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Related Manuals for Nouvag TCM 3000 BL
Summary of Contents for Nouvag TCM 3000 BL
- Page 1 Instructions for use TCM 3000 BL Morcellator Morcellator...
- Page 2 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.
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Page 3: Table Of Contents
Replacing the control unit fuse Safety inspections Malfunction and troubleshooting Spare parts list with order numbers Information on disposal Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 4: General Information
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. -
Page 5: Medical Application
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. -
Page 6: Scope Of Delivery, Accessories And Spare Parts
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... -
Page 7: Ambient Conditions
800 hPa – 1060 hPa 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. -
Page 8: Safety Information
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. -
Page 9: During Use
The risks and benefits of using tissue extraction bags to capture tissue released during laparoscopic power morcellation procedures remain to be determined. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 10: Device Overview
5. Thread for membrane screw 6. Motor connection plug 6. Membrane screw 7. Seal unit thread 8. Motor connection coupling Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 11 2. Zangenmaul 3. Cannula shaft 4. Fixed section Handle 5. Flexible leg 6. Locking device 7. Spring component Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 12: Tcm 3000 Bl Morcellator System Chart
Gear unit Trocar Sleeve Cutting tube Seal unit Obturator Handle Motor Option 3 Myoma drill Trocar Sleeve Gripper Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 13: Before Use
Before 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. -
Page 14: Assembly Of The Morcellator Set With Protective Tube (Option 1)
“NO CUT” are visible in the distal slot of the gear unit. The cutting tube is completely covered by the protec- tive tube. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 15 Plug the motor device connection plug into the motor connection of the control unit. The plug must lock in position. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
- Page 16 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. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 17: Assembly Of The Morcellator Set With Trocar Cannula (Option 2)
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. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 18 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. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
- Page 19 Check that the motor is clean and runs smoothly; if necessary clean it and treat with Nou-Clean care spray. • Repeat the function check. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 20: Mounting Gripper (As Per Option 3)
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. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 21: Use
Make sure that the product has been correctly prepared and inspected. Risk of injury The TCM 3000 BL - Morcellator control unit has been designed for operation with the morcellation blades as a set. The user is solely responsible if different products are used with the set. Incompatibility may risk injury to patients. - Page 22 The display shows the mode and the correspond- ing speed range that can be selected with the pe- dal. The corresponding LED lights up. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 23: Operation
Nouvag AG accepts no liability for any other applications. • Nouvag also recommends the use of a second gripper or a similar retaining device to prevent uncon- trolled movement of large Morcellator pieces of tissue. This will require an additional percutaneous access. - Page 24 Risk of injury! Damaged blades and cutting tubes must not be used. Cutting tubes must not be sharpened. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 25: Option 1: Morcellation With Protective Tube
Morcellator to pre- vent large quantities of gas from escaping. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 26: Option 2: Morcellation With Trocar Cannula
If the cutting tube is completely inserted, the cut- ting edge is now only partially covered by the Trocar Cannula. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 27 The retracted mouth of the gripper must not touch the blade. Repeat the process until the morcellated tissue has been completely removed. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 28: Option 3: Myomectomy
6. Removing additional tissue If necessary, re-insert the myoma drill and repeat the above process. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 29: After Use
Take the product to the preparation area imme- diately. Prepare the product as specified in this manual Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 30: Disassembling Trocar Cannula
Unscrew the valve body from the main body. 4. Remove the red O-ring from the valve body. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 31: Disassembly Of Motor
It can now be pulled out of the proxi- mal opening of the gear unit. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 32: Instrument Preparation
• Do not clean Morcellator with compressed air. • Use only cleaning and care spray recommended by Nouvag AG – other care sprays may destroy the Morcellator. • At unpacked steam sterilization of single items it must be regarded that they have a stable seat in the tray to prevent them from rolling around, causing damage. -
Page 33: Preparation Of The Trocar Cannula
• Assembly the Trocar Cannula in reverse order of disassembly (see chapter 6.4 “Disassembling Trocar • Cannula”). Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 34: Preparation Of Motor
• Do not kink the motor cable, otherwise it may be broken. • Use Nouvag AG cleaning and care spray exclusively, other care sprays may destroy the motor. • Steam sterilize the micromotor in a sterilization bag and then allow to cool. - Page 35 If the sterilized electric motor is not used immediately after sterilization, the material packaging must be la- beled with the sterilization date. It is advisable to add a sterilization indicator. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912...
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Page 36: Preparation Of Gear Unit
(see instructions on spray can). Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 37: Preparation Of Cutting Tubes, Protective Tubes, Obturators, Seals, Seal Unit And Myoma Drill
When removing the products, check whether visible contamination still remains in the gaps and the • grooves. If necessary, repeat the cycle or clean manually. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 38 Preparation of gripper The gripper shown in the picture is not a component of the TCM 3000 BL – Morcellator set, but can be ordered as an optional extra. The instructions for preparation are included with the user manual supplied with the gripper.
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Page 39: Maintenance And Repair
Adapter for Nou-Clean spray for care of electric motor 21 (Ref. 1974) Adapter for Nou-Clean spray for care of gear unit (Ref. 1928) Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 40: Replacing The Control Unit Fuse
The STI (Safety technical inspection) for the TCM 3000 BL - Morcellator shall be executed every 2 years by authorized experts. Results shall be documented. -
Page 41: Malfunction And Troubleshooting
If a fault cannot be rectified, please contact your supplier or an authorized service centre. The addresses are provided on the last page of the operating instructions. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... -
Page 42: Spare Parts List With Order Numbers
If they are not sterilized before disposal, please observe the national and local regulations for disposal of in- fectious waste. Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16 Instructions for use TCM 3000 BL Morcellator • 31946 • V20220912... - Page 43 Anhang Appendix Appendice Appendice Apéndice...
- Page 44 Electromagnetic compatibility (EMC) Remark: The Product subsequently referred to herein always denotes the TCM 3000 BL Morcellator. Changes or modifications to this product not expressly approved by the manufacturer may result in increased emissions or decreased immunity performance of the product and could cause EMC issues with this or other equipment. This product is designed and tested to comply with applicable regulations regarding EMC and shall be installed and put into service according to the EMC information stated as follows.
- Page 45 Guidance and manufacturer’s declaration – electromagnetic immunity for not life support equipment The Product is intended for use in the electromagnetic environment specified below. The customer or the user of the Product should assure that it is used in such an environment. Immunity tests IEC 60601 Compliance level...
- Page 47 Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Phone +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com A complete list of Nouvag certified service centers are found on the Nouvag website at: www.nouvag.com/service Post market surveillance In the event of problems with the product or in the event of a serious incident, please immediately download, compile and send the following form https://nouvag.com/media/attachments/2022/05/19/for_8-308.pdf...
- Page 48 Nouvag AG • St.Gallerstrasse 25 • CH-9403 Goldach Tel. +41 71 846 66 00 info@nouvag.com • www.nouvag.com Nouvag GmbH • Schulthaissstrasse 15 • DE-78462 Konstanz Tel. +49 7531 1290 - 0 info-de@nouvag.com • www.nouvag.com...