UreSil TRU-CLOSE Suction Drainage System is designed to be a completely closed system for abscesses and other fluid drainage.

Features

• A closed system design reduces the chances of cross-contamination.
• A compact and self-contained system allows full patient ambulation.
• The anti-reflux valve prevents liquids and air from backing into the catheter or wound drain.
• During activation, body fluids are not aerosolized because all fluids are contained in the system.
• All TCS bags come with a standard luer lock connector to fit all luer-locking drainage catheters.
• If the bellows fill, flow to the bag continues via gravity drainage as long as the bag is below the level of the drainage site.

INTENDED USE: For collecting drainage fluids. The Suction Drainage Bags are intended to be used to collect fluids drained from abscesses, the hepatic system, and the kidneys and can also be used for postoperative wound drainage. This product is intended for short-term use (less than 30 days). Replace the bag every 5 to 7 days or sooner if clinically indicated, for example, if malodorous or damaged.

INTENDED PATIENT POPULATION: This product is intended to be used with patients with placed drainage catheters or wound drains.

INTENDED USERS: This product is intended only for use as directed by a trained clinician. A nurse, caregiver, or patient may drain the fluids using the provided empty port (if present) and compress the suction bellows to continue suction drainage as directed by a trained clinician.

Patient and Nursing Information

• To adjust the tubing length, remove the tube from the top of the housing or pull off the luer lock connector and cut the tube with scissors to the desired length.
• Attach the bag to the drainage catheter or wound drain.
• To ensure continuous flow, attach the bag to the patient gown or bedding below the level of the drainage site.
• If the bag comes with an empty port, twist it closed.
• To activate the system, compress the bellows completely. Do not try to pump the bellows; it will fill as it draws fluid from the drainage site. If the bellows are not re-activated after filling, the system will convert to gravity drainage thus preventing fluid backup.
• To re-activate the system, compress the bellows. The fluid in the bellows will be discharged into the bag and the suction will be reestablished.
• The bag is strong enough to withstand a build up of air pressure within the bag. The bag is equipped with hydrophobic filter vents, which will vent collected air. Air can be manually forced out of the bag by gently squeezing the bag while the system is positioned vertically (housing above the bag).
• Although the graduation marks on the bag are approximations only, approximate volumes collected can be recorded on the white “write-on” area on the bag. When recording these approximations, first empty bellows contents into the bag.

UreSil and TRU-CLOSE are registered trademarks of UreSil, LLC.

CLINICAL BENEFITS: The Suction Drainage Bags are available in a variety of sizes and configurations. They can attach to any standard luer locking drainage catheter and can remove fluids using active suction or gravity. Additional clinical benefits:

• Simple and intuitive to operate.
• A compact and self-contained system allows full patient ambulation.
• During activation, body fluids are not aerosolized because all fluids are contained in the system.
• A closed system design reduces the chances of cross-contamination.
• An anti-reflux valve prevents liquids and air from backing up into the catheter.
• If the bellows fill, flow to the bag continues via gravity drainage as long as the bag is below the level of the drainage site.

PERFORMANCE CHARACTERISTIC: The Suction Drainage Bags are comprised of an inlet tube with a luer lock fitting for connection to a standard luer lock drainage catheter, internal anti-reflux valve, hydrophobic filter vents, suction bellows, and a Velcro belt system. Some versions of the bags have empty ports. Activation of the bellows initiates the suction drainage feature. Repeated activation of the bellows re-initiates the suction cycle. If the bellows fill, flow to the bag continues via gravity drainage as long as the bag is below the level of the drainage site. The bag is strong enough to withstand a buildup of air pressure within the bag. The bag is equipped with hydrophobic filter vents, which will vent collected air. Air can be manually forced out of the bag by gently squeezing the bag while the system is positioned vertically (housing above the bag).

Bags without empty ports only: Do not attempt to empty the bag during use. The bag can be emptied before disposal if desired by cutting off the bottom corner of the bag.

CONTRAINDICATIONS: Currently no specific contraindications are known for the Suction Drainage Bags.

WARNING: The reuse of this single-use device can lead to patient infection and/or device malfunction. Sterile if the package is unopened and undamaged. Do not use if the sterile package is damaged or is unintentionally opened before use.

SAFE DISPOSAL: Dispose of the used device in a container marked for biohazard (i.e. contaminated with potentially infectious substances of human origin).