Bowa ERGO 300, Инструкция по применению

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4 Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701
1 General information
1.1 Indications
Morcellator set for morcellation and extraction of tissue and for removing myomas or the uterus during laparoscopic pro-
cedures in gynecology.
1.2 Principle
The ERGO 300 - Morcellator is a control unit for the Nouvag Morcellator for use in morcellation and extraction 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 Insufflator. 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 covered 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 pre-
vents gas loss when withdrawing the instruments.
Option 3: Tissue removal (myomectomy) with myoma drill through the Trocar Cannula
Insertion of the myoma drill through the Trocar Cannula (Ø 12 mm) with separate access. Removal of tissue by the Morcel-
lator with grasping forceps according to option 1 or 2.
For a myomectomy only the Trocar Cannula (REF 5141nou) with a diameter of 12 mm may be used in connection with the
myoma drill.
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:
• for treatment of malignant tumors
• for treatment of vascularized tissue
• for 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 incision.
• Cases described in the literature, must be observed.
1.4 Target group
Younger women between 30 and 49 years of age. From the age of 50, the risk is increased, but an operation by morcellation
is still possible.