Nouvag TCM 3000 BL User manual

Morcellator
©NOUVAG AG • 31946 • V20220912 • All rights reserved.
TCM 3000 BL Morcellator
Instructions for use
EN

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DE
FR
IT
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PL
SK
CZ
Vorwort
Herzlichen Glückwunsch zum Kauf eines Produktes der Firma NOUVAG AG. Wir freuen uns, dass Sie sich für ein
NOUVAG Erzeugnis entschieden haben und danken Ihnen für Ihr entgegengebrachtes Vertrauen.
Diese Bedienungsanleitung wird Sie mit dem Gerät und seinen Eigenschaften vertraut machen, damit eine möglichst
lange und problemlose Funktion gewährleistet werden kann.
Im Anhang finden Sie die Konformitätserklärung und unsere autorisierten Servicestellen.
●• Bitte lesen Sie diese Anleitung vor Inbetriebnahme aufmerksam durch!
Foreword
Congratulations on your purchase of a NOUVAG AG product. Thank you for the confidence shown in our products.
Please consult the instruction manual for the use and maintenance of the device in order to ensure that it will
function properly and efficiently for many years.
You will find the conformity statement and list of authorized service representatives attached.
●• Please read instructions carefully before operating!
Préface
Félicitations vous venez d’acheter un produit NOUVAG AG. Merci de la confiance que vous montrez en nos
produits.
Merci de consulter le mode d’emploi pour l’utilisation et l’entretien de cet appareil de manière à vous assurer qu’il
fonctionnera correctement et efficacement pendant de nombreuses années.
Vous trouverez ci-joint les déclarations de conformité et la liste des agents agréés pour l’entretien.
●• Lire soigneusement les instructions avant utilisation!
Prefazione
Ci congratuliamo con Lei per l’acquisto di un prodotto NOUVAG AG e le auguriamo un susseguirsi di successi
professionali.
Questo manuale l’aiuterà a conoscere meglio l’apparecchiatura e le sue caratteristiche. Contiene indicazioni utili che
le assicureranno un funzionamento efficiente ed una lunga durata.
Qui allegato troverete la dichiarazione di conformità e la lista dei rivenditori autorizzati.
●• Prego leggere attentamente le istruzioni per l’uso prima di mettere in funzionamento!
Preposición
Muchas gracias por la compra de un producto NOUVAG AG.
Felicidades por la elección y la confianza depositada en nuestros productos.
Para garantizar una función duradera y eficiente del aparato, por favor consultar el manual de instrucciones.
El Certificado de Conformidad y la lista de Centros de Servicio se encuentran en el apéndice.
●• Por favor leer las instrucciones detenidamente antes de poner en marcha el aparato!
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 1
EN
Table of contents
1General information 2
1.1 Indications 2
1.2 Principle 2
1.3 Contraindications 2
1.4 Medical application 3
1.5 On receipt 3
1.6 Scope of delivery, accessories and spare parts 4
1.7 TCM 3000 BL Morcellator technical data 4
1.8 Ambient conditions 5
1.9 Warranty coverage 5
1.10 Right to make technical changes reserved 5
2Explanation of symbols 5
3Safety information 6
3.1 EMC Manufacturer’s Declaration of Conformity 6
3.2 Modification and misuse 6
3.3 Essential requirements 6
3.4 During use 7
4Device overview 8
4.1 TCM 3000 BL Morcellator system chart 10
5Before use 11
5.1 Connection to the power supply 11
5.2 Device preparation 11
5.2.1 Assembly of the morcellator set with protective tube (option 1) 12
5.2.2 Assembly of the morcellator set with trocar cannula (option 2) 15
5.2.3 Mounting gripper (as per option 3) 18
5.3 Mains connection 18
6Use 19
6.1 Using the control unit 19
6.2 Operation 21
6.2.1 Option 1: morcellation with protective tube 23
6.2.2 Option 2: morcellation with trocar cannula 24
6.2.3 Option 3: myomectomy 26
6.3 After use 27
6.4 Disassembling trocar cannula 28
6.5 Disassembly of motor 29
6.6 Disassembly of gear unit and morcellator with protective tube 29
7Instrument preparation 30
7.1 Control unit and pedal 30
7.2 Preparation of the trocar cannula 31
7.3 Preparation of motor 32
7.4 Preparation of gear unit 34
7.5 Preparation of cutting tubes, protective tubes, Obturators, seals, seal unit and myoma drill 35
8Maintenance and repair 37
8.1 General maintenance 37
8.2 Replacing the control unit fuse 38
8.3 Safety inspections 38
8.4 Malfunction and troubleshooting 39
8.5 Spare parts list with order numbers 40
8.6 Information on disposal 40
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
2 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
1General information
1.1 Indications
Morcellator set for morcellation and extraction of tissue and for removing myomas or the uterus during
laparoscopic procedures in gynecology.
1.2 Principle
The TCM 3000 BL - Morcellator is a control unit for the Nouvag Morcellator for use in morcellation and ex-
traction of tissue as well as for myoma removal at laparoscopic interventions. A rotating cylindrical tube
with a blade at the distal end is inserted through an abdominal cavity that has been enlarged by an Insuf-
flator. The tissue that is to be removed is guided to the cutting tube by a gripper, cut off and removed
through the tube.
This manual describes three different options for removing tissue by a laparoscopic procedure.
Option 1: Tissue removal by morcellation with protective tube
Instruments (gripper) are inserted through a protective tube sealed by a valve system. The valve can be cov-
ered by a thumb for removing the gripper from the sealed protective tube to prevent gas loss.
Option 2: Tissue removal by morcellation with Trocar Cannula
Instruments (cutter tube, gripper) are inserted through the Trocar Cannula. The Trocar Cannula contains a
valve that prevents gas loss when withdrawing the instruments.
Option 3: Tissue removal (myomectomy) with myoma drill through the Trocar Cannula
The myoma drill is inserted through the Morcellator (protective tube or Trocar Cannula). The Trocar Cannu-
la and the protective tube can be used with or without a cutting tube. No gas loss after removal of instru-
ments with the Trocar Cannula, minimum gas loss during removal from the protective tube, sealing unit can
be sealed with the thumb.
1.3 Contraindications
Relative or absolute contraindications may result from the general medical findings or in special cases in
which the patient’s risk for motor-driven tools is significantly increased. Ovaries, fallopian tubes, myomata
and other structures must be devascularized and dissected before morcellation.
The laparoscopic deployment of morcellators is contraindicated at:
• Treatment of malignant tumors
• Treatment of vascularized tissue
• Preparation of tissue
• In gynecologic surgery in which tissue to be morcellated is known or suspected to contain malignacy
• For removal of uterine tissue containing fibroids in patients who are…
• Peri or postmenopausal, or
• Candidates for en bloc tissue removal, for example through the vagina or via a mini-laparotomy inci-
sion
Cases described in the literature, must be observed.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 3
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1
8
9
10
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2
11
12
13
6
1.4 Medical application
This product is designed solely for use in medical facilities by medically qualified persons.
1.5 On receipt
• The shipping package must contain all parts listed in 1.6 Scope of delivery.
• If any parts are damaged or missing, contact the Nouvag agent from which the device was ordered or
Nouvag AG.
Immediate inspection of the TCM 3000 BL - Morcellator motor system set (Ref. 3287):
1. Control unit (3281)
2. Power cable, country-specific
3. Gear unit (5163nou)
4. Seal unit (5136nou)
5. 10 roof shaped seals (5167nou)
6. 10 membrane seals for all cutting tube diameters
(5166nou)
7. Electronic motor 21 (2090nou)
8. 2 fuses (21606)
9. Vario pedal (1507nou)
10. Adapter for Nou-Clean spray for cleaning gear unit (1928)
11. Adapter for Nou-Clean spray for cleaning electronic
motor 21 (1974)
12. Handle (5183nou)
13. Operation manual on CD-ROM (31946)
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
4 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
1.6 Scope of delivery, accessories and spare parts
Ref. Description Quantity
3287 TCM 3000 BL - Morcellator set comprises the following products ----------------------------------------- 1 unit
3281 TCM 3000 BL Morcellator control unit, device connecting cable 3 m, country specific ------------------ 1 unit
1507nou Vario pedal; IPX8; connecting cable 3 m ------------------------------------------------------------------------------ 1 unit
2090nou Electric motor 21, 3 m motor cable -------------------------------------------------------------------------------------- 1 unit
5163nou Morcellator gear unit ------------------------------------------------------------------------------------------------------- 1 unit
5183nou Handle, complete ----------------------------------------------------------------------------------------------------------- 1 unit
31946 Manual on CD-ROM -------------------------------------------------------------------------------------------------------- 1 unit
1974 Adapter for Nou-Clean spray for cleaning electronic motor 21 ------------------------------------------------- 1 unit
1928 Adapter for Nou-Clean spray for cleaning gear unit --------------------------------------------------------------- 1 unit
Accessories and spare parts for option 1:
5137nou Protective tube, Ø 12 mm ------------------------------------------------------------------------------------------------- 1 unit
5138nou Protective tube, Ø 15 mm ------------------------------------------------------------------------------------------------- 1 unit
5139nou Protective tube, Ø 20 mm ------------------------------------------------------------------------------------------------- 1 unit
5151nou Obturator, Ø 12 mm -------------------------------------------------------------------------------------------------------- 1 unit
5152nou Obturator, Ø 15 mm -------------------------------------------------------------------------------------------------------- 1 unit
5153nou Obturator, Ø 20 mm -------------------------------------------------------------------------------------------------------- 1 unit
5154nou Cutting tube, Ø 12 mm ----------------------------------------------------------------------------------------------------- 1 unit
5155nou Cutting tube, Ø 15 mm ----------------------------------------------------------------------------------------------------- 1 unit
5156nou Cutting tube, Ø 20 mm ---------------------------------------------------------------------------------------------------- 1 unit
5136nou Spare seal unit --------------------------------------------------------------------------------------------------------------- 1 unit
5167nou Roof shaped seal for all cutting tube diameters ----------------------------------------------------------------- 10 units
5166nou Membrane seal for all cutting tube diameters -------------------------------------------------------------------- 10 units
Accessories and spare parts for option 2:
5141nou Trocar Cannula for Ø 12 mm instruments ----------------------------------------------------------------------------- 1 unit
5142nou Trocar Cannula for Ø 15 mm instruments ----------------------------------------------------------------------------- 1 unit
5177nou Seals for Trocar Cannula for Ø 12 mm and 15 mm instruments ----------------------------------------------- 10 units
5180nou O-ring for Ø 12 mm and 15 mm Trocar Cannula ------------------------------------------------------------------- 10 units
Accessories and spare parts for option 3:
5193 Myoma drill Ø 10 mm ------------------------------------------------------------------------------------------------------ 1 unit
In line with regulations pertaining to hazardous materials, the item Nou-Clean care spray
(Ref. 1984) is not delivered with the control unit but can be ordered separately from any official
Nouvag service centre. www.nouvag.com
1.7 TCM 3000 BL - Morcellator technical data
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
Maximum motor speed ------------------------------------------------------------------------------------------------ 40,000 rpm
Maximum torque, motor ----------------------------------------------------------------------------------------------------- 6 Ncm
Maximum torque at transmission outlet ---------------------------------------------------------------------------- 80 Ncm**
Motor coupling ----------------------------------------------------------------------------------------- INTRA coupling ISO3964
Motor cable length ----------------------------------------------------------------------------------------------------------------- 3 m
Pedal cable length ------------------------------------------------------------------------------------------------------------------ 3 m
Morcellator speed ---------------------------------------------------------------------------------------------------- 50 – 1000 rpm
Protection class ----------------------------------------------------------------------------------------------------------------- class II
Applied part type ------------------------------------------------------------------------------------------------------------- Typ BF *
Pedal ---------------------------------------------------------------------------------------------------------------------------------- IPX8
Dimensions (W x D x H) -------------------------------------------------------------------------------------- 120 x 180 x 107 mm
Net weight control unit -------------------------------------------------------------------------------------------------------- 1.8 kg
* Applied part is the Morcellator
** Maximum torque is delivered at the speed range of 200 - 400 rpm
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 5
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1.8 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
1.9 Warranty coverage
Purchasing the TCM 3000 BL - Morcellator 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 months. Improper use or repair, or failure to observe these instructions, will relieve us from any obligation
arising from warranty provisions or other claims.
1.10 Right to make technical changes reserved
Illustrations, dimensions and weights and technical data may vary slightly as a result of continuing devel-
opment. We reserve the right to make changes and we are not responsible for printing errors.
2Explanation of symbols
Important information Autoclavable at 135°C
Warning Suitable for thermal disinfection
Manufacturer Protection against continuous submersion in
water.
Applied part of type BF is the Morcellator Protection class II
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. Local disposal
regulations apply.
CE mark with Notified Body Symbol indicating the order number
Intermittent operation, 1 min on, 1 min of
f
for 8 cycles
Symbol indicating the serial number with the
date of manufacture (year/month)
Observe the instructions for use Motor
Pedal Biohazard
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TCM 3000 BL - Morcellator
6 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
3Safety 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 - Morcellator different to the product description defined in chapter “Intend-
ed use and operation”, causes risks for patients and trained personnel. If physical examinations and thera-
pies are carried out without use of the devices then the devices must be removed from the place of treat-
ment. 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 envi-
ronmental factors in the close area of the TCM 3000 BL - Morcellator may cause unexpected or adverse op-
eration. Use only accessories and cables as specified in the product description. Further observe the EMC
manufacturers declaration of conformity.
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.
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 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 author-
ized NOUVAG service technicians.
Use Nou-Clean spray to care for the motor and gear
unit. Using other care products can result in mal-
functions and/or cause the warranty to be revoked.
Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fi-
broid surgery may spread cancer, and decrease the long-term survival of patients. This information should
be shared with patients when considering surgery with the use of these devices.
• Modification or manipulation of the TCM 3000 BL - Morcellator 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 - Morcellator outside the indications described in Section 1.1 is prohibited.
The user or operator is solely responsible for any such use.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 7
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3.4 During use
The device is not sterile on delivery. All
sterilizable parts must be sterilized before
use (see Chapter 7 Instrument prepara-
tion).
Never operate the clamping mechanisms of the cut-
ting tubes while the system is running. This could
result in instrument damage.
Operate the device only outside the dan-
ger zone of explosive, flammable mixtures
or gases.
Keep hands clear of the cutting tubes when operat-
ing the device. Danger of serious injury.
The motor ventilation slots must be kept
clear in order to prevent the motor from
overheating.
The TCM 3000 BL - Morcellator must be operated
under the continuous supervision of medically quali-
fied persons only.
Ensure that the operating voltage setting
corresponds to the local mains voltage.
Disregarding the guidelines on intermittent opera-
tion (1 min on, 1 min off for 8 cycles) may cause burns
at contact with the gear unit.
The risks and benefits of using tissue
extraction bags to capture tissue released
during laparoscopic power morcellation
procedures remain to be determined.
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TCM 3000 BL - Morcellator
8 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
 
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4Device overview
Front view Control panel Rear view
Gear unit Handle Motor
1. Display
2. Motor LED
3. Pedal connection
4. Motor connection
1. Vario button (variable speed range)
2. Low button (low speed range)
3. Medium button (medium speed range)
4. High button (high speed range)
5. Change rotational direction button
6. Up button (increase value)
7. Down button (reduce value)
1. Flange for protective tube connect
2. Thread for seal holder
3. Cutting tube holder
4. Seal unit with membrane screw
5. Thread for membrane screw
6. Membrane screw
7. Seal unit thread
8. Motor connection coupling
1. Release lever
2. Handle
1. Mains connection
2. Power switch
3. Fuse module
4. Window with national
voltage display
5. Type plate with type designation,
reference number, serial number, in-
formation on power supply and device
fuse
6. Potential equalization
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
1. Device connection plug
2. Motor cable
3. Motor cap
4. Motor
5. Handpiece holder
6. Motor connection plug
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
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


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Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 9
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Protective tube with Obturator
Cutting tube
Trocar Cannula
Gripper
1. Protective tube
2. Lock nut
3. Nose for tissue positioning
1. Protective tube
2. Seal cap holder
3. Valve actuator
4. Valve body
5. Main body
6.
Nose
for tissue positioning


1. Cutting edge
2. Locking pins





6





1. Mouth insert
2. Gripper mouth
3. Cannula shaft
4. Fixed section
5. Flexible leg
6. Locking device
7. Spring component
1. Mauleinsatz
2. Zangenmaul
} Handle
 
4. Obturator

Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
10 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
Option 3
Trocar Sleeve
Myoma drill
Gripper
Gear unit
Handle
Motor
Trocar Sleeve Cutting tube Seal unit
Obturator
Option 2
Control unit
Motor
plug
Pedal
plug
Pedal
to pedal
to motor
Protection Sleeve Gear unit
Handle
Motor
Cutting tube
Seal unit
Option 1
Obturator
4.1 TCM 3000 BL - Morcellator system chart
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 11
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5Before use
The TCM 3000 BL - Morcellator and all required accessories and instruments must be placed on a level non-
slip surface. Do not allow the operating range of the device with cable to be restricted by limiting factors.
The display, keypad and indicator lights must be fully visible at all times.
It is very important to ensure that no objects can fall on the pedal.
The power plug at the rear of the device must be accessible at all times.
5.1 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.
5.2 Device preparation
The device is not sterile on delivery. All sterilizable parts must be sterilized before use (see Chapter 7 In-
strument preparation).
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 Morcellator (as per option 1 to option 3) must be assembled under sterile conditions (wear gloves and
a mask, place Morcellator and accessories on a sterile surface).
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
12 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
5.2.1 Assembly of the Morcellator set with protective tube (option 1)
There is a risk of injury to tissue by the sharp edge at the distal end of the cutting tube.
• Handle the cutting tube carefully.
• If the cutting tube is not used, rotate the protective tube to the NO CUT position.
• If the cutting tube is not used, it must be placed on a flat, sterile surface so it cannot fall and cause
injury
• Check the cutting tube.
• Make sure that the cutting edge of the blade is sharp and undamaged (e.g. no cracks, deformation or
burrs).
• Use only cutting tubes in perfect condition.
1. Inserting the cutting tube through the gear unit
Remove the seal unit from the gear unit.
Insert the cutting tube through the gear unit. The two
guide pins on the cutting tube must fit into the slot on
the flange of the gear unit.
2. Fixing the cutting tube to the gear unit
Hold the cutting tube with one hand.
Connect the sealing unit to the gear unit with the bay-
onet closure with the other hand.
3. Mounting protective tube
Select a suitable protective tube.
Push the protective tube over the distal end of the
cutting tube. The guide pin of the protective tube must
be in the distal slot of the gear unit.
Lock the protective tube in position with a click.
4. Protecting the cutting tube
The distal end of the cutting tube is very sharp.
To prevent injury, the cutting tube must be covered at
all times when it is not in use.
To cover the cutting tube, rotate the protective tube
until the words “NO CUT” are visible in the distal slot
of the gear unit.
The cutting tube is completely covered by the protec-
tive tube.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 13
EN
5. Replacing seals
Remove the seal unit from the gear unit by rotating it
slightly.
Unscrew the membrane screw from the seal unit.
Check seals before use. Do not use damaged seals (frayed, discolored, yellowed, porous, non-elastic).
Position the edge of the roof shaped seal (1) to point to
the inside stop (2) of the seal holder (3) and press the
roof shaped seal in.
Position the edge of the membrane seal (4) to point to
the slot (5) of the membrane screw (6) and press the
membrane seal into the slot.
Screw the membrane screw (6) into the thread of the
seal holder (3) to the stop and connect the seal unit to
the gear unit.
6. Inserting Obturator
Insert the Obturator through the seal unit, gear unit
and protective tube to the stop.
7. Attaching handle
Lift and hold the release lever (1) of the handle (2).
Push the handle (2) over the motor connection of the
gear unit.
Release the handle release lever. The handle release
lever must lock in position.
Do not open the handle release lever to remove the handle during the procedure.
8. Connecting motor
Insert the motor coupling into the bottom end of the
handle.
Continue to insert the motor until it locks into the gear
unit’s motor connection.
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.
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9. Connecting pedal
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.
Functional check
• Check Morcellator for loose parts
• Check that Morcellator is correctly assembled
• Are all labels easily readable?
• Check cutting tube: cutting tube evenly ground, no broken edges or bends?
• Switch on control unit
• Switch on motor (press pedal).
• Run motor with Morcellator for about 20 seconds; it must reach the set speed.
• If it does not run evenly, switch off motor with Morcellator.
• Switch off control unit.
The control unit will only operate if the pedal has been connected to the control unit.
• Check that Morcellator is correctly assembled.
• Check that the gear unit runs smoothly; if necessary treat it with Nou-Clean care spray.
• Check that the motor is clean and runs smoothly; if necessary clean it and treat with Nou-Clean care spray.
• Repeat the function check.
Risk of injury by motor failure
Problem: the motor becomes very hot. Cause: the motor was damaged during preparation.
Remedy: do not continue to use the motor. Always have a spare motor available.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

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Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 15
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5.2.2 Assembly of the Morcellator set with Trocar Cannula (option 2)
Using the Trocar Cannula
The Trocar Cannula is used instead of the protective tube. The integrated valve flap prevents the escape
of gas when instruments are moved in and out.
The nose of the Trocar Cannula partially extends beyond the cutter tube to protect organs in the ab-
dominal cavity from the sharp blade. This requires the Morcellator to be rotated under visual supervision
(endoscopy) so the nose of the Trocar Cannula covers the cutter tube blade to protect the organ.
1. Visual check
• Check the product for sealing, corrosion and sterility.
• Ensure that it is free from rust, dents and scratches.
• The distal end of the Obturator must not be damaged.
• The sealing flap and the seal must not be damaged.
Risk of injury
Select blade. Make sure that the cutting edge of the blade is sharp and undamaged (e.g. no cracks or
burrs).
2. Insert the cutting tube through the gear unit
Remove the seal unit from the gear unit.
Insert the cutting tube through the gear unit. The two guide
pins on the cutting tube must fit into the slot on the flange of
the gear unit.
3. Fixing the cutting tube to the gear unit
Hold the cutting tube with one hand.
With the other hand screw the seal unit onto the gear unit.
4. Mounting Trocar Cannula
Select a suitable Trocar Cannula. Open the Trocar Can-
nula valve by actuating the lever to prevent damage to
the cutting tube by pushing the Trocar too far.
Push the Trocar Cannula over the distal end of the cutting
tube. The guide pin of the Trocar Cannula must be in the dis-
tal slot of the gear unit.
Lock the Trocar Cannula in position with a click.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
16 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
5. Replacing seals
Remove the seal unit from the gear unit by rotating it
slightly.
Unscrew the membrane screw from the seal unit.
Select a suitable seal.
Keep a roof shaped seal and a membrane seal ready.
6. Position the edge of the roof shaped seal (1) to point to the
inside contact (2) of the seal holder (3) and press the roof
shaped seal in.
Position the edge of the membrane seal (4) to point to the
slot (5) of the membrane screw (6) and press the membrane
seal into the slot.
7. Screw the membrane screw (6) into the thread of the seal
holder (3) to the stop and connect the seal unit to the gear
unit.
8. Inserting Obturator
Insert the Obturator through the seal unit, gear unit and
Trocar Cannula.
9. Attaching handle
Lift and hold the release lever (1) of the handle (2).
Push the handle (2) over the motor connection of the
gear unit.
Release the handle release lever. The handle release lev-
er must lock in position.







Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 17
EN
10. Connecting motor
Insert the motor coupling into the bottom end of the
handle.
Continue to insert the motor coupling until it locks into
the gear unit motor connection.
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 po-
sition.
11. Connecting pedal
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.
Functional check
• Check Morcellator for loose parts
• Check that Morcellator is correctly assembled
• Are all labels easily readable?
• Check cutting tube: cutting tube evenly ground, no broken edges or bends?
• Switch on control unit
• Switch on motor (press pedal).
• Run motor with Morcellator for about 20 seconds; it must reach the set speed.
• If it does not run evenly, switch off motor with Morcellator.
• Switch off control unit.
The control unit will only operate if the pedal has been connected to the control unit.
• Check that Morcellator is correctly assembled.
• Check that the gear unit runs smoothly; if necessary treat it with Nou-Clean care spray.
• Check that the motor is clean and runs smoothly; if necessary clean it and treat with Nou-Clean care
spray.
• Repeat the function check.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912

TCM 3000 BL - Morcellator
18 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
5.2.3 Mounting gripper (as per option 3)
5.3 Mains connection
Risk of electric shock
Connect the device to an earthed AC mains system that conforms to IEC guidelines only. Connect the
device to a power supply that corresponds to the connection values on the type plate on the back of the
device.
Risk of damage
Do not switch on the control unit and the other equipment until all cables have been connected.
Otherwise the equipment may be damaged.
The device is not water-proof.
Keep the device away from liquids. Keep the mains connection socket dry. Do not use the device if liquid
penetrates it.
Connecting the power cable
Switch off the power switch on the back of the device (“O” position).
Plug the included power cable into the socket on the back of the device.
Plug the other end of the power cable into the power socket.
Problem: the motor becomes very hot. Cause: the motor was damaged during preparation.
Remedy: do not continue to use the motor. Always have a spare motor available.
Grippers are available in various designs. The gripper shown here is not supplied with the Morcellator set;
it is an optional accessory. Detailed instructions for assembly and preparation are included with the grip-
per.
Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912