Nouvag TCM 3000 BL Morcellator Instructions For Use Manual

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Instructions for use

TCM 3000 BL Morcellator

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Page 1 Instructions for use TCM 3000 BL Morcellator...
Page 2 INSTRUCTIONS FOR USE CONGRATULATIONS ON YOUR PURCHASE OF A PRODUCT FROM NOUVAG. We are pleased that you have chosen a quality product from NOUVAG and thank you very much for the trust you have placed in us. These instructions for use will familiarize you with the device and its functions so that you can apply and use them correctly.
Page 3: Table Of Contents
Replacing the control unit fuse Safety inspections MALFUNCTION AND TROUBLESHOOTING Fault messages on the display ACCESSORIES AND SPARE PARTS Information on disposal TECHNICAL DATA WARRANTY COVERAGE Post market surveillance Service points APPENDIX © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 4: General Information
¬ Candidates for en bloc tissue removal, for example through the vagina or via a Mini-laparotomy incision. Cases described in the literature, must be observed. TARGET GROUP Women from age 18. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 5: Medical Application
¬ The shipping package must contain all parts listed in chapter [ Scope of delivery, accessories and spare parts > 6 ] ¬ If parts are damaged or missing, contact NOUVAG. Immediate control of the drive set « TCM 3000 BL Morcellator » (REF 3287):...
Page 6: Scope Of Delivery, Accessories And Spare Parts
Trocar sleeve Ø 12 mm 5142nou Trocar sleeve Ø 15 mm 5177nou Gasket for trocar flap Ø 12/15 mm, PU 10 pcs. 5180nou O-ring for trocar sleeve Ø 12/15 mm, PU 10 pcs. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 7 Drill for myoms Ø 10 mm, Length 330 mm 5141nou Trocar sleeve Ø 12 mm In line with regulations pertaining to hazardous materials, the lubricant spray is not delivered with the control unit but can be ordered separately. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 8: Safety Information
The use of third-party products is the responsibility of the operator. Functionality and patient safety cannot be guaranteed with third-party accessories. Repairs may only be performed by authorized NOUVAG service technicians The products described in this manual must be used by trained and qualified medical personnel only in accordance with the requirements and with reference to the manual.
Page 9: During Use
Keep hands clear of the cutting tubes when operating the device. Danger of serious injury. The TCM 3000 BL Morcellator must be operated under the continuous supervision of medically qualified persons only. Make sure that the operating voltage matches the mains voltage. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 10: Device Overview
Thread for seal holder Motor cap Cutting tube holder Motor Sealing unit with membrane Handpiece holder screw Motor connection plug Thread for membrane screw Membrane screw Sealing unit thread Motor connection coupling © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 11 Stopper pins TROCAR SLEEVE Protective tube Seal cap holder Valve actuation Valve body Main body FORCEPS (OPTIONAL) Jaw insert Jaw of forceps Tube shaft Fixed leg Flexible leg Stopper Spring component © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 12: System-Chart Tcm 3000 Bl Morcellator
OPTION 2 Obturator Transmission unit Sealing unit Trocar sleeve Cutting tube Cutting tube Control unit Pedal Handle Elektronic motor Pedal Motor plug plug OPTION 3 Myoma drill Trocar sleeve Grasping forceps © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 13: Before Use
The morcellator must be assembled under sterile conditions (wear gloves and a mask, place morcellator and accessories on a sterile surface). Aseptic regulations must be observed. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 14: Assembling The Morcellator Kit With The Protective Tube (Option 1)
The guide pin of the protec- tive tube must be in the distal slot of the gear unit. Lock the protective tube in position with a click. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 15 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. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 16 Risk of injury by motor failure! Problem: the motor is heating up. Cause: the motor was damaged during preparation. Remedy: do not continue to use the motor. Always have a spare motor available! © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 17: Assembling The Morcellator Kit With The Trocar Sleeve (Option 2)
Attaching the cutting tube to the gear unit Hold the cutting tube with one hand. With the other hand screw the sealing unit onto the gear unit. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 18 Screw the membrane positioning ring (6) into the thread of the seal holder (3) until it stops. Then screw the entire sealing unit onto the gear unit. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 19 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. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 20: Assembling The Forceps (Option 3)
Forceps are available in various designs. The pair shown here is not supplied with the morcellator kit; it is an optional accessory. The forceps come with a detailed assembly and preparation guide. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 21: Connection To The Power Supply
Switch off the power switch on the rear of the device (Position «O»). Plug the supplied power cable into the socket on the back of the device. Plug the other end of the power cord into the power outlet. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 22: Use
Precaution when changing parameters. Unusual behavior of the instruments while operating may provoke false reactions and jeopardize the patient. Each setting must be checked and the new behavior of the instrument must be familiarized with. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 23 The values shown on the display are speed ranges that can be called up using the pedal. In operation the display does not show any current speed values. The values described can deviate from the actual values by a maximum of ± 10 %. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 24: Procedure
Use the morcellator only for the morcellation of tissue that has been fully prepared and is clearly visible. NOUVAG accepts no liability for any other applications. NOUVAG also recommends the use of a second gripper or a similar retaining device to prevent uncontrolled movement of large morcellator pieces of tissue. This will require an additional percutaneous access.
Page 25 If the jaws of the gripper is not completely closed when it is pulled out of the protective tube, the blade will be damaged (see pictures). Damaged blades and cutting tubes must not be used! Cutting tubes must not be resharpened! © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 26 Make sure that the proximal opening of the seal- ing unit is closed immediately with your thumb when there is no instrument in the morcellator to prevent large quantities of gas from escaping. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 27 Rotate the trocar sleeve so the «CUT» position is Endoscope visible from above. When the cutting tube is completely inserted, the cutting edge is now only partially covered by the trocar sleeve. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 29 Carefully pull the forceps fully out of the gear unit and out of the patient. The retracted jaws must not touch the blade of the cutting tube. Removing additional tissue If necessary, re-insert the myoma drill and repeat the above process. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 30: After Use
Disconnect the connection plugs of the pedal and the motor from the control unit. Before preparation at the location of use Take the product to the preparation area immediately. Prepare the product as specified in this instructions for use. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 31 Unscrew the valve body from the main body. Remove the red O ring from the valve body. DISASSEMBLING THE MOTOR Disassemble the motor before decontamination. Unscrew handpiece holder from motor. Unscrew motor cap from the motor. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 33: Instrument Preparation
Perform cleaning, disinfection and sterilization after every treatment. To autoclave single items, such as cutting tubes, NOUVAG recommends the use of sterilization packages to prevent of damage. Make sure that the sterilization packaging is not more than 80 % filled.
Page 34 10. Under no circumstances should the products be cleaned in an ultrasonic bath! This leads to the impairment of functionality. 11. NOUVAG recommends using a sieve basket with a rinsing bar from 3mach (REF 51401), a reusable container for convenient preparation and storage (including transport) of the products. The sieve basket can be used for safe storage of the products both during the washing process and during and after sterilization until the products are used.
Page 35 4. Rinse dismantled products and their attachments from the outside for 10 seconds with a water pressure gun with a minimum pressure of 2.0 bar. Carry out mechanical cleaning with deionized water. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 36 3 seconds. Cover the pressure compensation opening with a cloth as shown in the picture and collect any oil introduced under pressure. 3. Wipe the transmission unit with a damp cloth. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 37 The forceps shown in the illustration are not included in the “Morcellator kit” , but can be ordered as an optional extra. The detailed preparation instructions are included with the instructions for use supplied with the forceps. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 38: Maintenance
Spray adapter (REF 19584) for the lubrication of the electronic motor 21 with lubricant spray (REF 2127). FLUSHING ADAPTER LUER-LOCK ¬ Replace missing adapter by a new one. Flushing adapter Luer-Lock (REF 19586) for pre- and machine cleaning of the gear unit (REF 5163nou). (REF 19586) (REF 19584) © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 39: Replacing The Control Unit Fuse
Results shall be documented. The service instructions, circuit diagrams and descriptions are avail- able on request from the manufacturer. NOUVAG offers a safety inspection service for its customers. Addresses can be found in the appendix of this instructions for use under .
Page 40: Malfunction And Troubleshooting
Pedal was pressed while switching the The pedal must be released for a short device on. period. If a fault cannot be rectified, please contact your supplier or an authorized service center. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 41: Accessories And Spare Parts
When disposing of the device, device components and accessories, the requirements specified in legislation must be followed. To ensure environmental protection, old devices can be returned to the dealer or manufac- turer. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 42: Technical Data
120 x 180 x 110 mm Net weight of control unit 1,8 kg * Applied part is the morcellator. ** Maximum torque is delivered in the speed range between 200 – 400 rpm. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 43: Warranty Coverage
6 months, wear parts are excluded from the warranty. During this warranty period, NOUVAG agrees to either repair or replace the product at its option if the product fails to function properly under normal use and service and such failure is due solely to a defect in workmanship or materials.
Page 44: Appendix
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 Product should b observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Product. over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 46 At 80 MHz and 800 MHz, the separation distance fort the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. © NOUVAG AG • 31946 • V20231201 • All rights reserved...
Page 48 NOUVAG AG NOUVAG GmbH St. Gallerstrasse 25 Schulthaissstrasse 15 9403 Goldach 78462 Konstanz Switzerland Germany Phone +41 71 846 66 00 Phone +49 7531 1290 - 0 info@nouvag.com info-de@nouvag.com www.nouvag.com www.nouvag.com © NOUVAG AG • 31946 • V20231201 • All rights reserved...

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