THE O R COMPANY OB-01 Uterine ElevatOR PRO Occluder Balloon Instructions
- June 9, 2024
- THE O R COMPANY
Table of Contents
THE O R COMPANY OB-01 Uterine ElevatOR PRO Occluder Balloon
INDICATIONS FOR USE / CLINICAL BENEFITS
The Occluder Balloon is a sterile single-use device intended to be used with the Uterine ElevatOR PRO device to maintain pneumoperitoneum during laparoscopic procedures including total laparoscopic hysterectomy (TLH), laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion and diagnostic laparoscopy by sealing the vagina once colotomy is performed.
CONTRAINDICATIONS
This device is not intended for use except as indicated.
CAUTIONS / WARNINGS
All users must read and be familiar with all instructions, warnings,
contraindications and precautions in this package insert before using the
device.
- This device should be used only by surgeons trained in intrauterine surgery, laparoscopic surgery, diagnostic procedures, gynecological pelvic anatomy, and placement of intrauterine retracting instruments.
- Device designed for short term use but not for more than 24 hours.
- DO NOT reuse this device. This device is intended for single use only. The design of this device may not perform as intended by the manufacturer if it is reused. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device.
- Device is sterile if the package is dry, unopened and undamaged. DO NOT use if the pouch is damaged or the packaged seal is broken.
- The Occluder Balloon is designed to accommodate no more than 120 cc of inflation (saline).
INSTRUCTIONS FOR USE Positioning
- Slide the balloon over the handle of the Uterine ElevatOR PRO and position the balloon near the vaginal cup as shown in Figure 1.
- Test inflate the Occluder Balloon (Figure 1 and 2) with 20-60 cc of sterile saline prior to patient insertion in order to verify proper operation of the occluding balloon and then deflate prior to patient insertion.
- Prior to making colpotomy incisions, inflate the Occluder Balloon with sufficient sterile saline or water to cause the inflated balloon to make continuous radial contact with the vaginal wall. 90 cc to 120 cc of inflation will generally be sufficient.
Removal and Disposal
- Before disposing of the Occluder Balloon, visually inspect the device to check it is intact and all components have been retrieved.
- Upon completion of the procedure, the device should be discarded in biohazardous waste as per standard procedure.
Note: Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
Distributed exclusively in USA by: Symmetry Surgical, 3034 Owen Drive,
Antioch, TN 37013, USA
Email:
customerservice@symmetrysurgical.com,
Telephone: USA & CANADA +1
800-251-3000 (Monday-Friday, 7:00AM –
5:30PM CST)
The O R Company Pty Ltd, 4/47 Wangara Road, Cheltenham, VIC, 3192, Australia.www.theorcompany.com
Issue date: 05/04/2022
PM_OB-01_101_V1