THE O R COMPANY UE-POR Uterine PositionOR Diagnostic Uterine Manipulator Instruction Manual

THE O R COMPANY UE-POR Uterine PositionOR Diagnostic Uterine Manipulator

INDICATIONS FOR USE / CLINICAL BENEFITS

The Uterine PositionOR PRO™ is indicated for manipulation of the uterus, and injection of fluids during laparoscopic procedures including laparoscopic supracervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy. 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
• Patients with a short (<4cm) uterine depth
• Patients with early-stage cervical malignancy undergoing a laparoscopic approach

During assisted reproduction technology (ART) procedure related to in vitro fertilization This device is not intended for use as a Laser Backstop.

CAUTIONS / WARNINGS

All users must read and be familiar with all the instructions, warnings, contraindications and precautions in this package insert before using the 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.
• 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
• 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.
• Lubricate the Intrauterine Balloon before insertion.
• Check the need to dilate cervix before insertion of the Uterine PositionOR PRO™. 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.
• As with all intrauterine devices, improper use carries a risk of uterine perforation and subsequent bleeding. The surgeon should examine the patient carefully for any indications of uterine perforation and subsequent bleeding and take appropriate clinical steps.
• DO NOT insert or remove the Uterine PositionOR PRO™ with the intrauterine balloon inflated.
• DO NOT use this device to manipulate when the intrauterine balloon is deflated.
• DO NOT use any liquid to inflate the Intrauterine Balloon (1, Figure 1). Use of fluid could potentially over-distend and rupture the balloon.
• DO NOT inject dyes / marking fluids into the Inflation Valve with Pilot Balloon. Dyes / marking fluids should only be injected through the Cap/Dye Injection port (6, Figure 1) on the rear of the handle. DO NOT attach other devices or lines to the pilot balloon.
• When injecting any liquid media, closely follow the manufacturer’s directions for use accompanying the product.
• Check the Pilot Balloon (7, Figure 1) 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 PositionOR PRO™ with a new unit.
• The Locking Assembly (3, Figure 1) must be locked at all times when using the Uterine PositionOR PRO™ for uterine manipulation.
• In laparoscopic supracervical hysterectomy, contact between Uterine PositionOR PRO™ 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 occur.
• Device designed for short term use but not for more than 24 hours.
• The Uterine PositionOR PRO™ 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 PositionOR PRO™ as a uterine sound.
•  The Uterine PositionOR PRO™ 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.
•  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.

INSTRUCTIONS FOR USE

A. Insertion and Positioning of the Uterine PositionOR PRO™

1. Remove the Uterine PositionOR PRO™ 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 with 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 PositionOR PRO™ 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 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.  If necessary, sound the uterus to determine approximate depth. The graduations are provided as a guide to accommodate the 5mm (0.2in) diameter of the Uterine PositionOR PRO™ shaft.
7. Lubricate the tip and intrauterine balloon (1, Figure 1) with a sterile surgical lubricant.
8. Carefully insert the proximal tip of the Uterine PositionOR PRO™ through the Cervical OS until the balloon is in the desired position within the uterine cavity. If the uterus is retroverted, rotate the
9. Uterine PositionOR PRO™ 180˚ prior to inserting the intrauterine balloon. Once inserted, rotate the Uterine PositionOR PRO™ 180˚ to antevert the uterus.
10. Remove the clamp from the cervix.
11. Using the handle (5, Figure 1), stabilize the external end of the Uterine PositionOR PRO™ to prevent inadvertent displacement or forward movement of the Uterine PositionOR PRO™ 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 the syringe to close valve and prevent inadvertent deflation of the balloon due to backward pressure.

B. Positioning of the Cervical Stop

1. Slide the Cervical Stop (2, Figure 1) along the Uterine PositionOR PRO™ until positioned against the cervix.
2. Move the locking assembly to the Cervical OS Stopper (2, Figure 1) and secure in place by turning the Thumbscrew (4, Figure 1) clockwise until tight. DO NOT overtighten the Thumbscrew.
3. To ensure that the intrauterine balloon has not ruptured during insertion, check the tautness of the pilot balloon.
4. Apply gentle traction to the Uterine PositionOR PRO™ shaft to ensure that device is secured and engaged to the uterus.

C. Removal and disposal of the Uterine PositionOR PRO™

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 by turning the Thumbscrew anti-clockwise and slide back towards the handle.
3. Carefully remove the device from the vagina. DO NOT use excessive force to avoid traumatizing the vaginal canal. Before disposing of the Uterine PositionOR PRO™, visually inspect the device to check it is intact and all components have been retrieved.
4. . Before disposing of the Uterine PositionOR™, visually inspect the device to check it is intact and all components have been retrieved.
5. Upon completion of the procedure, the Uterine PositionOR PRO™ should be discarded in biohazardous waste as per standard procedure.

INTRAUTERINE INJECTIONS

The Uterine PositionOR PRO™ 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 (6, Figure 1) at the rear of the handle. Use slow and steady pressure for injection of prescribed fluids. DO NOT inject dyes/marking fluids rapidly. 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.

References

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

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