered separately) for the base! The EndoPilot is connected to the stand by the tripod-screw. *CoPilot: a double holder is mounted on the base for the ultrasonic handpiece and motor. If you expand the device with the supplementary module CoPilot, the base has to be connected with the casing of the supplementary module. To do so, remove (if present) the rubber feet of the base and screw the base on the CoPilot-casing (use the screws provided by all means (23)). Please note that the base has to be suitable for the mounting on the CoPilot-casing. (older bases have no opening for the CoPilot-cable). Attention! If you mount the whole device on to a table or cart, please make sure by all means that the selected screws (3x Type M4 with 4 mm diameter) will not be screwed deeper than 5 mm into the ground plate of the CoPilot. In any case, check the length in advance. The device may be damaged if the screwing is too deep. Tighten the screws not to hard.

2.3. Connection

All connections are to be plugged in and may not be screwed! notch of the socket. The „Push and Pull“-connections for the hand pieces and the foot switch (3) are colour-coded (the numbers refer to the pictures on the inner coverpage):

Illustration 1 Connection Use

1a red BackFill Gun (11) / also to be used for Updates

1b black

1c blue

1d green Apex-cable (4a), connection to the patient (Lip Clip) (4c)

Foot Switch (3) / connect the power supply directly with the foot switch

1. Motor (6) or 2. DownPack handpiece (8) Alternative: Switch module for automatic switch between Motor and DownPack

Please make sure that the notch of the plug fits into the

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EndoPilot

*CoPilot When using the additional module CoPilot, the cable foot switch of the EndoPilot basic device is obsolete! The „Push and Pull“-connections for the handpieces are colour-coded resp. coded by additional symbols like with the EndoPilot:

Please make sure when connecting the ultrasonic handpiece to the ultrasonic cable that the handpiece is not twisted during connection. If you want to utilize your EndoPilot device with the supplementary module CoPilot, please read all sections in the operating manual marked with „*“ and execute the steps as described in „Setup CoPilot“. In order to realize the combination with the CoPilot module, the EndoPilot control unit must have the current software (Firmware v43 or higher) (please see data in the menu „Setup“). If older firmware is installed on your EndoPilot control unit, the device first has to be updated with current software. For older models, a hardware update may be necessary.

2.4. Touch-Display

Prior to the first use, pull off the protection foil. All functions of the EndoPilot are activated by the comfortable TouchDisplay. The Touch-Display allows an intuitive and self-explanatory handling. The display is operated directly with a soft finger touch. It is of course also possible wearing gloves. Alternatively, a small stick with a rounded plastic tip may also be used. For protection from scratches and dirt, we recommend our crystal-clear display protection foil. It can be orders as an accessory.

By no means may the display be operated with any metal objects (danger of breakage of glass)!

Illustration Connection Use

1a red

1b black

1c blue 1. Motor (6) 1d green Apex cable (4a), connection to the patient (Lip clip)(4c)

15a red

15b black Power supply (2) with power supply adapter cable (22) 15c blue DownPack – handpiece (8) 15d grey Ultrasonic handpiece cable (18) and ultrasonic handpiece (16)

BackFill Gun (11)/ in addition, for updates of the EndoPilot control unit Connection to the supplementary module CoPilot via Connecting cable (15e)

For updates of the CoPilot device. Optional: Connection for a peristaltic pump. Always cover this socket with the delivered cap

With the menu.

2.5. Foot Switch

Functions of the foot switch (also foot switch single):

• Start/stop of the motor, the ultrasonic or heating of the DownPack

• Saving of the measured root length (s. chapter 3)

• Activate the EndoPilot from the sleep-mode

Functions of the wireless twin foot switch*:

• Pedal ”START” as described above

• Pedal “SELECT“ long pressing: select function (ultrasonic or motor)

In order to change the batteries (2 pieces 1,5V Type AAA), please open the battery compartment on the bottom plate of the foot switch. Remove old batteries. Insert new batteries, paying attention to the correct pole direction. Push the battery compartment back into its place in the casing. Put the ground plate back in and tighten the screws. Dispose of the old batteries as per regulation. Do only use brand name batteries. Use only batteries of the same type. Caution! Remove the batteries if you do not use the foot switch for a longer period of time.

To ensure an uninterrupted usage, spare batteries should always be available. In case of need, the EndoPilot can be used with the help of the standard cable foot switch at any time (socket 15b)! The connection of the power supply to the cable foot switch is possible, but not necessary as long as the battery is charged,

-button, you always return to the Start Menu. With the – button, you always return to the previous

short pressing: choosing the next file within the file sequence

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EndoPilot

2.6. Switch on, Standby, Switch off, Battery-Operation*

Connect the foot switch (3) with the power supply (2). Put the power supply into the socket (green LED in the power supply has to light up). Now, the plug of the foot switch has to be plugged into the black connection (1b) of the EndoPilot. If the device is not being used for some time, it automatically switches to the sleep-mode. The display light is turned off. The device is turned on again by a short step on the foot switch or touch of the touch-display. The menu displayed as last will be displayed again.

In order to avoid waste of electricity in the standby-mode, the EndoPilot should be disconnected if it will not be used for a longer period.

*CoPilot: When expanding the device with the „CoPilot“ module, the cable foot switch (3) of the EndoPilot basic device becomes obsolete. For charging, the power supply has to be connected to the CoPilot with the help of the adapter cable (22). The device can be switched on with the switch on the front of the device. If the charge drops to 10% of the capacity, the CoPilot must be loaded. Otherwise, the unit turns off to avoid a total discharge of the battery and destruction.

Charge the battery periodically, the LED at the front of the device shows the charging level (red LED means charging is necessary). If the battery is fully charged (constant green LED), the power supply may be plugged off.

The display switches off after several minutes of idling. By touching the display or by pressure on the wireless foot switch, the display will switch on again. The supplementary module CoPilot will completely switch off after 10, 20 or 40 minutes of idling, it can only be re-activated by the switch at the front of the device. (The turn-off time can be selected via the menu).

2.7. Preparation of the Root Canal – Motor and Contra-Angle

The EndoPilot contra-angle (5) is mounted on the motor (6). Use only contra-angles with 1:1 gear. The integrated Apex length measurement (s. chapter 4.7.1.) via the contra-angle (during the preparation) does only work in connection with the original-EndoPilot contra-angle

If the contra-angle was changed or sterilized, it is necessary to run the calibration-process under the menu item

C a l i b r a t i o n . Contra-angles may only be changed upon standstill of the motor (s. chapter 7).

Operating Remarks:

Before starting the device, please check if the motor is tightly snapped into the contra-angle. Do not put any pressure on the push-button of the contra-angle because this may cause frictions or mismeasurements!

Depending on the shape of the root canal, the Endo-files are bent and stressed during usage. The device reduces the risk of file-breakage; however, this danger cannot be eliminated completely. Please ensure that you know the allowed torques value of the instruments. Select the correct file. Never use deformed or damaged files!

The menu offers a variety of settings. The device permits to individually change all parameters like speed, torque and operation mode, etc.. Parameters, which deviate from the manufacturers settings may lead to file fractures and other damages. The company Schlumbohm deviating from the manufacturers settings.

To avoid file-breakage, please pay attention to the following points:

• Never use pressure to insert the file or to move it forward.

• Nickel-titanium files also break due to material fatigue. Only prepare as many canals as allowed by the

manufacturer of the files.

• In order to use NiTi-instruments effectively, experience and practice are indispensible.

• Practice on extracted teeth or Endo-plastic blocks.

LED Motor: GREEN: The torque is below 80% of admissible load

RED : The torque is above 80% of admissible load

will not be liable for damages deriving from operations

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EndoPilot

2.8. Filling Technique - DownPack (D-Pack)

The DownPack handpiece (8) shares the blue connection with the motor (6). (*CoPilot: if expanding the device by the „CoPilot“ module, the DownPack handpiece is always connected to the blue notch (15c) of the CoPilot)

Do not put the DownPack handpiece down on electrically conducting surfaces, this could lead to induction of separate source voltage. Do not connect the DownPack handpiece at the same time with the Apex-cable. Put down the handpieces only on the EndoPilot tripod or a temperature-resistant tray. Please keep in mind that the tip becomes very hot.

Operating the heating tip: Open the tongs by two turns of the nut and insert the heating tip (7) (always insert the piston to mechanical stop). The tip is fixed by screwing the nut tight. Before using it, make sure that the heating tip is firmly fixed. A twisting tip can cause injuries. If necessary, the multi-tool (12) may be used to loosen the nut. Please pay attention to limited life expectancy of the heating tip which differs depending upon the frequency of use, stress and deforming. Check the heating tip before each use on its function and on its good mechanic condition. Use of excessive force may lead to breaking and to injuries caused by slipping.

Never use heating tips from other manufacturers!

use the DownPack handpiece simultaneously with the Apex cable.

Do not Due to the continued induction of heat into the point of treatment, a warming up of the tooth and the surrounding tissue may occur. Provide for sufficient waiting times and act carefully. An exaggerated heating may change of the characteristics of the filling material.

LED DownPack:

Red blinking: DownPack is operating, heating procedure is running (Usage s. chapter 5.1).

2.9. Filling Technique - BackFill (B-Fill)

Connect the BackFill Gun (11) with the delivered cable to the red connection (1a) at the device. The BackFill needle (9) must be tightened with the key (12) to prevent leakage of gutta-percha at the screwing connection. Form the needle between the forming rolls of the multi-tool. Always be careful that the needle is not being bent or torn out of the screwing base. Avoid bending back and forth. Please always use a Heat insulator (10), which should only be put on shortly before usage in order to avoid burns. Press the release (11a) and pull the piston (11b) a bit backwards. Then always insert only 1 pellet Guttapercha (13) at a time in the upper opening of the Gun. If the Gun is already heated, do so quickly in order to avoid the inner parts to agglutinate. By using the lever (11c), you push the Guttapercha into the heating chamber with the help of the piston (11b) and later on through the needle. Make sure that the small screw and the seal at the end of the piston (11b) is in place and tightened securely. As long as the set temperature has not been reached and the Guttapercha is still rigid, do not press too hard as that may damage the Gun. If the heating times are longer, the outer parts of the Gun will also be warmed up. Check the temperature of the protection cap (10). Do not touch the patient’s lips or mucous membrane with the needle. During the filling process, the needle should be able to rise with the filling material.

put the BackFill Gun on electrically conducting surfaces; this could catch external voltage.

Do not

use the BackFill Gun simultaneously with the Apex cable.

Do not Put down the BackFill Gun only on the EndoPilot tripod or on a temperature-resistant tray.

Use of excessive force may break the needle and cause injuries. Please take care that the Gun is cleaned and prepared before each use. Use a new needle each time as well as a new Guttapercha-pellet for each treatment. After the usage and as long as the handpiece is still hot, press all remains of Guttapercha out of the Gun. Only use the original Guttapercha-pellets. For remarks on dismantling, please see preparation instructions (s.chap.16)!

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EndoPilot

3. - 6. Functions Start Menu

3 Manual root length measurement

4 Motor system for NiTi files

6 Ultrasonic function

5.2 BackFill-Gun

5.1 DownPack hand piece

Next menu

3. Manual Root Length Measurement

In this menu, you can probe the canal manually, that means by a file lead by hand. For this purpose, the lip clip (4c) as well as the file clamp (4b) are used.

The horizontal line determines the position in the root canal where the "Auto-stop"-function is reached when using the mechanic preparation. The setting can be stored either directly at the display by moving the line (short tip of the finger) or also comfortably by pushing the foot switch. With this function, it is, for example, possible to transfer an X-ray verified position of a pilot instrument onto the screen.

The setting of the line is stored until the device is switched off. If the device is switched on again, the line is re-set to a standard value.

Parallel to the graphic display, a value (here 34) is also shown, this is the length of the line in the display, however NO indication of millimetres. This number is only for a better orientation.

put the measuring cables on electrically conducting surfaces, this could lead to

Do not induction of separate source voltages.

ATTENTION: If the file gets in touch with the lip clip, this will cause a short-circuit. With this short-circuit, you may test the function of the display and the Apexlocator.

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EndoPilot

3.1. Advice for an accurate Measurement

Put on the lip clip (4c) in the cheek pouch of the patient (the side which is opposite to the operating area). Before you start the length measurement, the root canal should be rinsed with NaCl-solution and then be dried (for example with a cotton-pellet), in order to avoid leakage current and, as a consequence, incorrect measurements. It is recommended to wear protective gloves during the measurement in order to isolate the measuring current. For the manual measurement, the file has to be connected with the file clamp below the shaft and shall be inserted slowly into the root canal.

Please keep in mind that, principally, mismeasurements may occur during the electronic canal measurement caused by variable disturbances (conductive fillings, cracks in the tooth, etc.)

The results should always be compared with an x-ray photo.

4. Motor system

When selecting the motor system, you will reach the Favorites menue.

4.1Favorites

System ‘ProTaper’ chosen as example for a favorite (can be deleted again with X )

Space for an other system (press file file symbol)

4.3 MyFile System

4.2 Selection of a file system

4.1. Favorites

The menu favorites offers the possibility to select from a wide range of pre-programmed file systems 3 favoured file systems. This offers the advantage of immediate access to the file systems used most of the times and saves the repeated selection from the whole assortment of file systems.

The favoured file system is selected by pressing the file symbol Via the symbol X the selection can be deleted easily and can then be selected anew.

This menu does not have to be used. If you do not want to select any favorites, choose the menu item „all file systems“ (Chapter 4.2) Here, a system can be chosen directly from the alphabetical list of file systems.

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EndoPilot

4.2. Selection of a file system

If you have selected the menu item „all file systems, the menu opens with all available file systems. First, you will get to page 1, additional file systems follow on the next pages.

By a short touch on the desired file (s. right e.g. ProTaper , resp. ProFile), you will get to the respective file system.

Within the selected file system, a touch of the headline with the system name will lead back to the menu favorites.

With the

key, you will get back to the Start Menu.

4.3. MyFile System

The device offers a special function with the M y F i l e S ys t e m .

With the MyFile-system, individual file sequences, independent of the manufacturer, can be defined. To do so, files will be selected from the extensive file library and then be stored one after the other (Hybrid-technique).

The system can be accessed in the menu „favorites“ or from every file menu oft the file systems. In the MyFile system, 5 different sequences with each 10 files can be stored individually.

By touching My F i l e S ys t e m in the menu „favorites“ (see illustration Chapter 4), you can choose from the following:

My Sequence 1 to My Sequence 5

With these namings, the own sequences can be differentiated easily. In each of these areas, up to 10 files can be stored.

In the menu to the right, for example, the menu item „My Sequence 1“ was selected.

By touching the file symbol on the right, the alphabetical overview oft the file systems opens. Again by touching, the desired system will be selected, then the file can be selected (in this

illustration, the file ProTaper F2 has been selected). Behind each entry, a X appears on the right. Via this field, the selection can be deleted easily.

In one sequence, the same file may also be used several times. This may be reasonable if the same file shall be used with different settings.

By touching on the desired file, in this case “PT F2 25/08”, the user reaches the file menu “preparation” (Chapter 4.5). In this menu, the EndoMotor can be started by using the foot switch.

In the menu preparation 4.5, the file parameters (Chapter 4.6) can be set freely via the key

F . D a t a . The data will be stored in the MyFile-System. The pre-programmed file data (Data

from the file manufacturer) in the basic file system under al l f i l e s y s t e m s . Remain unchanged. They will not be overwritten by the individually changed data.

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EndoPilot

4.4. Selection of a sequence / file

4.2 File system

4.4 Sequence / File

After selecting the file system, the system overview opens. The general structure is the same for all systems, it differs, however, by particularities and sequences of the individual file system resp. manufacturer. With ProFile (see illustration), for example, the sequence is selected first and in the next step the file.

The file system ProTaper Next does not offer this sequence selection. A file selection is offered directly.

In the selected file system, a touching of the headline with the system name (in our illustration P r o F i l e resp.

ProTaper Next) leads back to the menu „favorites“. With the key, you can return to the Start Menu.

4.5. Preparation

In the preparation menu, the EndoMotor is operated via the foot switch. The upper line shows the selected file. Underneath, the speed and torque values of the file are shown.

The Apex screen is always displayed which enables a manual probing with the help of the file clamp. Please note that the file clamp has to be put down on an isolated surface as otherwise it may cause mistakes in the root canal measurements with the contra-angle.

The settings which are valid for the entire preparation can be selected in the menu O p t i o n s (chapter 4.7 ). With the F . D a t a -key, you reach the sub-menu file parameters. It offers the possibility to change the individual

parameters for the selected file (Chapter 4.6 file parameters).

Selected file, back to file sequence (see chapter 4.4.)

Preparation line (see chapter 3.)

Go to next or previous Box selection + Wear indicator

file of the sequence (File Management – only

visible after selection of a limit)

File alarm

Reset the counte

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EndoPilot

4.6. File Parameters (F. Data)

File indicator

Operation Mode selectable (Twist on/off-anti clockwise-reciprocal )

Speed-value of the file Torque value of the file

Wear-values of the file in the selected box Selected wear limit (up to 25) for the file alarm

In the menu Operation Mode, Twist, anti-clockwise rotation and reciprocal can be selected.

The speed- and torque-values may be changed after selecting R P M or N c m by the + and - -keys which are then displayed. The individual key RPM Reset or N c m R e s e t between the . + and - -key resets the values to the factory settings (according to the recommendation of the file manufacturer). In the menu function R e s e t (s. chap.9), all values of the files can be reset to the factory settings at once.

Please note: Keep in mind that the file manufacturers provide themselves the right to change and adjust the instrument parameters. The data stored in this device were determined with utmost care according to manufacturer's recommendations. Future changes may be individually adjusted by the user or by running an update.

4.6.1. Reciprocal Function

General

With the reciprocal technique which was already known in the 80’s as Balanced-Force-technique, an endo-instrument is set into a cyclic right-left-movement. The instrument is pulled rhythmically from the canal by the user in order to remove chips. The advantage of this technique is the significant time-saving. Often, less files than usual are used for the preparation. In practice, NiTi-instruments, originally only intended for fullyrotating operation as well as special instruments especially determined for the reciprocal operation are currently being used.

Other than the known, rigid drive mechanisms, the EndoPilot offers a free selection of the parameters. The movement can be adjusted by the user according to the canal and the instrument. As there are currently no data published by the file manufacturers, it is necessary that the user determines the parameters suitable for him and his file system. In concrete, this can be done for testing purposes by preparing training blocks. The pre-selected values should in any case be adjusted. It has to be pointed out that experience and training are prerequisites for this technique. The user should obtain experiences on extracted teeth. It has to be assumed that the use of different file systems will lead to different results. In order to avoid a deforming of the file, the same values should always be used for left and right rotation. The pause offers an intermittent operation and reduces the impulse load on the file.

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EndoPilot

The setting and the utilization:

Under the overview a l l f i l e s y s t e m s (see Chapter 4.2.), the device offers the file system R e c i p r o c a l . It is the representative for new coming file systems which shall be used in the reciprocal mode. The pre-selected values still have to be adjusted by the user (see below).

Furthermore, it is possible to select the reciprocal function for every file from the other pre-programmed file systems originally designed for full rotation. The function is selected in the menu F-Data of the particular file under O p e r a t i o n

M o d e . The parameters are set by selecting the fields L , P , R as well as R P M via the - or the + key.

L Duration of left rotation (x10 msec) P Duration of pause between left and right movement (x10 msec) R Duration of right rotation (x10 msec) R P M Rotation speed of file as with full rotation

Save with Sa v e .

In the operating menu a „R“ shows the reciprocal function. During your work, please pay attention to a constant removal of chips.

Remark: The torque is supervised in this operating mode, also. However, since there is no softstart-phase in this mode, if high torque values are selected, the torque control may already trip out when starting the motor. In this case, a higher torque limit should be selected.

The cyclic drive This function offers a step-by-step drive in direction of the rotation. In order to set this function, one of the parameters L or R is set to zero, the other parameter indicates the length of the step. The pause between the movements offers a partial resetting of the torsion at the instrument.

4.6.2. File Management / Selection of a Box

The patented file management supervises the wear, resp. the load of the selected file. All important values like speed, torque and duration of use are added and shown as parameter (see Chapter 4.5. illustration on the right). The canal curving too can be pre-selected as factor

under O p t io n (see Chapter 4.7). An individual limit for the file alarm for each file can be set under F . D a t a (see Chapter 4.6). In order to set a file alarm, it has to be activated via S e t and the limit value (up to 25 is

possible).

Only after a limit was set, the wear indicator will be shown in the file menu (see Chapter 4.5). By touching the wear indicator Box:.. , a window for the file box selection opens (see illustration on the right).

In total, up to 8 file boxes with any number of files, but different in size, can be managed. After selecting a box (1-8), all wear-values of the files from this box used during will be booked on the account of this box. If the counter exceeds the defined limit, the note: "File Alarm – File renewed?" is displayed.

If a used file is replaced, the counter has to be re-set to zero with the ne w -key under F .

D a t a (see chapter 4.6).

Even more convenient is the counter reset by tapping the file alarm.

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EndoPilot

4.7. Options

The settings, which will be valid for the entire treatment can be selected in the menu O p t i o n s .

The setting of the curvature of the root canal serves for the calculation of the wear.

The following can be selected as r o o t - c u r v a t u r e :

easily (Factor 1x) medium (Factor 2x) – pre-set strong (Factor 3x).

A p e x - f u n c t i o n s , here you can select (see chapter 4.7.1):

auto-stop (arbitrary, stopping time: 0,5, 1, or 2 seconds) no auto-stop

off

audible assistance , here you can select:

off closer to apex - the closer the file gets to the Apex,

the shorter the time between the tones. Motor Load - the stronger the torque-load (file is approaching the maximum torque limit), the shorter the times between the tones.

The function 1:1 calibrate contra-angle so should be used after each change and each sterilization of the

contra-angle. This can compensate smaller torque-losses at the contra-angle and helps to ensure a stable usage of

small torque-limits. If the calibration is not possible, the contra-angle is dirty or damaged. In this case, please contact the manufacturer.

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EndoPilot

4.7.1. Apexlocator – Root Canal Measurement during Preparation

Check the apex-cable and the correct connection by a short contact of the lip clip to the connected file. The error message S h o r t C i r c u i t has to be displayed (see page 14 at the bottom).

A comfortable function of the EndoPilot is the measurement during the mechanic preparation. In general, all remarks in chapter 3 (Manual Root Length Measurement) apply here as well. Difference: The task of the file clamp is here taken over by the contra-angle. The measurement signal is transferred to the file by the isolated contra-angle. The lip clip is further on necessary in order to close the electric circuit.

The results should always be compared with an x-ray for confirmation.

Overall, there are 3 operating modes available:

1. Apex-function auto-stop 0,5 sec./ 1 sec./ 2 sec.

The position resp. the movement of the file in the root canal is displayed on the symbolised Apex during preparation and the manual probing. While the motor is started by the foot switch, the parameters cannot be entered or changed.

1. If the horizontal line (which might have been adjusted by manual measurement) is reached, the motor stops for the selected time (0,5; 1 or 2 seconds).

2. An acoustic signal and flashing red LED`s at the motor signalize that, with immediate effect, the maximum torque limit of the file will be reduced.

The symbol ("torque reduced") close to the apex reduces the cutting force of the file in the apical area and provides for a constant disposal of the dental chippings out of the canal.

2. Apex-function no auto-stop

The position resp. the movement of the file in the root canal is displayed on the symbolized apex during the preparation and manual probing. While the motor is started by the foot switch, the parameters cannot be entered or changed.

If the horizontal line (which may have been adjusted by manual measurement) is reached, an acoustic signal will sound. The motor does not stop and the torque will also not be reduced.

3. Apex-function off

If the A p e x - f u n c t i o n is turned off, the file menu is still displayed. However, a measurement resp. display of it does not take place.

Please note: An electronical length determination is only possible with conductive tool shafts. The "Alpha" file system from the company Gebr. Brasseler uses isolated plastic shafts. A length determination during preparation is consequently not possible.

appears in the upper right corner of the display. The patented torque-reduction

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EndoPilot

5. Obturation

5.1 Setting DownPack Temperature

5.2 Setting BackFill Temperature

5.1. DownPack

In this menu, you can select the temperature of the heating tip. The bar graph will be set to the requested temperature (Touch-Display). The heating process starts by the foot switch. If the requested temperature is reached, an acoustic signal will sound. Either by releasing the foot switch or at the latest after 40 seconds, the heating process will be stopped. During the heating process, the connected BackFill Gun is shut-off for a short time. Please see also chapter 2.8.

5.2. BackFill

When the BackFill Gun is connected, you can select the temperature of the Gun's heating cylinder in this menu. The bar graph will be set to the requested temperature. The heating process is started as soon as a temperature was selected (the flashing of the display shows that the temperature has not been reached yet). If the temperature has been reached, an acoustic signal will sound. After about 15 minutes, the heating process will automatically stop (acoustic signal).

By pushing the O F F -key at the lower bottom of the bar graph, the heating process can be stopped manually. Please see also chapter 2.9.

The patient may not be connected to the Apex-cable during the obturation (D-Pack and BackFill)!

The selected temperatures

are only examples

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EndoPilot

6. Ultrasonic Function*

6.1 Selection of ultrasonic power in percent

6.2 Selection of run time in seconds Push the small triangles to change the values

6.3 Ultrasonic instrument selection

With the I n s t r u m e n t button the output power is selected for the activation of rinsing liquids.

When inserting the instruments, please make sure that only instruments with correct screw threads are used.

Tighten the selected instrument at first by hand and then with the provided wrench until its torque limit is reached. Please note that not all instruments available on the market can be tightened with the provided torque wrench. When using fixed wrenches, take care not to tighten the instruments too hard, the hand-piece and the instrument can be damaged. Change the instruments only when the ultrasonic handpiece is switched off. Do not twist the cable connection of the hand-piece. Do not use any instruments, which are deformed or showing wear and tear. Please note the product lifetime of the instruments. Work without excessive pressure on the instruments, instrument breakage can cause injuries. Dispose of the used instruments in an appropriate way. Make sure that a contamination or infection is excluded.

To avoid a heating of the instrument and the spot of treatment, external cooling, should, if possible, be provided. When working in the root canal, always use sterile water.

Please note that freely swinging, thin instruments may also break without any external pressure, by the ultrasonic swinging only. Flying splinters can cause injuries. The device may not be used if the ultrasonic handpiece was disconnected from the handpiece cable. Never touch the contacts of the handpiece cable! Always only select program parameters which are appropriate for the instrument. When disruptions or malfunctions occur, do not continue to use the instrument, contact the manufacturer immediately. Please make sure that the ultrasonic tips are used according to their scope of application. Do not use any other ultrasonic handpieces or cables.

During the ultrasonic use the patient may no longer be connected to the Apex cable! Remove the lip clip from the patient’s mouth if you are working with the ultrasonic handpiece or other handpieces. The Apex connection may only be used in combination with the EndoPilot motor handpiece. Put the handpieces back into the holder after use. The handpiece connection of the ultrasonic handpiece to the cable and the inner contacts have to be absolutely dry. Watch out for damages of the insulation and of the hand-piece. Use only impeccable hand-pieces and ultrasonic cables. Damaged insulations may cause electric shocks. Hold the cover of the red socket at the CoPilot always closed. Use a cofferdam with each treatment, this avoids the inhalation or swallowing of small parts. Please do not leave the device unattended, make sure that the foot switch is not pressed unintentionally.

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EndoPilot

6.1. Selection of the Ultrasonic output level*

The level of intensity is freely selectable on the touch display. Please select an appropriate level of intensity. At the beginning, always select a low output level and then increase it up to the level needed. Do not activate the instruments if they are still on air (without contact to the tooth). The ultrasonic device is intended for an intermittent (interrupted) use. In order to avoid heating, do not run the device longer than 2 minutes at maximum power or 4 minutes at minimum power.

Ensure sufficient cooling-off times: 2 minutes use at maximum performance, 6 minutes cooling-off. 4 minutes use at minimum performance, 6 minutes cooling-off.

6.2. Selection of Run-Time*

Rinsing liquids often require pre-set application times. The selection of the run-time enables to work with defined activation times. The CoPilot run-time can be freely selected from 1 to 240 seconds. After the countdown it stops automatically with an audible signal!

Always select a very low ultrasonic power level at first and increase the energy only when needed. The ultrasonic device is intended for intermittent (interrupted) use, always ensure sufficient cooling-off times (see above).

6.3. Ultrasonic-Instrument-Selection

With the Instrument button (resp. name of the selected instrument), a choice of ultrasonic instruments can be called. The relevant performance parameters are pre. The choice of the instrument is stored and retained, even if you turn off the CoPilot.

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EndoPilot

8. -. Setup-Functions

7. Calibration

8. Setup CoPilot

9. Reset

10. Setup

previous menu

7. Contra-angle calibration

After each sterilization and each change of the contra-angle the function "1:1 contra-angle calibration" should be called up. Hereby slight torque losses at the contra-angle could be set off. This function always allows a safe operate at low torque limits. If the calibration is not possible, the contra-angle is very dirty or damaged. In this case, please contact the manufacturer.

8. Setup CoPilot / Wireless foot switch*

In the CoPilot menu the following settings can be made:

CoPilot active / inactive

With this setting you can select if the functions of the *CoPilot module can be used. The key “active” connects EndoPilot and CoPilot. The key “inactive” disconnects them. If the EndoPilot shall be used again without the CoPilot and if the connection cable (15e) has been disconnected the EndoPilot will detect the absence of the CoPilot module and will automatically set the function to “inactive”. If the ultrasonic function is inactive, the key “ultrasonic” is blocked in the main menu.

Auto off

With this function you can determine the period after which the device automatically turns off. You can choose between 10, 20 and 40 minutes.

Wireless Foot Switch In general, the wireless foot switch and the CoPilot module have already been matched prior to delivery. In case a new wireless foot switch shall be used, then the switch and the device still have to be matched to each other. With the function wireless foot switch, the new switch can be paired. To do so, press the key “wireless foot switch” on the display and select teach-footswitch. Now use the foot switch several times in a row. After a while the device will show “wirelessfootswitch found”.

It is also possible to deactivate existing wireless foot switches, resp. to delete them from the database. To do so, press the key “wireless foot switch” and select delete all.

CoPilot Information For service questions, further information on the CoPilot module can be shown here.

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EndoPilot

9. Reset

By re-setting, all file parameters and MyFile-settings will be set back to the factory settings.

10. Setup / Updates / Tones

In the S e t u p Menu, the general device information is displayed. They may be of help especially for service and updates.

With the Menu T ones you may select individually the acoustic signals of the device.

In the sub Menu „Service“ a code can be entered. Additional functions and help-function for the service can be enabled.

11. - 16. Appendices

11. Maintenance

You will also find information on maintenance in the instructions in chapter 16. Check cables and connections at least every 5 months.

Attention!

• Do not lubricate the motor for any reason!

• Please make sure that no lubricant or cleaning liquid gets into the motor! Let excess oil drip out of

the contra-angle before using it again after maintenance. To do so, put the contra-angle in an upright position. The contra-angle should only be lubricated before sterilisation.

• Before you use the ultrasonic hand-piece, please check the insulation for any damages and make sure that the axis of the swinger is firmly anchored in the casing. Do not use any damaged ultrasonic hand-pieces or cables.

• Caution! Remove the batteries if you do not use the foot switch for a longer period of time

The EndoPilot does not contain any parts which can be repaired on-site. If the device opened or modified, the warranty is immediately expired (see chapter 14). A repair may only be executed by the manufacturer!

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EndoPilot

12. Trouble Shooting

If the EndoPilot does not seem to work properly, it does not necessarily have to be a device error. First, please check device with the help of the following table, in order to exclude any handling errors or disturbances (like, for example, anatomic peculiarities).

Problem Possible Reason Solution

Device in general

Device shows no function and display does not work.

Use of Touch-Display not possible, device does not react.

No acoustic signals Tones are turned off Turn the tones on again. Foot switch without function

EndoMotor

Instrument does not turn. Calibration not been done Execute calibration with contra-angle. Motor damaged Check the cables and the plug for damages.

Contra-angle damaged Check if the axle can be turned freely.

Apexlocator

No measurement possible Contact problems Are lip clip and cable connected correctly?

Lip clip at the wrong

Wrong contra-angle Please check if the EndoPilot contra-angle has been

Root canal calcified or

Root canal very dry Rinse with NaCl. Dry access cavity with cotton pellet. Blocking by old filling /

DownPack

Instrument does not heat Instrument damaged Insert new heating tip. Instrument is turning Use the tool to tighten the nut.

BackFill

No Guttapercha at the needle Pellet is used up Is the piston completely in front position?

Instrument turns Turn the knob clockwise until the stop (see 2.9) Piston is blocked (cannot be pulled back during cleaning)

Ultrasonic

Low performance Tip not tightened,

No function Tip not tightened, cable

Wireless foot switch

No function Batteries empty Open the battery compartment at the ground plate of the

No function Switch not recognized The wireless-switch should be paired / see chapter 8

If the problem cannot be solved, please contact your supplier or Schlumbohm GmbH & Co. KG directly.

No power Is the power supply connected correctly (LED must be

shining)? Plug in the D-Pack hand-piece only after turning the device on.

Touch of display damaged Result of using excessive force.

Contact the manufacturer.

Foot switch damaged Check the cables and the plug for damages.

Check if the motor is running with contra-angle.

Are lip clip and file clamp absolutely clean? Make sure that a short circuit is shown on the display when file contact and lip clip are touching each other. The lip clip must be connected to the female connector of

connection

obliterated

medicated substances

Hand-piece too cold Was the heating time long enough? Is the heating chamber

Guttapercha remnants The remnants stick to the piston, the gun has to be emptied

deformed or worn out

eventually damaged

the Apex-cable (socket)!

connected. Did it snap in correctly? Bring lip clip and NiTifile in touch with each other. Does the display show a short circuit? Check x-ray photo, eventually catheterisation with suitable file until working length.

X-ray for comparison! Complete removal of old Guttapercha remnants or of medicated substances.

warm?

Insert a new pellet.

completely while it is still warm.

Tighten instrument with tool Exchange instrument Tighten instrument with tool Contact your supplier or Schlumbohm GmbH & Co. KG

foot switch and change batteries

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EndoPilot

13. Error Messages

For some user errors or disturbances, the device will display error messages. The following errors are, for example, detected automatically:

• Motor not connected

• D-Pack not connected

• BackFill not connected

• External voltage on the Apex-cable or contra-angle

• Short circuit (File clamp resp. NiTi-file touches the lip clip)

• Calibration not possible (Friction in the contra-angle too strong, service is necessary)

If the coded error messages are displayed, for example E2, please contact the manufacturer.

14. Warranty / Liability

The company Schlumbohm year from the date of the original invoice. The product warranty by Schlumbohm of the entire device or of individual parts. The decision if a repair or replacement will done, rests solely with the manufacturer.

In the case of an alleged defect during warranty, the customer has to inform the Schlumbohm® Customer Service immediately. The Customer Service will give further instructions, usually directing to turn in the entire device for service. The costs of the return consignment are at the expense of the sender.

User errors void the warranty. Schlumbohm® does not warrant for wear and dirt in the hand-pieces and contra-angles. Schlumbohm® does not warrant for breakage of the display-glass.

Schlumbohm involves coincidental utilization of other medical devices (e.g. pacemaker).

does not assume any risk or liabilities arising from the clinical use of its products, whether or not such use

warrants this product against defects in material and workmanship for the period of one

includes the repair or the replacement

15. Technical Data

Type Electric supply (1)

Electric safety class Output Operation Speed Torque Device class IP Safety Class

MD-Class / EU Class Environment conditions Weight

Subject to technical changes! (1) Other power supplies must not be used, because safety-relevant!

EndoPilot

Input: 90-264V/AC Power supply according to IEC601 Output: 12V/1,25A /DC (for medical devices) II max. 3V/5A bzw.12V/1,25A (DC) The device is designed for short-term use. 200-1000 rpm +/- 10% 0,2 - 5 Ncm +/- 10% EN 60601-1, Type BF IP52 EndoPilot and foot switch with cable IP42 CoPilot and wireless foot switch IIa 10° C - 40°C / RH: 20-80%, not condensing 450 g EndoPilot control unit 1950 g CoPilot 700 g Base

16. Cleaning, Disinfection, processing of devices

Process the product after each use resp. after each patient. Also the brand-new product has to be prepared before its first use. Please find the instructions in the attached processing instructions on the next pages. The structuring derives from the possible equipment versions of the device. Users with, for example, the EndoPilot Type Comfort (Function motor and Apex finder) will find the major notes in Part I

16.1 Part I: Steering unit with equipment holder, contra-angle and motor

16.2 Part II: Apex cable, DownPack handpiece and BackFill Gun

16.3 Part III: CoPilot device, ultrasonic cable and ultrasonic handpiece

*related to the additional module “CoPilot” - 28 - 609 2201 v12 www.schlumbohm.de

EndoPilot

16.1. procedural instruction part I : Control-Unit, Contra-angle and Motor

Note: (This instruction is valid for new products also) Motor, control-box, foot switch (wireless foot switch) and cables are to be wipe-disinfected, the parts can be cleaned and disinfected applying quick-acting-disinfection-spray FD 333 www.duerrdental.com time 5 min (wipe out the edges carefully) completely be wet surfaces. Observe instructions of the spray manufacturer. The contra angle has to be steam sterilized additional, machine preparation is possible.

with a disposable tissue, exposure

CAUTION:

Restrictions of treatment: Frequent treatment has no or little impact on this instrument. The end of

INSTRUCTIONS: Destination of usage: Remove surface contamination using a disposable (paper) tissue.

Storage and transport: Contra angle and motor are to be processed immediately after usage.

Preparation before cleaning: For cleansing disconnect contra angle from motor, take out the

Cleaning: automatic

Cleaning: manual

Disinfection: Material: Quick-acting-disinfection-spray FD 333, disposable tissues,

Drying: Dry motor and contra angle with a disposable tissue, in addition, blow

Continued on next page

During the cleaning of contra angles it is necessary to pay attention on the process. Automatic-cleaning is only possible for the contra angle. Expose contra angle to 138°C maximum. Motor and contra angle may not be submerged in fluids! Motor must not be steam sterilized. The processing has to be done by skilled personnel only.

the lifetime is usually determined by wear and damages caused by usage.

Do not allow residuals to dry, do not use protein-fixing cleaning and disinfection agents. Avoid waiting time.

instrument.

A. Only the contra angle can be processed automatically

-Material: Quick-acting-disinfection-spray FD 333, disposable tissues, thermo disinfector, for example: Miele Professional G7881 (device for mechanical cleansing and disinfection, equipped for cleaning contra angles type critical B with higher processing requirements)

-Process: For pre-disinfection: spray a disposable tissue with FD 333 and thoroughly wipe contra angle, remove adhesions, rinse the contra angle with de-mineralized water and wipe it with a disposable tissue. Place the contra angle in the thermo-disinfector, follow the manufacturers-instructions of the device and the cleansing and rinsing agents. The process has to be validated and supervised. B. Material: Quick-acting-disinfection-spray FD 333 disposable tissues, spray-adapter for ISO-contra-angles and oil spray F1 (product of W&H www.wh.com

-Process: spray a disposable tissue with FD 333 and, thoroughly wipe motor as well as contra angle (separately), remove adhesions, be wet surfaces completely, exposure time 5 min (observe instructions of the spray manufacturer) (do not apply the spray to the motor directly as the inner parts of the motor may come in contact with any fluid). Rinse the contra angle with de-mineralized water, in addition, and brush it off (soft plastic brush). Attach the contra angle to the adapter of the oil spraycan and spray continuously for about 1 sec. Remove surplus oil and contaminations with a dry tissue.

Process: spray a disposable tissue with FD 333 and, again, thoroughly wipe motor as well as contra angle (separately), be wet surfaces completely, exposure time 5 min (observe instructions of the spray manufacturer). Rinse the contra angle with de-mineralized water, in addition, and brush it off (soft plastic brush).

the contra angle dry with oil-free, dry and germ-low compressed air (use sterile-filter).

)

FD 333 Quick-acting-disinfection-spray (www.duerrdental.com)

*related to the additional module “CoPilot” - 29 - 609 2201 v12 www.schlumbohm.de

EndoPilot

Part I – Continued …

Maintenance:

Inspection and checking of the function: Packing: Contra angle: separately in standardized sterile-bag for steam sterilization

Sterilisation: Steam sterilization (fractioned vacuum) autoclave device class B: 5 min at 134°C, 2

Storage: No special requirements. Additional information: When sterilising several instruments in one cycle, maximum load capacity of the

Contact to manufacturer: For questions please contact your dealer or the manufacturer www.schlumbohm.de

The instructions stated above have been validated as SUITABLE by the medical device manufacturer for the preparation of a medical product prior to its re-usage. The person who does the treatment is responsible that the treatment that actually took place with the equipment, material and personnel used in the treatment institution leads to the desired results. To ensure this it is normally necessary to validate and routinely supervise the process. Each deviation from the instructions provided should be evaluated carefully by the person executing the treatment with regard to effects and negative consequences.

C. Material: disposable tissues, Quick-acting-disinfection-spray FD 333

www.duerrdental.com

(product of W&H www.wh.com

-Process: spray the oil continuously through the contra angle for about 1 sec, remove surplus oil with a disposable tissue. Turn the contra angle downwards (the head), attach the motor (no oil may flow into the motor). Keep the motor running for about 30 sec to remove surplus oil. Start with minimum rotational peed and increase to maximum speed. If contaminants leak out, repeat the whole cleansing, disinfection, drying, and maintenance process Alternatively we recommend oil-service with W&H Assistina (please see the manufacturer’s instruction) Finally wipe motor and contra angle (separately) thoroughly. All parts: Inspect the parts for signs of damage and wear. Do not use damaged components.

Size of packing has to be sufficient. Caution! Motor: The motor must not be sterilised

bar. Treatment duration should be sufficient for the potential germs, if necessary, choose the prion-program (for example: Melag Vakuklave 43 B)

autoclave must not be exceeded.

, spray-adapter for ISO-contra-angles and oil spray F1

)

FD 333 , Quick-acting-disinfection-spray (www.duerrdental.com)

*related to the additional module “CoPilot” - 30 - 609 2201 v12 www.schlumbohm.de

EndoPilot

16.2. Procedural Instruction part II: Apex-cable, D-Pack-handpiece and BackFill-gun

Note: (This instruction is valid for new products also)

1. Apex-cable (the main cable without file-cable with file-clip as well as lip contact)

2. Down-Pack hand piece with cable and

3. BackFill gun with cable are to be wipe-disinfected (see A.), they can be cleaned and disinfected with a disposable tissue applying quick-actingdisinfection-spray FD 333 www.duerrdental.com exposure time 5 min (wipe out the edges carefully) completely be wet surfaces (do not apply the disinfectant directly onto the hand pieces, but spray it on a tissue) observe instructions of the spray manufacturer. The following components are intended for manual cleaning and steam sterilization (B.):

1. file-cable with file-clip and the lip-clip (not the main Apex-cable with plug)

2. nut (the screw-cap of the DownPack hand piece), O-ring (blue) and pen-tip (heating instruments)

3. heat insulator and needle (the disposable needles are to be processed before usage)

CAUTION:

Restrictions of treatment: Frequent treatment has no or little impact on this instrument. The end of the lifetime is

INSTRUCTIONS: Destination of usage: Remove surface contaminations with a disposable (paper) tissue.

Storage and transport: Hand pieces (gun) and cables are to be processed immediately after usage. Do not allow

Preparation before cleaning: 1. Disconnect lip contact from the apex-cable

Cleaning: automatic: Caution: The product is not designed for automatic-cleaning Cleaning: manual:

Disinfection: - Equipment: Quick-acting-disinfection-spray FD 3331 www.duerrdental.com, disposable

During the cleaning of electronical hand pieces it is necessary to pay attention on the process. Expose the autoclaveable components to 138°C maximum. Hand pieces (gun) and cables may not be submerged in fluids! The processing has to be done be skilled personnel only. Automatic-cleaning is not possible.

usually determined by wear and damages caused by usage. Needles are to be used only once!

Note regarding the B-Fill (BackFill) gun: Empty the Guttapercha filling completely by actuating the gun (in operating condition). Now press the silver coloured locking knob and pull the piston (using the black button) out of the gun.

residuals to dry, do not use protein fixing cleaning or disinfection agents. Avoid waiting time. (BackFill gun has to be cooled down)

2. Detach pen tip, nut (screw cap) and O-ring

3. Remove the heat insulator and unscrew the needle from the cooled gun

(dispose the needle appropriately). Press the locking knob of the BackFill gun (11a) and turn the knob (knurled) of the guide-cylinder (11d) for approximately 180° to the left. Now release the locking knob and pull the knurled knob slowly out of the housing (about 2 cm).Turn the knurl knob for another 90° to the left (nose points upwards). Press the locking knob and pull the guide-cylinder entirely out of the gun. (The piston with the black knob, as well as the guide-cylinder are intended to be wipe-disinfected together with the BackFill gun)

(see picture in the operating manual)

A. (all parts which may not be steam-sterilized and the file cord)

- Equipment: Quick-acting-disinfection-spray FD 333 tissues

- Process: Spray a disposable tissue with FD 333 and thoroughly wipe the cables as well as handpieces (or gun), guide cylinder and piston (see above); remove adhesions, be wet surfaces completely, exposure time 5 min (observe instructions of the spray manufacturer) (Neither the inner parts of the handpiece (or gun), nor the plug may come in contact with any fluids, therefore do not spray them directly). After an initially cleaning of the BackFill gun insert the cleaning drill from the muzzle, by screwing it into the heating chamber of the gun. Residues of cooled Guttapercha can be removed (move back and forth through the piston). Now dip the cleaning brush of the gun into Isopropanol 70% (the brush should only be damped, but not drop) and brush the gun inwardly. Repeat this procedure until all residues are removed.

tissues

- Process: Spray a disposable tissue with FD 333 and thoroughly wipe the cords as well as the handpieces (or gun), guide cylinder and piston again, be wet the entire surface, exposure time 5 min (observe instructions of the spray manufacturer) (exposure time depends on the potential germs). Subsequently rinse the guide-cylinder and piston of the BackFill gun with de-ionized water containing low levels of germs and endotoxines (aqua purificata). Wipe the heating chamber with brush and aqua purificata. It is vital to ensure that the cleaning agents are removed completely (for further instructions see C.)

www.duerrdental.com, disposable

*related to the additional module “CoPilot” - 31 - 609 2201 v12 www.schlumbohm.de

EndoPilot

Part 2 – Continued …

Cleaning: manual:

B. (all parts for steam sterilization, except file cable see above)

1. lip clip

2. nut (screw cap of the Down-pack hand piece), O-ring (blue) as well as pen tip (heating instruments)

3. heat insulator and needle (the disposable needles are to be processed before usage) (see chapter “Needle”)

-Material: Combined cleaning and disinfection agent ID213

disposable tissues, ultrasonic

bath with instrument-tank, brush for interior drillings 3 mm (no metal bristles)

-Process: for initial disinfection submerge all parts intended for processing in a fresh bath with combined cleaning and disinfection agent ID213

. This procedure is necessary for protecting your safety and it stops the drying of adhesions. Please adhere to the concentrations indicated by the manufacturer. Do not submerge the parts overnight, do not keep the parts longer than 4 hours in the pre-cleaning-bath.

-For removing contaminations from the components use disposable tissues and cold running water. NOTE: Use an appropriate brush when cleaning drills. Wear protective clothing.

-Process: submerge the parts in a fresh solution with combined cleaning and disinfection agent ID213

in the ultrasonic bath. The parts have to be entirely covered and may not touch each other. Please adhere to the concentrations indicated by the manufacturer.- To entirely clean the components from contaminations, use a soft brush and clean all inner as well as outer surfaces several times. Examine the parts to ensure appropriate cleansing. The cleaned parts have to remain in the bath for the exposure time indicated by the manufacturer. Needle (new) take one needle out of the transport packing, wear clean disposable gloves. Place the needle separately in a clean, disinfected vessel with fresh combined cleaning and disinfection agent ID2131 in the ultrasonic device. Adhere to concentrations and exposure times indicated by the manufacturer. Cleansing and disinfection has to be carried out separately from the other parts to avoid contaminating the needle with suspended solids.

-Rinsing: Take out all parts and rinse them thoroughly with de-ionized water containing low levels of germs and endotoxines (aqua purificata). Use the ultrasonic bath, change the water several times, it is vital to ensure that the cleaning and disinfection agents are removed completely (for further instructions see C.).

Drying:

C. Wipe handpieces (or gun) and cables with a disposable tissue. In addition blow dry the file cable with file clip, lip clip, nut (screw cap), O-ring and pen-tip (heating instrument), as well as needle, heat-cover, guide-cylinder and the piston of the BackFill gun with oil-free, dry and germ-low compressed air (use a sterile filter).

Maintenance: No maintenance necessary

Insert the piston with the black knob and the guide-cylinder of the B-Fill gun into the gun. To do so press the locking knob and insert the guide cylinder, the nose pointing upwards, into the gun, as far as possible. Turn now the knurled knob 90° to the right. Push the knurled knob entirely into the housing. Turn now the knurl knob for another 180° to the right.

Inspection and checking of the function:

All parts: Inspect the parts for signs of damage and wear. Do not use damaged components.

Packing: All parts intended for steam sterilization: separately in standardized sterile-bags for steam

sterilization. Packaging has to be sufficient. The disinfected handpieces (or gun) and Apex cable (main-cable with plug) can be stored in a plastic bag (unsealed / no autoclaving) Attention ! Do not autoclave other parts than the intended.

Sterilisation: Steam sterilization (fractioned vacuum) autoclave device class B: 5 min at 134°C, 2 bar.

Treatment duration should be sufficient for the potential germs, if necessary, choose the prion-program (for example: Melag Vakuklave 43 B)

Storage: No special requirements. Additional information: When sterilising several instruments in one cycle, maximum load capacity of the autoclave

must not be exceeded.

Contact to manufacturer: For questions please contact your dealer or the manufacturer www.schlumbohm.de The instructions stated above have been validated as SUITABLE by the medical device manufacturer for the preparation of a medical product prior to its re-usage. The person who does the treatment is responsible that the treatment that actually took place with the equipment, material and personnel used in the treatment institution leads to the desired results. To ensure this it is normally necessary to validate and routinely supervise the process. Each deviation from the instructions provided should be evaluated carefully by the person executing the treatment with regard to effects and negative consequences.

cleaning and disinfection agent ID213 (www.duerrdental.com)

*related to the additional module “CoPilot” - 32 - 609 2201 v12 www.schlumbohm.de

EndoPilot

16.3. Procedural Instruction Part III: 1. CoPilot device 2. Ultrasonic cable and 3. Ultrasonic handpiece

Note: (This instruction is also valid for new products) Device and handpiece cable are designed to be wipe-disinfected, they can be cleaned and disinfected with a disposable tissue applying quick-acting-disinfection-spray FD 333 www.duerrdental.com, exposure time 5 min (wipe out the edges carefully), completely wet surfaces. Observe instructions of the s pray manufacturer. In addition, steam-sterilize the handpiece and the tool, a mechanical preparation is not possible.

CAUTION:

Restrictions of treatment Frequent treatment has no or little impact on this instrument. The end of the lifetime is

INSTRUCTIONS: Destination of Usage: Remove surface contaminations with a disposable paper tissue Storage and Transport: Process the ultrasonic cable and the ultrasonic handpiece immediately after use. Do not

Preparation before cleaning: Disconnect ultrasonic handpiece from cable, remove instruments with the help of tool and

Cleaning/Disinfection automatic: Cleaning: manual - Equipment: Quick-acting-disinfection-spray FD 3331, disposable tissues, rinsing adapter

Disinfection: - Equipment: Quick-acting-disinfection-spray FD 3331, disposable tissues, rinsing adapter

Drying: Wipe the ultrasonic handpiece, front-cap, tool, the ultrasonic cable and the device with

Continued on the next page

Special attention has to be paid when cleaning ultrasonic handpieces. Only the ultrasonic handpiece is suited for steam-sterilization. Expose the ultrasonic handpiece to 138°C maximum. Do not submerge the ultrasonic handpiece and the ultrasonic cable in fluids! The ultrasonic cable may not be steam-sterilized! The processing has to be done by sufficiently trained personnel only.

usually determined by wear and damages caused by usage..

allow residuals to dry, do not use protein fixing cleaning or disinfection agents. Avoid waiting time.

screw off the grey front-cap from the handpiece Warning: The product is not designed for automatic-cleaning.

and standard disposable syringe

- Process: Spray a disposable tissue with FD 3331 and thoroughly wipe the ultrasonic cable, front-cap, tool, the ultrasonic cable and the device. Remove all adhesions. Wet surfaces completely, exposure time 5 min (observe instructions of the spray manufacturer). (The inner parts of the plug may not come in contact with any fluids, therefore do not spray them directly). Rinse the ultrasonic handpiece by using the rinsing adapter (picture 17) and a standard syringe from the back with demineralized water for 20 seconds. Thoroughly wipe all edges and also the thread of the ultrasonic hand piece.

and standard disposable syringe

- Process: Spray a disposable tissue with FD 3331 and thoroughly wipe the ultrasonic handpiece, front-cap, tool, the ultrasonic cable, the device and also the rinsing adapter, remove all residuals. Wet all surfaces, exposure time 5 min (observe instructions of the spray manufacturer). (The inner parts of the plug may not come in contact with any fluids, therefore do not spray them directly). Thoroughly wipe all edges and also the screw thread of the ultrasonic hand piece.

disposable paper tissue. In addition, blow-dry the ultrasonics handpiece with oil-free, dry and germ-low compressed air (use sterile filter).

*related to the additional module “CoPilot” - 33 - 609 2201 v12 www.schlumbohm.de

EndoPilot

Part III – Continued…

Maintenance: Maintenance not necessary Control and Review: All components: execute visual control for damages and wear.

Packaging: Screw the front-cap on the ultrasonic handpiece. Individually shrink-wrap the

Sterilization: Steam-sterilization (fractioned vacuum) Autoclave device class B: 5 min. at 135°C

Storage: No special requirements, please make sure that the ultrasonic cable will not be

Additional information: Please remove all fluid remains before use, especially on the electric contacts.

Contact to the manufacturer: For question please contact your dealer or the manufacturer www.schlumbohm.de

Thoroughly check the handpiece and cable for defects of the insulation. Ensure a firm position of the swinger in the body of the ultrasonic handpiece. Do not use any damaged components.

ultrasonic handpiece, the tool and the rinsing adapter in standardized sterile bags for steam-sterilization. The packaging has to be large enough. Attention! The cable may not be sterilized

2bar. The holding time should be appropriate for the germs to be expected, if necessary, select prion–program (Example Melag Vakuklave 43 B) Attention! The cable may not be sterilized!

buckled

When sterilizing several instruments in one sterilization cycle, make sure not to exceed the maximum load of the autoclave.

*related to the additional module “CoPilot” - 34 - 609 2201 v12 www.schlumbohm.de

Schlumbohm EndoPilot,EndoPilot Comfort Plus,EndoPilot Comfort,CoPilot User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual