Nouvag TCM 3000 BL User manual

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 1
EN
Table of contents
1General information 2
1.1Intended use and operation 2
1.2Contraindication 2
1.3Medical application 2
1.4Technical data, TCM 3000 BL 2
1.5Ambient conditions 2
1.6Warranty coverage 2
2Explanation of symbols 3
3Safety information 3
3.1EMC Manufacturer’s Declaration of Conformity 3
3.2Modification and misuse 4
3.3Essential requirements 4
3.4During use 4
4Scope of delivery, accessories and spare parts 5
5Device overview 5
6Before use 6
6.1 Device setup 6
6.2Connection to the power supply 6
6.3Device preparation 7
6.3.1Connecting the motor cable 7
6.3.2Connecting the pedal cable 7
6.3.3Attaching the handpiece onto the motor 8
7Operation 8
7.1Switching the TCM 3000 BL on or off 8
7.2Program overview 8
7.2.1Program for 1 : 1 handpiece 8
7.2.2Program for Dermatome 9
7.2.3Program for surgical micro saws 9
7.2.4Program for the Tattoo handpiece 9
7.3Setting the handpiece in motion 9
7.4Functional check 9
8Cleaning and disinfection 10
8.1Reprocessing of the control unit and the pedal 10
8.2Reprocessing of the Electronic motor 21 10
8.3Reprocessing of the handpieces 10
9Maintenance and repair 11
9.1Replacing the motor cable 11
9.2Replacing the control unit fuse 11
9.3Safety inspections 11
9.4Malfunction and troubleshooting 12
10Spare parts and accessories 13
10.1Information on disposal 14


TCM 3000 BL
2Operation instructions TCM 3000 BL, REF 31739, V33/19
1 General information
1.1 Intended use and operation
The TCM 3000 BL is a device for controlling an electronic motor combined with an appropriate handpiece
according to the intended use. It’s applied in an operation theater for Dermabration and Reconstructive
Surgery as well as for sawing, drilling, milling and grinding at bones. Handpieces like the 1 : 1 handpiece,
dermatomes, the tattooing handpiece and different kind of micro saws can be applied.
1.2 Contraindication
Relative or absolute contraindications can arise from the general medical diagnose, or in special cases by a
significantly increased risk to the patient through the use of motor-driven systems.
Relevant cases in the literature must be taken into consideration.
1.3 Medical application
This product is designed solely for the use in medical facilities by medically qualified persons.
1.4 Technical data, TCM 3000 BL
Voltage --------------------------------------------------------------------------variable: 100 V/ 115 V/ 230 V, 50–60 Hz
Fuse, power supply -------------------------------------------------------------------------------------2 fuses T 1 AL 250 V AC
Power consumption ----------------------------------------------------------------------------------------------------------60 VA
Motor speed range -------------------------------------------------------------------------------------------- 500 – 40.000 rpm
Maximum motor torque----------------------------------------------------------------------------------------------------- 6 Ncm
Motor coupling --------------------------------------------------------------------------------------- INTRA coupling ISO 3964
Cable length, motor -------------------------------------------------------------------------------------------------------------- 3 m
Cable length, pedal --------------------------------------------------------------------------------------------------------------- 3 m
Protection class ----------------------------------------------------------------------------------------------------------------Class I
Applied part ---------------------------------------------------------------------------------------------------------------- Type BF *
IP code, pedal --------------------------------------------------------------------------------------------------------------------- IPX8
Dimensions (W x D x H) ------------------------------------------------------------------------------------- 120 x 180 x 115 mm
Net weight, control unit ------------------------------------------------------------------------------------------------------1.8 kg
* Applied part of type BF is the instrument (handpiece) used with the TCM 3000 BL
1.5 Ambient conditions
1.6 Warranty coverage
Purchasing the TCM 3000 BL entitles you to a 1-year warranty. If you return the warranty card for registra-
tion within four weeks of the date of purchase, warrant 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 in-
structions, relieve us from any obligation arising from warranty provisions or other claims.
Transport and storage: At operation:
Relative humidity: max. 90 % max. 80 %
Temperature: 0 – 60°C, (32 – 140°F) 10 – 30°C, (50 – 86°F)
Atmospheric pressure: 700 – 1060 hPa 800 – 1060 hPa

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 3
EN
2 Explanation of symbols
3 Safety information
Your safety, the safety of your team, and of course that of your patients is very important to us. It is there-
fore essential to bear the following information in mind:
Every use of the TCM 3000 BL different to the product description defined in chapter 1.1, “Intended use and
operation”, causes risks for patients and trained personnel. If physical examinations and therapies are car-
ried out without use of the devices then the devices must be removed from the place of treatment. Avoid
any connection or close adjacency to other devices.
3.1 EMC Manufacturer’s Declaration of Conformity
The use of (RF) Radio Frequency emitting devices and equipment as well as the occurrence of negative
environmental factors in the close area of the TCM 3000 BL may cause unexpected or adverse operation.
The connection or the placing of other devices in close vicinity is not allowed.
The product is suitable for use in establishments of the industrial sector and hospitals. When used in the
domestic establishments, this unit may not provide adequate protection for radio services. The user must
take remedial measures such as implementation or reorientation of the product.
Use only accessories and cables as specified in the product description. Further observe the EMC manufac-
turers declaration of conformity.
Important information Autoclave at 135°C
Warning Suitable for thermal disinfection
Manufacturer Protection against continual submerging.
Type BF applied part.
Applied part is the instrument
Symbol indicating the serial number with the
date of manufacturing
Certified by the Canadian Standards As-
sociation (CSA)
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.
Conform to European standards,
with notified body
Symbol indicating the order number.
Observe instructions for use Motor
Pedal Biohazard
Potential Equalization

TCM 3000 BL
4Operation instructions TCM 3000 BL, REF 31739, V33/19
3.2 Modification and misuse
3.3 Essential requirements
Before use read this manual and the man-
uals for all other equipment used in the
procedure thoroughly. Familiarize yourself
with the functions and handling of the
appliance.
The products described in this manual must be used
by trained and qualified medical personnel only in
accordance with the requirements and with refer-
ence to the manual.
For the protection of the patient, the user
and third parties the products used must
be prepared as specified in the manual.
Improper use or repair of the device, or failure to
observe these instructions, will relieve us from any
obligation arising from warranty provisions or other
claims.
The use of third-party products is the
responsibility of the operator. Functionali-
ty and patient safety cannot be guaran-
teed 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 working order
and are clean, sterile and operational.
Repairs may only be performed by service
technicians, authorized by the manufac-
turer of the device.
Use NouClean spray for maintenance and care o
f
the
motor and handpieces. Using other care products
can result in malfunctions and/or cause the warranty
to be revoked.
3.4 During use
The device is not sterile on delivery. All
sterilizable parts must be sterilized before
use (see Chapter 8, cleaning and disinfec-
tion).
Do not remove handpieces while the motor is run-
ning. It could result in instrument damage
Operate the device only outside the dan-
ger zone of explosive, flammable mixtures
or gases.
The TCM 3000 BL must be operated under the con-
tinuous supervision of medically qualified persons
only.
The motor ventilation slots must be kept
clear in order to prevent the motor from
overheating.
Ensure that the operating voltage setting corre-
sponds to the local mains voltage.
• Modification or manipulation of the TCM 3000 BL and its accessories is prohibited.
The manufacturer is not liable for any damages resulting from unauthorized modifications or manipula-
tions. The warranty will be cancelled.
• Use of the TCM 3000 BL outside the indications described in Section 1.1 is prohibited.
The user or operator is solely responsible for any such use.

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 5
EN
4 Scope of delivery
REF Description Quantity
3285 TCM 3000 BL set comprises the following products------------------------------------------------------------------ 1
3280 TCM 3000 BL control unit, device connecting cable 3m, (country specific) ---------------------------------------1
1507nou VARIO-Pedal, IPX8, connecting cable 3 m----------------------------------------------------------------------------------1
1170 Handpiece cradle-----------------------------------------------------------------------------------------------------------------1
2112nou Electronic motor 21 with ISO 3964 coupling, 3 meter motor cable, operations manual included-------------1
31739 Operation manual TCM 3000 BL on CD-ROM----------------------------------------------------------------------------1
1942 Spray nozzle for NouClean spray for maintenance and care of the electronic motor 21------------------------1
1958 Spray nozzle for NouClean spray for maintenance and care of handpieces ---------------------------------------1
In line with regulations pertaining to hazardous materials, the item NouClean care spray
(REF 1984) is not delivered with the control unit but can be ordered separately from any official
Nouvag service center. www.nouvag.com
5 Device overview
Front view Control panel Rear view
1. Display
2. LED Motor indication light
3. Pedal connection
4. Motor connection
1. «1 : 1» key (Program for 1:1 handpiece)
2. «DTM» key (Program for Dermatome)
3. «SAW» key (Program for all micro saws)
4. «THP» key (Program for Tattoo handpiece)
5. «Changing rotational direction»
6. «» (decrease value)
7. «» (increase value)
8. Motor-LED
1. Mains connection
2. ON/OFF main switch
3. Fuse module
4. Country voltage indication
5. Type plate with type designa-
tion, reference number, serial
number, information on power
supply and device fuse
6. Potential equalization

TCM 3000 BL
6Operation instructions TCM 3000 BL, REF 31739, V33/19
6 Before use
6.1 Device setup
●Installation layout
● Place the TCM 3000 BL and all required accessories and instruments on an even, non-slip surface and
make sure you have good access to all controls.
●The installation of the device in close proximity to other devices is prohibited due to EMC – please see
section 3.1 and the manufacturer’s EMC declaration in the appendix of this manual.
●Do not allow the operating range of the device (including the cable and handpiece) to be compromised
by limiting factors.
●The system display must be fully visible at all times.
●The 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.
●The motor ventilation slots must be kept clear in order to prevent the motor temperature from becom-
ing excessive.
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
voltage setting next to the power switch.
• In order to prevent the risk of electric shock, the device may only be connected to a power network with a
PE protective earth conductor.
If the voltage shown does not correspond to the local mains voltage, the grey fuse holder must be set to the
correct voltage:
1. Switch the device off.
2. Unplug the power cable.
3. Use a screwdriver to open the fuse slot.
4. Remove the fuse holder.
5. Remove the grey fuse holder and reinsert it so that the local mains voltage setting is shown in the small
window.
6. Slide the grey fuse holder back in and close the fuse slot.
7. Check the mains voltage shown on the fuse slot.
8. Plug the power cable back into the device.

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 7
EN
6.3 Device preparation
The device is not sterile on delivery. All sterilizable parts must be sterilized before use (see Chapter 8
Cleaning and disinfection).
If the accessories have already been sterilized: when removing them from the sterile packaging, ensure
that the sterile packaging is not damaged and that the sterility indicator confirms sterility and shelf life of
the sterile item has not expired.
The assembly of accessories is carried out under sterile conditions (wear gloves and a mask, place accesso-
ries on a sterile surface).
6.3.1 Connecting the motor cable
Align the red dot on the device connection plug of the
motor with the red dot on the motor connection of the
control unit.
Plug the motor device connection plug into the motor
connection of the control unit. The plug must lock in
position.
6.3.2 Connecting the pedal cable
Align the red dot on the device connection plug of the
pedal with the red dot on the pedal connection of the
control unit. Plug the pedal device connection plug into
the pedal connection of the control unit. The plug must
lock in position.
With the TCM 3000 BL control unit only the electronic
motor 21 (REF 2112nou) may be used.
Sterilize the motor (motor is not sterile on delivery). If
the motor has already been sterilized when removing
from the sterile packaging, ensure that the sterile pack-
aging is not damaged and the sterility indicator confirms
sterility. The sterile packaging must show the date on
which the shelf life of the sterile item is due to expire.
(Refer to chapter 8, cleaning and disinfection)
With the TCM 3000 BL control unit only the VARIO
pedal (REF 1507nou) may be used.

TCM 3000 BL
8Operation instructions TCM 3000 BL, REF 31739, V33/19
6.3.3 Attaching the handpiece onto the motor
Attach desired handpiece onto the motor. The following handpieces are available:
Handpiece 1 : 1 Dermatome 25/50/75/100 mm Micro Sagittal Saw, REF 5110nou Tattoo handpiece
REF 1710nou REF 1992nou/1991nou/1990/ Micro Oscillating Saw, REF 5090nou REF 5020nou
1983nou Micro jig Saw, REF 5040nou
7 Operation
7.1 Switching the TCM 3000 BL on or off
The device is switched on (I) or off (O) with the main switch „I/O“, at the power supply module, at the rear
of the device. The display on the TCM 3000 BL is then illuminated.
After switching the device on the last used setting will be
activated and displayed.
7.2 Program overview
Select the program on the operation panel according to the applied handpiece.
The activated Program is confirmed with an indication light on the key as well as on the display.
7.2.1 Program for 1 : 1 handpiece
Press 1 : 1 key according to the applied 1 : 1
handpiece on the motor.
Press -key for decreasing or -key for in-
creasing the value of the desired speed.
Press REV.-key to change the direction of rota-
tion of the applied instrument.

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 9
EN
7.2.2 Program for the Dermatome
Press DTM-key according to the applied Der-
matome handpiece on the motor.
The ideal rotational speed for the dermatomes
is 14.000 rpm and can not be changed.
7.2.3 Program for surgical micro saws
Press SAW-key according to the applied micro
saw hand-piece on the motor.
The ideal rotational speed for the all 3 micro
saws is 15.000 rpm and can not be changed.
7.2.4 Program for the Tattoo handpiece
Press THP-key according to the applied micro
saw hand-piece on the motor.
The ideal rotational speed for the Tattoo hand-
piece is 12.000 rpm and can not be changed.
7.3 Setting the handpiece in motion
The motor with the attached handpiece is only set in motion when
the pedal is pressed. The speed for the 1 : 1 handpiece is regulated
by variation of the pressure on the pedal.
The Dermatomes, the Tattoo handpiece and the micro saws are all
running with a fixed speed. The variation of the pedal therefore
has no influence on the speed. The rotational speed stays the
same constantly.
7.4 Functional check
Prior to each use of the device a functional check must be performed for the device and the whole periph-
ery.
 Check motor and attached handpiece for lose parts and eventually loose connection.
 Are all labels and inscription well readable?
 Switch on device.
 Press the pedal all the way it will go for about 20 seconds. Motor and handpiece must reach and hold the
preset rotational speed.
 Release the pedal and switch off the device.
The motor with the attached handpiece can only be operated via the connected pedal.

TCM 3000 BL
8Operation instructions TCM 3000 BL, REF 31739, V33/19
8 Cleaning and disinfection
8.1 Reprocessing of the control unit and the pedal
The control unit and the pedal do not come into direct contact with the patient.
Wipe the outside using microbiologically tested surface disinfectant or a 70 % isopropyl alcohol solution.
8.2 Reprocessing of the Electronic motor 21
The reprocessing instructions of the electronic motor are described in the operating instructions of the
electronic motor, which are supplied together with the electronic motor.
8.3 Reprocessing of the handpieces
The reprocessing instructions for the applied handpiece is included in the packaging of the handpiece.
Risk of infection!
The product should be prepared in accordance with the instructions given in this manual before using it
for the first time and for each subsequent use. The inadequate and/or incomplete preparation of the
product can cause an infection of the patient. Observe the following specific instructions.

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 11
EN
9 Maintenance and repair
9.1 Replacing the motor cable
 Replace defective motor cable by a new one (REF 76052)
9.2 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:
1. Switch the device off.
2. Unplug the power plug.
3. Open the fuse slot using a screw driver.
4. Replace the faulty fuse T 1 AL, 250 V AC.
5. Slide the fuse holder back in and close the fuse slot.
6. Check the mains voltage shown in the fuse slot window.
7. Plug in the power plug.
1. Fuse slot locking mechanism
2. Window showing the voltage setting
3. Fuse slot
4. Fuse 1
5. Fuse 2
9.3 Safety inspections
The essential requirements have been defined and within the risk analysis assessed. The approved results
have been filed in the risk management deposited with the manufacturer.
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.
The STI (Safety technical inspection) for the TCM 3000 BL shall be executed every 2 years by authorized ex-
perts. Results shall be documented.
The service instructions, diagrams and descriptions are available on request from the manufacturer.
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 providers
1 2 345

TCM 3000 BL
12 Operation instructions TCM 3000 BL, REF 31739, V33/19
9.4 Malfunction and troubleshooting
Malfunction Cause Solution Refer to the
operation instruction
Device is not operational
(Display is not active)
Control unit is not switched
on.
Set the power switch I/O
to „ I “
7.1 Switching the TCM 3000 BL on
or off
Control unit is not connected
to the power supply.
Connect the control unit with
the power supply.
6.2 Connection to the power
supply
Incorrect operating voltage Check for correct operating
voltage
6.2 Connection to the power sup-
ply
Faulty fuse Replace the fuse 9.2 Replacing the control unit fuse
Motor is not running Motor is not activated Press pedal to activate the
motor
7.3 Setting the handpiece in mo-
tion
Motor is not connected Connect motor cable with the
control unit
6.3.1 Connecting the motor cable
Handpiece is not correctly
attached
Firmly press handpiece
against the motor until it
engages.
7.4 Functional check
Pedal is not functioning
(Display is active)
Pedal is not or not correctly
connected
Connect pedal cable with the
pedal plug of the control unit.
6.3.2 Connecting the pedal cable
If a fault cannot be rectified, please contact your supplier or an authorized service center.
The addresses are provided on the last page of the operating instructions.

TCM 3000 BL
Operation instructions TCM 3000 BL, REF 31739, V33/19 13
EN
10 Spare parts and accessories
Spare parts REF
Electronic motor 21, up to 40.000 rpm, motor cable 3 m, including operation manual --------------------------------2112nou
VARIO pedal, IPX8, connection cable 3 m---------------------------------------------------------------------------------------- 1507nou
Accessories REF
Dermatome 25 with ISO 3964 coupling, 25 mm cutting width, 1.00 mm max. cutting depth, 14.000 rpm------- 1992nou
Dermatome 50 with ISO 3964 coupling, 50 mm cutting width, 1.00 mm max. cutting depth, 14.000 rpm -------1991nou
Dermatome 75 with ISO 3964 coupling, 75 mm cutting width, 1.00 mm max. cutting depth, 14.000 rpm ------- 1990nou
Dermatome 100 with ISO 3964 coupling, 100 mm cutting width, 1.00 mm max. cutting depth, 14.000 rpm --- 1983nou
Dermatome spare blades, 25 mm cutting width ----------------------------------------------------------------------------------- 1997
Dermatome spare blades, 50 mm cutting width ---------------------------------------------------------------------------------- 1996
Dermatome spare blades, 75 mm cutting width ----------------------------------------------------------------------------------- 1995
Dermatome spare blades, 100 mm cutting width ----------------------------------------------------------------------------------1919
Dermatome reduction base plate for Dermatome 100 to 75 mm --------------------------------------------------------------19872
Dermatome reduction base plate for Dermatome 100 to 50 mm -------------------------------------------------------------- 19871
Dermatome reduction base plate for Dermatome 100 to 25 mm---------------------------------------------------------------19869
Dermatome reduction base plate for Dermatome 75 to 50 mm ----------------------------------------------------------------19887
Dermatome reduction base plate for Dermatome 75 to 25 mm-----------------------------------------------------------------19886
1 : 1 handpiece with ISO 3964 coupling, attachable cooling nozzle, quick release clamping,
for instruments with 44 mm length and Ø 2.35 mm, up to 50.000 rpm----------------------------------------------------1710nou
Micro Jig Saw, MSS 5000 with ISO 3964 coupling, attachable cooling nozzle,
clamping mechanism with knurled screw for blade clamping, 15.000 rpm---------------------------------------------- 5040nou
Micro Oscillating Saw, OMS 5000 with ISO 3964 coupling, attachable cooling nozzle,
clamping mechanism with knurled screw for blade clamping, 15.000 rpm---------------------------------------------- 5090nou
Sagittal Micro-Saw, MOS 5000 with ISO 3964 coupling, attachable cooling nozzle,
clamping mechanism with screw nut for blade clamping, 15.000 rpm -----------------------------------------------------5110nou
Tattoo handpiece with ISO 3964 coupling, cutting depth up to max. 2.0 mm, 12.000 rpm------------------------- 5020nou
To order additional parts, please contact our customer service department.
The user manual is not available in printed form with this product. The user manual as PDF is on the CD-ROM that
was included in the delivery. A CD-ROM drive and the Adobe Acrobat software is needed to read or print this user
manual. To order the user manual in printed form please check on the type plate for the address or the website.
If you send us the article number (31739 EN) with the language code and the note „Printed copy“, a printed manual
will be sent to you free of charge.

TCM 3000 BL
14 Operation instructions TCM 3000 BL, REF 31739, V33/19
10.1 Information on disposal
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. Prevailing national and local disposal regula-
tions apply.
When disposing of the device, device parts and accessories, the requirements specified in legislation must
be followed.
To ensure environmental protection, old devices can be returned to the dealer or manufacturer.
Motors that have reached the end of their service life must not be disposed of with household waste.
Motors must be sterilized before disposal. The national and local regulations for disposal of electronic waste
must be observed.
If they are not sterilized before disposal, please observe the national and local regulations for disposal of
infectious waste.