Nouvag TCM Endo R11 User manual

31649 • V48/15 • NOUVAG AG©, all rights reserved, subject to change
TCM Endo R 11
Endodontic root canal preparation
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EN: Subject to change. Pictures and technical data may slightly dier due to consistent 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 desenvolvimento do produto poderá resultar em ligeiras diferenças relativamente a figuras e dados técnicos
EN Operation Manual

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 1
EN
Table of contents
1Product description 2
1.1 Intended use and operation 2
1.2 Contraindications 2
1.3 Technical data, TCM Endo R 11 2
1.4 Ambient conditions 2
1.5 Warranty coverage 2
2Explanation of symbols 3
3Safety information 3
3.1 EMC Manufacturer’s Declaration of Conformity 3
3.2 Modification and misuse 3
3.3 Essential requirements 4
3.4 During use 4
4Scope of delivery 4
5Device overview 5
6Startup 6
6.1 Device setup 6
6.2 Connection to the power supply 6
6.3 Device preparation 7
7Operation 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
8Cleaning, disinfection and sterilization 10
8.1 Control unit and On/Off pedal 10
8.2 Micro motor Endo 10
8.3 Winkelstück 2:1 Endo 11
8.4 Handpiece cradle 11
9Maintenance 12
9.1 Replacing the control unit fuse 12
9.2 Safety inspections 12
10 Malfunction and troubleshooting 13
11 Accessories and spare parts 13
12 Information on disposal 13

TCM Endo R 11
2Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
1Product description
1.1 Intended use and operation
The TCM Endo R11 is a microprocessor controlled endodontic motor system. It controls the rotational speed
and the torque of the motor. The rotational speed is constant until the torque reaches the predefined level.
In order to protect the rimmer, you can choose between two torque controlling modes, the Automatic Lim-
iter (AL) and the Automatic Reverse (AR) mode. The reziprocal movement of the instrument is implement-
ed, to prevent of file breakage and to bring out the removed dental debris, for a fast and effective root can-
nal preparation.
1.2 Contraindications
Relative or absolute contraindications may result from the 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 for
registration within four weeks of the date of purchase, warranty coverage will be extended for a further
6 month.
Consumable parts are not covered by the warranty. Improper use or repair, or failure to observe these
instructions, relieve us from any obligations arising from warranty provisions or other claims.
Voltage (switchable): 100/115/230 V~, at 50 – 60 Hz
Power consumption: 36 VA
Fuses: 2 x T1 AL 250 VAC
Protection class: Class I
Applied part: Type BF
Speed range, contra angle: 150–650rpm
Dimensions, W x D x H: 115 x 180 x 100 mm
Weight: 1.1 kg

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 3
EN
2Explanation of symbols
3Safety information
Your safety, the safety of your team, and of course that of your patients is very important to us.
It is therefore essential to bear the following information in mind:
3.1 EMC Manufacturer’s Declaration of Conformity
Please observe the information on electromagnetic compatibility provided with these operating instruc-
tions.
3.2 Modification and misuse
Important information Autoclavable at 135°C
Warning Suitable for thermal disinfection
Manufacturer Observe the instructions for use
Type 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 body Symbol indicating the order number.
•Modification or manipulation on the TCM Endo R 11 and its accessories is prohibited. The manufacturer
is not liable for any damages resulting from unauthorized modifications or manipulations.
The warranty is lapsed.
•Use of the TCM Endo R 11 outside of the indications described in Section 1.1 is prohibited. The user or
operator is solely responsible for any such use.

TCM Endo R 11
4Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
3.3 Essential requirements
The device is not sterile on delivery. All steriliza-
ble parts must be sterilized before use (refer to
chapter 8 Cleaning, disinfection and steriliza-
tion).
Improper use or repair of the device and failure
to observe these instructions relieve us from any
obligation arising from warranty provisions or
other claims!
The use of third-party products is the responsi-
bility of the operator. Functionality and patient
safety cannot be guaranteed with third-party
accessories.
Prior to using the device, before startup, and
before operation, the user must always ensure
that the device and accessories are in good
workin
g
order and are clean, sterile and o
p
era-
Repairs may only be performed by authorized
NOUVAG service technicians.
The TCM Endo R 11 may only be operated under
constant supervision of qualified and trained
3.4 During use
Do not use the device in the vicinity of flamma-
ble mixtures.
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 prior warning. Handpieces
must be properly maintained according to the specific maintenance schedule and inspected for signs of
wear prior to each use.
4Scope of delivery
Ref. Description Quantity
TCM Endo R 11 (Ref. Set: 1518)
1514 Control unit TCM Endo R 11 ------------------------------------------------------------------------------------------------1 unit
1902nou Micro motor Endo, autoclavable ------------------------------------------------------------------------------------------1 unit
1683nou Endo Contra Angle 2:1, PEEK, autoclavable -----------------------------------------------------------------------------1 unit
1479nou On/Off pedal-------------------------------------------------------------------------------------------------------------------1 unit
1170nou Handpiece cradle--------------------------------------------------------------------------------------------------------------1 unit
1933 Spray nozzle for Nou-Clean Spray for maintenance and care of Endo-handpieces---------------------------1 unit
31649 Operating instructions for TCM Endo R 11 on CD-ROM ------------------------------------------------------------1 unit
In line with regulations pertaining to hazardous materials, the article 1984, Nou-Clean Spray is not
delivered with the control unit but can be ordered separately from any official Nouvag service center.

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 5
EN
5Device overview
Front view
Rear view












1. Control unit TCM Endo R 11
2. Operation panel
3. Display
4. On/Off pedal
5. Socket 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 device fuse





TCM Endo R 11
6Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
6Startup
6.1 Device setup
• Place the TCM Endo R 11 with all required accessories and instruments on an even, non-slip surface and
make sure you have good access to all controls.
• Do not allow the operating range of the device (including cable) and the connected instrument to be com-
promised by limiting factors.
• The systems display must be fully visible at all times.
• The foot switch with pedal must be placed within stepping distance between the patient and the surgeon.
• It must be explicitly ensured that no objects can fall on the pedal.
• The power plug at the rear of the device 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 local mains voltage, the grey fuse holder must be set to the
correct voltage.
A) Unplug the power cable.
B) Use a screwdriver to open the fuse slot.
C) Remove the fuse holder.
D) Remove the grey fuse holder and reinsert it, in the way that the local mains voltage setting appears in
the small window.
E) Slide the fuse holder back in and close the fuse slot.
F) Check the mains voltage shown on the fuse slot.
G) Plug the power cord back into the device socket.

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 7
EN
6.3 Device preparation
1. Connect the plug of the pedal with the pedal
socket of the control unit.
2. Connect the plug of the micro motor with the
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 specific
service voltage!

TCM Endo R 11
8Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
7Operation
7.1 Switching device on and off
The power switch „I/O“ at the rear of the device is used to switch the con-
trol unit on and off. The display shows the basic setting.
The device can be switched off at any time irrespective of any procedure for
switching off the 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 Limiter and Automatic Reverse)
Switch rotational direction of the micro motor (instrument).
Activate reciprocal mode. AL and AR mode is not active.

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 9
EN
7.4 Starting motor
To start the motor press the pedal. At releasing the pedal the motor stops. The motor can only be activated
by the use of the pedal.
7.5 Automatic Limiter (AL)
The Automatic Limiter (AL) limits the torque applied to the instument. If the selected torque level is
reached, the speed will drop down to zero rpm if the force is not redued. The torque persists until the force
is alleviated.
7.6 Automatic Reverse (AR)
Automatic Reverse (AR) is a special function to protect rimmers against breakage. When the torque on the
contra angle reaches the preselected value, the motor changes the rotational direction for 1 round and
switches back to the forward rotation.
7.7 Reciprocal mode
The reciprocal mode is implemented to prevent of file breakage and to bring out the removed dental 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
device.
General function:
1. Use the main switch, at the rear of the device, to switch the device on. The start screen shows Speed 300,
torque 25, reverse mode and AR mode.
2. Press On/Off pedal, instrument starts rotating.
3. Release On/Off pedal, instrument stops.
Rotational direction of micro motor:
1. Press key for rotational direction. On the display the symbol changes.
2. Press On/Off pedal, instrument rotates in the oposite direction. An interrupting tone is emitted that signal-
izes the inverted rotation.
3. Release On/Off pedal, instrument stops.
Troubleshooting:
To find out about malfunctions and errors please refer to chapter 10 „Malfunction and troubleshooting“.

TCM Endo R 11
10 Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
8Cleaning, disinfection and sterilization
The following points in particular are important with regard to caring for the material:
● Perform cleaning, disinfection and sterilization after every treatment!
● Always autoclave the material in sterilization packaging.
● Make sure that sterilization packaging is not more than 80 % filled.
● Autoclave the material at 135°C for at least 5 minutes.
● If sterilized 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 disinfection, the front plate of the control unit is not sealed for this purpose.
8.2 Micro motor Endo
The micro motor does not come into contact with the patient.
Wipe the outside using micro-biologically tested surface disinfectant or a 70 % isopropyl solution.

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

TCM Endo R 11
12 Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15
9Maintenance
9.1 Replacing the control unit fuse
Users can replace faulty control unit fuses themselves. These are located at the rear of the device in the
fuse slot beside the power switch:
•Unplug the power plug.
•Open the fuse slot using a screw driver.
•Replace defective fuses T 1 AL 250 VAC.
•Slide the fuse holder back in and close the fuse slot.
•Plug in the power plug again.
1. Fuse slot locking mechanism
2. Fuse slot
3. Fuse 1
4. Fuse 2
1. Fuse slot locking mechanism
2. Display window for voltage setting
3. Fuse 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 of 2 years applies to the TCM Endo R 11.
NOUVAG AG offers a safety inspection service for its customers. Addresses can be found in the appendix
of this operation manual under “Service centers”. For further information please contact our technical ser-
vice department.
Further international service centers are listed on the Nouvag website:
www.nouvag.com > Service > Service centers
12 345

TCM Endo R 11
Operating Instructions, TCM Endo R 11, Ref. 31649, V48/15 13
EN
10 Malfunction and troubleshooting
Malfunction Cause Solution Reference in manual
Device is not operational Control unit is not
switched on
Switch main switch “I/O”
to “I”
7.1 Switching device on and off
No connection to
electricity- supply
Connect power cord to
electricity-supply
6.3 Device preparation
Wrong voltage Check power supply and
change voltage if needed
6.2 Connection to the
power supply
Defective fuses Replace fuse 9.1 Replacing the control unit fuse
Pedal is not functioning Control unit is not
switched on
Switch main switch “I/O”
to “I”
7.1 Switching device on and off
Pedal is not connected
properly
Check plug connection,
replug
6.3 Device preparation
Micro motor is not
functioning
Control unit is not
switched on
Switch main switch “I/O”
to “I”
7.1 Switching device on and off
Motor is not connected
properly
Check plug 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
Spare parts Ref.
Mikro motor Endo ----------------------------------------------------------------------------------------------------------------------------1902
Contra angle 2:1 ------------------------------------------------------------------------------------------------------------------------------- 1683
On/Off pedal ---------------------------------------------------------------------------------------------------------------------------------- 1479
Accessories Ref.
Transport suitcase TCM Endo R 11 -------------------------------------------------------------------------------------------------------- 1078
To order additional parts, please contact our customer service department.
12 Information on disposal
When disposing of the device, device parts and accessories, the regulations prescribed by law must be observed.
Do not dispose of devices with houshold waste!
To ensure environmental protection, old devices can be returned to the dealer or manufacturer.
Motors that have reached the end of their service life may not be disposed of with houshold waste.
Motors must be sterilized before disposal. Please observe currently valid national disposal regula-
tions for infectious waste.