THE O R COMPANY DUMI-350A DUMI ManipulatOR Diagnostic Uterine ManipulatOR Injector Instruction Manual

: June 9, 2024
: THE O R COMPANY

Table of Contents

INDICATIONS FOR USE / CLINICAL BENEFITS
CONTRAINDICATIONS
INSTRUCTIONS FOR USE
References
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THE O R COMPANY DUMI-350A DUMI ManipulatOR Diagnostic Uterine ManipulatOR Injector Instruction Manual

INDICATIONS FOR USE / CLINICAL BENEFITS

The DUMI ManipulatOR™ is indicated for manipulation of the uterus, and injection of fluids during diagnostic laparoscopy, mini laparotomy, fertility exams, and salpingoplastic procedures. The curved shaft of adjustable length allows for atraumatic insertion and manipulation of both retroverted and anteverted uterus

CONTRAINDICATIONS

Device should not be used in:

Patients with 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 (IVF)
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 / WARNINGS

All users must read and be familiar with all the instructions, warnings, contraindications, and precautions in this package insert before using the
device.

Device is designed 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.
ONLY luer slip syringes must be used in conjunction with the air inflation valve and ONLY luer lock syringes must be used in conjunction with the dye injection port.
DO NOT use the DUMI ManipulatOR™ as a uterine sound.
Caution should be exercised in patients with cervical or uterine pathology.
Before insertion, test the intrauterine balloon (A) for proper inflation and function by inflating and deflating the intrauterine balloon with air.
Before insertion, lubricate the distal catheter tip (C) and intrauterine balloon (A).
Before insertion, determine the necessity of dilating the cervix to avoid tearing the inflatable 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.
After insertion and inflation, ensure the balloon is properly inflated. (Squeeze pilot balloon (B) and check its tautness.)
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 Luer Lock Adapter (F).
DO NOT attach other devices or lines to the pilot balloon.
DO NOT insert or remove the DUMI ManipulatOR™ with intrauterine balloon inflated.
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.
deflated balloon may cause injury and trauma to the uterus. If the intrauterine balloon has ruptured, stop all manipulation immediately. Remove and replace the DUMI ManipulatOR™ with a new unit.

WARNINGS: GENERAL

Only physicians may order the DUMI ManipulatOR™. This device should be used only by surgeons trained in proper techniques for intrauterine surgery, laparoscopic surgery, diagnostic procedures, gynaecological pelvic anatomy, and placement of intrauterine retracting instruments.

To avoid potential injury to the uterine wall or inadvertent expulsion of the device from the uterus during the procedure, ensure the intrauterine balloon is inflated prior to manipulation.
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 attach other devices or lines other than the syringe to inject dyes / marking fluid to the injector port.
The DUMI ManipulatOR™ 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.
The DUMI ManipulatOR™ 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.
ln laparoscopic supracervical hysterectomy , contact between the DUMI ManipulatOR™ 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.
DO NOT bend the DUMI ManipulatOR™.
If the surgeon has used the DUMI ManipulatOR™ 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.
The safety and effectiveness of the DUMI ManipulatOR™ has not been demonstrated in the settings of uterine bleeding and during adverse reactions such as cramping, or infection.
Device designed for short term use but not for more than 24 hours.

WARNINGS: DEVICE REMOVAL

To avoid traumatizing the vaginal canal and/or component detachment when removing the DUMI ManipulatOR™ from patient, DO NOT use excessive force upon device removal.
Following removal of the DUMI ManipulatOR™ from patient, conduct visual inspection of the DUMI ManipulatOR™ to ensure that the device is completely intact.

INSTRUCTIONS FOR USE

1. Verify that the sterile pouch has not been opened or damaged.
Prior to insertion, test the function and integrity of the intrauterine balloon (A) by drawing 6-7cc of air into a standard luer slip syringe and insert into the Inflation Valve at the end of the pilot balloon (B). Inject air to confirm balloon remains inflated. DO NOT use if intrauterine balloon does not remain inflated. Discard and use another DUMI ManipulatOR™ unit.
After the successful balloon test, deflate the balloon by removing all air with the syringe and remove syringe.
Sound the uterus for depth and direction prior to device insertion. Set the insertion length on the DUMI ManipulatOR™ accordingly using the spring-loaded locking mechanism on the handle. The direction of handle movement along the catheter is indicated on the handle. Graduation marks (centimeter) are located on the catheter for guidance.
Determine if the cervix requires dilation. The inflatable balloon may tear if the passage is not wide enough.
Lubricate the distal tip (C) and intrauterine balloon (A) for easy insertion.
Guide the DUMI ManipulatOR™ carefully along the natural axis of the cervix to avoid injury.
Insert the DUMI ManipulatOR™ into the uterus until the face of the cervical stop (C) touches the external cervix. lf the uterus is retroverted, rotate the DUMI ManipulatOR™ 180° prior to inserting the intrauterine balloon. Once inserted, rotate the DUMI ManipulatOR™ 180° to antevert the uterus.
Inflate the balloon slowly with 3 to 10 cc of air until the cervical stop is pulled tightly against the cervix. When detaching the syringe, hold the plunger to prevent the reflux of air back into the syringe.
Pull gently on the DUMI ManipulatOR™ to ensure balloon inflation is adequate. Excessive balloon inflation may cause utero tubal spasm and physiological closure of patent tubes.
To ensure the balloon did not rupture during procedure, check the tautness of the pilot balloon (B). A soft balloon indicates a ruptured or leaking balloon.
To remove the DUMI ManipulatOR™, insert a syringe into the valve and deflate the balloon, then remove the DUMI ManipulatOR™ carefully.
Before disposing of the DUMI ManipulatOR™, visually inspect the device to check it is intact. The device should be discarded in bio-hazardous waste as per standard procedure.
Intrauterine Injections: The DUMI ManipulatOR™ has a channel for injection of appropriate dyes or marking materials. Connect a luer lock syringe to the luer lock adapter (F) 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.

INSTRUCTIONS