THE O R COMPANY UE-OBPRO-32 Uterine ElevatOR Pro with OccludOR Balloon Instruction Manual

THE O R COMPANY UE-OBPRO-32 Uterine ElevatOR Pro with OccludOR Balloon

INDICATIONS FOR USE / CLINICAL BENEFITS

The Uterine ElevatOR PRO with OccludOR Balloon™is indicated for manipulation of the uterus, and injection of fluids or gasses during laparoscopic procedures including total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy, laparoscopic tubal occlusion, and diagnostic laparoscopy. The Uterine ElevatOR PRO with OccludOR Balloon™ maintains pneumoperitoneum during laparoscopic procedures by sealing the vagina once colpotomy is performed. The device mobilises the uterus, enhancing visualisation of key structures and anatomical landmarks. In addition, its ability to articulate and mobilize the uterus and cervix facilitates the safer and more optimal use of other surgical devices.

CONTRAINDICATIONS

Device should not be used in:

• patients with a known or suspected pregnancy
• patients with known or suspected uterine or tubal infection
• patients with media allergy
• during assisted reproduction technology (ART) procedure related to in vitro fertilization
• patients with a short (<4cm) uterine depth
• patients with early stage cervical malignancy undergoing a laparoscopic approach
  This device is not intended for use as a Laser Backstop.

CAUTIONS

• The 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.
• Caution should be exercised in patients with cervical or uterine pathology.
• Prior to use, test the intrauterine balloon for proper inflation and function by inflating and deflating the intrauterine balloon with air
• Do not insert or remove the Uterine ElevatOR PRO with OccludOR Balloon™ with intrauterine balloon inflated.
• Lubricate the intrauterine balloon before insertion.
• Check for the need to dilate cervix before insertion of the Uterine ElevatOR PRO with OccludOR Balloon™. The cervical os should be at least 5mm (0.2in) in diameter to facilitate safe insertion and to reduce the risk of uterine perforation, injury to the cervix and/or intrauterine balloon rupture.
• When injecting any liquid media, closely follow the manufacturer’s directions for use accompanying the product.
• Use of the Uterine ElevatOR PRO with OccludOR Balloon™ in hysterosalpingography and Rubin’s Test should be completed under anesthesia.
• Caution must be used when using energy devices with this device. Any prolonged direct contact may damage devices.
• The OccludOR™ Balloon is designed to accommodate no more than 120 cc of inflation (saline).

WARNINGS: GENERAL

• All users must read and be familiar with all instructions, warnings, contraindications and precautions in this package insert before using this device.
• This device should be used only by surgeons trained in proper techniques for intrauterine surgery, laparoscopic surgery, diagnostic procedures, gynecological pelvic anatomy, and placement of intrauterine retracting instruments.
• As with all intrauterine devices, improper use of the Uterine ElevatOR PRO with OccludOR Balloon™ can result in uterine perforation and 3. Vaginal Cup 7. Inflation Valve with Balloon subsequent bleeding. The surgeon should examine the patient carefully for any indications of uterine perforation and subsequent bleeding and 4. take appropriate clinical steps.
• DO NOT use this device to manipulate when the intrauterine balloon is deflated.
• To avoid potential injury to the uterine wall or inadvertent expulsion of the device from the uterus during the procedure, DO NOT underinflate the intrauterine balloon. Inflation with 7-10cc of air is recommended to compensate for injected air trapped in the pilot balloon and inflation tube. DO NOT exceed 10cc of air.
• DO NOT use any liquids to inflate the intrauterine balloon. Use of fluid could potentially over-distend and rupture the balloon.
• DO NOT inject dyes / marking fluids into the pilot balloon. Dyes / marking fluids should only be injected through the injector port on the rear of the handle. DO NOT attach other devices or lines to the pilot balloon.
• DO NOT inject dyes / marking fluids rapidly.
• DO NOT attach other devices or lines other than a luer lock syringe to inject dyes / marking fluid to the injector port.
• The Uterine ElevatOR PRO with OccludOR Balloon™ must be inserted along the direction of the uterine cavity, (anteriorly in an anteverted uterus, posteriorly in a retroverted uterus) to reduce the potential of uterine perforation. Pelvic examination should be performed to determine the direction of the uterus. Sound the uterine cavity to assess the uterine depth. Extra caution should be exercised in the case of a very small uterus.
• DO NOT use the Uterine ElevatOR PRO with OccludOR Balloon™ as a uterine sound.
• Ensure cervical cup selected is not undersized. Undersized cup may cause misplacement of cervical cup around cervical os.
• The Uterine ElevatOR PRO with OccludOR Balloon™ is not recommended for use in a large, post-partum uterus as movement of the device may result in uterine wall lacerations and subsequent bleeding.
• Check the pilot balloon frequently to ensure inflation of the intrauterine balloon. If the intrauterine balloon ruptures, the pilot balloon will not feel firm when squeezed. If the intrauterine balloon has ruptured, stop all manipulation immediately. Remove and replace the Uterine ElevatOR PRO with OccludOR Balloon™ with a new unit.
• When in use, the locking assembly must remain locked at all times to ensure the safe positioning of the cervical cup and vaginal cup. If the locking assembly becomes inadvertently open or loose, immediately secure it before proceeding with uterine manipulation.
• ln laparoscopic supracervical hysterectomy, contact between the Uterine ElevatOR PRO with OccludOR Balloon™ and dissecting instruments must be avoided during uterine dissection and excision to reduce the risk of patient injury. Damage to the device and/or intrauterine balloon rupture may also occur.
• lf bending of the Uterine ElevatOR PRO with OccludOR Balloon™ is deemed necessary for use with robotic instruments, all device systems must first be tested prior to use to ensure functionality.
• If the surgeon has used the Uterine ElevatOR PRO with OccludOR Balloon™ and the uterus has not been removed, the surgeon should examine the patient carefully for any indications of uterine perforation and subsequent bleeding and take appropriate clinical steps.
• Device designed for short term use but not for more than 24 hours.
• 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.

WARNINGS: DEVICE REMOVAL

• Failure to separate the vaginal cup from the tissue may result in detachment of the cervical cup and/or patient injury (Section C, Step 3).
• Prior to device removal, ensure the locking assembly (4, Figure 1) is unscrewed via the thumbscrew (5, Figure 1) and swipe finger around the edge of the vaginal cup to separate the tissue from the vaginal cup to prevent tissue damage.
• To avoid traumatizing the vaginal canal and/or component, DO NOT use excessive force upon device removal.
• Vaginal delivery of a large uterus may result in patient injury. Methods to reduce the size of the uterus prior to removal through the vaginal canal should be considered.

INSTRUCTIONS FOR USE

Read and become familiar with all instructions and cautions before using this device.
A) Size Selection

1.  Under direct visualization, examine the patient’s cervix to determine the diameter of the cervix.
2. Choose a Uterine ElevatOR PRO with OccludOR Balloon™which has a cervical cup (2, Figure 1) that most closely approximates size of cervix (Figure 2).
3. Ensure the cup size selected is larger than the cervix. This places the vaginal fornices on stretch, allowing the cervix to be contained within the internal diameter of the cup, thus preventing the unintended inclusion of structures such as the ureters in the dissection plane during uterine division and/or colpotomy.

B) Insertion into the Uterine Cavity

1.  Remove the Uterine ElevatOR PRO with OccludOR Balloon™ from its sterile packaging and inspect for damage caused by shipping. Discard if any damage is noted.
2. Prior to insertion, test the integrity of the intrauterine balloon by drawing 7-10cc of air into a standard luer slip syringe and insert into the Inflation Valve at the end of the pilot balloon (7, Figure 1). Inject air to confirm balloon remains inflated. DO NOT use if intrauterine balloon does not remain inflated. Discard and use another Uterine ElevatOR PRO with OccludOR Balloon™ unit. After the successful balloon test, deflate the balloon by removing all air with the syringe and remove syringe.
3.  The patient should be placed in the lithotomy dorsal position.
4. With the cervix under direct visualization, the surgeon should grasp the anterior cervical lip with an appropriate clamp or similar toothed instrument.
5.  If necessary, sound the uterus to determine approximate depth. The graduations are provided as guide for comparison to a graduated uterine sound.
6. lf required, dilate the cervix to accommodate the 5mm (0.2in) diameter of the Uterine ElevatOR PRO with OccludOR Balloon™ shaft.
7. lf suturing of the cervical cup is desired, sutures should be placed prior to the insertion of the Uterine ElevatOR PRO with OccludOR Balloon™.
8. Lubricate the tip and intrauterine balloon (1, Figure 1) with a sterile surgical lubricant.
9.  Carefully insert the proximal tip of the Uterine ElevatOR PRO with OccludOR Balloon™ through the cervical os until the balloon is in the desired position within the uterine cavity. lf the uterus is retroverted, rotate the Uterine ElevatOR PRO with OccludOR Balloon™ 180° prior to inserting the intrauterine balloon. Once inserted, rotate the Uterine ElevatOR PRO with OccludOR Balloon™ 180° to antevert the uterus.
10.  Remove the clamp from the cervix.
11. Using the handle (7, Figure 1), stabilize the external end of Uterine ElevatOR PRO with OccludOR Balloon™ to prevent inadvertent displacement or forward movement of the Uterine ElevatOR PRO with OccludOR Balloon™ until positioned.
12. Reattach the syringe to the pilot balloon (7, Figure 1) and inflate the intrauterine balloon with air until you feel resistance or 10cc of air has been injected, whichever comes first. DO NOT exceed 10cc of air. Carefully remove syringe to close valve and prevent inadvertent deflation of the balloon due to backward pressure (Figure 4).

C) Positioning the Cervical / Vaginal Cup

1. Move the cervical cup (2, Figure 1) along the Uterine ElevatOR PRO with OccludOR Balloonâ„¢ shaft until the outer edge surrounds the vaginal fornix. Ensure proper placement of the cervical cup before proceeding. lf suturing the cervical cup in place, thread suture through suture holes in cervical cup prior to positioning Once cervical cup has been placed appropriately, the suture can be tied off.
2. Slide the vaginal cup (3, Figure 1) along the Uterine ElevatOR PRO with OccludOR Balloonâ„¢ shaft until it meets the back side of the cervical cup and is completely seated against the vaginal walls to ensure maintenance of pneumoperitoneum as required.
3.  Move locking assembly (4, Figure 1) down to vaginal cup (3, Figure 1) and secure in place by turning the thumbscrew (5, Figure 1) clockwise until tight. DO NOT overtighten the thumbscrew.
4. To ensure that the intrauterine balloon has not ruptured during insertion, check the tautness of the pilot balloon.
5. Apply gentle traction to the Uterine ElevatOR PRO with OccludOR Balloon™shaft to ensure that device is secured and engaged to the uterus.

D) OccludOR™ Balloon

1. Test inflate the OccludORâ„¢ Balloon (Figure 5 and 6) 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.
2. Prior to making colpotomy incisions, inflate the OccludORâ„¢ 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.

E) Removal and Disposal of Uterine ElevatOR PRO with OccludOR Balloon™

1. Reattach an empty syringe to the Inflation valve at the end of the pilot balloon (7, Figure 1); fully withdraw the air from the intrauterine balloon to deflate.
2.  Unlock the locking assembly (4, Figure 1) by turning the thumbscrew (5, Figure 1) anti-clockwise and slide back towards the handle (6, Figure 1).
3. Separate the tissue from the vaginal cup using finger.
4. Fully retract the vaginal cup (3, Figure 1) to the handle (6, Figure 1).
5. Carefully remove the device from the vagina. DO NOT use excessive force to avoid traumatizing the vaginal canal.
6.  Before disposing of the Uterine ElevatOR PRO with OccludOR Balloon™, visually inspect the device to check it is intact and all components have been retrieved.
7.  Upon completion of the procedure, the Uterine ElevatOR PRO with OccludOR Balloon™ should be discarded in biohazardous waste as per standard procedure.

Intrauterine Injections

The Uterine ElevatOR PRO with OccludOR Balloon™ has a channel for injection of appropriate dyes or marking materials. Remove the cap and insert a luer lock syringe in the dye injection port at the rear of the handle. Use slow and steady pressure for injection of prescribed fluids. 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.

1. Intrauterine Balloon
2. Cervical Cup
3. Vaginal Cup
4. Locking Assembly
5. Thumbscrew
6. Handle
7. Inflation Valve with Balloon

References

• Minimally Invasive Surgery - Non-Invasive Surgical Instruments - Symmetry Surgical®

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