General Information; Indications; Principle; Contraindications - Nouvag TCM3000BL Instrucciones De Uso

1

General 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.
2 Instrucions for use for TCM 3000 BL - Morcellator, Ref. 31946, V26/16
TCM 3000 BL - Morcellator