Asurys™ Fluid Management System

The Asurys Fluid Management System is intended for use in conjunction with an endoscope to provide irrigation and distention within endourological procedures.

Not for use with blood products or for intravenous fluid delivery.

Use of this device for distention is contraindicated whenever endoscopy for endourological procedures is contraindicated. See the Operation Manual of your endoscope for absolute and relative contraindications.

• Keep magnetically susceptible medical devices such as cochlear implants, neurostimulators, stents, and shunts more than 15 cm (6 in) away from the Console.
• The ILP measurements which are shown on the Asurys Fluid Management System screen are measured by LithoVue Elite; refer to the LithoVue Elite Single-Use Digital Flexible Ureteroscope Instructions for Use and the StoneSmart Connect Console User’s Manual for information on use and troubleshooting of the pressure monitoring feature.
• When considering pressure readings, exercise clinical judgment, as the clinical implication of intraluminal/intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors. The current recommendation discussed in the literature is to maintain ILP as low as possible while maintaining good visibility to prevent complications such as pyelovenous backflow and sepsis. Physicians are encouraged to continuously consult current literature for up-to-date practices.
• When the intraluminal pressure setting for the procedure is exceeded, before continuing to irrigate, exercise clinical judgment, as the clinical implication of intraluminal/intrarenal pressure measurements may vary depending upon a variety of patient and procedural factors.
• Do not rely on the pressure readings if the LithoVue Elite pressure sensor is obstructed (e.g., tissue, biomass, debris, stone) since this may result in inaccurate pressure readings. Doing so may result in excessive or inadequate fluid/pressure being delivered to the patient and may cause patient injury including, but not limited to, over-distention, edema, embolism, heart failure, infection, inflammation, renal failure, or tissue damage.
• Not following the instructions on the graphical user interface (GUI) may lead to inaccurate pressure readings which may lead to excessive fluid and/or pressure being delivered to the patient and may result in patient injury including, but not limited to, over-distention, edema, embolism, heart failure, infection, inflammation, renal failure, or tissue damage.
• Do not use manual flow control (stopcock or clamp) in LITHOVUE ELITE Mode with pressure sensing. ClariSee Flow Compensation will be activated.
• To reduce the risk of overshoots, increase pressure/flow slowly and monitor the ILP and fluid flow during increases. When turning flow on or abruptly increasing flow in LITHOVUE ELITE Mode, the Asurys Fluid Management System may initially overshoot both the ILP limiter setpoint and the steady-state flow rate while the system equilibrates. Such overshoots have been observed regardless of ureteral access sheath size used. Overshoots in pressure or flow rate may result in the over-distention of the urethra, bladder, ureter, or kidney; pyelovenous, pyelosinus, pyelolymphatic, or pyelotubular reflux which could result in urosepsis or sepsis; renal injury (tissue damage); extravasation; or perforation.

• When using the Asurys Fluid Management System in LITHOVUE ELITE Mode, only use tools that are 1.9 Fr or smaller. Larger tools have not been tested, and their use may not provide optimal performance or ease of use of the LITHOVUE ELITE Mode.

Possible complications of endourological procedures requiring intraoperative irrigation, including those procedures in which the Asurys Fluid Management System is used, include, but are not limited to:

• Allergic reaction
• Arrhythmia
• Avulsion
• Burn
• Discomfort
• Dysuria
• Excess/over-distention
• Edema
• Electric shock
• Electrolyte imbalance
• Embolism
• Extravasation
• Heart failure
• Hematoma
• Hematuria
• Hemorrhage
• Hypothermia
• Hypotension
• Incontinence
• Infection
• Inflammation
• Laceration
• Multiple organ failure
• Pain
• Perforation
• Pleural effusion
• Renal insufficiency/failure
• Respiratory distress/insufficiency
• Respiratory failure
• Sepsis
• Tissue damage
• Unretrieved device fragment