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TCM Endo R 11 

 

Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15

 

11 

 

EN

8.3

 

Contra angle 2:1 Endo 

 

 

INSTRUCTIONS 

At location of use 

Wipe dirty surfaces with an expendable cloth/ tissue paper.

Storage and transport 

No special requirements. Due to the risk of drying and corrosion, reprocessing must be performed without undue 
delay. 

Preparation for cleaning 

Remove file. 

Automatic cleaning and 
disinfection 

Equipment: Washers and disinfectors with a special loading rack, which ensures handpiece connection to the 
washer/disinfector and channel irrigation. A fine-mesh basket shall be used for the small parts. Rinse the contra 
angle from the rear. Use a neutral or alkaline cleaning agent in the recommended concentration. 

 

1.

 

Load contra angle in the load carrier (irrigation of the channels must be ensured). 

2.

 

Set cleaning cycle with effectual rinsing and cleaning. Carry out rinse cycle with demineralized water. 

3.

 

For thermal disinfection rinse with demineralized water at 93°C for 10 minutes. 

4.

 

By taking out the contra angle, check whether there's still visible dirt in gaps. If necessary repeat cycle or clean 
manually. 

Manual cleaning 
 

Equipment: Neutral cleaning agent, soft brush, running water 

Procedure: 

1.

 

Rinse surface dirt off the contra angle under running water. 

2.

 

Apply cleaning agent with brush on all surfaces as well as gaps. 

3.

 

Thoroughly rinse the contra angle under running water. 

Manual disinfection 

For manual disinfection, wipe the contra angle with a cloth soaked in a disinfectant solution on an  
ethyl alcohol basis. 

Drying 

If the drying/disinfection device does not provide any drying program dry contra angle manually or in a drying 
chamber. 

Inspection and  
maintenance 

Check for visual damage, corrosion and wear. 

 

After cleaning and disinfection spray contra angle thoroughly with Nou Clean spray and 
briefly wipe with a moistened cloth (See illustrations on the spray can). 
 
 

Packaging 

Single: Pack the contra angle in an individual sterile supply package. The bag must be large enough that the seal is 
not under tension. 

 

Sets: Arrange the contra angles into the foreseen trays or put onto an all-purpose sterilization tray. 

Sterilization 

Autoclave in vacuum autoclaves at 135°C for at least 5 minutes*. Do not exceed the maximum load of the sterilizer, 
if several instruments are sterilized during one sterilization cycle. Observe a drying phase for autoclaves without 
post-vacuum. Allow the contra angle to dry in the bag with the paper side upwards. 

 

*The temperature hold times must comply with the local guidelines and standards. 

Storage 

No special requirements. The sterilization indicator and sterilization date should be marked on the packing, if the 
sterilised contra angle is not used immediately after sterilization. 

 

The instructions given above have been validated as suitable by NOUVAG AG for preparing a medical product for reuse. The onus is on the processor to ensure that 
the processing actually carried out with the equipment, materials and personnel used achieves the desired results in the processing device. To this end, validation and 
routine monitoring of the procedure are normally required. Likewise, any departure from the instructions provided by the processor should be evaluated carefully in 
terms of its effectiveness and possible detrimental consequences. 
 
 

8.4

 

Handpiece cradle 

Soiled handpiece cradles are cleaned using a neutral or an alkaline cleaning agent in the recommended con-
centration. Sterilize it in accordance with the same instructions as for the Contra angle 2:1 Endo. 

 
 
 
 
 
 
 
 
 

 

Reprocessing restrictions 

Frequent reprocessing hardly affects the contra angle. The products life end usually is determined by damage, 
wear and tear caused by usage. 

Ref. 1933 

Summary of Contents for TCM Endo R11

Page 1: ... further development FR Sous réserve de modifications techniques En raison du développement constant de nos produits les figures et les caractéristiques techniques peuvent différer légèrement ES Reservado el derecho a realizar modificaciones técnicas Las imágenes y los datos técnicos pueden variar mínimamente debido al desarrollo del producto PT Resevamo nos o direito a alterações técnicas O desen...

Page 2: ... overview 5 6 Startup 6 6 1 Device setup 6 6 2 Connection to the power supply 6 6 3 Device preparation 7 7 Operation 8 7 1 Switching device on and off 8 7 2 Operation panel 8 7 3 Setting up parameters 8 7 4 Starting motor 9 7 5 Automatic Limiter AL 9 7 6 Automatic Reverse AR 9 7 7 Reciprocal mode 9 7 8 Function control 9 8 Cleaning disinfection and sterilization 10 8 1 Control unit and On Off peda...

Page 3: ... general patient status or the risks of anesthesia related to the treatment 1 3 Technical data TCM Endo R 11 1 4 Ambient conditions Transport and storage Operation Relative humidity Max 90 Max 80 Temperature 0 C 60 C 10 C 30 C Atmospheric pressure 700 hPa 1060 hPa 800 hPa 1060 hPa 1 5 Warranty coverage Purchasing the TCM Endo R 11 entitles you to a 1 year warranty If you return the warranty card f...

Page 4: ...e BF applied part is the connected instrument Electrical and electronic devices that have reached the end of their service life comprise hazardous waste and may not be disposed of together with household waste Valid local disposal regulations apply Certified by the Canadian Standards Association CSA Symbol indicating the serial number with the date of manufacture year month CE symbol with notified...

Page 5: ...xtures At the choosing of the instrument the operator has to make sure it s biocompatible according to EN ISO 10993 Electric micromotors generate significantly more power than traditional air turbines and air motors Poorly maintained worn damaged or misused handpieces may generate frictional heat capable of causing serious burn injuries to the patient Heat generation may occur quickly and without ...

Page 6: ...t for On Off pedal 6 Plug of On Off pedal 7 2 1 Endo Contra Angle 8 Instrument for root cannal preparation optional 9 Handpiece cradle 10 Mikro motor Endo 11 Socket for Mikro motor Endo 12 Plug of Mikro motor Endo 13 Fuse compartment with voltage setting 14 Device main switch 15 Power plug socket 16 Type plate with type designation reference number serial number information on power supply and dev...

Page 7: ...e must be accessible at all times 6 2 Connection to the power supply Before plugging the power cable into the power socket for the first time you must check the supply volt age setting next to the power switch In order to prevent the risk of an electrical shock the device may only be connected to a power network with a PE protective ground conductor If the voltage shown does not correspond to the ...

Page 8: ...motor socket M of the control unit 3 Attache the contra angle with clamped instru ment to the micro motor Check seating of the contra angle with a gentel counter movement 4 Plug the power cord with the appropriate end into the socket of the control unit 5 Connect the power cord with the electrical outlet Before switching on make sure that the power supply of the device matches the country s specif...

Page 9: ...he device 7 2 Operation panel n d e r g e 7 3 Setting up parameters Reduce speed Increase speed Reduce torque Increase torque Select between AL and AR function Select rotation direc tion of instrument Activate reciprocal mode Select speed with the Speed und Speed keys Select torque with the Torque und Torque keys Switch between Auto Limiter and Auto Reverse mode Refer to chapter 7 6 Automatic Limi...

Page 10: ...ental debris for a fast and effective root cannal preparation 7 8 Function control Prior to the startup of the TCM Endo R 11 and the use of accessory equipment the user must always ensure that each individual component is in good working order free from defects clean sterile and operational All inscriptions on the device and its accessories must be readable and there must be no loose parts in the ...

Page 11: ...rilized material is not used immediately the material packaging must be labeled with the sterilization date Nouvag AG recommends including a sterility indicator 8 1 Control unit and On Off pedal Control unit and On Off pedal do not come into contact with the patient Wipe the outside using micro biologically tested surface disinfectant or a 70 isopropyl solution Don t use spray cleaning and spray d...

Page 12: ...nd disinfection spray contra angle thoroughly with Nou Clean spray and briefly wipe with a moistened cloth See illustrations on the spray can Packaging Single Pack the contra angle in an individual sterile supply package The bag must be large enough that the seal is not under tension Sets Arrange the contra angles into the foreseen trays or put onto an all purpose sterilization tray Sterilization ...

Page 13: ...slot 4 Fuse 1 5 Fuse 2 9 2 Safety inspections The performance of safety inspections on medical devices is required by law in several countries The safety inspection is a regular safety check that is compulsory for those operating medical devices The objective of this measure is to ensure that device defects and risks to patients users or third parties are identified in time An inspection interval ...

Page 14: ... connection replug 6 3 Device preparation Contra angle is not work ing properly Contra angle is not connected properly to the motor Press contra angle firmly to motor check seating 6 3 Device preparation If a fault cannot be rectified please contact your supplier or an authorized service center The addresses are provided on the last page of tis operating instructions 11 Accessories and spare parts...

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